No injection treatment has been proven to be effective in wrist osteoarthritis. When conservative measures fail, its management involves invasive surgery. Emergence of biotherapies based on adipose derived stem cells (ADSC) offers promising treatments for chondral degenerative diseases. Microfat (MF) and platelets-rich plasma (PRP) mixture, rich in growth factors and ADSC could be a minimally invasive injectable option in the treatment of wrist osteoarthritis. The aim of this uncontrolled prospective study was to evaluate the safety of a 4 mL autologous MF-PRP intra-articular injection, performed under local anesthesia. The secondary purpose was to describe the clinical and MRI results at 12 months of follow-up. Patients’ data collected were: occurrence of adverse effects, Visual analog scale (VAS), Disabilities of the Arm, Shoulder and Hand score (DASH) and Patient-Rated Wrist Evaluation (PRWE) scores, wrist strength, wrist range of motion and 5-level satisfaction scale. No serious adverse event was recorded. A statistically significant decrease in pain, DASH, PRWE and force was observed at each follow-up. Our preliminary results suggest that intra-articular autologous MF and PRP injection may be a new therapeutic strategy for wrist osteoarthritis resistant to medical symptomatic treatment prior to surgical interventions. Wrist osteoarthritis (OA) is a progressive non-inflammatory joint disease involving radiocarpal and/or midcarpal cartilages. It is one of the most common afflictions encountered by hand surgeons. Although it can be well tolerated for years, it leads to long-term severe functional impairments including pain and loss of strength and motion. Wrist OA is usually secondary to post-traumatic sequelae with two main etiologies: malunions of the distal radial articular surface due to intra-articular fractures, and disturbance of carpus biomechanics due to peri-scaphoid lesions . Rarely, wrist OA is due to idiopathic causes like carpal avascular necrosis (Kienböck’s or Preiser’s disease) or congenital wrist abnormalities (Madelung’s deformity) ,2,3,4. CThere is a real therapeutic gap between conservative treatments and invasive surgeries in the treatment of wrist OA. Finding a minimally invasive therapy that would delay the need for surgical treatment is a challenge in the management of this condition. Biological injectable options and cell therapy have recently emerged in treatment of chondral degenerative diseases with promising results. Among them, Platelet-Rich-Plasma (PRP), defined as an autologous plasma suspension of platelets, is used in reparative and regenerative processes due to the high concentration of growth factors contained in platelets ,15,16. PThe combination of autologous microfat and PRP (MF-PRP), respectively rich in multipotent stem cells and growth factors, aims to create an optimal environment for cartilage cell regeneration. This regenerative product has been previously described in racehorses with good results associated with efficacy as assessed by significant reduction in lameness and an early return to competition . Given tOur hypothesis is that standardized intra-articular injection of this innovative treatment (Autologous MF-PRP) could relieve pain and improve function in patients with wrist OA resistive to previous well-conducted conservative treatment. The aim of this study was to assess feasibility and safety of autologous MF-PRP intra-articular injection in the treatment of wrist OA in these patients. The secondary purpose was to provide preliminary clinical results and Magnetic Resonance Imaging (MRI) findings after a 12 months follow-up.A single site uncontrolled feasibility trial of phase I–IIa ran from June 2017 to February 2019 and was performed in collaboration between the Hand and Limb Reconstructive Surgery department of La Timone University Hospital, the Plastic and Reconstructive Surgery Department of La Conception University Hospital, and the Cell Therapy Department of La Conception University Hospital. After a first screening, the suitability of patients for inclusion was assessed by a hand surgeon, according to the inclusion and exclusion criteria presented in The procedure consisted of two consecutive surgical steps performed under local anesthesia in an operation theatre and the preparation of the experimental products performed in the cell therapy department. The first surgical step consisted of MF and blood harvesting and the second step correspond to the reinjection of the autologous MF-PRP product inside the wrist. The entire procedure was carried out over half a day in an outpatient setting.® (10 mg/mL) with adrenaline (0.005 mg/mL). 50 mg of adipose tissue were harvested using a Hapifat® kit . A St’rim cannula  was both connected to a 10 mL syringe and a purification Puregraft 50® bag through a Fat Lock System® . 18 mL of blood was collected by venipuncture using a 21-gauge needle filling one 20-mL syringe containing 2 mL of Anticoagulant Citrate Dextrose Solution, Solution A (ACD-A) . The harvesting of adipose tissue was performed on the inner side of the knees after infiltration with a local anesthetic solution composed of 140 mL of injectable serum and 60 mL of xylocaine System® . Both prThe blood was transferred into the Hy-tissue 20 PRP device  before centrifugation using the Omnigrafter 3.0  and PRP Large Volume Cycle (3200 rpm for 10 min). All plasma was recovered using a 10 mL syringe through the Push-out system. 300 µL of whole blood and PRP preparation were sampled to determine platelet, leukocyte and RBC concentrations.The harvested adipose tissue was purified twice using a 1:1 rinsing with saline solution  allowingFinal experimental products were packaged in two 5 mL syringes, each containing 2 mL of PRP and purified MF. These 2 syringes were connected to each other by a 3-way valve in closed position.Cell count: whole blood and each PRP preparation were sampled to determine platelets, leukocytes and red blood cells counts using automated hematology blood cell analyzers Sysmex XN-10  in accordance with recently published guidelines .Microbiological assay: 250 µL of PRP or MF were sampled in Bactec culture bottles . The Bactec method  uses a computer-controlled incubation/detection system. The media used contained proprietary factors designed to inactivate a wide variety of antibacterial and antifungal agents. Bactec culture bottles were incubated at 37 °C for a total of 10 days, and automated readings were taken every 10 min. Detection of organisms resulted in an audible alarm and automatic recording at detection.2 to allow contact with collagen. After this incubation, 500 μL of non-supplemented Dulbecco’s Modified Eagle Medium (DMEM)  was added to the mixture and incubated for 24 h at 37 °C with 5% CO2. After 24 h the samples were centrifuged  at 1500 rpm for 5 min to remove MF, and samples were stored at −80 °C until used for analysis. A combination of 12 cytokines and growth factors classified as inflammatory , anti-inflammatory  and regenerative  were measured using a Magpix instrument  allowing simultaneous measurement of the different analytes in small sample volume.Mixed products Growth Factors Release Measurement. 500 μL of MF and PRP were mixed and then placed in a 48-well collagen coated plate  and incubated for 30 min at 37 °C with 5% CO® (10 mg/mL) without adrenaline at the dorsal side of the wrist, 4 mL of MF-PRP was injected with a 16-gauge needle into the radiocarpal joint near the scapholunate ligament. The injection site was located 10 mm distal and 5 mm ulnar to the radial tubercle. The exact location of the needle was verified under fluoroscopic guidance . Pain according to the Visual Analog Scale (VAS) was also recorded during intra-articular injection. An analgesic immobilisation procedure with a specific cast providing compression, stabilization and cryotherapy  was immediately put in place for 7 days. Patients went home with instructions to limit the overuse of the wrist and to use paracetamol or ice on the injected area to relieve pain if necessary. Non-steroidal anti-inflammatory drugs were prohibited for 7 days following the injection. During the follow-up, no treatment restriction was applied and, thereafter, a gradual return to normal sporting or recreational activities was tolerated.The two 5 mL syringes were connected and mixed by gently shaking back and forth ten times to obtain a final homogeneously mixed product of 4 mL. After 4 steps of skin decontamination and local anesthesia with xylocainePatients were prospectively assessed at baseline and at 7 days and 1, 3, 6 and 12 months after injection. The primary endpoint was the safety of the treatment evaluated by the occurrence of adverse events up to one month after injection. Secondary clinical endpoints were assessed at 3, 6 and 12 months and included subjective pain rating by a VAS (0–100 mm), functional evaluation utilising the Disabilities of the Arm, Shoulder and Hand score (DASH) and the Patient-Rated Wrist Evaluation (PRWE), objective wrist strength measured by the Jamar hydraulic Hand dynamometer (average score of 3 consecutive measurements), objective wrist range of motion measured using a goniometer and patient’s satisfaction rated on a 5-level scale: Very dissatisfied, Dissatisfied, Neutral, Satisfied and Very satisfied.3), a 2D fat saturated TSE sequence  and a 3D VIBE sequence .MRI examination was performed on a Verio 3 T Siemens MRI scanner  with an 8-channel transmitter/receiver flexible coil wrapped around the wrist. Patients were in the supine position with the hand attached to a plastic support located a few centimetres above the abdominal wall. The carpal bone region was scanned coronally using a 2D T1 TSE sequence  MRI were anonymized and randomized. The 3D sequences after reformatting in the same section were read in a blinded way by a senior radiologist specialized in osteoarticular imaging. Two parameters were studied between pre and post MRIs: the structural modification of the cartilage of the joint by analysing change in the thickness of the radioscaphoid space in the presence of oedema. The radioscaphoid space was measured between the line joining the subchondral bone plate of the scaphoid to the radius  facing sector II and III of the scaphoid . Both paThe degree of confidence of the radiologist was scored between 0 and 2 using a Likert scale .The sample size was fixed at 12 patients without formal calculation (no available data) based on typical sample sizes in early evaluation of a new biological and cell therapy.p = 0.5) was performed. Longitudinal changes on the DASH of 10.83 points and on the PRWE of 11.5 points represent the MCID [Quantitative variables are described as mean ± standard deviation (SD) with median [minimum–maximum] in the MCID ,34. The Twelve patients (8 men and 4 women) aged of 53.8 ± 14.8 years were included in the study and followed until 12 months. They had wrist OA of grade 3 or 4 according to Kellgren and Lawrence classification with a mean duration of disease of 6.6 ± 9.1 years since diagnosis. The wrist OA was due to SLAC (n = 4), SNAC (n = 4) and radius malunions (n = 4). The radiocarpal joint only was affected in 8 cases, while both radial and mid-carpal joints were involved in 4 cases. The dominant hand was affected in 7 patients. The baseline characteristics of the patients are presented in No serious adverse event was recorded. The main side-effect was pain at the harvesting adipose tissue sites with a mean VAS value of 28.3 ± 15.9 (0–50) seven days after injection. This pain was relieved by grade 1 analgesics and completely resolved after one month follow-up. Half of the patients reported no pain or mild pain (VAS less than 3) during intra articular injection. Two patients reported moderate pain (VAS from 3 to 6) and four patients reported pain greater than 6. In all cases, the pain disappeared completely within one minute after the injection and all patients were able to resume their regular activities one week after the injection. Bacteriological contamination of the MF was reported in two batches. The bacterial species found in both samples were Staphylococcus epidermidis in one and propionibacterium acnes in the other. No clinical symptoms were observed but both patients were treated with antibiotics for 10 days as a precaution.A statistically significant improvement in pain according VAS was observed at each follow-up  with a mQualitative MRI analysis of cartilage structural changes at 12 months showed improvement in 3 patients (25%) with a Likert confidence scale of 1 (n = 2) and 0 (n = 1). No change was noted in 6 patients (50%) with Likert confidence scale of 2 (n = 1), 1 (n = 2) and 0 (n = 3) while possible impairment was observed in 3 patients (25%) with uncertainty for all patients. Regarding the variation in oedema, the radiologist confidence level was higher : 3 (25%) patients were improved, 7 (58 %) showed no difference while 2 (17%) patients were impaired. The aim of this study was to evaluate the feasibility and the safety of intra articular injection MF-PRP in treatment of wrist OA. The only side effect reported in our cohort was pain at the harvesting adipose sites which was relieved with grade 1 analgesics and completely resolved after 1 month. This adverse event is commonly observed after any liposuction and also reported in other similar studies ,37,38,39Pain and swelling are common after injection in the knee but rather rare in carpo-metacarpal injection . DelayedA bacteriological contamination of MF was identified in two cases without clinical consequence. As a precaution, we treated these patients with antibiotics after medical advice from infectious disease specialists. Although this aspect raises concerns about patient safety, this type of contamination has been previously described by Louis et al. also using MF (4/30 products) and Garza et al. using SVF (2/26 products) ,53. None® bag membrane required to remove oily substances and blood residues [Many regenerative therapies, based on bone marrow or adipose tissue-derived multipotent stem cells capable of differentiating into cartilage cells have been evaluated for the treatment of OA. Adipose tissue is considered a valuable source of multipotent stem cells with up to 40 times the concentration of bone marrow . The mosresidues . Althougresidues ,57,58,59Regarding the efficacy of autologous unfractionated adipose tissue for pain relief, several authors have reported injections in OA of the thumb carpometacarpal joint, but this has never been performed in wrist OA. In 2017, Herold et al. were the first to study autologous unfractionated adipose tissue obtained by liposuction and centrifugation in the treatment of carpometacarpal OA of the thumb . The meaNone of the studies mentioned prior used combined adipose tissue with PRP. The use of MF-PRP should improve clinical outcomes as it has been reported that PRP increases MSC proliferation and chondrogenic differentiation in vitro ,63,64,65Wrist denervation is classically one of the first surgical option offered for severe and persistent wrist OA. It is the only surgical procedure that preserves the joint anatomy and mobility of the wrist. Although this surgical procedure has shown globally encouraging results in chronic wrist OA, results are heterogeneous regarding different parameters such as improvement in mean pain scores (36–92%), or increase in grip strength (7–64%) and failure rate  . In our The major limitation of our study is the absence of a placebo group, which is a significant weakness given the considerable placebo effect in OA care . Indeed,Moreover, no data is available to clearly explain the mechanism of action of MF-PRP in OA although the main hypothesis is linked to anti-inflammatory properties as well as regenerative capacity likely due to the ADSCs kept intact into MF and growth factors contained in the PRP.MF-PRP injection in wrist OA is a safe procedure and provides significant clinical benefit on function and pain relief for up to 12 months. Larger and placebo-controlled studies are required to confirm whether these new strategies can improve pain relief and wrist function and induce significant and measurable structural benefit, ultimately delaying and avoiding the need for a major surgical procedure.


Children undergoing tonsillectomy have severe pain in the postoperative period. One of the pharmacological options for analgesia is opioids, such as morphine. However, the risks of adverse effects, such as increased recovery time from anesthesia and respiratory depression, can limit its use.To evaluate the use of intraoperative intravenous morphine to reduce immediate postoperative pain in children undergoing tonsillectomy.In this double-blind randomized study, children aged 3–10 years were submitted to tonsillectomy, with or without adenoidectomy, and divided into two groups. Children in group M received 0.1 mg/kg of intravenous morphine during anesthetic induction, while those in the control group received conventional anesthesia without morphine. Postoperative pain perceptions were assessed at 30, 60, 120, 180 and 240 min after recovery from anesthesia, by the children themselves and also by their parents or guardians, using a facial pain scale.p =  0.023), while according to their parents/guardians, the pain was less intense in the evaluations performed at 30 (p =  0.002), 60 (p =  0.006) and 180 min (p =  0.007) after awakening. Moreover, postoperative analgesics were less requested by children in the morphine group. No observed side effects were associated with the use of morphine.A total of 57 children were included, 30 in the group with morphine and 27 in the group without morphine. According to the children themselves, the postoperative pain was less at the evaluations performed at 30 min after awakening from anesthesia (A single dose of intravenous morphine during anesthetic induction reduced the intensity of immediate postoperative pain in children undergoing tonsillectomy, without increasing the time of awakening from anesthesia and with lower consumption of rescue analgesics. Tonsillectomies are one of the most common procedures performed in children worldwide.Opioids are one of several effective pharmacological treatment options in reducing post-tonsillectomy pain, acting not only as analgesics,Morphine is an opioid with a widely known analgesic potential, being prescribed also for the relief of postoperative pain in pediatrics. However, its associated risks may include increased postoperative anesthetic recovery time, excessive sleepiness, aspiration and hypoxia, especially in pediatric patients with comorbidities such as obesity or severe sleep apnea.10Another challenging aspect of postoperative pain in children can be its measurement, as the pain experienced by them can be often difficult to quantify, especially in patients under five years of age.The aim of this study was to evaluate the efficacy of intraoperative intravenous morphine in reducing postoperative pain in children undergoing tonsillectomy with or without adenoidectomy.This was a blind, randomized and controlled study, approved by the local ethics committee  and registered at REBEC . The study occurred from June 2016 to June 2019, and included children aged 3–10 years old, classified as American Society of Anesthesiologists (ASA) physical status 1–2, with indication for tonsillectomy, with or without adenoidectomy, for the treatment of respiratory sleep disorder caused by obstruction due to adenoid enlargement, with over 70% obstruction at the nasal videoendoscopy and/or tonsil hypertrophy grades III or IV; or recurrent tonsillitis, defined as 7 confirmed infections in 1 year, or 5 confirmed infections per year for 2 years or still 3 infections a year for 3 years. It was estimated that with 27 patients in each group, the study would have an 80% power to detect clinically important differences between the groups at the faces pain scale (FPS), assuming a large effect size (Cohen’s d = 0.80), with a 5% significance level. The sample size was increased by 10% to compensate for possible losses over the followup period, resulting in a total size of 60 patients, who were randomized to both groups.The children who met the inclusion criteria were treated with a same-day surgery (outpatient) protocol, and during the preanesthetic consultation, these children and their parents or guardians were invited to participate in the research, with minors and adults signing the free and informed consent form. After agreeing to participate, they were shown a validated pain assessment scale using faces , for the purpose of familiarization,The exclusion criteria included comorbidities such as cardiopulmonary dysfunction, cerebral palsy, obesity, chronic use of analgesics, anticonvulsants or neuroleptics, complications related to anesthesia , history of hypersensitivity to anesthetics and need for medications in addition to those described in the protocol.2. All patients were anesthetized by the main investigator and the surgeries were performed by otorhinolaryngology resident physicians. Surgery duration was defined as the period between the first incision and the final hemostasis, the time of anesthesia as the time between the beginning of inhalation anesthesia and the time of extubation, and the time of awakening from anesthesia as the time of sevoflurane withdrawal up to tracheal extubation. A chronometer was used to record all times.The tonsillectomy surgeries were performed using the dissection technique (cold knife surgery) and hemostasis with standard surgical sutures using catgut thread. General anesthesia was used, and the monitoring consisted of pulse oximetry, cardioscopy, non-invasive blood pressure measurement and capnography. Anesthetic induction was carried out with 6%–8% sevoflurane under mask and oxygen with FiO2 of 100%. After the venoclysis was started, intravenous administration of propofol (2 mg/kg) and fentanyl (0.5 µg/kg) was performed, with orotracheal intubation. The patients were then divided into two groups. The randomization list was previously generated through a computer program, with random letters (M for morphine or O for no drugs) placed in and distributed in opaque brown paper envelopes, sealed and sequentially numbered, which were kept secret until the intraoperative moment. Thus, those in group M received 0.10 mg/kg of intravenous morphine during the anesthesia induction period, whereas those in group O did not receive any additional medication. Dimenhydrinate (1.25 mg/kg), ondansetron (0.15 mg/kg), dexamethasone (0.10 mg/kg), dipyrone (30 mg/kg) and ranitidine (1 mg/kg) were also administered intravenously to all patients. The anesthesia was maintained with 2%–4% sevoflurane and 50% FiOAt the end of the procedure, the patients were extubated with intact protective reflexes , spontaneous and effective breathing, crying and movement, and sent to the post-anesthetic recovery room (PACU), where they were continuously monitored for at least four hours by an anesthesiologist different from the one who performed the anesthesia, by the nursing team and also by the child's guardian, all of whom were blinded to the use of morphine. Thus, with the exception of the anesthesiologist who performed the anesthesia and drew the envelope, all other professionals and also the family members were blinded to the study groups. The main objective was pain assessment, which was performed using the SPF scale in the PACU, recording data at 30, 60, 120, 180 and 240 min after the subjects awoke from the anesthesia. The face pain scale (FPS) depicts seven faces, which are shown and scored, from one corresponding to the absence of pain status to the one that reflects the worst possible pain . If according to the FPS scale, the child and also their parents/guardians indicated pain intensity greater than or equal to 2, analgesia was performed by the intravenous administration of 0.5–2 µg/kg of fentanyl and, if necessary, repeated. In these cases, these patients were excluded from the subsequent hourly assessments of pain level, avoiding the influence of this analgesic on the results. Supplemental oxygen was administered through a nasal catheter or oxygen mask if oxygen saturation decreased below 94%. As secondary outcomes, the use of rescue analgesics in the postoperative period and the occurrence of adverse events, such as nausea, vomiting, bleeding, excessive sleepiness, pruritus and respiratory depression, as well as any other unexpected symptoms or events, were recorded. The Aldrete-Kroulik scale was also used for discharge from the PACU.p < 0.05 and statistical analyses were performed using the SAS® software, version 9.4 .The groups were compared regarding age, weight, duration of surgery and awakening time from anesthesia using the Mann-Whitney non-parametric test. Group M was compared to group O to determine any differences in pain perceptions over time, as reported by patients and their parents/guardians. In these comparisons, a mixed model and analysis of variance (ANOVA) of repeated measures was applied. The Kaplan-Meier estimator was used to construct the survival curves between the two groups to estimate the probability of survival of the need to use rescue. The comparisons were made using the log-rank test. The level of significance was set at Sixty children were selected, 30 in group M and 30 in group O, with a mean age of 5.9 ± 2 years, 60% of which were males. Three patients, all belonging to the control group (group O), were excluded from the study : one duep =  0.036) and parents/guardians (p =  0.003) evaluation scores in relation to group M and group O , while all other assessments were similar (p =  0.002), 60 (p =  0.006) and 180 min (p =  0.007) after awakening from the anesthesia , demonstrating that the pain scale behavior over time of followup did not differ between the children's and parents' assessments for any time . As for the adverse effects, only one patient in group O experienced nausea and vomiting, with no reports of other complications.The use of rescue analgesics was different in the groups, with 14 patients (51.85%) in group O who needed rescue analgesia in the postoperative period, on average after 53.57 min and with an average dose of 0.65 mcg/kg of fentanyl, while only one patient (3.33%) in group M required analgesics, at 120 min . A KaplaChildren undergoing tonsillectomy experience significant pain and severe postoperative functional limitations for up to two weeks,To avoid such effects and provide adequate postoperative analgesia, several strategies are used, such as pre-anesthetic medication, active participation of parents during the perioperative period and non-pharmacological and pharmacological measures. Some drugs can increase the risk of postoperative hypoxia, as in the case of opioids such as codeine (CYP2D6 polymorphisms)16According to the results of the present study, intraoperative administration of 0.1 mg/kg of intravenous morphine in children undergoing tonsillectomy reduced the intensity of postoperative pain in the assessment made by the children themselves and also in the assessment of their parents/guardians, being effective in reducing pain after 30 min of awakening from the anesthesia, according to the patients, and after 30, 60 and 180 min, according to the parents/guardians, decreasing the use of rescue analgesic medication in the postoperative period and without prolonging the time of awakening from the general anesthesia in these patients or the adverse effects in the immediate perioperative period. It is important to note that there was still one patient in the group who received morphine who needed rescue analgesics in the postoperative period, indicating that the analgesia may not be adequate in all cases and reiterating the need to implement other alternative options for analgesic treatment.Morphine is a narrow therapeutic index drug, with variations in the analgesic response and side effects, ranging from inadequate pain relief to the extreme of severe adverse results. Much of this inter-individual variability can be explained by single nucleotide polymorphisms in a subset of genes that encode proteins involved in pain mechanisms and opioids. The study of the association between this genotype and the clinical results associated with analgesia and adverse effects could identify, through genetic tests, which patients would benefit from its use,No severe adverse events were observed in the outcome of this clinical trial. Some approaches used may have minimized the onset of these effects, such as the absence of pre-anesthetic medications like benzodiazepines or alpha-2 agonists, such as clonidine. The administration of morphine right after anesthetic induction, providing more time for its circulation and early therapeutic approach of its unwanted clinical effects, such as apnea, as well as the duration of surgery, which lasts on average 43 min, may also have contributed to the absence of these effects, since the surgeries were performed by residents and took longer than if they had been performed by more experienced surgeons. Another factor may have been the absence of children with major comorbidities, such as underweight, obesity or severe sleep apnea, which may lead to an increased risk of postoperative hypoxia.An important aspect of this type of study may be the difficulty with which children clearly demonstrate their pain level and their need for analgesics, since the ability to adequately assess pain usually begins to develop only around at the age of five.Another important aspect is that the FPS scale is not valid to evaluate postoperative pain through parents and caregivers. However, no pain scale was standardized to be used by parents in the immediate postoperative period, up to 4 h, as in this study. Nevertheless, the modified FPS may be equivalent to the PPPM (Parents’ Postoperative Pain Measure), a scale particularly useful for parents to assess pain at home after outpatient surgery, for pain quantification in children after tonsillectomy.Postoperative analgesia should be considered even before the surgical stimulus, starting with the use of pre-anesthetic medications and parental monitoring, going through anesthetic-surgical techniques for a peaceful awakening and culminating with rescue analgesics in the postoperative period. However, the careful approach regarding analgesia in these children can often lead to excessive sedation in the postoperative period, increasing the risk of complications, such as respiratory depression. Some drugs used as pre-anesthetic medication, such as midazolam, clonidine or ketamine, can improve analgesia, but can also potentiate complications. Measures for the prevention and treatment of pain in this type of patient and the safety in the postoperative period, preventing adverse effects, can show a fragile balance, varying between the provided analgesic efficacy and the assured safety. In this study, we chose to avoid excessive sedation after the awakening from the anesthesia, and for this reason we do not use pre-anesthetic medications.Studies with morphine, administered alone or at other doses, associated with other analgesic drugs or even in different age groups, can add more knowledge to those presented by this study.According to the results of this study, morphine administered intravenously and during the intraoperative period in children undergoing tonsillectomy reduces the intensity of immediate postoperative pain, without increasing the time of awakening from anesthesia and with less consumption of rescue analgesics in the postoperative period, without significant adverse effects.The authors declare no conflicts of interest.


Pain is prevalent among patients with cancer who are being treated with radiotherapy. However, the prevalence of pain varies across regions, and pain management is affected by several factors. This cross-sectional study aims to determine the prevalence of pain, assess the adequacy of pain management and identify factors affecting pain in patients undergoing radiotherapy. A total of 94 patients were included in the study. The prevalence of pain was determined through the Brief Pain Inventory tool, while the adequacy of pain management was assessed through the Pain Management Index. Demographic, clinical and treatment-related factors were obtained and analysed for association with the presence of pain and the adequacy of pain management. Of the 94 patients, 59 (62.8%) experienced pain while 35 (47.2%) did not. The mean pain intensity score of patients was 3.6 (standard deviation: 2.3). Most patients (67.8%) experienced mild pain with low pain interference (67.8%) on daily functions. Of the 59 patients who experienced pain, 34 (57.6%) had inadequate pain relief while 25 (42.2%) had adequate pain control. Being admitted at the hospital during radiotherapy was significantly associated with adequate pain relief. Use of analgesic was also significantly associated with pain management, with a higher rate of weak and strong opioid use in those with adequately treated pain. In this single-institution study, the prevalence of pain was high. Pain management was inadequate in more than half of the patients experiencing pain. A disparity in the prescription of analgesics, particularly opioids, was observed. Patients with inadequate pain management were less likely to receive opioids, which likely reflects the presence of several barriers that limit its access to patients. Pain is the most recurrent and debilitating symptom of advanced and metastatic malignancies . In factIn 1986 (revised in 1996), the World Health Organization (WHO) developed the WHO analgesic ladder for pain control in order to decrease the prevalence of inadequate analgesia . The guiAssessing the inadequacy of pain relief is important as it is a predictor of functional impairment . The PaiA large proportion of patients referred to our service for radiotherapy whether in the adjuvant, definitive or palliative setting experience pain. Apart from the pain brought by the disease itself, radiotherapy also contributes to the experience through its various acute and late toxicities. Long waiting time, treatment manipulation and daily treatment are some of the treatment-related factors that may cause further pain to patients. Identifying factors influencing pain will help us in implementing strategies to alleviate the pain of our patients and enhance their quality of life (QOL).The objectives of this study are to determine the prevalence of pain, to assess the adequacy of pain management and to identify factors affecting pain in patients with cancer referred to our service for radiotherapy.This was a cross-sectional, non-interventional, prospective study conducted in a period of 2 days separated by 3 months to ensure no repeated participation from the patients. The study was conducted on 4 April and 19 July 2022 at the Division of Radiation Oncology, University of the Philippines-Philippine General Hospital. All patients treated on 4 April and 19 July who were eligible for the study were included. Patients were eligible for inclusion if they were at least 18 years old, were undergoing radiotherapy regardless of type or stage of disease and were willing to participate in the interview. Patients were excluded if they had any unstable psychiatric or mental condition. After obtaining written informed consent from the patients, demographic, clinical and treatment-related information were gathered on a case record sheet. A total of 94 patients were included. On 4 April 2022, a total of 48 patients were treated in the institution, of which 39 were included. Four paediatric patients were excluded, while five patients did not consent to the study. On 19 July 2022, a total of 72 patients were treated, of which 55 were included. Five paediatric patients were excluded, while seven patients declined to participate and five patients who underwent radiotherapy were missed for inclusion. This yielded a response rate of 77%.Patients were then interviewed using the Brief Pain Inventory (BPI) tool. The BPI tool assesses the severity of pain (BPI pain score) and its impact on the daily functions of patients (BPI pain interference). Rating of pain was from 0 (no pain) to 10 (pain as bad as you can imagine). For the interpretation of scores, the BPI pain score categorisation was 0 for absence of pain, 1 to 4 for mild pain, 5 to 6 for moderate pain and 7 to 10 for severe pain . BPI paiData on the PMI score was then obtained. The PMI score is a simple index that usually indicates how well the reported pain is managed by the prescribed analgesics . CalculaA patient’s analgesic score was calculated according to the type of analgesic the patient is currently taking. A score of 0 was assigned to no analgesic medication, 1 to non-opioids such as NSAIDs or paracetamol, 2 to weak opioids (tramadol or codeine) and 3 to strong opioids . To calculate the PMI score, the pain score was subtracted from the analgesic score. Depending on the values ranging from −3 to 3, pain management was determined to be adequate or inadequate. A negative PMI score corresponded to inadequate pain management while a score of 0 or greater corresponded to adequate pain management.p < 0.05.Demographic, clinical and treatment-related characteristics were summarised through descriptive statistics. Frequency, proportion, mean and standard deviation (SD) were computed wherever appropriate. Data were not assessed to determine distribution. Regression analyses was performed to assess the association, and their statistical significance, of obtained variables with presence or absence of pain and in cases where pain is present, whether pain is adequately or inadequately managed. Statistical significance was set at The protocol was approved by the research ethics board of the University of the Philippines-Manila (UPMREB 2021-0653-01).A total of 94 patients were enrolled in the study. The mean pain intensity score of the patients was 3.6 (SD: 2.3). BPI scores were used to evaluate the severity of pain and the impact of pain on the daily functions of patients. According to the BPI pain score, 40 patients (67.8%) experienced mild pain, 11 patients (18.6%) had moderate pain and 8 patients (13.6%) had severe pain. The BPI pain interference score revealed that 40 patients (67.8%) suffered low pain interference on their daily activities while 19 (32.2%) experienced high pain interference . Table 4Of the 59 patients 62.8%) who experienced pain, 34 (57.6%) had inadequate pain relief while 25 (42.2%) had adequate pain control. The association between the adequacy of pain management with patient and treatment characteristics is listed in 2.8% who In this single institution study, we noted a high prevalence (62.8%) of pain in 94 oncologic patients undergoing radiotherapy. Among these, the majority experienced mild pain (67.8%) with low pain interference (67.8%) on day-to-day personal life. Strikingly, more than half (57.6%) of patients who experienced pain were inadequately managed. Most of the patients with mild pain were not on any analgesic, and strong opioids were prescribed to only a few number of patients.The prevalence of pain in our study population is consistent with that of published data indicating a 59% prevalence of pain in patients undergoing oncologic treatment and a 64% prevalence in patients characterised as advanced or metastatic . In contThe high prevalence of pain and inadequate pain management in our cohort of patients would likely have negative implications in their outcomes. Inadequately treated pain can decrease compliance of patients to radiotherapy which may result to treatment interruptions or deficiencies. Treatment interruptions have been shown to adversely impact outcomes in a number of disease sites –17. MoreThe high prevalence of pain and inadequate pain management in our cohort of patients may have some cultural implications. In an article on Filipino attitudes toward pain medication, Galanti  stated tIn our study, the use of analgesic was significantly associated with adequate pain relief, with a higher rate of weak and strong opioid use in those with adequately treated pain. As the use of opioids occupy two steps of the WHO ladder in pain management, its use or non-use could significantly impact the adequacy of analgesia of our cancer patients. Various local studies have mainly shown that a barrier to an optimal pain control in the Philippines is the infrequent use of these medications. In our study, only four patients were prescribed with strong opioids despite almost a third of patients experiencing moderate to severe pain. In the Philippines, several regularity barriers to accessibility of strong opioids include burdensome procedures relating to prescription, physician prescriber restrictions, requirement for special prescription forms and excessive bureaucratic regulation policies , 21. AltAnother aim of this study was to assess factors related to radiation oncology practice that might influence pain. This has been previously investigated in a radiotherapy unit in France. Their results showed that objective length of waiting time for a session, transportation and mobilisation for a session positioning significantly aggravated the pain of a considerable number of patients . In our It should be noted however that despite the high prevalence of pain and inadequate pain management in our cohort, most of these patients experienced mild pain with low pain interference. Forty (40) patients experienced mild pain and 22 of them were not taking any analgesics.These patients comprise 65% (22 out of 34) of patients with inadequately treated pain. In addition, 28 of patients with inadequately treated pain had a PMI score of −1, whereas 6 patients had a PMI score of −2. The PMI has its own criticisms. A prospective observational study has shown that PMI scores of −1 do not always indicate inadequate pain management. The study revealed that patients with adequate pain management (particularly those with PMI score of 0) have higher pain interference than those with a PMI score of −1 . FurtherFurther studies to characterise the origin of pain of patients , the prescription practice of physicians and the attitudes of patients toward pain and pain medications are recommended. Assessing these variables will aid in formulating strategies to address the high prevalence of pain. A high proportion of pain due to radiation-related toxicities could motivate more regular screening of side effects experienced by patients during treatment as well as more access to healthcare personnel for pain-related concerns. On the other hand, a high proportion of pain due to treatment manipulation can alert the radiotherapy personnel on the implementation of practices that ensure comfort of patients. It is also important to evaluate the knowledge and practice of physicians and oncologists in pain and pain management, including their possession of a special licence for narcotics prescription and their pattern of prescribing analgesics to their patients. As a rigorous process of narcotics license application is one of the identified barriers to optimal cancer pain management, determining the proportion of physicians in the institution who have this license is vital. Collaboration with government agencies to setup satellite hubs in the hospital to guide licence application could be organised. Furthermore, refresher lectures on pain management could be facilitated. Lastly, determining the attitudes of patients towards pain and pain management is vital to addressing the issue. A regular forum or focused group discussion could be assembled to tackle misconceptions on pain and pain medications and to encourage positive health-seeking behaviour. It is also equally important to understand the social factors that play into the attitudes and practices of patients towards pain including financial implications and social support.In this single institution study, the prevalence of pain was high. Pain management was inadequate in more than half of the patients experiencing pain. A disparity in prescription of analgesics, particularly opioids, was observed among those with adequately treated and inadequately treated pain.As undertreatment of cancer-related pain remains a common problem worldwide, it is important to determine factors that hamper provision of optimal care even at an institutional level. This study characterises the pain and the pattern of analgesic use in a small cohort of patients. It highlights the socioeconomic factors, cultural influences and decreased prevalence of opioid use as potential barriers to pain management. Despite the availability of opioids in our national formulary, several barriers exist that limit its access to patients including regulatory restrictions and prohibitive costs. To address these, a collective effort from all stakeholders is imperative. Additionally, it may be beneficial to evaluate the knowledge and practice of physicians regarding pain management and to investigate further the perception and attitudes of patients towards pain medications.The authors declare that they have no conflicts of interest.The authors received no financial support for the research, authorship and/or publication of this article.


Background and objectiveUpper trapezius can cause neck pain, and restrict functional activities and cervical range of motion (ROM), and hence its management should be part of a global rehabilitation program. Owing to the heterogeneity of the existing trials, various techniques of manual physical therapy might be potent, though the scope of their efficacy is currently unspecified. The reciprocal inhibition technique of the muscle energy technique (MET) works on both agonist as well antagonist muscles for the reduction of pain and to improve overall functional activities. The aim of this study was to analyze the effect of the reciprocal inhibition technique of MET on pain, cervical ROM, and functional activities in patients with upper trapezitis.MethodsAn interventional cross-sectional study involving 30 patients with neck pain due to upper trapezitis was conducted. The outcome measures were as follows: numerical pain rating scale (NPRS) score for pain intensity, universal goniometer for cervical ROM, and neck disability index (NDI) score for functional activities. The reciprocal inhibition technique involved a five-second hold, five-second rest, followed by stretching with a 10-60-second hold, with five repetitions. Patients were treated for five sessions a week for two weeks.ResultsPaired t-test was used to compare the group's mean values before and after therapy. Our findings revealed that NPRS score, cervical ROM, and NDI score notably improved (p=0.001).ConclusionThe reciprocal inhibition technique of MET in patients with upper trapezitis showed significant improvement in neck pain, cervical movement, and functional activities. Further studies with larger sample sizes are warranted to validate our findings. The most extensive type of pain in non-traumatic musculoskeletal conditions is neck pain, with a frequency of about 75.7% ,2. It haSeveral different therapy procedures can be used to treat upper trapezitis, but there is no consensus among the experts on the best course of action. The muscle energy technique (MET) is a type of manual physical therapy where the patient applies muscle contraction against the resistance provided by the therapist in a precisely controlled position and direction ,11. IndiThe reciprocal inhibition approach has the benefit of being safe and effective in acutely or chronically tight and painful muscles that make controlled contraction of the affected muscles challenging . In suchStudy design and settingThis study was conducted in the Department of Musculoskeletal Sciences, RNPC OPD & AVBR Hospital, Sawangi, Wardha. Cases of upper trapezitis seeking outpatient treatment in the Department of Musculoskeletal Sciences were selected according to the inclusion criteria. This was designed as an interventional cross-sectional study that was planned for one year with a sample size of 30.Inclusion and exclusion criteriaPatients aged between 18 and 60 years who were willing to participate irrespective of gender with a pain intensity on NPRS between 4 to 8 and restricted cervical ROM were included. Patients with any particular causes of neck discomfort, such as tumors, intervertebral disc prolapse, pathology of the shoulder joint, neurological abnormalities affecting the upper limb, coagulation disorders, or trauma, and those who underwent surgery on the cervical spine in the previous 12 months, those with a history of cervical spine fractures or trauma, cervical radiculopathy or myelopathy symptoms, and vascular syndromes like VBI were excluded.MethodologyPatients were given an information sheet in which the methodology of treatment was described in their local language. Only those patients willing to enroll were instructed to sign the informed written consent.Before beginning the study, the institute's ethical committee gave its approval. The case history and physical conditions of the patients were thoroughly documented. Before starting treatment, numerous tests were done to rule out any other conditions. The outcome measures used in this study were cervical goniometry for ROM, the neck disability index (NDI) for functional activities, and the numerical pain rating scale (NPRS) for pain. The data were gathered at baseline, before the start of the intervention, and following the conclusion of each intervention session.InterventionPatients received care using the MET reciprocal inhibition method. Hot fomentation using a hot pack was given for 10 minutes. This was followed by five repetitions of reciprocal inhibition with 20% isometric contraction of the trapezius muscle for a five-second hold and five-second rest followed by the stretching of the upper trapezius muscle for a 10-60-second hold. The patients received the treatment for two weeks, five days a week . The patOutcome measuresPain IntensityNPRS was utilized to determine the pain intensity. The numbers 0-10 were written on a 10-cm line, with 0 signifying no discomfort and 10 signifying the worst suffering. The maximum pain score was between 1 and 10 with 1 indicating the least pain and 10 signaling the most severe pain. The patients were requested to mark on the line according to their severity of pain .Range of Motion and Functional ActivitiesThe cervical movements were assessed using a universal goniometer for flexion, extension, lateral flexion, and rotation. NDI was used to evaluate functional activity limitation due to neck pain. In research and clinical contexts, NDI, which measures disability in individuals with neck discomfort, is crucial and is believed to have high reliability .The data were recorded at the baseline and end of two weeks. The data were analyzed using IBM SPSS Statistics . Proportion, mean, and standard deviation (SD) were analyzed using the chi-square test. Paired t-test was used to compare the group's mean values before and after therapy. A p-value of less than 0.05 was used to determine the significance level.A total of 30 participants were included in the study, of which 18 were females and 12 were males. Two weeks of treatment protocol led to significant differences between pre- and post-pain scores. After two weeks, reciprocal inhibition resulted in a substantial decrease in pain (p=0.001). Following the reciprocal inhibition technique, the cervical ROM, including flexion, lateral flexion, extension, and rotation, considerably improved (p=0.001). Reciprocal inhibition led to statistically significant improvement in the NDI scores as all functional activities improved (p=0.001) (Table The current study was conducted to assess the effect of the reciprocal inhibition technique of MET on cervical pain, ROM, and functional activities limited due to neck pain. The reciprocal inhibition technique of MET results in the reduction of pain due to the stimulation of mechanoreceptors and proprioceptors by simultaneous isometric contraction and stretching of the muscles and this further makes consecutive stretch more tolerable and easier. The outcomes of this study in terms of pain reduction and improvement in cervical ROM and functional activities were comparable to those of earlier studies using MET's post-isometric relaxation approach, where the aforementioned aspects showed improvement in a wide range of neck-pain conditions. Based on previous studies on MET, the post-isometric relaxation technique has been most commonly used as the treatment technique of choice, and it has been highlighted in the literature that post-isometric relaxation of MET is notably efficacious in reducing pain and improving ROM and functional activities ,5,6. HowPhadke et al. examined the effects of the post-isometric relaxation technique on mechanical neck pain and found that MET significantly reduced pain and improved daily functioning . Jalal eThe management of upper trapezitis should be made part of a thorough rehabilitation program as it has the ability to cause pain, impede cervical ROM, and inhibit functional activities. Based on the outcomes of our study, clinicians may use reciprocal inhibition stretching as a component of their rehabilitation program, depending on the muscle that has to be treated. The reciprocal inhibition technique may also be used as a manual technique of choice in the treatment of upper trapezitis.This study has a few limitations, primarily its small sample size and short duration. Further studies with longer duration of interventions and larger sample sizes are required to gain deeper insights into this topic.In patients with upper trapezitis, the reciprocal inhibition technique of MET demonstrated a significant improvement in terms of pain, cervical ROM, and functional activities throughout five sessions per week for two weeks. This study's findings endorse the utility of reciprocal inhibition-MET in managing patients with upper trapezitis.


Clinical management of musculoskeletal shoulder pain can be challenging due to diagnostic uncertainty, variable prognosis and limited evidence for long-term treatment benefits. The UK-based PANDA-S programme (Prognostic And Diagnostic Assessment of the Shoulder) is investigating short and long-term shoulder pain outcomes. This paper reports linked qualitative research exploring patients’ and clinicians’ views towards primary care consultations for shoulder pain.Semi-structured interviews were conducted with 24 patients and 15 primary care clinicians. Twenty-two interviews  were conducted as matched patient-clinician ‘dyads’. Data were analysed thematically.Clinicians reported attempts to involve patients in management decisions; however, there was variation in whether patients preferred treatment choice, or for decisions to be clinician-led. Some patients felt uncertain about the decisions made, due to a lack of discussion about available management options. Many General Practitioners expressed a lack of confidence in diagnosing the underlying cause of shoulder pain. Patients reported either not being given a diagnosis, or receiving different diagnoses from different professionals, resulting in confusion. Whilst clinicians reported routinely discussing prognosis of shoulder pain, patients reported that prognosis was not raised. Patients also expressed concern that their shoulder pain could be caused by serious pathology; however, clinicians felt that this was not a common concern for patients.Findings showed disparities between patients’ and clinicians’ views towards shoulder pain consultations, indicating a need for improved patient-clinician communication. Findings will inform the design of an intervention to support treatment and referral decisions for shoulder pain that will be tested in a randomised controlled trial.The online version contains supplementary material available at 10.1186/s12891-022-06059-1. Musculoskeletal (MSK) shoulder pain is common and associated with impacts for the individual, healthcare and society , 2. ManyThere are many uncertainties regarding the clinical management of shoulder pain. Whilst research has highlighted modest short-term effects of commonly used treatments such as corticosteroid injection, therapeutic exercise and manual therapy, there is limited evidence for long-term benefits –10. TherThese uncertainties can also result in challenges for clinicians when deciding on the most appropriate treatments for patients. These challenges have been highlighted by general practitioners (GPs) in the Netherlands, particularly in relation to diagnostic uncertainty , and UK Patients’ and clinicians’ views towards treatment decision-making have been explored in patients with long-term pain (the majority with over 1-year pain duration) . HoweverThis study is linked to an 8-year research programme funded by the UK National Institute for Health Research (NIHR) and Versus Arthritis: Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S). PANDA-S is investigating the short and long-term outcomes of shoulder pain, with the aim of informing the design of an intervention to support clinicians and patients to make optimal decisions regarding self-management, treatment and referral. A longitudinal cohort study is currently being undertaken of 492 patients with shoulder pain presenting to UK NHS general practices and physiotherapy services . ParticiIn the qualitative study, one-to-one semi-structured interviews were carried out at a single time-point with patients and clinicians, with data analysed using thematic analysis and drawing on the constant comparison method, influenced by grounded theory . Where pThe study settings were general practices and physiotherapy services in the West Midlands, North West and Thames Valley/South Midlands regions of England. The study received ethical approval from the NRES Committee Yorkshire & The Humber - Sheffield, 16/10/2018, ref.: 18/YH/0346.Patients were recruited by invitation letter and then via phone, having consented to contact as part of their participation in the PANDA-S cohort study. Patients were purposively sampled from the baseline questionnaires completed in the cohort, to capture a range of characteristics; including, age, gender, pain duration, self-reported pain intensity and geographical location. Patients who agreed to take part in an interview were also asked for their permission to contact the clinician with whom they consulted for their shoulder pain, in order to invite them to a separate interview. Patients gave permission for this in all cases.Clinicians were contacted via emailing their practice administrator or practice manager, followed by a telephone call or further email. In cases where patients could not remember the clinician’s name, the practice manager first identified which clinician the patient had consulted, and then put the research team in touch with the clinician.Given that all of the patients interviewed had consulted with a GP ─ as well as one First Contact Practitioner (FCP) (FCPs are utilised in UK primary care as the first point-of-contact for MSK presentations) who was based in a general practice─ at a later stage in the study recruitment it was decided to invite MSK physiotherapists to standalone interviews (i.e. not as part of a dyad), to also explore their views and experiences. Whilst the physiotherapists were invited from services participating in the cohort study, they had not consulted with patients recruited to the qualitative study. The intention was to explore their views about management of shoulder pain more generally, both in treating patients who had self-referred to physiotherapy services and those patients referred to physiotherapy from general practice. Physiotherapists were contacted directly via email and invited to participate. All of the physiotherapists who were invited agreed to be interviewed.Eleven patient interviews took place at participants’ homes; and 13 via telephone. Interviews lasted between 21 minutes and 53 minutes. Five clinician interviews took place at their practice/clinic, and 10 were via telephone. Clinician interviews lasted between 19 minutes and 38 minutes. All of the interviews conducted after the start of the COVID-19 pandemic  were via telephone. All interviews were conducted by BS , an experienced qualitative researcher from a social science background. BS was not previously known to the participants.All participants were given an information leaflet explaining the study prior to providing written informed consent (for in-person interviews) or audio-recorded informed consent (for telephone interviews) at the start of the interview. Interviews were audio-recorded. Field notes were not made during interviews as it was felt this could negatively impact upon the rapport between researcher and participants. Informed consent was reaffirmed verbally at the end of each interview.Separate topic guides were used for patient and clinician interviews, covering a range of areas relevant to the study aims . The independent coding was carried out after the data collection had been completed. The aim was to understand cross-disciplinary perspectives on the data and, through discussion, to come to an agreement on shared meanings and interpretations. Based on these analyses, four main themes were developed. These themes, along with accompanying data extracts, were then presented to the study’s CAG and PPIE groups in separate meetings, in order to gain their perspectives. Members of both groups expressed strong agreement with the themes developed and the research team’s interpretations of these themes. Supplementary files A further stage of analysis was then carried out in which identified themes were explored specifically in relation to the 11 patient-clinician dyads. This involved close analysis of each of the matched patient-GP transcripts, and the matched patient-FCP transcripts, in order to explore the key themes within the context of views towards individual consultations. Analysis was therefore both across and within cases, allowing for a broader understanding of patients’ and clinicians’ views, as well as fine-grained, idiographic investigation of patients’ and clinicians’ perspectives on individual consultations.In what follows we outline the characteristics of the participant sample, before reporting the key themes.Twenty-four interviews were conducted with patients and 15 with clinicians, between May 2019 and June 2021, which included a 10-month break in recruitment to the qualitative study from March 2020 to January 2021 as a result of the COVID-19 pandemic. Twenty-two interviews  were conducted as ‘dyads’, where the patient and the clinician they had consulted with for their shoulder pain were interviewed separately about the same consultation. The other 17 interviews  were standalone interviews, i.e. they were not part of a ‘dyad’. In the case of the 13 patient standalone interviews, this was because 13 of the ‘matched’ clinicians either did not reply to the invitation, or declined citing lack of time, and 11 were interviewed (resulting in 11 ‘dyads’).The patients interviewed had all consulted with a GP, except for one patient who had consulted with an FCP. Patient and GP interviews were conducted as near as possible to the time of the consultation in which the patient was identified for PANDA-S. In some cases, this was several weeks, but others were interviewed a few months after the consultation. Thirteen patients had had one GP consultation at the time they were interviewed, in which they were first told about the PANDA-S study. Eleven reported in the interview that they also had consulted a second time, either due to ongoing symptoms, arranged follow-up, or to receive investigation results.Eleven patients were female and 13 male, aged from 38 to 79 years (average age: 62). Eleven patients were currently in employment, representing a range of occupation types, 12 were retired, and 1 was currently not in work. Patients were located across each of the UK geographical regions recruited from for the cohort: West Midlands, North West, South East and South Midlands. Pain severity at its worst over the past week, measured at baseline in the cohort study varied between 3/10 and 10/10, with an average of 6.7/10. Duration of the current episode of shoulder pain measured at baseline ranged from 2 to 6 weeks to over > 1 year. Table Of the 15 clinicians interviewed, 10 were GPs, 1 was an advanced practice physiotherapist working in a general practice as a First Contact Practitioner (FCP), and 4 were physiotherapists. Eight clinicians were female and 7 male. Five GPs were female and 5 male; 2 MSK physiotherapists were female and 2 male, and the 1 FCP was female. The length of time clinicians had been practising ranged from 3 to 32 years. Clinicians were located across each of the geographical regions recruited from for the cohort.Decision-making and discussion of management optionsDiagnosis of shoulder conditionsDiscussion of prognosisGiving and receiving reassuranceThe four main themes identified were:These four main themes are outlined in the following sections. Supplementary file You need to take into account the patient demographics: age, sex, occupation and their presenting history, history of how the pain has started and presents … but I think it’s got to be a shared decision process between you and the patient as to which route they want to take … ultimately it’s patient choice. This correlates with the views of some patients who reported making the final decision between treatments offered to them by the clinician:P: He said I could leave it a while and have an injection, or I could refer you to physiotherapy. So, I thought I’d try physioInt: So it sounds like the doctor gave you some choice of which you preferred?P: Yeah, it was my choice … I thought the physio might be a better long-term solution to the underlying problem rather than injection Clinicians reported that, in the absence of ‘red flag’ symptoms, in most cases they favoured initial conservative management, such as self-management advice, analgesia or referral to physiotherapy. However, some clinicians reported offering more invasive options, such as corticosteroid injection, at an early stage if the pain was significantly impacting the patient’s everyday life, or the patient was seeking short-term pain relief. This was the case in the following extract from a clinician-patient dyad, in which the GP gave the patient an injection in the consultation:So there was bicipital tendinosis, and [the patient] came back (for a follow-up consultation) and said the pain was still the same, it was still disturbing his sleep, what would be a quick fix. So we spoke about the pros and cons of injection, and he did have an injection … people do come with a pain, it’s affecting their sleep, it’s affecting their lifestyle. For people like this patient, who it does give them relief, then I think it’s a service that’s appreciated. The matched interview in this dyad shows consistency with the clinician’s account, in that the patient also highlighted the impact of the pain on his sleep as being his main concern. The patient reported having been hesitant about an injection, but expressed a strong preference for the decision about his treatment to be led by the GP:It was a few days after when it started to occur and I couldn’t sleep. Oh, it was a nightmare. The whole of my arm ached … I couldn’t care less about medical stuff. I’ll leave that to the doctors. I’m not interested. All I want them to do is to treat me. So all I wanted, get rid of this pain in my arm, whatever way, let them tell me. I didn’t fancy an injection in my shoulder. I got home and thought, ‘What have I done?’. But do you know, from then on after that night it went easier. Clinicians similarly highlighted this preference of some patients not to be involved in their treatment decisions and instead wanting the clinician to take a directive approach, deferring to their clinical knowledge:I do try and do shared management decision-making as much as possible with people and some patients are very amenable to that, and other people say ‘Well you’re the doctor, what should I do? What would you recommend?’. And then you think ‘Right okay, I think we probably should do this first and this next’. However, some patients’ views challenged the dichotomy between patient choice and clinician-led decision-making. They indicated that, even if they preferred the eventual decision to be taken by the clinician, they still wanted to engage in a form of shared decision-making involving discussion about available options and for the clinician to outline a potential treatment pathway. However, for many patients they reported that these discussions had not taken place:He basically told me what it was [i.e. bursitis], felt along my shoulder and explained where things were and that there was the fluid sac or something, so basically that was it … if other treatment is available like physio or if I need another scan or anything like that, I would have liked to have discussed that because I don’t just want to be told, ‘oh well it’s this, learn to live with it’. Some patients also reported a lack of information from the clinician about why the recommended treatment was the most suitable and how it would treat their symptoms. They seemed to indicate a reluctance to raise these concerns during the consultation, but then felt dissatisfied following the consultation:Basically the doctor asked me, would I like to have the steroid injections and I asked him ‘would it do me any good?’; which he said he thought it would, made my appointment … and that was basically the end of the consultation … when you come away you think, ‘what did I learn then?’. It was nothing, I learnt nothing, I didn’t know what the injection would do or why. Clinicians highlighted a number of considerations in the management of shoulder pain, such as the patient’s age, occupation, pain history and the impact of pain on their daily lives. However, they indicated that whilst these factors may influence their decisions, they routinely attempt to involve patients in decision-making through offering them a choice of treatments:It’s nice to be told what it is [i.e. bursitis] … they could actually tell me what I can take to relieve the pain and not just keep saying ‘oh we don’t know, try this, it’s just something you are going to have to live with’ … I know now that if it gets worse I can go to the doctors and they are aware of what it is and maybe how they can treat it. However, several patients reported that their GP either did not offer them a diagnosis or explanation of possible causes of their shoulder pain, or that they conveyed uncertainty. In many cases this resulted in the patient being referred for further investigation:The GP thought that it was potentially something to do with the ligaments, just something’s worn out there and she thinks the bones are actually scratching on each other and that’s why it’s causing this sharp pain. It’s like the nerve’s been damaged there, that’s what she thinks has been going on … she will see on the ultrasound. She can’t say 100% but that’s what she's guessing. This diagnostic uncertainty was reflected in clinicians’ views. Many GPs reported lacking confidence in diagnosing shoulder conditions due to a perceived lack of skill in shoulder examination, leading them to commonly send patients for investigations such as an ultrasound scan:I’m conscious that I do probably far too many ultrasounds … and I probably need to brush up on specific shoulder examination skills in order to be able to more specifically diagnose a specific tendonitis or bursitis or impingement or whatever, rather than just thinking ‘ooh it could be this that or the other’, without having to image; unless there were any red flags obviously. There was variation in the data, however, as all of the physiotherapists and a few GPs reported having greater confidence in diagnosing shoulder conditions. For many of these clinicians, providing a diagnosis was perceived to be a key part of their professional role:If my role isn’t to diagnose people, then what am I doing? Of course it is … I’m perfectly happy in that part of my role. But I also am aware sadly of things like NICE [National Institute for Health and Care Excellence] guidance which seems a lot more investigation-focused, and I do think maybe some of my younger colleagues are more inclined to sort of hedge before making a definitive diagnosis, whereas I’m quite happy to put the code in, subacromial and move on. So yes, I think that’s an absolutely crucial part of my role. The majority of clinicians reported that during the initial stages of the COVID-19 pandemic, the need to conduct consultations remotely via telephone or video call had made diagnosing shoulder conditions more difficult. This was because in many cases physical contact with the patient was felt necessary for assessment and diagnosis. Additionally, examinations were limited by the patient’s ability to follow the clinician’s instructions in carrying out arm movements, as well as ensuring that these movements were captured on the screen:To assess strength appropriately in different movements and different directions, you’re reliant on the patient having something suitable in their home to be able to do it for starters. Secondly, then to be able to position the phone in such a way that you can see them doing it, which sometimes isn’t the case. You also then need to be able to guide them with the technique … one of the things then you’re looking at with your rehab folk is trying to normalise that movement pattern. Sometimes that does require physical feedback, not just verbal feedback. So I think it’s a challenge to do over video. It’s not impossible, but it’s immensely difficult. This view was mirrored by patients, who felt that remote examinations were less thorough than in-person, hands-on examination, and also reported difficulty performing movements in line with the clinician’s instructions over video. As a result, patients reported feeling less confident when a diagnosis was provided:You don’t get a full examination unless you meet the person I’d imagine. I think you can only do so much on the telephone or on video. I’m disappointed really that she was taking my [previous] diagnosis without examining me … I’ve had a video call from her and it was comical, absolutely comical. ‘Right put your phone in front of you, lift your arm up so I can see it’. [I replied] ‘Look, if I put my phone there I can’t see it, so I can’t see what you can see, so I can’t do the exercise’. Several patients reported receiving different diagnoses from different professionals, leading them to experience confusion. This is exemplified in the following clinician-patient dyad. The patient reported feelings of uncertainty, having been told by his GP that he had arthritis, but by another professional that he had subacromial shoulder pain (i.e. impingement):They’ve been telling me different things. The first doctor who rang said it’s just arthritis … they referred me to physiotherapy … but the man who did my scan at the hospital told me it was quite a bad impingement. So I didn’t know which one to believe. The First Contact Practitioner (FCP) that the patient consulted with explained that, based on the patient’s X-ray and her examination, both diagnoses were indicated:He had an X-ray of his shoulder which showed calcific rotator cuff tendonitis and subacromial bursitis and then the ultrasound showed some moderate OA (osteoarthritis) changes in his acromioclavicular joint. Normal long head of biceps, no rotator cuff tear but some thickening of the bursa which was felt likely to be representative of impingement. Receiving a diagnosis for their shoulder pain was important to patients, partly to reassure them that the pain was not caused by serious pathology , but also this was seen to be key to receiving the right management:The pain is getting worse and there will be a point where I won’t be able to move my arm beyond that point [signals waist height]. And so that’s obviously going to limit my movement, which will impact my job severely. And who knows?” However, the majority of patients reported that their shoulder pain prognosis had not been discussed with the clinician. Many perceived that this was because the clinician was unlikely to know how their pain may progress, particularly if a diagnosis had not been established. Some patients appeared accepting of this uncertainty so long as a clear management plan was in place:Int: Did the GP give you any idea about the future, whether it might be something that could be resolved, or … ?P: No, no, nothing, the GP didn’t really say, but nobody knows … she doesn’t really know exactly what's wrong with me, she can’t give me promises, because then I could be, ‘oh yeah, she said it’ll be fine, you know after this injection’, and then if it isn’t, I’d be like well ‘why did she say that?’ So I think it’s more not giving me false hope, she's like ‘okay, let’s see what we can do, we can offer you this and that, and if none of this works, we will try something else’. In contrast to this, other patients reported that they would have liked their prognosis to have been discussed in the consultation:Int: Did they talk to you at all about the future outlook, the prognosis?P: No, nothing of the sort. No, we didn’t talk about thatInt: Is that something you’d liked to have discussed with the clinician?P: Absolutely yeah. Managing expectations yeah, it’s a big thing isn’t it? Just to give me an idea if you’re going to get better or have I just got to live with it. Clinicians’ accounts showed discrepancy with these views, as all clinicians reported that they routinely discuss shoulder pain prognosis in consultations. They perceived this to be important for encouraging patients to engage with a management plan:Int: Would you discuss with patients how their pain might progress?P: Yeah all the time. I usually say, ‘right, for this sort of problem, from previous experiences and from the research out there it looks like it will take X amount of time to get better and if you engage with your physio programme the aim is to reduce that timescale of course’ … just give them that advice on timescales and what we do next should they not improve within that timescale. Some clinicians reported a more cautious approach whereby they give patients a general idea of a timeframe for recovery rather than a specific prognosis. They also highlighted the importance of ensuring patients have realistic expectations about their recovery:I want people to be realistic, so I don’t want them to expect it to get hugely better immediately and then be upset that it isn’t. So I will often say something like, ‘Shoulder problems can go on for months’ because I want them to have some realistic expectations. But I would then try and counter it by saying, ‘But if we do this and that and the other we’ll aim to make it feel better along the way and improve more quickly.’...because if you tell someone with a frozen shoulder the natural history is 18 months without any treatment, I mean that’s just depressing, but also realistic. So I kind of hedge my bets in the middle a little … what I don’t want them to do is ring me in a week and say, ‘It’s not better yet.’ So it’s just getting that balance really. The disparity in patients’ and clinicians’ accounts of discussing prognosis in consultations is exemplified in patient-clinician dyads. The following patient reported that neither diagnosis nor prognosis were discussed with his GP, and that his expectation was that his shoulder pain may never resolve:The doctor didn’t actually say what he thought it was, he just thought the way to go forward was physiotherapy … my feeling is that I’ve probably got to live with it. I don’t really know what to expect. I’m not optimistic because I’m not 100% sure it’ll ever go. This contrasts with the GP’s account in which he reports having communicated to the patient a diagnosis of frozen shoulder and outlined the likely timeframe for recovery:Int: Did you discuss [the pain condition] with him in the consultation?P: Yes, yes. I always do, I always give explanation to patients that what I think it is, in lay terms, a frozen shoulder, and I gave him an idea of what it was about and then I referred him to physio … prognosis is vitally important. You need to give them an idea of timeframe because otherwise they’re not getting better. You’ve got to tell them the likelihood, how long it’s going to last before getting better, otherwise they come back and they don’t have faith in your management. Patients reported concerns about how long their shoulder pain might last and whether it could worsen or recur. In some cases, patients appeared to catastrophize about the future:I don’t see necessarily that patients have that mentality and worrying about it being something nasty. However, I do see a lot more that they worry about whether they’re allowed to do certain things. So are they allowed to lift their arm if it’s painful? So I see a lot more worry about the pain or how long did it last rather than it being due to a non-MSK or a more sinister pathology. Patients’ accounts showed some discrepancy with these views, however, as patients reported concerns that something serious may be causing their shoulder pain, such as cancer, or a serious injury to the bones or ligaments. They therefore reported feeling reassured if they received a diagnosis:Looking for exercises to help it, you go onto Google and it comes back you’ve got cancer straight away, isn’t it? Everything, ‘Oh yeah, points to cancer’ … Once I knew it was tendonitis I was happy. I wasn’t happy, but I was happy if that makes sense. The disparity between clinicians’ and patients’ views is reflected in the following dyad. The patient expressed concern that something serious may be wrong with his shoulder, but this appears to have either not been communicated, or not identified by the clinician:You always think these things, is it some sort of bone cancer? Or, I’m not sure what can be done on ligaments or muscles that would be more serious, I’m not that familiar with things that go wrong in your shoulder. But yes you always wonder could it be something very serious, have I done some serious injury and not realised it? Is it some disease that’s eating away at my muscle or bone? I don’t think it was anxiety as such. It was more like he said, ‘I’d like not to have this pain please, if you can?’ rather than anything else. I certainly wouldn’t describe anxiety as a presenting feature with this chap. In some cases, when asked in interviews patients reported that they had not in fact expressed these concerns to their clinician:P: When you get things like this you think the worst. I’m a bit of a worrier and I just think oh, cancer or something like thatInt: Was she able to reassure you that it wasn’t?P: No, no, noInt: Did you express those concerns to her?P: Well I didn’t, no. I didn’t actually, no. Some patients who had not received a diagnosis for their shoulder pain suggested a tension whereby on the one hand they felt a sense of reassurance through having confidence in the expertise of their clinician, particularly where there was a strong therapeutic rapport, but at the same time they felt a lack of reassurance with regard to the cause of their pain:She allows you time to go through everything and talks to you about everything, she’s a fabulous doctor. But in this situation she wouldn’t be able to tell me exactly what it was … so it was sort of reassuring but it wasn’t, at the same time. A few GPs displayed a recognition of this tension, and highlighted the challenge they faced in attempting to reassure patients within the frame of diagnostic uncertainty. They reported addressing this through being honest about these uncertainties, and involving the patient in discussing management:I think [the patient] was happy that the X-ray didn’t show any arthritis particularly, but I think he was then worried to say ‘Well what is it? What’s causing it?’. And I think that’s the difficult point where you say ‘Well it could be any number of things’ … I believe very much so that we need to be honest with our patients if we don’t know the answer. What I often will say is ‘Look, these are the possibilities and these are the things I’m going to do to rule in or rule out those possibilities’. And I try and have a conversation about it and do shared management decision-making as much as possible. Clinicians also highlighted the need, in some instances, to provide reassurance about the relative value and risks of treatment options; for instance, reassuring patients that physiotherapy will not cause them harm or worsen their pain, even if the cause of pain is unclear:Sometimes patients are nervous to go to physio if they don’t know what’s going on and we do find that’s sometimes a bit of barrier. Some of these people find it very reassuring to have something in terms of a scan or an X-ray that says ‘This is what’s happening’. Some people seem to worry that the physio will make things worse and I try to explain to a lot of patients that physio is very unlikely to make anything worse; chances are it’ll probably make things better. Clinicians reported that patients commonly needed reassurance about the impact of shoulder pain on their function and daily activities. However, they felt that, unlike spinal pain, patients do not tend to have concerns about serious pathology related to their shoulder:In this article we aimed to explore, and develop a better understanding of, patients’ and clinicians’ perspectives towards primary care consultations for shoulder pain. This aim was achieved through the generation of rich, in-depth insights regarding the management of shoulder pain, from the perspectives of the two groups of participants. In particular, the findings show some consistencies between the views of patients and primary care clinicians towards shoulder pain management, but also a number of disparities, which could reflect miscommunication or misunderstanding within consultations, or a lack of recall following the consultation. Both clinician and patient data indicated that there was variation in patients’ preferences towards shared decision-making. However, some patients reported leaving the consultation with a lack of clarity about their management, as they did not feel that available management options had been discussed, nor a clear treatment pathway outlined. Diagnostic uncertainty was apparent in the accounts of some clinicians and patients, and as a result patients expressed concerns that there may be something seriously wrong with their shoulder. Clinicians perceived these types of concerns to be uncommon for patients with shoulder pain, and therefore did not always provide the ‘cognitive reassurance’, i.e. information about aetiology  that patSome of our findings show similarity with previous qualitative research on shoulder pain management. The importance that patients placed on receiving a diagnosis for informing the management of their shoulder pain corroborates Cuff and Littlewood’s  findingsAnother similarity between ours and Ottenheijm et al’s  findingsOur finding that patients experienced concerns and anxiety about their shoulder pain shows similarity with other studies. However, the patient concerns about serious underlying pathology such as cancer, or serious injury, that we identified were not observed in these studies. Instead, patient anxiety was found to be a result of delays in receiving a diagnosis , functioThe issues and concerns identified among patients and clinicians about shoulder pain consultations being carried out remotely via telephone or video, show both similarities and differences with other literature. Donaghy et al.  found thA strength of this study is the parallel investigation of the views of both patients with shoulder pain and primary care clinicians. This included 11 patient-clinician dyads (i.e. 22 matched interviews), which represents a novel aspect of the study, allowing for direct comparison of views towards the same consultation. The multi-disciplinary team involved in data analysis is also a strength, as well as the input from our PPIE group and Clinical Advisory Group, which increases the trustworthiness of the findings presented. A further strength is that whilst this study was conducted in a UK NHS setting, because of the focus on the primary care consultation itself, many of these findings could also be applicable to other non-UK settings.A limitation of the study is that participants were interviewed several weeks after the consultation took place, therefore recall will likely have been a factor in some cases. GPs were able to use their clinical notes to aid their memories, but these notes would likely have included only a brief record of the decisions made. Therefore, where differences were identified between patients’ and clinicians’ accounts of what was discussed in the consultation, this disparity could have been due, in part, to participants misremembering, or being unable to recall certain details. However, this does not negate the usefulness of the findings, because if patients were unable to recall crucial information about diagnosis, prognosis or treatment decisions, or if clinicians recorded or recalled information differently from the way in which it was discussed, this can represent a key barrier to positive patient experiences of care and possibly outcomes.Another potential limitation is the possibility of selection bias in the clinicians who participated. Thirteen of the clinicians ‘matched’ to patients either did not reply to the invitation, or declined citing lack of time; therefore, those who did agree to be interviewed may have differed in some ways. For instance, it may be that the clinicians who agreed to be interviewed had more interest or experience in managing shoulder pain, or more interest in research generally, and therefore were more motivated to participate. Whilst we do not have the information available to assess for any differences in characteristics between those clinicians who did and did not participate, this potential for difference is something that should be considered when interpreting the interview findings.When interpreting the findings, it is important to acknowledge the influence of the researcher on participants’ responses in interviews; however, a reflexive approach was adopted throughout, in which the researcher attended to, and acknowledged any biases and preconceptions. Patients and clinicians were made aware that the researcher conducting interviews (BS) was a social scientist and was not from a clinical background, and that the team were interested in understanding both positive and negative aspects of their experiences. The other team members involved in the analysis were from nursing (GWJ) and general practice (CB) backgrounds, and these clinical backgrounds will likely have influenced their interpretations of the data. CB, in particular, currently works as a GP alongside her academic role, and therefore brought a general practice perspective to the data. This may have resulted in preconceptions about primary care shoulder pain management that were informed by her own management in consultations, but this may also have been of benefit in interpreting the clinicians’ reported views and experiences.In this paper we have presented findings on patients’ and clinicians’ views towards primary care consultations for shoulder pain. This included, influences on, and uncertainty regarding, decision-making and the importance of diagnostic and prognostic information when negotiating treatment and referral options.There are a number of implications that can be drawn out for future clinical practice and research. This is particularly in relation to the disparities identified between patients’ and clinicians’ accounts of the consultation and its outcomes. These disparities point to apparent miscommunication and/or miscomprehension and lack of recall of key information following the consultation. This may have led to many patients reporting uncertainty about their shoulder pain diagnosis, prognosis or the available treatment options. It is therefore important that, in line with UK National Institute for Health and Care Excellence (NICE) guidelines for shoulder pain management , cliniciWith regard to decision-making about treatment and referral options, training for clinicians should address the nuances around shared decision-making for shoulder pain. Whilst clinicians were aware of the importance of shared decision-making, this appeared to be dichotomised in terms of patients either wanting to be offered a choice of treatments such as physiotherapy or corticosteroid injection, or preferring the decision to be clinician-led. Clinicians should therefore be aware that even when the patient displays an apparent lack of willingness to engage with shared decision-making focused on patient choice, they may still wish to engage in a different form of shared decision-making. Clinicians should therefore be encouraged to discuss all of the available options with patients and outline a clear treatment pathway. Additionally, patients’ worries about their shoulder pain being related to serious underlying pathologies such as cancer were not identified by clinicians, perhaps due to patients’ reluctance to voice these concerns to their clinician. It is therefore important that clinicians are made aware of the need to always ask patients If they have any specific concerns about their shoulder pain, in line with the ICE consultation model  . They shThe findings presented here will directly inform the design of a clinical intervention as part of the PANDA-S programme, that will be tested in a future RCT. The intervention will address the issues raised in these findings, with the intention of helping clinicians to identify and address the needs, concerns and priorities of patients with shoulder pain, and to improve communication about treatment and referral decisions. Through this we will aim to optimise the management of shoulder pain within primary care consultations, with the goal of improving patient outcomes.Supplementary file A. PANDA-S Interview Topic Guide: Patients.Supplementary file B. PANDA-S Interview Topic Guide: Clinicians - GPs.Supplementary file C. PANDA-S Interview Topic Guide: Clinicians - Physiotherapists.Supplementary file D. Theme 1.Supplementary file E. Theme 2.Supplementary file F. Theme 3.Supplementary file G. Theme 4.Supplementary file H. Outline of patient-clinician dyad interviews.