Only few studies have yet investigated whether perioperative administration of pregabalin can reduce the incidence of postoperative chronic neuropathic pain after total hip arthroplasty (THA). This prospective, randomized study compared placebo with pregabalin in the hope that a lower pregabalin dose would improve analgesia without increasing side-effects after THA.This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. The study was approved by the Institutional Review Board in Weifang People's Hospital and written informed consent was obtained from all subjects before enrolment. A total of 120 patients who meet inclusion criteria are randomized to either pregabalin or placebo group. The primary objective of the study was visual analog scale score. As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.The null hypothesis of this study was that pregabalin would reduce pain after THA.This study protocol was registered in Research Registry (researchregistry5669). THA is known to be a painful orthopedic procedure and moderate to severe pain is common, especially immediately postoperatively and during active motion. Poorly controlled pain can result in poor function with physical therapy, prolonged hospitalization, and reduced patient satisfaction. Therefore, adequate analgesia following THA continues to be a topic of interest.Total hip arthroplasty (THA) is one of the most effective orthopedic procedures to relieve pain and improve function in patients with symptomatic hip arthritis.–6 Neuropathic pain is a distressing condition that is characterized by allodynia, hyperalgesia, edema, and skin color changes of the limb. Treatment of neuropathic pain is often both challenging and prolonged, with substantially diminished quality of life. Gabapentin and the related more potent compound pregabalin have been shown to be beneficial in the treatment of neuropathic pain.–9 Because of the chronic and distressing nature of neuropathic pain, as well as the difficulty in treatment and resolution, preventing development of this syndrome is highly advantageous.Despite advances in surgical technology and perioperative anesthetic management, the incidence of chronic neuropathic pain after THA surgery has not decreased.,11 As a result, the drug inhibits neuronal excitability, especially in the central nervous system.–13 Pregabalin has been shown in multiple studies to be an effective analgesic agent in both peripheral and central neuropathic pain,–16 and it is also effective in reducing post-THA pain.–6Pregabalin is an analog of gamma aminobutyric acid. Pregabalin decreases the synaptic release of multiple neurotransmitters  by binding to the α2δ-subunits of the presynaptic voltage-dependent calcium channels.–6 This prospective, randomized study compared placebo with pregabalin in the hope that a lower pregabalin dose would improve analgesia without increasing side-effects after THA. The null hypothesis of this study was that pregabalin would reduce pain after THA.However, only 3 clinical studies have yet investigated whether perioperative administration of pregabalin can reduce the incidence of postoperative chronic neuropathic pain after THA.2This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. The study was approved by the Institutional Review Board in Weifang People's Hospital (WF2020010058) and was registered in the Research Registry (researchregistry5669). Written informed consent was obtained from all subjects before enrolment. This study was performed and reported in accordance with the principles of the Declaration of Helsinki (2000).2.1Eligible patients were 18- to 80-year-old Chinese speakers judged able to follow the protocol, planned to undergo primary THA and regional anesthesia and to be discharged home or to a participating rehabilitation center. Exclusion criteria included planned general anesthesia, allergy, or intolerance to one of the study medications, American Society of Anesthesiologists physical status of IV, hepatic failure, renal failure, difficult-to-manage diabetes mellitus (including insulin dependence), chronic gabapentin or pregabalin use (regular use for longer than 3 months), and chronic opioid use (regular use for longer than 3 months).2.2An equal number of envelopes for each treatment group were prepared using a computerized random number generator by a study assistant who did not take part in any subsequent part of the study, and was not in contact with the rest of the study team throughout the entire study duration. He prepared 120 identical sequentially numbered, opaque, sealed and stapled envelopes; 60 envelopes contained instructions for mixing solutions for pregabalin group, and the other 60 for placebo group. The envelopes were kept in a file with the principal investigator  tablet 5 mg every 6 hours as needed for moderate pain. Subjects received intravenous and/oral opioid medication as pain rescue during hospitalization and subsequently, opioid consumption during hospitalization was collected and converted to oral morphine units for data analysis purposes.2.5The primary objective of the study was to evaluate the efficacy of pregabalin compared to placebo in the reduction of pain in THA patients. The severity of pain was assessed by using the visual analog scale (VAS) for pain intensity; it consisted of a 100 mm long line with 2 descriptors at each end representing pain intensities (no pain and extreme pain). Subjects were asked to mark their pain intensity somewhere on the line, then the VAS score was assessed by measuring the distance from the “no pain” end to the mark placed by the subject. VAS pain assessments were performed at baseline, on day 3, day 9 ± 3, day 25 ± 7, day 90 ± 6, and day 180 ± 12.As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison. Opioid consumption  before first dose of investigational product until hospital discharge or day 3 (whichever occurs first) was recorded. Harris Hip Score was originally developed to evaluate the treatment of posttraumatic arthritis, but is now widely used for any osteoarthritis of the hip, and has been found to be responsive for these patients. The score has a maximum of 100 points (best possible function), covering pain , function and activities , and range of motion and absence of deformity . Range of motion, Harris Hip Score and patient satisfaction were obtained both before and after arthroplasty by a dedicated physiotherapist specialist.2.6t test was used for the normally distributed numerical data. A nonparametric analog was used where appropriate. The χ2 test was used to compare categorical variables. A P value <.05 was considered statistically significant.The sample size was determined for the primary endpoint and was calculated using PASS 2011 software . According to the results of our previous study, the postoperative VAS score was 2.16 in the control group. We anticipated a difference of 0.72 in the VAS score. With a power of 0.90 and significance level of 0.05, the required sample size was calculated as 50 in each arm. Considering possible exclusion, we decided to include 60 patients in each group. Statistical analysis was performed by an independent expert, not involved in the study protocol. Median and mean (range) values were presented. The unpaired 3 Some studies show that pregabalin given before surgery can reduce dental pain after molar extraction, reduce postoperative morphine requirements after THA,–6 and attenuate postoperative pain after laparoscopic cholecystectomy; however, other studies show no beneficial effect of pregabalin on acute postoperative pain when administered preoperatively for minor gynecological surgery.Pregabalin is an α 2 δ ligand that modulates the activity of voltage gated calcium channels. In the US, pregabalin is indicated for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, with spinal cord injury, postherpetic neuralgia, fibromyalgia, and as an adjunctive therapy for adult patients with partial onset seizures.This prospective, randomized study compared placebo with pregabalin in the hope that a lower pregabalin dose would improve analgesia without increasing side-effects after THA. The strength of this study was its prospective and randomized design. Three studies have recently been published evaluating the effects of pregabalin in THA. The present study continues to provide ongoing data showing the differences in the clinical results between the 2 groups.Conceptualization: Yuangui Zhang.Data curation: Xiaoqian Wang.Formal analysis: Yuangui Zhang, Xiaoqian Wang.Funding acquisition: Guimin Dong.Investigation: Yuangui Zhang, Xiaoqian Wang.Methodology: Guimin Dong.Resources: Guimin Dong.Software: Xiaoqian Wang.Supervision: Guimin Dong.Validation: Yuangui Zhang.Visualization: Yuangui Zhang.Writing – original draft: Yuangui Zhang, Xiaoqian Wang.Writing – review & editing: Guimin Dong.


To examine secular trends in the progression of clinical and patient-reported outcomes in early RA.A total of 2701 patients recruited to the Early Rheumatoid Arthritis Study or Early Rheumatoid Arthritis Network with year of diagnosis from 1986 to 2011. The 5-year progression rates for patients diagnosed at different points in time were modelled using mixed-effects regression; 1990, 2002 and 2010, were compared. Clinical markers of disease included the 28-joint count DAS and the ESR. Patient-reported markers included the HAQ, visual analogue scale of pain and global health, and the Short-Form 36.Statistically significant improvements in both 28-joint count DAS and ESR were seen over the 5 years in patients diagnosed with RA compared with those diagnosed earlier. By 5 years, 59% of patients with diagnosis in 2010 were estimated to reach low disease activity compared with 48% with diagnosis in 2002 and 32% with diagnosis in 1990. Whilst HAQ demonstrated statistically significant improvements, these improvements were small, with similar proportions of patients achieving HAQ scores of ≤1.0 by 5 years with a diagnosis in 1990 compared with 2010. Levels of the visual analogue scale and the Mental Component Scores of the Short-Form 36 indicated similar, statistically non-significant levels over the 5 years, irrespective of year diagnosed.This study demonstrates improvements in inflammatory markers over time in early RA, in line with improved treatment strategies. These have not translated into similar improvements in patient-reported outcomes relating to either physical or mental health. Changes in the presentation and clinical management of RA has seen improvements in inflammation.These improvements in inflammation, however, are not translating into improvements in patient-reported outcomes.More emphasis needed on mental health, pain and fatigue in research and clinical care.The last 30 years have seen many changes in the presentation of RA in the clinics, as well as how it is managed therapeutically. Recent data from early RA cohorts highlight how new RA patients are presenting with increased levels of comorbidities and higher levels of obesity , as wellThere is growing evidence that these therapeutic changes have had positive effects on lowering inflammation and halting the progression of structural joint damage . Data frStudies have shown that psychological distress, including depression and anxiety, is more prevalent in patients living with RA , althougPrevious studies examining secular changes in HRQoL outcomes have primarily focussed on functional disability using the HAQ, as this is a common outcome measure in arthritis. The current evidence base suggests that whilst patients diagnosed and treated in earlier cohorts demonstrate statistically significant differences in HAQ, these changes relate to small absolute differences in the overall score , 11. DesTo date, there has been no study utilizing longitudinal analytical techniques to assess secular trends in long-term trajectories of pain, functional disability and HRQoL in early RA patients diagnosed over a 30-year time frame. This study examines progression of disease activity, functional disability and measures of HRQoL from two early longitudinal RA cohorts, recruiting between 1986 and 2011. Longitudinal data for both cohorts allows for the estimation of 60-month trajectories over different time periods. It is hypothesized that 60-month trajectories of disease activity and other objective markers of inflammation have seen improvements in more recent decades, but functional disability, pain and HRQoL remain largely unchanged.The data used for this study were collected from two longitudinal inception cohorts: the Early Rheumatoid Arthritis Study (ERAS) and the Early Rheumatoid Arthritis Network (ERAN). ERAS recruited 1465 patients from across the UK between 1986 and 2001, while ERAN recruited 1236 patients from across the UK between 2002 and 2011. All patients had a confirmed diagnosis of RA and were recruited within 2 or 3 years of symptom onset, typically prior to conventional DMARD initiation. Maximum follow-up for ERAS was 25 years (median 10 years) and for ERAN was 11 years (median 3 years). Standard clinical, laboratory and radiographic data were collected at baseline, 6 months and 12 months, and then yearly thereafter.All patients were treated based on standard clinical practice at the time . For ERAFor ERAS, the original three variable 44-joint DAS (DAS44) was used to measure disease activity, comprised of the 44 swollen joint count, Ritchie Index for tender joint count and ESR. For ERAN, the 4-variable 28-joint count DAS (DAS28) was used, comprised of the revised 28 swollen joint count and tender joint count, ESR and a Patient Global Assessment (PGA). For those where ESR was missing, but a value of CRP was available, the DAS28-CRP version was used . To enabThe UK version of the HAQ disability index was used to collect data on patient’s functional disability . ConsistFor patients recruited into ERAN, the PGA was recorded, which is a sub-component of the DAS28 and asks patients to rate their overall health on a visual analogue scale (VAS) from 0 to 100. However, patients recruited to ERAS did not record PGA (except in one centre), but instead rated current pain levels using a 0–100 VAS.n = 85) with both the PGA and pain VAS, it was found that both scores correlated highly , with Bland and Altman plots indicating only a 0.39 mean difference (95% limits of agreement –23.57 to 22.80) between the scores. As such we decided it was appropriate to compare changes in VAS over time across both cohorts , 50% reached LDA in where they were diagnosed in 2002 , and 63% were estimated to reach LDA if they were diagnosed in 2010 .P < 0.001) and 2002 (P < 0.001)  . This waP < 0.05) and between those diagnosed in 2010 and 2002 (P < 0.05) for both outcomes, these differences were small. This is reflected in the logistic regression models looking at the probability of achieving HAQ scores ≤1.0 and VAS scores ≤10 units, where by month 60 the probability for HAQ was similar across the recruitment periods. Some 54% of patients indicated a HAQ ≤1 at 60 months where they were diagnosed in 1990 , compared with 61% of patients who were diagnosed in 2002  and 60% of patients diagnosed in 2010   . The VAS0, 0.70) .For those patients in the ERAN cohort where the SF-36 was collected, mixed-effects linear models were used to estimate both the PCS and MCS, as well as the Physical Function, Bodily Pain, Vitality and Mental Health sub-components. As the SF-36 data were only available in ERAN, only 2002 and 2010 recruitment periods were modelled. The progression of these scores are illustrated in P < 0.001) and month-60 (P < 0.05). This improvement was reflected by similar improvements in both Physical Function and Bodily Pain. However, by month 60, the magnitude of the improvement had reduced. The improvement for patients diagnosed in 2010 was reflected in a greater likelihood of achieving a PCS ≥50 of 21%  by month 60, compared with those diagnosed in 2002 with just 5% .Relative to 2002, patients diagnosed in 2010 had significantly better PCS at both baseline (P < 0.05) relative to those diagnosed in 2002, the magnitude of this difference was much lower. As with the PCS, this difference diminished over time and by month 60 was statistically non-significant. This was reflected in both the Vitality and Mental Health sub-components. The likelihood of achieving a MCS ≥50 units was similar in both 2010  and 2002 .In contrast, whilst patients diagnosed in 2010 experienced significantly better MCS at baseline  did indicate statistically and clinically significant reductions in levels of fatigue for those patients treated with anti-TNF-α ; howeverPrevious studies have found little evidence of an association between inflammatory markers and fatigue , and anyThe use of prospective, observational cohort data allows for the estimation of important outcomes in a true to life, naturally treated, clinical setting. Unlike clinical trials, where patients with high disease levels are typically over-represented, the inclusive nature of the cohorts allows for a wide spectrum of RA patients to be included in the analysis. The emphasis on early RA also allowed for the estimation of the progression of these outcomes at treatment initiation.However, prospective cohorts are prone to attrition and missing data can hinder the statistical power of longitudinal analysis, particularly when examining group-level differences. The presence of missing data was largely accounted for through the use of mixed models, which utilizes full-information maximum likelihood to estimate missing data using the predictions from observed data in the models.As ERAS is a historical cohort, it did not collect PGA scores. In order to overcome this, pain scores measured in ERAS using a 0–100 VAS were used. It could be argued that both measures are measuring different constructs: PGA a more overall general health measure, whereas pain VAS specifically targets RA-related pain. Nevertheless, from a statistical point of view, these two measures correlate highly, and demonstrate high levels of agreement. As such, the pain score is likely to be a suitable approximation of the ERAS patients’ PGA score had they been collected routinely.The role of improved therapeutic managements has been instrumental in lowering inflammation and reducing the inflammatory aspects of the disease over the last 30 years, the so-called objective markers. However, there is a clear need to examine the subjective aspects of the disease , which iFuture research should begin to focus on examining possible sub-groups of patients that may progress differently over time, as has already been evidenced with HAQ , 45. Ear


Piriformis syndrome accounts for approximately 6% of patients who present with sciatic pain. There are many treatment options ranging from physical therapy, to trigger point injections, to surgical intervention. We discuss a surgical method that represents a minimally invasive technique for the treatment of piriformis syndrome.We describe a novel operative approach and technique for release of the piriformis muscle in the treatment of piriformis syndrome. Described are the preoperative planning, incision and approach, and technique for identifying and releasing the piriformis muscle.Three patients were treated for piriformis syndrome using the described technique. Each patient displayed successful relief of their symptoms immediately following the surgical procedure and at delayed follow-up.Early experience with our method of piriformis release suggests that it is well suited for the treatment of piriformis syndrome. The novel integration of pre-operative trigger point localization coupled with intraoperative neuromonitoring allows effective pain relief with minimal morbidity. Piriformis syndrome (PS) is a controversial and uncommon condition that is characterized by symptoms caused by irritation or compression of the sciatic nerve as it travels underneath the piriformis muscle just distal to the sciatic notch . It is sThe treatment of PS has traditionally been conservative in nature with noninvasive treatment including activity modifications, physical therapy, and use of anti-inflammatory medications, muscle relaxants, and/or neuropathic pain medications , 5. WhenA series of 3 patients were chosen to undergo this surgical technique for treatment of PS. They were treated between 2012 and 2016 by the senior author. The 3 patients selected had all failed conservative management and met the criteria for surgical intervention. Institutional review board (IRB) approval was not obtained because it was not required for case reports or case series at our institution. Our hospital IRB states that cases with 4 or less patients do not need to be reviewed. Additionally, all patients mentioned in the series were of the investigators’ own patients involved in direct patient care. Therefore, consent from the patients used in this study was not obtained because this study is exempt under 45-CFR-46.Prior to surgical selection, the 3 chosen patients underwent a thorough examination and workup. Furthermore, they all had to attempt conservative medical treatment including steroid injections and physical therapy for at a minimum of 6 weeks. Given their presenting symptoms, the number one differential to rule out was lumbar radiculopathy. Therefore, they all underwent magnetic resonance imaging (MRI) of their lumbar spine, which were negative for any pathology that could explain their current symptomology. Additionally, the senior author of this paper, a board certified neurosurgeon who has been working in neurosurgery and with peripheral nerve disorders since 2003, examined and selected each patient for surgical intervention.The first step for the surgical treatment of PS was to localize the trigger point in the pre-operative area and clearly mark it with a marking pen. This is the critical step in our new technique, because the trigger point was used as the entry point for a surgery. Applying firm point pressure in multiple areas around the anatomical location of the pisiforms muscle until the exact location is found that recreates the patient’s sciatic nerve pain and is how the trigger point is identified. Once in the operating room, the patients were placed under general anesthesia and positioned prone on the operating table. Then, a 3–4-cm incision was drawn with the trigger point as the midpoint of the incision along the direction of the piriformis muscle between the sacrum and the greater trochanter of the femur. The patients were then prepped and draped in a standard surgical fashion.Following draping, 10 cc of 0.25% Marcaine with epinephrine was injected into the epidermis and dermis layer. Following incision with a 10 blade, a secondary knife and a monopolar were used to cut down through the subdermal fat layer until the fascia over the gluteus maximus was identified. An Adson-Beckman retractor was then placed. Subsequently, Metzenbaum scissors were used to cut the fascia over the gluteus maximus, and a tonsil dissector was used to bluntly dissect through the gluteal muscle until the inner fascia is identified  with stimulation at 0.5 mA producing muscle twitches in the distribution of the sciatic nerve. A hand-held retractor is used to elevate the piriformis muscle in this process Fig. . After tThe fascia overlying the gluteus maximus is then closed with interrupted 2-0 Vicryl sutures and the dermis with interrupted 3-0 Vicryl sutures. The skin is closed with a running 4-0 subcuticular Monocryl and steri-strips. The patient is discharged from the recovery room with standard post-op follow-up.The described surgical technique was performed in three patients who failed conservative management. The first patient was a 70-year-old female with a 3-year history of left buttock and leg pain. She underwent multiple lumbar epidural injection and two lumbar foraminotomies without any relief. She was found to have a trigger point in the region overlying the left piriformis musculature and sciatic nerve. She did not undergo EMG studies of her lower extremities at our facility. She failed conservative management with physical therapy and 2 trigger point injections with only temporary resolution of her symptoms. Given the resolution of her symptoms with trigger point injections, the decision was made to proceed with surgery.The second patient was a 51-year-old female with a 1-year progressive history of right buttock pain that radiated down the right leg. Her lumbar MRI was negative, and she was found to have classic symptoms of PS including a trigger point at the piriformis musculature overlying the sciatic nerve on the right. She failed conservative management of physical therapy, medications, and trigger point injections. Her EMG findings were inconclusive. Given her continued pain and failure of conservative management, the decision was made to proceed with surgery.The third patient was a 39-year-old female with a multi-year history of pain that started in her right buttocks and radiated down her right leg. She was diagnosed with PS and had a classic trigger point at the piriformis musculature overlying the sciatic nerve on the right. She failed conservative management with physical therapy and trigger point injections with only temporary relief. Her EMG results were inconclusive. However, given her temporary relief with the trigger point injections, the decision was made to proceed with surgery.All of our patients had immediate relief of their symptoms after surgery. Our median length of follow-up was 12 months with a range of 6–18 months postoperative. All 3 patients returned to clinic for their scheduled 2-week postoperative exam and incision check. Additionally, they were all seen in clinic at 3 months and 6 months postoperatively. One patient moved after her 6-month follow-up, and the last 2 were seen at 12 months and 18 months, respectively. At their last follow-up, 2 out of the 3 patients were still completely symptom free with the third patient reporting pain associated with lumbar radiculopathy at her 18-month follow-up She was symptom free for 12 months following her surgery but developed a new pain in her left leg that she stated was different from her initial sciatic pain. This new pain was successfully treated with conservative management. There were no surgical complications with any of the patients.PS is a controversial condition in which the sciatic nerve is compressed by the piriformis muscle causing buttock and leg pain. Patients typically have a classic trigger point in the region of the piriformis muscle overlying the sciatic nerve , 8. PS aTraditional open surgical treatment of PS consists of a long curvilinear incision in the shape of a reverse question mark around the entire lateral aspect of the gluteus maximus with an inferior stem at the base of the gluteus into the midline of the hamstring muscle. The gluteal muscle is then divided and reflected medial to expose the sciatic nerve. The nerve can then be traced up to the sciatic notch, relieving any constrictions on the way. The open method is a beneficial approach because it allows full exposure of the sciatic nerve and important vasculature in the area , 8, 12. Endoscopic surgical treatment of PS consists of the placement of two ports in the thigh using the femur as the primary landmark. The first port is placed 1 cm superior to the tip of the greater trochanter, while the second port is placed approximately 6–7 cm distal from the first. The ports are placed through small stab incisions in the skin. The sciatic nerve is then identified, and any constrictions are released with the use of an endoscope . The benAs an alternative to the above procedures, the minimally invasive approach described in this manuscript provides the advantages seen in both the traditional open and endoscopic methods. Our surgical approach provides excellent visualization of critical structures with minimal morbidity and short hospitalization. With the small incision and direct corridor to the nerve constriction, this minimally invasive approach can be mastered without requiring the steep learning curve as seen in the endoscopic approach. Most importantly, bleeding and injury to surrounding structures are less likely and easier to control as compared to the endoscopic method. Additionally, all three of our surgical procedures using this technique were performed as outpatient procedures with long-term pain relief without prolonged hospital stay and increased morbidity as seen in the traditional open surgical technique.The primary limitation of our study is the small sample size with only 3 patients treated, and they were all women. Given that piriformis syndrome does have a 6:1 female to male ratio, it is not surprising that with such a small sample size, all outpatients were women. The small sample size of our study is due to the low incidence of piriformis syndrome already mentioned and the even lower incidence of patient’s who require surgical intervention, which should be reserved for medically refractory cases . In addiThe primary limitation of this surgical technique is that it requires neuromonitoring in order to carry it out correctly. Neuromonitoring can be an expensive addition to surgery and is not always readily available. Additionally, only clinicians that have a basic understanding of peripheral nerves and gluteal anatomy should perform this surgical technique.This minimally invasive technique for treating piriformis syndrome is an effective treatment for this patient population. The positive results seen in our patients utilizing the novel integration of pre-operative trigger point localization coupled with intraoperative neuromonitoring make this surgical approach an attractive option.


Gingival recession is a common finding in the adult population. It is considered a challenge for clinicians to obtain a complete root coverage of Miller class III recession. The aim of this case series was to assess the outcomes achieved with the use of modified VISTA technique (m-VISTA) in patients having multiple Miller class III recessions after 6 months.Ten patients , who showed multiple Miller class III recessions (depth ≥ 2 mm) and who met the established inclusion and exclusion criteria, were treated by postgraduate students with the use of m-VISTA technique.A total of 38 recessions were performed. The recessions were mainly located in the mandible (80%), which included six molars. The mean baseline recession was 3.12 mm. Post the intervention, a mean root coverage of 58.72% was achieved, with complete root coverage observed in 29% of the recessions.m-VISTA may offer several advantages in the treatment of Miller class III gingival recession. Nevertheless, more clinical trials with a longer follow-up period are needed to arrive at a concrete conclusion about its advantages.Trial registration: NCT03258996.Data registration: 08/18/2017.The online version contains supplementary material available at 10.1186/s12903-021-01511-5. Periodontitis is considered to be the sixth most prevalent disease worldwide . If not Over the last few decades, multiple surgical approaches have been described for the treatment of this type of recession , 9. ThesUntil now, the evidence regarding root coverage in Miller class III recessions  has beenvestibular incision subperiosteal tunnel access (VISTA) [While CAF  has been (VISTA) , have be (VISTA)  consists (VISTA) . While t (VISTA)  in the m (VISTA) .The aim of this case series is to present the modified VISTA (m-VISTA) technique in a step-by-step manner and describe the results that are obtained in 6 months after the treatment of multiple Miller class III recessions   were consecutively enrolled between January 2018 and February 2019 after obtaining their informed consent. All patients included in this clinical study were explored clinically and radiographically to establish a precise periodontal diagnosis. Patients who showed multiple Miller class III recessions [1–61) werPatients presenting multiple Miller class III recessions   using a calibrated periodontal probe . Calibration analysis was performed by measuring the multiple recessions of four patients who did not take part in the study during the two different visits, which were at least 24 h apart. The intraclass correlation coefficient was > 0.75%. The following clinical parameters were assessed at baseline and 6 months after the surgery: probing depth , gingival recession , width of the gingival recession , width of the keratinized gingiva , distance from the contact point to the interdental papilla , patient’s full mouth plaque index (FMPI) , and fulThe patients’ perceptions of acute post-surgical pain were assessed using a pain diary designed by the UPV/EHU. An additional file presents this in more detail  to the most likely esthetic outcome (VAS = 100). Finally, the presence or absence of postsurgical complications (PSCs) was recorded.Patients were instructed to rinse their mouths with a mouthwash (0.12% of chlorhexidine digluconate) for a minute prior to the surgery , extending it sufficiently beyond the mucogingival line into the alveolar mucosa. This is done first through a vertical incision and then through gingival margins, completely releasing the tunnel-papillae complex, thus facilitating its passive coronal replacement Fig. b.Next, a CTG with a thickness of approximately 2 mm and a sufficient length to cover the lesions was harvested on the same side of the palate using the UPV/EHU technique  Fig. 1cc1c. The By using the positioning suture, the CTG was placed through the vertical incision. The needle was inserted in the most distal gingival sulcus, crossing the tunnel and coming out through a single vertical incision. Following the piercing of the graft, it returned through the tunnel following the same route. The same procedure was repeated in the mesial direction. The graft was easily and precisely placed in the recipient site with the assistance of a periostotome and by pulling the suture slightly.The graft and tension-free tunnels were simultaneously sutured and coronally replaced. The suturing of both the CTG and the flap with vertical double-crossed sutures , anchoreThe post-surgical protocol included the following steps: (a) taking amoxicillin 875 mg/clavulanic acid 125 mg  orally every 8 h for 7 days; (b) taking ibuprofen 400 mg  orally every 8 h for 2 days; (c) carrying out mouthwashes with chlorhexidine digluconate 0.12%, twice a day for 6 weeks; (d) avoiding the brushing of the surgical site during the first 3 weeks post the intervention; (e) local application of cold for 2 days; and (f) having a soft diet, avoiding trauma in the treated area and avoiding physical exercise during the first week after the surgery. According to the protocol, ibuprofen had to be taken for 2 days. The patients were instructed to lengthen this period if necessary and record this additional medication intake in the pain diary.Sutures were removed from the palate and the recipient site for weeks 1 and 2 after the surgery  performed the statistical analysis using IBM® SPSS® Statistics 20 software. A patient was considered as the unit of analysis. Clinical attachment level (CAL) was calculated (CAL = PD + REC) at the baseline at the 6 months mark , none of them were alcoholic or drug abusers. All patients showed good oral hygiene, with the mean plaque control (FMPI) being 13.50 ± 6.69% and the bleeding index (FMBI) being 8.94 ± 4.43% , which included six molars. These recessions showed a mean PD of 1.80 ± 0.52 mm, a mean REC of 3.12 ± 0.89 mm, a mean CAL of 4.93 ± 1.29 mm, a mean GRW of 4.37 ± 1.13 mm, a mean KGW of 2.63 ± 1.22 mm, and a mean CP-IP of 2.51 ± 1.46 mm  of the patients had no pain. Only two patients were referred to have had pain 1 week after the surgery  , and forWith respect to MRC, our results were more modest than those reported by a recent study , in whicAnother important factor would be the characteristics of the gingival recession at baseline , 12, 25,In addition, the location of the recession could influence the success of the treatment, as the mandible  and the With regard to the type of graft used or the harvesting location, together with the surgical technique, the differences have also been reported. Gil et al. 2018  harvesteAnother controversial issue is the thickness of the CTG when treating Miller class III recession . EsteibaTo our knowledge, no study on mucogingival surgery has assessed post-surgical acute pain with a VAS scale at so many follow-up points; however, it has been applied in trials in which impacted wisdom teeth were extracted , normallFinally, it should be noted that the present study has a few limitations, such as it being a case series with a limited number of patients and recessions. The sample was obtained from a university clinical setting, where the patients’ expectations were not very high. This would also explain the high VAS values observed when assessing the esthetic outcome. In addition, the operators had low surgical experience and the Miller class III recession was difficult to treat; however, reasonable short-term outcomes were achieved.Within the limitations of this case series, it can be concluded that the modified VISTA technique offers several advantages in the treatment of Miller class III gingival recession.More clinical trials with a longer follow-up are needed when Miller class III recessions are treated with different mucogingival surgical techniques that use the same kind of graft and assess the patients’ perception.Additional file1. The pain diary specially designed at our university to register the patients’ perceptions of acute post-surgical pain, for there is no evidence of post-surgical pain in mucogingival surgery during the first 24 h. The UPV/EHU-Pain Diary has two pages. In the first page, all the recordings are registered, and in the second page, there are instructions for the patients, and an explanation of how to fill the pain-diary. The recorded parameters in this UPV/EHU-Pain Diary were as follows: highest intensity of perceived pain , minutes of the duration of this perceived pain, and additional drug intake by the patients apart from the initially prescribed treatment. The UPV/EHU-Pain Diary should be recorded until the pain disappears.


Pain control is an essential component of musculoskeletal injury treatment in the emergency department (ED). We evaluated the most effective type of cryotherapy for analgesia of acute musculoskeletal injury and the impact on opioid utilization.This was a prospective, randomized, single-blind controlled trial of adult ED patients who presented with acute musculoskeletal pain. Patients were randomized to either intensive targeted cryotherapy (crushed wetted ice in a plastic bag) or agitated chemical cold pack applied to the injury site for 20 minutes. All other diagnostic and therapeutic orders were at the discretion of the treating physician. Visual analog pain scores were measured at the time of cryotherapy application, at 20 minutes , and at 60 minutes .We enrolled 38 patients, 17 randomized to intensive targeted cryotherapy and 21 to chemical cold packs, with well-matched demographics. The intensive targeted cryotherapy group achieved significantly greater pain relief at 20 minutes , 1.3 – 2.9] vs 0.9 , P < 0.05) and at 60 minutes , number need to trial (NNT) = 3.2. Opioid administration in the ED was significantly lower in the intensive targeted cryotherapy group , NNT = 3.6. Those who received a discharge opiate prescription had significantly higher 60-minute pain scores .Intensive targeted cryotherapy provided more effective analgesia than chemical cold packs for acute musculoskeletal injuries in the ED and may contribute to lower opioid usage. Musculoskeletal injuries are the most common class of presenting complaints for emergency department (ED) visits, with pain relief being the primary reason for seeking medical care.3A common ED practice is the application of chemical cold packs (CCP) to the skin of the injured area for rapid analgesia. However, wetted crushed ice  in a plastic bag has been found to produce lower skin surface temperatures than a CCP after 15–20 minutes.Opioid pain medications are often used for analgesia in the ED, with 15% of all adult patients from 2016–2017 receiving a prescription for opioids upon discharge.pm and 9 pm. The study was approved by the institutional review board .This was a prospective, randomized, single-blind controlled trial conducted in an academic tertiary Level I ED with more than 70,000 annual patients. From February–April 2016, research assistants enrolled patients daily between 12 Eligible patients were aged 18–65 presenting with complaints of acute musculoskeletal pain. They were identified based on chief complaint and triage note in the electronic health record. Exclusion criteria included trauma activation, patients with a known pregnancy, open fracture or obvious deformity likely to require closed reduction, hip fracture, altered mental status, or if the patient was receiving an investigational drug as part of an ongoing trial. Trained research assistants approached eligible participants in the waiting room where informed consent was obtained and cryotherapy initiated. Participants enrolled on even days of the month were randomized to CCP, and those on odd days received ITC.Participants received either an activated CCP  applied to the skin at the site of injury, or wetted crushed ice that was double-bagged in thin, sealed plastic bags and wrapped in place by plastic wrap, both by an ED technician. Based on the thermodynamics of the CCP, optimal sustained cooling by CCP alone would require replacing the pack every nine minutes.What do we already know about this issue?Anecdotes and literature from other fields of medicine demonstrate that cryotherapy has analgesic effects for patients with musculoskeletal (MSK) injuries.What was the research question?Does intensive targeted cryotherapy (ITC) relieve pain or reduce the need for opioid pain relievers in the ED?What was the major finding of the study?Compared to usual care, ITC is an effective analgesic and is associated with lower opioid utilization.How does this improve population health?Cryotherapy holds promise as a safe and effective alternative to opioids for patients with acute MSK injuries, and thus could help address the opioid epidemic.Pain severity was measured using a validated 100-millimeter (mm) visual analog scale.The primary outcome was the change in pain severity at 60 minutes, at which time tissue temperatures post-cryotherapy are shown to have returned to normal.2. P-values < 0.05 were considered significant and 95% confidence intervals (CI) were used. We conducted all analyses using IBM SPSS Statistics .We calculated outcomes per intent-to-treat analysis. To achieve 80% power , 38 participants were required to detect a difference of 13 mm in pain severity score. Pain score change was analyzed by t-test, administration of opioids or benzodiazepines in the ED by Fisher’s exact test, and discharge prescriptions by χP = 0.97).There were 57 patients who were initially considered eligible, with 38 who consented, enrolled, and were analyzed for outcomes. Twelve individuals refused participation on CCP days, and seven on ITC days. Baseline characteristics were similar between groups . Two patP = 0.31). The ITC group achieved statistically significant pain reduction at 20 minutes , P < 0.05) and 60 minutes   and CCP groups   < 0.05) . At 60 mP = 0.69) nor in absence of pharmacologic analgesia during the visit . The likelihood of a participant receiving opioid prescriptions was not correlated with injury type (P = 0.47). One (6%) ITC participant received opioids in the ED compared to seven (33%) in the CCP group (P < 0.05), with a NNT of 3.6 for ITC to reduce one patient receiving opioids.There was no significant difference between the groups with non-opioid analgesic or non-steroidal inflammatory use , but prescriptions were not significantly associated with injury type (P = 0.47). There was no statistically significant difference in discharge opioid prescriptions  nor when prescriptions included benzodiazepines . Non-opioid discharge prescriptions were provided to four (24%) participants in the ITC group and five (24%) participants in the CCP group, with similar absence of discharge prescriptions between the groups . There were no adverse events in either group and the respective cryotherapy modality was in position at the site of injury at 20 minutes for all participants before being removed by staff.Those who received a discharge prescription for opioids had significantly higher pain scores at 60 minutes . However, our primary outcome of pain at 60 minutes was selected to allow for tissue temperature normalization and greater clinical relevance.It was not logistically feasible to include a placebo arm, but as participants were blinded to which treatment arm was experimental and which was an active control, this unlikely affected the primary outcome. Possible selection bias was mitigated by allocating participants to treatment arms based on the day of the month, and by separating the roles of various members of the research team. Specifically, the research assistants were trained to enroll and consent participants for the study, so long as the inclusion criteria were met (and the exclusion criteria were not), regardless of the day of the month. These research assistants were blinded to the hypotheses of the study and were undergraduate students with training in Health Insurance Portability and Accountability Act requirements and informed consent . Although the chart reviewers were blinded to treatment received, it was impossible to blind the treating physician; thus, the potential impact this had on analgesics is unknown. However, as no treating physicians were aware that analgesia was a studied variable in this trial, it was unlikely that awareness of cryotherapy type effected opioid usage.Although participants were enrolled in triage prior to a physician encounter, the time between cryotherapy application and physician interaction was not standardized and could have influenced pain severity and the likelihood of opioid administration. Finally, because the CCP did not likely stay as cold as the crushed ice for the full 20 minutes of application, the beneficial effect shown could be explained by the duration of effective cryotherapy received by participants. Measuring pain scores at 60 minutes attempted to account for tissue temperature equilibration, but our methodology may underestimate the analgesic potential of CCPs.Intensive targeted cryotherapy provided more effective analgesia than chemical cold packs for patients with acute musculoskeletal injuries in the ED and may contribute to lower opioid usage.


The clinical follow-up of patients for degeneration of the supraspinatus tendon is limited by the lack of objective assessment of pain evolution over time. We therefore tested a new method to collect follow-up data on patients treated either by surgical cuff repair or rehabilitation.We report the feasibility this method in terms of recruitment of clinicians and patients and their compliance.In this multicenter longitudinal observational study, between September 2015 and March 2019, patients consulting either for surgical repair or rehabilitation were examined at baseline and after twelve months by their clinician, including the Mini-DASH questionnaire. Fortnightlys, during one year, patients were asked about number of days their shoulder problem affected their daily life, number of nights woken up from shoulder pain, and present pain score, using text-messages for sending and responding to questions. A system administrator supervised responses and non-compliant subjects were contacted and assisted with the procedure. The CONSORT statement for pilot studies was followed.and had clinical data at twelve months, i.e. 39% of the intended study sample and 72% of the 222 subjects with SMS data.Four of 11 invited clinicians accepted participation and collected data till the end. Of the 410 patients we originally planned for, 252 were included in the study, but complete data for the clinicians’ follow-up at 12 months were missing for 30. Of the 222 subjects with SMS data files, 190 (85%) provided at least 80% of their fortnightly messages. All three SMS messages were answered equally often. In total, 160 study subjects answered at least 80% of times The most important difficulty of this study was the enrolment and compliance of clinicians. The collection of SMS data was less successful than in previous studies, but French people accepted well this new method which is much easier and specific than collecting data through clinical records. The quality of the SMS data was acceptable. However, because of the limited number of complete datasets, only a limited number of questions from the original study protocol can be answered. The rotator cuff consists of a group of four muscles with their tendons that stabilize the shoulder. These are the supraspinatus, infraspinatus, teres minor, and the subscapularis muscles. Painful shoulders associated with degenerative pathologies of the rotator cuff are a public health issue due to their prevalence, cost of care, and the disability they may cause , 2. EpidThe degeneration of the rotator cuff starts as a subacromial impingement syndrome that is considered as an initial step according to the Neer theory . It evolAlthough a painful shoulder often is believed to be directly linked to one or several degenerated tendons, there is a discrepancy between the degree of degeneration and pain. Thus, we have previously shown that the prevalence of the degenerative rotator cuff lesions increases linearly throughout life and that, although the prevalence of shoulder paint also increases with age, pain is reported to a much lesser extent, to rather diminish in later age .Treatments of these conditions are mainly conservative  or surgical . Rehabilitation is mainly done first and surgery when conservative treatment fails. But, according to the literature, there is no difference between these two approaches in terms of short or long term outcome .In the case of the degenerated supraspinatus tendon, passive movement of the shoulder is rarely affected, concerning mainly large rotator cuff tears . During Presently, clinical development (the trajectory) of the degenerated rotator cuff is not well understood. Clearly, the clinical study of this condition depends on two major factors: the assessment of pain and its monitoring over the time.Therefore, the objective assessment of pain is the biggest challenge of the clinical examination and in research. There are several explanations. In clinical practice, monitoring of pain is quite often « incomplete » because control consultations are necessarily apart. These time intervals may contribute to modify the evaluation of the past pain provided by the patients (memory decay) . Pain isOur knowledge is still unclear regarding the mode of progression of pain, whether in relation to the prognosis after treatment or its natural course. Current conventional surveys or clinical studies have the same problems, as the monitoring of pain is difficult to perform . TypicalUntil now, data collection for clinical and research purposes has been through retrospective reporting  but new technology, using an electronic data collection method, makes it possible to collect frequently longitudinal data cheaply and with a much better compliance . FurtherIn conclusion, there are multiple unanswered questions regarding the evaluation and the evolution of pain associated with degeneration of the supraspinatus tendon as well as the choice of the most appropriate treatments and their ranking based on outcome. The use of a better method of collecting data in the clinical setting and in surveys would help providing answers to these questions. We therefore planned a study, in which various treatment approaches would be monitored in a multicenter study, using the answers given on frequent automated text messages (‘SMS’) over 1 year.This type of data collection has been used in previous studies, particularly in the Nordic countries , 14–18. The aim of this study was to test the feasibility of this method to collect data for treatments of the degenerated supraspinatus tendon using a dual follow-up: classic medical assessment and SMS track.The objectives of the study were to report on the various hurdles throughout the data collection that had an effect on the final study sample. Thus, we reported on the number of data collecting clinicians, the number of patients who entered the study and completed the study, separating these by those who i) had complete patient files and ii) those who had complete (> 80%) SMS responses over the year of data collection, and combining these two variables into iii) those who had both. Thereafter, we planned to comment on the problems that were identified, provide remedial suggestions, and, if relevant, give advice on future similar studies undertaken in French populations. The CONSORT statement for pilot studies was followed.This is a multicenter observational study of patients consulting in the primary or secondary sector, treated with current modalities for pain believed to be related to degeneration of the supraspinatus tendon. As this was a multicenter practice-based study, treatment was decided by clinicians according to their usual clinical approach and no attempt was made to guide or monitor their activities. All clinicians filled out a base-line questionnaire provided by the researchers. The clinical monitoring with the treating practitioner was also standardized to take place at baseline and at three, six and 12-months. In addition, a questionnaire was answered by the patient at baseline and the one-year assessment. Meanwhile, patients were surveyed by the research team using SMS every 2 weeks during 1 year from the beginning of the treatment period via three questions with simple quantitative answers.Patients were recruited consecutively in health practitioners’ offices of the primary or secondary sector. Adult patients, who were treated for any kind of shoulder pain related to degeneration of the supraspinatus tendon, who consulted the participating clinicians, were eligible. Additional inclusion criteria were that they were French speaking, that they had a cell phone, and that they knew how to use text messages.Non-inclusion criteria were: pain occurring after severe trauma , shoulder instability, presence of neuropathic pain or an associated complex regional pain syndrome, suspicion of frozen shoulder syndrome, presence of glenohumeral osteoarthritis on the radiological report, symptomatic acromio-clavicular osteoarthritis, calcific tendinopathy, diabetes, rheumatic, neurological, inflammatory or secondary pathologies. Patients with severe pathologies, such as cancer under treatment or inflammatory disease were also not included.Baseline data were recorded by the treating clinicians at the first visit and included personal data, initial examination findings, the mini-DASH questionnaire , diagnosClinicians invited to participate consisted of a convenience sample of orthopedic surgeons, other medical practitioners, physiotherapists, and a physiotherapist/chiropractor all with a professional experience exceeding 10 years. Personal contacts were made with these persons, including two meetings for one group of practitioners working in the same center, to create interest and encourage participation. Both the main supervisor (OG) and the research officer (KV) participated in the data collection.Patients were recruited by the practitioners who participated in this study. The latter briefly explained the purpose of the research, that baseline and follow-up data would be recorded, and that participants were expected to respond via text messages over a one-year period to simple questions sent on their mobile phone about the pain and daily activities. They were also informed that participation was voluntary and that all data analysis and reporting would be anonymous, making it impossible to identify any participants. Patients who accepted participation were recruited into the study by the treating clinician. Absence of refusal was recorded at the first visit according to French law. To be included in the study, patients had to send a first SMS to the SMS-Track System after having been provided with the telephone number by their clinician. Then, a research assistant would call the participants to explain how to answer the questions. The nature and frequency of the questions were specified. Patients who agreed to participate but failed to transmit their phone number to the SMS-Track System would thus appear to be included in the study but would not have any SMS data, for which reason their data would be unexploitable.Impingement syndrome: shoulder pain with “normal” X-rays and ultrasound, showing at the most an effusion of the sub-deltoid bursa.Tendinopathy without tear: “normal” X-rays (i.e. no degenerative joint changes) and ultrasound showing tendon lesions  without any perforation.Incomplete perforating tear of the supraspinatusComplete supraspinatus tearDiagnosis was based on an orthopedic examination supplemented by basic imaging, usually at least an ultrasound and an X-ray of the shoulder . Surgery would either consist of an arthroscopic or open tendon repair procedure, which would typically be performed after a failed rehabilitation treatment or directly in case of a big supraspinatus degenerative tear. The conservative treatment mainly involved rehabilitation, supervised or unsupervised, sometimes accompanied by manual therapy, acupuncture, medication or injections. All previous treatments were noted, as shown in Additional File Clinicians filled out an initial assessment form at the first visit, representing the base-line examination, including the patient’s personal data, results of the clinical history, the physical examination, the additional screening tests, and the final diagnosis on the type of lesion encountered  applied, possible sick leave, if the patient continued to perform the painful shoulder movement activities (work or leisure), and shoulder incapacity . This system has shown to have high compliance in the collection of data, especially when prompted answers are short and simple. It has also ensured, in previous research, a very high level of response, up to 90% .It has been noted that it enables an effective collaboration and compliance of the study participants, when clear information is given to them from the start of the study. All data collected by the system was directly and immediately accessible by the administrator who was able to contact participants, who did not answer or gave inappropriate answers.How many days did your shoulder bother you from doing your daily life activities during the past 2 weeks? (answer between 0 and 14)How many nights did your shoulder wake you up during the past 2 weeks? (answer between 0 and 14)Score between 0 and 10 the maximum pain you experienced yesterday during the day?The questions asked were:Data collection related to the clinical visits were recorded on paper files that were entered in a database after the 12 months assessment. The SMS Track data were automatically entered into a data file without any personal information except the phone number. Non-responders or people who misused the answer instructions were contacted individually by the research assistant and taught how to answer correctly. The only link between the written clinical file to the text-message file was the person’s telephone number. The databases were merged prior to any analysis, and the telephone numbers removed after generation of a random index.The three text message questions were sent and received from a server as encrypted messages. Collected data were not stored in the server but in a computer without internet connection.Sex, work, sport, and leisure activities, activities with arm-in-the-air, stress during these activities, education level, place of initial consultation when entering the study, type of diagnosis, severity / chronicity of the supraspinatus degenerative lesion, and the mini-DASH disability questionnaire score.Type of treatment and type of supraspinatus lesion.Number of days with bothersome pain, number of nights waking up because of pain, number of days with certain (to be defined) level of disability. Different trajectories of pain . These data will be provided by the SMS-Track software. The levels of disability and pain at the various follow-up times will be determined through the mini-DASH score and additional questions asked by the clinician.In the main study, the following analyses were planned:Base-line data: A descriptive analysis will be done of the clinical and demographic data on the participants. The follow-up data involving the Mini-DASH questionnaire will be reported at the end of the follow-up visits and compared to the base-line scores.The SMS data will be used to determine the evolution of the supraspinatus painful lesion, to establish subgroups that can be treated as discrete variables. Such subgroups could be described based on their trajectory curves over 1 year, describing for example, time to improvement and time to new events, They can also be used to classify different patterns in relation to pain reporting, such a presence of more or less constant pain, presence of intermittent pain, almost no pain. The total number of days of pain can be taken into account as well as the individual evolution curves over the one-year period. The analyses will therefore depend to a large degree on the look of the data.n = 10, woman n = 10) [In the perspective of a multivariate analysis, the basic sample is estimated at 50 patients. Each possible response to the additional different variables studied increases the size of ten subjects (i.e. sex: man  n = 10) . The numThe total number of days with pain recorded with text messages will be compared to the pain duration at the 12 months follow-up visit as estimated by the clinicians, using percentages with a 95% confidence interval. The type of pain evolution over time reported with text-messages will be assessed by visual analysis and compared to the final category reported by the physician . Independent prognostic parameters  will be tested in a bivariate analysis. Ideally, other variables  should be tested in a multivariate analysis to search for independent relationships with the two treatments groups and the major diagnostic groups, also controlling for treating clinician.This observational study did not present any specific risk since patient care did not differ from the current practice of each practitioner involved in the study. All received text messages were encrypted and the data were totally anonymized before any analysis by substitution of the phone number by a random index number, therefore, the results were analyzed and reported anonymously. In the paper files completed by the practitioner the phone numbers as well as the initial letters of the name and surname of the patients were removed physically, this means that also paper files are rigorously anonymous.The three neutral encrypted questions sent by SMS and the answers, leading to three meaningless numbers that were sent back at random time, were very unlikely to be intercepted and used maliciously by external persons.Given the use of information technology via the Internet and the use of potentially sensitive patient data, an authorization was obtained, according to French law, from « Commission Nationale de l’Informatique et des Libertés »  and fromAn SMS Track pilot study was conducted to test its applicability in France. Seventeen patients were selected according to the previously described criteria over a period of 1 month. All subjects answered correctly to the SMS questions and we assumed that the study procedure would be acceptable.Among eleven physicians who were asked to participate, nine initially accepted to be involved . Each practitioner was asked to include 50 patients during the year of inclusion, which would result in 450 patients, a sufficient number even if there would be some dropouts. Finally, only five of them included patients. One of the five stopped because of health problems before the end the of inclusion phase. Thus, three orthopaedic surgeons and one physiotherapist/chiropractor (the research officer) completed the study.Table The recruitments started gradually in September 2015. The aim was to include the 410 patients over a period of 1 year, i.e. until September 2016, to have received the follow-up on the last patients by September 2017. Because the insufficient number of patients, we had to increase the inclusion period for 6 months and prolong the follow up period until March 2019. Despite this modification, the objective of 410 subjects could not be achieved. The main cause was the lack of compliance from the clinicians.Regarding the clinical files, 206 patients were included; among them 17 decided to leave the study. Finally, 189 patients were recorded with a clinical file. Of these, 109 had a complete file , and 179 had information from at least the first and the last visits, with at least (the important) question 15 from the last visit, whether recorded at the medical visit or by phone.Regarding to the SMS data, 223 started the data collection, of which one dropped out. Out of these 222 SMS files, 30 were found not to have a corresponding clinical file. Unfortunately, the SMS files included only the phone number and no information about the clinician in charge of the patient. Since phone numbers for anonymity reasons had been removed before any analysis of the files, it was impossible to track efficiently these missing clinical files. Out of the 222 files, 190 (85%) had completed at least 80% of the fortnightly text messages.Finally, for 160 study subjects there were both a clinical file and at least 80% of the fortnightly text messages. This corresponds to 160/410 (39%) of the intended study sample, 160/222 (72%) of those who had provided any type of data at the end, and 190/222 (85%) of the subjects with SMS data.Concerning the diversity of health professionals our objective was to obtain a range of patients with supraspinatus lesions, because, it was likely that the mildest cases would preferentially have gone to a private practice while the most important cases would have gone to larger clinics and the hospital. The different geographical locations of the centers and practices were likely to contribute to the diversity of tendon lesions too.The sample size was much lower than expected but the quality of the clinical files for the initial assessment was noted to be acceptable during data entry, but the 12 months follow-up had clearly been difficult to obtain. Nevertheless, the most important question (Question 15), on shoulder incapacity, which would be used to compare the information collected during 1 year by SMS data, was secured either by telephone interview or by mail, if the last follow-up visit data were missing.We concluded that it would be possible to establish the pain trajectories using the SMS data over 1 year in 190 study subjects, 50 surgically treated subjects and 140 who were treated conservatively. The difference in numbers was explained by the fact that we failed to recruit a sufficient number of surgeons into the study.Because of the small study sample, bi-variate analyses would be possible only for a limited number of predictor variables vs. a limited number of pain trajectory types. Nevertheless, it would be possible to visualize the SMS trajectories for numbers of days with pain, number of nights waking up due to pain, and the severity of pain over 1 year and to do this for the two treatment types . For the same reason , only preliminary analyses should be performed to test the associations between baseline variables and trajectories, and to make a comparison between question 15 and SMS trajectories.In this study, we collected frequent text-message data over 1 year on patients who were either treated by rehabilitation or surgical cuff repair for degeneration of the supraspinatus tendon. Although this method of data collection has been used previously with success for other musculoskeletal problems, it was the first time it was used in France and on other problems than the spine. We were interested to see, how easily it could be implemented in a culture often considered to be somewhat “non-compliant”.The weaknesses of this study were mainly related to the data collecting clinicians, who were non-compliant both in relation to recruiting patients and to complete correctly and return data files. This is a common phenomenon among clinicians, who are not directly implied in a research setting. This difficulty was probably worsened because the main investigator of the study was unable to accompany the clinicians appropriately over a long period of time for health reasons.The lack of participation by clinicians has probably not biased the results in relation to severity of problem, as they had nothing to “prove” by including or excluding patients in the study. It was probably more a question of clinicians’ lack of time and interest. Clearly, all patients were not called in for the pre-planned follow-up visits or did not wish to attend. This became more marked towards the end of the follow-up period. Patients consulting an orthopaedic surgeon but not operated would probably not be interested in returning for control visits several times for a year. Fortunately, we had anticipated this difficulty by making it possible to collect the most important information through a telephone interview.As soon as the patient has accepted to participate, SMS data collection worked well; better than the clinical follow up. The data collection manager did not encounter any particular problems when checking that patients used the SMS system properly. In general, there were only some technical problems related to the phone or problems understanding the three questions asked. The only difficulty encountered concerned the duration of the follow-up period. Approximately 20% of the subjects in the SMS file had to be reminded and re-motivated to complete the study till the very end. Thus, their compliance was quite acceptable in relation to the text messaging, indicating that the general public find it easy to respond to text messages and that this type of study can be carried out also for shoulder problems.The missed follow-up visits of patients either early or later related rather to the clinical files, so whatever the reason, recovery or non-recovery, this would not affect the trajectory analyses, which would be based on the SMS data that continued to be provided by the study subjects.Other strengths of this study were that it made it possible to observe the clinical reality, as it was carried out as a multi-center practice-based project, involving ‘ordinary’ patients and clinicians, who were aided in their recruitment procedure by a clinically relevant recruitment manual. The SMS track system limits as much as possible the memory decay and also memory recall bias since the intervals between the interrogations are very short and unrelated to contact with the treating clinician. Tracking continuously the evolution of pain should provide information regarding the different patterns of pain course over time, which cannot be obtained through ordinary retrospective questionnaires.To collect information via SMS system is much easier than via clinical records. In some studies, focusing mainly on pain and function evolution, the SMS Track method deserves to be used to increase the quantity of information on large samples of patients. In addition, this method would diminish the number of clinical assessment consultations that most of the time are time consuming and the “fragile” parts of any clinical study.Our results show that French patients accepted well to provide fortnightly SMS data over 1 year and that this method of data collection was more successful than the follow-up procedures managed by their clinician, and that it could be a cheap, easy and useful alternative to track patients without the involvement of clinicians. Therefore, it should be considered for use in chronic or long-lasting disorders.Additional file 1. Assessment of potential participants.Additional file 2. Determination of the sample size.


Current principles of postoperative pain management are primarily based on the types and extent of surgical intervention. This clinical study measured patient’s self-anticipated pain score before surgery, and compared the anticipated scores with the actual pain levels and analgesic requirements after surgery.This prospective observational study recruited consecutive patients who received elective surgery in the E-Da Hospital, Taiwan from June to August 2018. Patients were asked to subjectively rate their highest anticipated pain level  for the scheduled surgical interventions during their preoperative anesthesia assessment. After the operation, the actual pain intensity (NRS 0–10) experienced by the patient in the post-anesthesia care unit and the total dose of opioids administered during the perioperative period were recorded. Pain scores ≥4 on NRS were regarded as being unacceptable levels for anticipated or postoperative pain that required more aggressive intervention.P = 0.006). Patients who took regular benzodiazepine at bedtime (P = 0.037) and those scheduled to receive more invasive surgical procedures were most likely to anticipate for higher pain intensity at the preoperative period (P < 0.05). Higher anticipated pain scores (preoperative NRS ≥ 4) were associated with higher actual postoperative pain levels (P = 0.007) in the PACU and higher total equivalent opioid use (P < 0.001) for acute pain management during the perioperative period.A total of 996 patients were included in the study. Most of the patients (86%) received general anesthesia and 73.9% of them had a history of previous operation. Female anticipated significantly higher overall pain intensities than the male patients (adjusted odd ratio 1.523, 95% confidence interval 1.126–2.061; This observational study found that patients who are female, use regular benzodiazepines at bedtime and scheduled for more invasive surgeries anticipate significantly higher surgery-related pain. Therefore, appropriate preoperative counseling for analgesic control and the management of exaggerated pain expectation in these patients is necessary to improve the quality of anesthesia delivered and patient’s satisfaction.The online version contains supplementary material available at 10.1186/s12871-021-01303-y. Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing –5 and inSeveral perioperative factors such as age, catastrophic pain scores, gender, psychological distress, and operation type have been suggested to be closely associated with the postoperative pain intensity and analgesic usage –14. It hThis prospective observational study was approved by the ethics committee and the institutional review board of E-Da Hospital, Taiwan . Consecutive patients who received elective surgery under general or regional anesthesia during June 2018 to August 2018 were included in this study and patients scheduled for emergency operations or those who required postoperative intensive care were excluded .In clinical care, NRS greater than 4 are defined as unacceptable surgical pain levels that required analgesic intervention . FurtherA total of 996 eligible patients were included in the study, as one patient was excluded due to incomplete data Fig. . Most ofP = 0.006) (Table P = 0.037) (Table P = 0.097) (Table Table 6) Table . Further7) Table , the effP < 0.001)   Fig. . Multiva5) Table . In addiP = 0.007) and also received significantly higher total equivalent opioid doses during the perioperative period (P < 0.001)  (Table  (Table 41) Table .Table 4A major limitation in postoperative pain management has been the fact that a patient’s personal perception of pain may not always be taken into account during preoperative pain counseling. Acute postoperative pain is a subjective and multidimensional experience that is extremely hard to measure and manage optimally. In fact, a previous study found that pre-exposure to a stressed or anxious condition significantly increased the subjective pain perception to a standard noxious stimulation than those who were pre-exposed to a happy condition .Gender is commonly considered as a strong predictor for pain perception and analgesic requirements after surgery , 25. Howmajor depression, insomnia, and catastrophizing pain) can have a decreased tolerances for postoperative pain [Previous studies have suggested that patients with psychosomatic and behavioral disorders  in our hospital. This short questionnaire were designed to be simple and practical so that it could be applied to the general population in a time-efficient manner. The comprehensive versions for diagnosing depression and chronic insomnia were not used in this study. Furthermore, the use of a structured self-rating Pain Sensitivity Questionnaire may also provide higher sensitivity to predict the development of acute postoperative pain , 41. ThiOur study demonstrated that female gender, regular benzodiazepine use at bedtime and who scheduled to receive more invasive surgical procedures anticipate significantly higher pain intensity before surgery, and they are associated with higher actual pain scores and increased analgesic requirements during the perioperative period. Therefore, these patients may require additional assessments and pain management counseling during their pre-anesthesia consultation. Appropriate preoperative counseling for analgesic control  and the management of unnecessary anticipated pain levels could improve the quality of anesthesia delivery and patient perioperative satisfaction.Additional file 1: Supplementary table 1. Surgical procedures with different levels of expected pain [ted pain Additional file 2: Supplementary table 2. Variance inflation factors (VIF) for the degree of multicollinearity among patient’s characteristic and surgical-related variables that associated with preoperative anticipated pain. ASA: American Society of Anesthesiologists. *A total of 27 groups of surgical procedures were classified into 5 levels, as lowest, low, moderate, high and highest expected pain [ted pain


About 10–15% of women of childbearing age have endometriosis. The present study aimed to investigate the relationship between the severity of symptoms of endometriosis and the spread as well as the stage of the disease on ultrasonography. The present cross-sectional study evaluates the relationship between the severity of endometriosis symptoms and the spread of disease on ultrasonography in patients with endometriosis.Considering different analyses, the cumulative size of posterior deep infiltrative endometriosis (DIE) (less than 1 cm) is significantly correlated with minimal severity of dyspareunia and chronic pelvic pain. The incidence of dyspareunia was more prevalent in patients with complete stenosis of Douglas pouch than those with incomplete stenosis. Furthermore, the incidence of severe and very severe pain in patients with Douglas pouch stenosis is relatively higher than that in patients without stenosis. Only dyspareunia is related to the stage of endometriosis, and patients with dyspareunia are five times more at risk of a higher stage of the disease. The severity of dyspareunia is related to the stage of endometriosis and the severity of Douglas pouch stenosis. The results showed a correlation between chronic pelvic pain and r-ASRM score (revised American Society for Reproductive Medicine score). Endometriosis refers to the extrauterine presence of endometrial glands and stroma leading to reactive inflammation and fibrosis .Endometriosis affects 10–15% of women of childbearing age. Most of the patients are in the 18–25 age range , 4. EndoDeep infiltrative endometriosis (DIE) is a specific form of endometriosis which refers to endometrial implants above 5 mm penetrating the peritoneal surface. These implants are highly active and almost associated with pelvic pain symptoms. The most common effected areas for these implants include posterior areas, uterosacral ligament (USL), torus uterus , posterior wall of the vagina, and posterior wall of the rectum . AlthougAccurate mapping of disease spread is critical for determining treatment strategy; however, the accuracy of TVS is confirmed. The dynamism of ultrasound increases its value and evaluates areas not examined by other imaging modalities.Considering the importance of endometriosis and its relatively high prevalence among women as well as the wide range of endometriosis symptoms (including asymptomatic to severe life-threatening pain), researchers of this study sought to study the relationship between the various symptoms of the disease and the spread of its anatomical involvements. Moreover, accurate diagnosis of disease spread using non-invasive methods can be effective in the treatment and follow-up of patients. TVS is the most accessible imaging method as well as the selective modality for differentiating endometrioma from other cystic lesions. The present study seeks to identify cases of endometriosis which do not require invasive treatment or laparoscopic diagnosis. Furthermore, preoperative non-invasive mapping and grading of disease in patients requiring surgery can help improve surgical outcomes.machine with three models including C-10 3v, C5-1, and L12-3 examining vaginal probe (10-3 MHz), curve probe (5–1 MHz) and linear probe (12–3 MHz), respectively. All ultrasound examinations were performed by an experienced radiologist who was unaware of the type and severity of the patient’s pain. It wasdone based on the systematic protocol introduced by the International Deep Endometriosis Analysis (IDEA) Consensus Group [This cross-sectional study evaluates the relationship between the severity of endometriosis symptoms  and the spread of disease on ultrasonography in patients with endometriosis. Target population included women with endometriosis symptoms , referring to the radiology ward of Hazrat Rasool Akram Hospital in Tehran from 2018 to 2020. All patients had a complete gynecological examination by a gynecologist. None of the patients had a previous history of surgery due to endometriosis. Inclusion criterion included patients with endometriosis symptoms and a diagnosis of endometriosis based on ultrasound examination and laparoscopic confirmation. The definitive diagnosis of all patients during this period was confirmed by laparoscopy and pathological examination. The required information was extracted from the patient's ultrasound examination report and questionnaires then included in the special forms designed for this purpose. The severity of pain was determined by Point Pain Numbered Scale 11 (NRS11) . Patientus Group . Ultrasous Group . The disus Group . For thiResults were statistically analyzed using the SPSS 24. To describe quantitative data, mean and standard deviation and for qualitative data, frequency and percentage were used. Accordingly, Chi-square and Fisher's statistical tests were used to investigate the association of any of the symptoms such as dysmenorrhea, dyspareunia, and pelvic pain with endometrioma, Douglas pouch stenosis, intestinal involvement, and stage of the disease.. Finally, to examine the relationship between each symptom and the stage of the disease, a logistic regression test for sequential data was used.A total of 296 patients underwent ultrasonography based on endometriosis protocol at the Department of Radiology between January 2018 and August 2020. Out of 296 patients, 142 cases were excluded as follows: patients with incomplete ultrasound report (0.67%), with amenorrhea ; with the previous resection of DIE , with an insufficient description of the posterior DIE , and patients who do not intend to participate in the study . Finally, 154 patients remained to be examined. The demographic characteristics and clinical data of patients are presented. The mean age of participants was 32.4 ± 6.2 years. The presence and severity of pain based on the disease stages (according to r-ASRM classification) are presented in Table Of the 154 women studied, 150 (48.7%) had dysmenorrhea, 75 (97.4%) had dyspareunia, and 75 (48.7%) had chronic pelvic pain.The cumulative size of posterior DIE is (less than 1 cm) significantly correlated with minimal severity of dyspareunia (p = 0.04) and chronic pelvic pain (p = 0.03). Patients with complete stenosis of Douglas pouch had higher dyspareunia than those with incomplete Douglas pouch stenosis. Further, the incidence of severe and very severe pain in patients with Douglas pouch stenosis is relatively higher than that in patients without stenosis.Using logistic regression analysis, it can be concluded that only dyspareunia is related to the stage of the disease so that patients with dyspareunia are 5 times more at risk of a higher stage of the disease.Endometriosis is one of the challenges for women with pelvic pain and infertility. Chronic pelvic pain affects about 15% of women of childbearing age and reduces their quality of life . The infThis study aimed to explore the relationship between the severity of endometriosis symptoms  and the spread of the disease. The results show that only the severity of dyspareunia is related to the stage of endometriosis, and the odds ratio of endometriosis was 0.24 in the absence of dyspareunia. In previous studies, many attempts have been made to clarify the association of the type and location of lesions and the spread of the disease with the severity and symptoms of the disease, which has had no consensus on results .The growth of nerve fibers in ectopic implants is considered as the mechanism of severe pain in endometriosis –22. AccoIn the present study, there was no relationship between dysmenorrhea and chronic pelvic pain, and disease severity. The results of this study are inconsistent with those of Varcellini et al. , who fouResults of the present study suggested that there is a significant relationship between dyspareunia and posterior DIE lesion, and has been strongly confirmed in other studies. Anatomically, the most stretched area during intercourse is the retro-cervical area , which iStudies show that the association between ovarian endometriosis and dysmenorrhea has conflicting results. Although endometrioma was common among the patients in the present study (83.4%), no significant association was found between endometrioma and dysmenorrhea, which is consistent with the results of some researchers (Radhika et al. , PorporaThe results of the present study show that the severity of dyspareunia is related to the stage of endometrioma and the severity of Douglas pouch stenosis. The present study shows the correlation between chronic pelvic pain and r-ASRM score. Additional prospective studies are needed to validate the results of this study.Some aspects of this study that are affected by cultural considerations or moral codes includedthe frequency and details of sexual activity and symptoms like dyspareunia, which may cause biases in data collection.