Impingement syndrome was shown to be associated with shoulder pain in 44–70% of patients worldwide. It usually occurs due to imbalance and insufficient activation of the rotator cuff (RC) muscles.  This study explores the relative effects of handgrip-strengthening exercises on shoulder function, pain, strength, and active range of motion as part of the treatment program for the patients with primary subacromial impingement syndrome.  A total of 58 patients aged 18-50 years with primary subacromial impingement syndrome were randomly enrolled to participate in this single-blind randomized clinical trial. Out of them, only forty patients have eligibly matched the inclusion criteria and randomly assigned to one of two groups to undergo a standardized therapeutic program consisting of two sessions a week for 8 weeks. The control group prescribed ultrasound therapy, ice, and stretching exercises, while the experimental group followed the same program with the addition of handgrip-strengthening exercises (HGSE). Both patients of conventional therapy (control) and handgrip-strengthening exercises  were advised to adhere also to stretching and HGSE exercises once a day at home for eight weeks. The outcomes were the shoulder function, pain intensity, muscle strength, and active range of motion of the shoulder joint.  Patients treated with conventional interventions plus handgrip-strengthening exercises showed the significant improvement over time in shoulder pain and function, strength of rotator cuff muscles, and pain-free range of motion forward flexion, abduction, and external and internal rotation through eight weeks in the experimental group compared to control patient group treated with conventional interventions. In addition, patients of both control and experimental groups showed no significant difference in the adherence to respective home-based stretching and HGSE exercises once a day at home for eight weeks.  Adding handgrip-strengthening exercises to conventional intervention increases the efficacy of treatment for patients with primary subacromial impingement syndrome in terms of shoulder function, pain, muscle strength, and active range of motion. Shoulder dysfunction is a common complaint of patients visiting physiotherapy clinics, with 20–30% of the general population having been diagnosed with shoulder pain . It was The condition of subacromial impingement syndrome (SAIS) is a common shoulder pathology in general practice, which ranges from bursitis and degeneration of the RC tendons to full-thickness tendon tears –8. SAIS Furthermore, SAIS was shown to be associated with some mechanical factors such as trauma, tension overuse, or improper force-coupling of the RC , and shoExercise therapy is the most effective treatment for subacromial impingement syndrome (SAIS) , 21. MosIt was hypothesized that the addition of handgrip-strengthening exercises to a standardized conventional treatment for SAIS will produce superior results in terms of function, pain reduction, muscle strength, and pain-free range of motion (AROM) of the shoulder compared with standardized conventional treatment alone. Thus, the aim of this study was to investigate the relative effect of handgrip-strengthening exercises in terms of improvement of shoulder function, pain, strength, and pain-free active range of motion (AROM) in patients with primary SAIS. In this study, patients were classified into two groups: patients treated with standardized conventional treatment  and patients treated with conventional therapy along with handgrip-strengthening exercises (HGSE). All patients were asked to adhere also to exercises at home once a day for eight weeks.A total of 58 patients aged 18-50 years from the King Abdul-Aziz Hospital & Oncology Center and the East Jeddah General Hospital, Jeddah, KSA, were recruited to participate in this single-blind randomized clinical trial. Patients diagnosed by a referred medical orthopedist as unilateral SAIS for less than one year with a reported pain intensity of 3 to 8 were included in this study. However, patients with a history of shoulder fracture or dislocation, osteophytes, or labral tear that precludes the ability to perform exercises of the upper extremities; a history of cardiac, neurological, or musculoskeletal disease; a history of shoulder, cervical, or thoracic surgery or patients who had hand or forearm dysfunction, rheumatoid disease, diabetes, malignancy, or pregnancy were excluded from this study. Only 38 patients who matched with the proposed inclusions completed conventional treatments and handgrip-strengthening exercise interventions for 8 weeks as reported in flow chart .Regarding the ethical guidelines of the 1975 Declaration of Helsinki, the present study was approved by the ethics committee of the College of Applied Medical Sciences, King Saud University . The study was also approved by the Research Ethics Committee of the Ministry of Health Directorate of Health Affairs, Jeddah .NCT03468088. All participants were assigned a written informed consent before data collection. Research design, demographic, and clinical data of the participants are present in a flow chart  or handgrip-strengthening  intervention , 31. ForIn this intervention, firstly, patients with primary SAIS received ultrasound therapy (US). Each patient seated in an adjustable chair with back support and their feet on the floor; then US therapy was performed.2. Usually, no sensation of heat would be felt, but the intensity was reduced if the patient felt discomfort. A typical US treatment would take 8 minutes.The chair was positioned beside a table, and the patient's shoulder rested on the table beside the body with the elbow flexed at 90°. A round-headed probe was placed in direct contact with the patient's skin over the shoulder joint. Ultrasound gel was applied to all surfaces of the head to reduce friction and assist in transmission of the ultrasonic waves. Pulsed therapeutic US was applied at a frequency of 3 MHz and intensity of approximately 1.5 W/cmDuring treatment, the head of the US probe was kept in constant motion, which should ensure no discomfort to the patient. The application of ice is widely used for reducing pain in shoulder impingement syndrome –31. The w (1 + r/30), assuming r > 1, where r is repetition every patient had his/her own adjustable heavy-grip handgripper.Handgrip-strengthening exercises (HGSE) were performed under therapeutic supervision in addition with the standardized conventional intervention for the patients with primary SAIS in experimental group as previously mentioned in the literature , 32, 33.The arm position was adjusted every 2 weeks as patient tolerance increased. In the first and second weeks, exercise were carried out at 30° of abduction, changing to 60° of abduction in the third and fourth weeks, and 90° of abduction in the fifth and sixth weeks Figures . FinallyAll patients in the conventional (control) and handgrip-strengthening-treated groups  were subjected for the estimation of pain intensity (VAS score), shoulder function (DASH score), muscle strength , and pain-free active range of motion (ROM) measures at respective time intervals: baseline, 4 weeks, and 8 weeks of treatments.Prior to strength testing, patients were asked to fill out DASH questionnaires, to apply marks to the point that they felt represented their perception of their current state. Isometric strengths of internal and external rotation were assessed using hand-held dynamometer (HDD) with the patient seated in the neutral position, maintaining the shoulder at 0° of abduction, holding the forearm in the neutral position with the elbow flexed at 90° .The curved-end attachment of the HHD was placed about 0.5 inches proximal to the ulnar styloid process. The participant was asked to perform a glenohumeral internal or external rotation motion, back-off to midrange and hold the position as shown in Figures Subsequently, assessment of shoulder joint AROM was carried out using the smartphone clinometer as shown in Power estimates were based on a standard deviation of 9, which was obtained from a recent published research work with the same design . It was Statistical analyses were performed using SPSS software . Each participant allocated a numerical code to use on questionnaires and forms during the study, also used for recording data in SPSS. Continuous data were presented as descriptive statistic means and standard deviations (SD), and categorical data were presented as frequencies. A chi-square test or Fisher's exact test (as appropriate) was used to examine significant differences in categorical variables between the experimental and control groups. At baseline, data were checked for normality and most of the variables were not normally distributed. Therefore, the nonparametric analysis was conducted. The Mann–Whitney Test used to examine significant differences in continuous variables between the experimental and control groups. The Wilcoxon signed rank test was used to examine significant differences in continuous variables between baseline, week 4, and week 8 in both groups. Repeated Measure Analysis of variance (ANOVA) was carried out to compare the dependent variables of pain intensity; shoulder function; internal and external rotation strength; and AROM of forward flexion, abduction, and internal and external rotation between the experimental and control groups at baseline, after 4 weeks, and after 8 weeks of intervention. The null hypothesis (Ho) reported that the addition of handgrip-strengthening exercises to a standardized conventional treatment for SAIS will produce superior results in terms of function, pain reduction, muscle strength, and AROM of the shoulder compared with conventional treatment alone was rejected, and the alternative hypothesis (Ha) that the addition of handgrip-strengthening exercises has no additional benefit was accepted.A total of 58 patients with primary SAIS were randomly allocated in this study. Out of them, only 34 SAIS patients completed conventional treatments and handgrip-strengthening exercise interventions for 8 weeks. Descriptive statistics for the demographics and clinical characteristics of the SAIS patients who completed physical therapy treatment interventions as shown in p < 0.05) were reported in handgrip-treated SAIS compared to those treated with conventional treatments  compared to those treated with handgrip-strengthening exercise interventions . However, a significant difference in the VAS, DASH score, the strength of external rotator, and pain-free AROM of forwarding flexion (eatments .p > 0.05), whereas adherence to physiotherapy sessions wasp = 0.193and adherence home program wasp = 0.067. Only one patient in the experimental group mentioned that she has pain and heaviness during and after handgrip-strengthening exercises.To evaluate the adverse effects of handgrip-strengthening exercises, the adherence to supervised  and unsupervised (home program) exercises training for both clinical interventions was reported in both control and experimental groups . The resIn this study, primary SAIS patients treated with handgrip-strengthening exercise showed significant improvement in shoulder function, muscle strengths, pain, and pain-free active range of motion (AROM). Compared to control SAIS patients, primary SAIS patients treated with handgrip-strengthening exercise for 8 weeks showed significant improvements in shoulder function, muscle strengths, pain, and pain-free active range of motion (AROM) except pain-free ROM of both external rotation (ER) and internal rotation (IR) of the rotator cuff (RC) muscles as shown in In In this study, changes in pain-free active range of motion (AROM) were reported also in patients with primary SAIS treated with handgrip-strengthening exercise  compared to patients treated with conventional physical therapy interventions (control patient group). Active range of motions (AROM) of forward flexion and abduction of the rotator cuff (RC) muscles were significantly improved following handgrip-strengthening exercise interventions for 8 weeks compared to those treated with conventional physical therapy interventions . HoweverThe improvements of clinical outcome measures: VAS, DASH, muscle strength, and pain-free active ROM, of patients with primary SAIS in conventionally treated patients (control group) and handgrip-strengthening exercise-treated patients  were shown to be time-dependent as shown in The results showed that all clinical measures: VAS, DASH, muscle strength, and pain-free active ROM, were significantly improved over scheduled time of treatment. The clinically improved measures are significantly correlated at time intervals; 4 weeks , 8 weeksIn this study, a total of 38 patients with primary SAIS who matched with the proposed inclusions participated in this single-blind randomized clinical trial (SBRCT). Patients were classified into two groups: patients treated with conventional therapy  and patients treated with conventional treatments and handgrip-strengthening exercise interventions. All patients completed the proposed treatments for 8 weeks. In addition, patients of the two groups were asked to perform the same respective stretching and HGSE exercises  at home once a day for eight weeks.The data showed that treatment with handgrip-strengthening exercises along with conventionally therapy interventions significantly improved primary SAIS in terms of improvement of shoulder function, pain, strength, and pain-free active range of motion (AROM) in patients with primary SAIS. Both treatment programs were effective in decreasing pain, functional disability, and pain-free active ROM of forwarding flexion of the shoulder joint in patients with primary SAIS. More enhancement in shoulder function, pain, strength, and pain-free active range of motion (AROM) was reported in primary SAIS patients treated with handgrip-strengthening exercises, respectively, for 8 weeks. In addition, the results showed that the improvement was time-dependent, whereas four weeks of handgrip-strengthening exercises were sufficient for improving all outcome measures, in which the program was focusing on further improvement in rotator cuff strength by handgrip-strengthening exercises.Previous research studies suggested that in order to differentiate between subjects with SAIS who had significantly improved shoulder pain versus those who remained stable, the minimally clinically important change (MCIC), for VAS, should be at least 1.4 cm . On the In the current study, the mean improvement of VAS score in the experimental group was statistically significant and clinically relevant (mean improvement = −3.69 > MCIC for VAS score) while it was in the control group (mean improvement = −2.01). Moreover, the mean improvement of the DASH score in the primary SAIS who treated with handgrip-strengthening exercise was also clinically relevant (mean improvement = −25.16 > MCIC for DASH score) while it recorded a mean improvement (−19.96 > MCIC for DASH score) among conventionally treated primary SAIS patients.The results of this study suggest that the addition of handgrip-strengthening exercises to conventional treatment is more effective than the conventional treatment alone in terms of decreasing pain and shoulder disability and improving pain-free active ROM and muscle strength, which support the study's hypothesis. Several components in handgrip-strengthening exercises may contribute to these positive results in a way which handgrip strength influence the rotator cuff. Firstly, the neurological connection was between handgrip and RC. Simply, during handgrip-strengthening exercises, the brain would facilitate the RC muscles to turn on for the arm to function properly and avoid injury. Therefore, the strong handgrip would be to increase the neural drive from hand and shoulder. In previous clinical works, it was found that concurrent activation of indirect propriospinal pathways in handgrip-strengthening exercises provides adaptable movement control allowing integration of sensory information from the shoulder and hand , 40, 41.In addition, handgrip-strengthening exercises were shown to help in the activation of rotator cuff (RC) muscles and decrease activation of the middle and anterior portion of the deltoid. Therefore, when an exercise-based therapy was applied to treat patients with SAIS, targeting rotator cuff muscles with minimal involvement of the deltoid muscles will be effective –44. SimiThe progression and positioning of handgrip-strengthening exercises were designed in this study based on previous EMG studies that found that the handgripping was accompanied by a change in excitability of rotator cuff in different shoulder position , 33. In In the current study, the maximum improvement was in the first 4 weeks when the patient performed the handgrip strengthening exercises in 30° and 60° shoulder abduction position where the maximum decreasing of RC activation may have happened. Our finding is consistent with others , who comPrevious studies showed an association between the clinical manifestation of primary SAIS and a decreasing in both rotator cuff strength and shoulder function, which result in the changes in deltoid activation and altered GHJ stability , 49, 50.The finding of our study showed that the handgrip-strengthening exercises not only improved RC strength  but also improved most of outcome measures in greater extent compared to conventionally treated SAIS patients. Indefinitely, our results were supported by the studies, which say that strengthening exercises for rotator cuff muscles can optimize the therapeutic effect on the patient with primary SAIS and minimize associated symptoms , 54, 55.The program used for investigation consisted of handgrip-strengthening exercise by GD Grip Pro (has strength adjusting function) 10 times for three sets twice a day. After 4 weeks, they found that a participant showed significant improvement in external rotation peak torque which significantly matched with our results at respective time intervals: 4 weeks and 8 weeks, respectively. Thus, the adding of handgrip-strengthening exercises in treating interventions could be effective for pain reduction and improvement in functional disability, strengthen rotator cuff muscles, and activate ROM of the shoulder for the patient with primary SAIS.In addition, our study reported that the treatment with handgrip-strengthening exercises along with conventional interventions is time-dependent. Since the maximum result of pain reduction and improvement in function, RC strength, and pain-free active ROM were attained in week 4 only in experimental group, the authors recommend the addition of handgrip-strengthening exercises to conventional treatment if reduction of pain and improving RC strength, shoulder function, and active ROM of shoulder were the goals of treatment. Thus, in this cases, the treatment frequency and duration remain a source of debate in the literature. In the present study, the treatment sessions of primary SAIS took place twice a week for 8 weeks, which is consistent with previous recommendations , 57–59.In this study, the effects of hand dominance and gender specificity were evaluated in primary SAIS patients conventionally treated with handgrip-strengthening exercises. The results obtained showed that only one-quarter of participants were of their dominant side when treated with handgrip-strengthening exercises. The handgrip-strengthening exercises for this group were a challenge in order to weaken muscle strength and controlling of movement. On the other hand, half of the participants with conventionally treated interventions have a primary SAIS on their dominant side. Therefore, the exercises for a nondominant hand do more than training for the hand; it is also training for the brain. Our data are line with those who reported that the handgrip strength is significantly stronger in a dominant side and controls force better, but there are no differences between sides left or right , 60.Gender has important roles in the quality of life and extent of shoulder pathology. Female candidates for rotator cuff-related surgeries reported more emotional difficulties . In the Finally, our results recommend that treatment with handgrip-strengthening exercises for 4 weeks could be sufficient for pain reduction strength rotator cuff muscles and improvement in functional disability and active ROM of the shoulder. Such finding may help clinicians by getting greater improvement during shorter recovery time. Finally, treatment with handgrip-strengthening exercises for four weeks significantly reduced the pain of the strength rotator cuff muscles and improved both functional disability and active ROM of the shoulder. These findings might be helpful for both patients and health care providers by getting greater improvement of the SAIS patients within a shorter recovery time with minimum expenses whereas the adjustable handgripper is a low-priced exercise therapy.To the best of the authors' knowledge, this RCT is the first to evaluate the relative effect of handgrip-strengthening exercises in the treatment of primary SAIS. Both treatment programs were effective. However, patients treated with handgrip-strengthening exercises for 8 weeks showed significantly less shoulder pain with more improvement of shoulder function than those who received only conventional treatments.Finally, improvement in rotator cuff muscles strength was reported more in patients who were treated with handgrip-strengthening exercises. This might give more concentration on handgrip stretching exercise therapy in the future nondrug trials against shoulder pain.There are some limitations to consider in the present study. It was not possible to blind the patient and the therapist, and so only the assessor was blinded in the current study. Although the adherence to supervised  and unsupervised (home program) exercises training in both conventional therapy and handgrip-treated SAIS patient groups showed no significant difference, the study utilized self-reported measures, which might be prone to recall bias with larger samples.Adding handgrip-strengthening exercises to conventional intervention increases the efficacy of treatment for patients with primary SAIS in terms of shoulder function, pain, muscle strength, and AROM. Thus, future research should also explore the components and parameters that should be included in handgrip strengthening exercise program in order to achieve maximal effects.


The Global Leader Initiative on Malnutrition (GLIM) criteria have been recommended for malnutrition diagnosis recently, for which the first step is malnutrition risk screening with any validated tool. This study aims to investigate the incidence of nutritional risk and malnutrition in Crohn’s disease inpatients and compare the suitability of Nutritional Risk Screening 2002 (NRS-2002) and Malnutrition Universal Screening Tool (MUST) as the first-step screening tool for GLIM criteria.We retrospectively analyzed the clinical data of Crohn’s disease inpatients in our hospital from August 2016 to December 2019. NRS-2002 and MUST were used for nutritional screening at the time of admission. GLIM and Patient Generated-Subjective Global Assessment (PG-SGA) were used for malnutrition assessment, respectively. Patients without nutritional risk screened by NRS-2002 but with malnutrition risk screened by MUST were especially screened out. The appendicular skeletal muscle mass index (ASMI), fat-free mass index (FFMI), body fat percent (BFP), and body cell mass (BCM) were measured by the Biospace Inbody S10 composition analyzer.A total of 146 Crohn’s disease patients were enrolled, of which 62.3 and 89.7% had nutritional or malnutrition risk according to NRS-2002 and MUST, respectively. The prevalence of malnutrition assessed by GLIM was 59.6% (87 cases) and 82.2% (120 cases) when NRS-2002 and MUST were used as the first step of GLIM respectively. Meanwhile, 99 patients (67.8%) had malnutrition when assessed by PG-SGA. There were 41 patients who were not at nutritional risk according to NRS-2002 but were at malnutrition risk determined by MUST. At last, 33 patients were GLIM-defined, and 16 patients were PG-SGA-defined malnutrition among the 41 patients.The nutritional risk or malnutrition is common in Crohn’s disease inpatients. It is recommended to use a variety of nutritional assessment tools for Crohn’s disease inpatients. MUST can be used as a good supplement for the patients with a score of NRS-2002 lower than 3 in order to decrease the miss rate of GLIM-defined malnutrition. Crohn’s disease (CD) is a chronic, systemic autoimmune, transmural inflammation disease of the whole intestine. Reduced nutrient absorption, increased nutrient requirements, gastrointestinal nutrient losses, and chronic inflammation exposure increased the risk of malnutrition in CD patients –3. ThereAccording to the Global Leadership Initiative on Malnutrition (GLIM) 2019, the diagnosis of malnutrition can be divided into two steps: screening and assessment. First, screening to identify nutritional risk status by using any validated screening tool, and second, assessment for diagnosis and classification of the severity of malnutrition (at least 1 phenotypic criterion and 1 etiologic criterion should be included) , suggestTherefore, we used NRS-2002 and MUST for nutritional screening, respectively, and used GLIM and PG-SGA for malnutrition assessment, respectively, to investigate the significance of various nutritional risk screening and malnutrition assessment tools in the nutritional diagnosis of CD patients.This study retrospectively analyzed the clinical data of Crohn’s disease inpatients in our hospital from August 2016 to December 2019. Participants were patients with Crohn’s disease admitted to the Department of Gastroenterology in the Third Xiangya Hospital, Central South University, during that period. This study has been approved by the Institutional Review Boards of the Third Xiangya Hospital, Central South University (2019-S540). A waiver of informed consent has been obtained for this retrospective study.The inclusion criteria were as follows: (1) The patients were 18-90 years old. (2) CD was diagnosed according to the Montreal classification . AccordiPatients were assessed for malnutrition using the GLIM criteria, which used a two-step model for the diagnosis. The first step was to identify at-risk status by the use of any validated screening tool. Second, patients who screen positive in the first step receive further screening to identify the malnutrition with GLIM .2; 1 with the BMI 18.5–20 kg/m2; 2 with the BMI < 18.5 kg/m2), involuntary weight loss in the past 3-6 months , and suffering from acute disease or without nutritional intake for 5 days (2 points if either of them applies). MUST score ≥ 1 was considered of malnutrition risk, which is recorded as MUST (+).In our study, we used NRS-2002 or MUST as the first step to identify patients who were at nutritional or malnutrition risk. NRS-2002 consists of the severity of disease , impaired nutritional status which was scored according to the BMI, weight loss or reduced food intake, and the age with 70 years old as the dividing line. The final score of NRS-2002 ranges from 0 to 7. A score of 3 to 7 indicated that the patient had the nutritional risk , which w2 if < 70 years or < 20.0 kg/m2 if > 70 years; and (3) reduced muscle mass: a low fat-free muscle index (FFMI)  or a low appendicular skeletal muscle mass index (ASMI) . Etiologic criteria included reduced food intake or assimilation, and disease burden or inflammation. As GLIM consensus mentioned that most chronic organ diseases, such as CD, are associated with reduced food intake or impaired absorption and assimilation, patients diagnosed with CD in this study were all thought to meet the etiologic criterion. To figure out malnutrition with GLIM, at least one phenotype criterion and one etiologic criterion should be presented  involuntary weight loss: > 5% within 6 months or > 10% beyond 6 months; (2) low BMI for Asian: < 18.5 kg/mresented . And thePatients also received malnutrition assessment of PG-SAG. PG-SGA consists of two sections: the first includes the questionnaire about recent weight loss, food intake, symptoms that could interfere with food intake, and the physical activity level of the patients. For the second section, information is collected about the relationship between the disease and nutritional needs, metabolic requirement, and physical examination of the patient. Each item noted above has a separate score, and scores for each of the parameters were added up and given a total score. A total score greater than or equal to 4 was defined as malnutrition and recorded as PG-SGA (+).2). ASMI = ASM/(height × height), FFMI = FFM/(height × height), body fat percent (BFP) = body fat mass/body weight × 100%, and body cell mass (BCM) = intracellular water + protein. The threshold for low muscle mass in men is ASMI < 7 kg/m2 or FFMI < 17 kg/m2, and in women is ASMI < 5.7 kg/m2 or FFMI < 15 kg/m2 , which relied upon bioelectrical impedance analysis (BIA) technology, using an eight-point tetrapolar electrode system method which assesses the impedance to six specific frequencies  and the impedance at three specific frequencies  of a small alternate electrical current applied on the body. The height and the body weight were measured at shoes-free and fasting status, and the BMI was calculated. Eventually, data including weight, body mass, BMI, fat-free mass (FFM), appendicular skeletal muscle mass (ASM), and fat mass (FM) could be obtained. The FFMI and ASMI were calculated by dividing a patient’s FFM or ASM values by the height squared . Variables were subjected to test for normal distribution by the Kolmogorov–Smirnov test. The variables with normal distribution were expressed as means and standard deviation (SD). The variables with non-normal distribution were expressed as median and interquartile range (IQR). The variables with normal distribution were compared with t-test, while the variables with non-parametric distribution were compared with Mann–Whitney U test. The chi-square test was used for categorical variables. A value of 2. The mean albumin and hemoglobin were 37.06 ± 4.00 and 120.14 ± 18.00, respectively  were recruited into the present study. All the patients were younger than 70 years old. The mean BMI was 17.72 ± 2.29, and 63.0% (92/146) of the patients had a BMI lower than 18.5 kg/mectively .2, female < 5.7 kg/m2), with the mean ASMI of 6.50 ± 0.45 kg/m2 for male and 5.02 ± 0.54 kg/m2 for female. More than two-thirds  of the patients had a low FFMI , with the mean FFMI of 15.37 ± 1.42 kg/m2 for male and 13.43 ± 1.12 kg/m2 for female. The mean BFP (%) was 10.80 ± 9.00, with the mean BFP(%) of 10.74 ± 5.13 for male and 19.80 ± 6.59 for female. And the mean BCM (kg) was 28.53 ± 4.73  of the patients had a low ASMI  of the CD patients’ age were between 17 and 40 years old. Almost half  of the patients’ lesion site was in ileal, and almost two-thirds  of the patients’ disease behavior was stricturing .There was 62.3% (91/146) of the patients had nutritional risk when screening by NRS-2002 (≥ 3 scores) and 89.7% (131/146) had malnutrition risk after screening by MUST (≥ 1 scores). There was 67.8% (99/146) of the patients had malnutrition after assessed with PG-SGA  .p = 0.64 and 0.08, respectively), and the BMI, BCM, BFP, ASMI, and FFMI were all significantly lower in the malnourished patients than in normal nourished patients   and 82.2% (120/146) in the cohort of GLIM defined malnutrition using NRS-2002 and MUST as the first step, respectively. In the two cohorts, there were all no significant differences in age between the malnourished and well-nourished patients ( < 0.05) .p = 0.20 and 1.0, respectively), and the BMI, SMI, and FFMI were all significantly lower in the former group  , 41  of whom had a MUST score greater than or equal to 1 (MUST +), and 14  of whom had a MUST score lower than 1 (MUST -). Between the patients with NRS-2002 (−) & MUST (+) and the patients with NRS-2002 (−) & MUST (−), there were no significant differences in age regardless of the age subgroup ( < 0.05) .p were all > 0.05)  .2, only 1 due to the unplanned weight loss of 5-10% in the past 3–6 months. There were 61.0% (25/41) patients who had a MUST score greater than or equal to 2 points due to BMI < 18.5 kg/m2. Slightly more than one-third  and more than four-fifths  of the patients were diagnosed as malnutrition assessed by PG-SGA and GLIM, respectively. Among the 41 patients, slightly less than one-third  had a low ASMI, 61.5% (8/13) of whom were male and 38.5% (5/13) of whom were female. Almost four-fifths  had a low FFMI, 78.1% (25/32) of whom were male and 21.9% (7/32) were female (There were 41 patients with NRS-2002 (−) and MUST (+). Among them, 39.0% (16/41) patients had a MUST score of 1 point, with 93.8% (15/16) scoring due to BMI of 18.5∼20.0 kg/me female .The nutritional status of CD patients is not optimistic. There exists a high prevalence of nutritional risk or even malnutrition among CD patients. Y Wu et al. assessed the nutritional risk in CD patients using NRS-2002 and found the prevalence was 65.2% 464/712) (12 (7). IMalnourished patients with CD are more likely to be hospitalized following emergency department attendance and more likely to be admitted to the hospital due to infection , 21. In Laboratory tests of serum proteins, such as albumin and hemoglobin, are frequently used to assess protein malnutrition in clinical practice. However, our results showed that only 14.4% (21/146) of the CD inpatients had hypoalbuminemia and no patients had hypo-hemoglobinemia, suggesting that albumin and hemoglobin cannot be used as the only indicator for nutritional assessment.As for GLIM, the diagnosis of malnutrition includes screening and assessment. NRS-2002 is the most widely used as the first step of GLIM. Are there other tools that can be used as the first step of GLIM? Xu et al.  first usIn our study, nutritional risk screening was performed in both MUST and NRS-2002, and it showed that 28.1% (41/146) was still identified as malnutrition risk through MUST as NRS-2002 evaluated no nutritional risk. Among the 41 patients, we found that 80.5% (33/41) were defined as malnutrition by GLIM; meanwhile, 31.7% (13/41) and 78.0% (32/41) were with low ASMI and FFMI, respectively. It suggested that NRS-2002 may miss some patients with nutritional risk or sarcopenia, for which MUST may be used as a supplement to NRS-2002.2 as medium risk, without paying attention to the general condition of the patients. However, NRS-2002 defines BMI relatively strictly, requiring a BMI < 18.5 kg/m2 combined with impaired general condition. Our study showed that 36.5% (15/41) of the patients were diagnosed as malnutrition risk by MUST due to BMI 18.5–20.0 kg/m2 and 61.0% (25/41) due to BMI < 18.5 kg/m2 without involved poor general conditions. Second, the rate of unplanned weight loss and the time range are different. The rate of weight loss in NRS-2002 is fixed at 5%, and the time range is 3 months, 2 months, and 1 month, respectively. The shorter the time, the higher the score. However, the time range in MUST was fixed in the past 3–6 months, with the weight loss rates of <5%, 5-10%, and >10%, respectively, which makes some patients with a weight loss rate >5% in the past 6 months but with no weight loss in the past 3 months are rated as medium malnutrition risk by MUST but are rated as no nutritional risk by NRS-2002. There was one patient in our study fell into this category. Third, NRS-2002 covers the food intake, which may affect the nutritional status of the patients, and the age criteria, i.e., ≥ 70 years old can get 1 extra point, which MUST lacks. Since all the CD patients enrolled in our study were younger than 70 years old, it makes the advantage of NRS-2002 unable to reflect.NRS-2002 and MUST have similarities and differences. The similarities are that both of them contain the BMI, weight loss, and disease status. The differences, which may lead to the result of NRS-2002(−) but MUST (+), are as follows. First, the cut-off value of BMI is different. MUST defines BMI of 18.5–20.0 kg/m2 and 20.0 kg/m2. (2) BMI < 18.5 kg/m2 without poor general conditions. (3) Patients with low ASMI or FFMI.In conclusion, NRS-2002 and MUST have their own advantages and disadvantages. Combining the two may reduce the missing rate of the patients at potential malnutrition risk. Nutritional risk screening tools are recommended to be used flexibly for CD patients, especially as the patient has one of the characteristics as follows: (1) NRS-2002 shows no nutritional risk, but BMI is between 18.5 kg/mThe ASMI used in the assessment of muscle mass reduction refers to the Asian Working Group for Sarcopenia for Asians (AWGS) standard, while FFMI is applicable to European populations. The absence of Chinese cut-off reduces the applicability of the study and requires more evidence-based medical evidence. However, we revealed that MUST can be used as the first step in CD patients with an NRS-2002 score less than 3, which prevented the entrance of the second step of GLIM.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by the Institutional Review Boards of the Third Xiangya Hospital, Central South University (2019-S540). The Ethics Committee waived the requirement of written informed consent for participation.HL and ML designed the study and were the guarantors of this work. MW, CT, QG, JW, and GF conducted the study and analyzed and interpreted the data. MW wrote the manuscript. MW, GF, and WW performed the data collection. All authors approved the final version of this manuscript and agreed to be accountable for the content of the work.


In patients with lumbar disc protrusion (LDP), one of the most common causes of LBP, the nucleus pulposus bulges against the disc and then protrudes into the spinal cord, but the annulus fibrosus remains intact; (2) Objectives: The primary objective of this study was to determine the efficacy of a rehabilitation treatment (RT) comprising electrotherapy (ET), hydrotherapy (HT) and individualized physical therapy (PT) versus ET alone in patients with LDP. The second objective was to investigate whether there is a correlation between early RT and the symptomatology of patients with LDP; (3) Methods: The research was conducted between July 2021 and January 2022 at the Ceres Hotel Treatment Centre from Baile 1 Mai, Romania, and all the study subjects signed an informed consent form. For this study, the block randomization method was used to randomize subjects into groups that resulted in equal sample size, in order to maintain a reasonably good balance among groups. Therefore, the two groups had the same number of subjects (30 subjects) and the randomization was made taking into account the patient’s motivation or the subject’s willingness to receive not only electrotherapy treatment, but also the physical exercises and hydrotherapy. The eligibility criteria were: low back pain for more than three months, an MRI confirmed diagnosis of LDP , and ability to perform a PT program. The control group received only a classical ET program. In addition, the patients in the experimental group received a complex individualized PT program associated with HT and ET. To achieve these objectives, the study subjects were monitored for spinal mobility , trunk flexor and extensor muscle strength , level of pain , and the degree of limitation in activities of daily living (Oswestry Disability Index—ODI); (4) Results: Comparing the evolution of the subjects, using the One-Way ANOVA between groups, we observed a significant improvement in all variables [SF-MPQ , VAS , mobility FTF , LS , LE strength , LF strength , disability  after six months of treatment for the experimental group subjects. A clear correlation was found, using the Bravis–Pearson test, between the earliest possible initiation of RT and improvement of patients’ symptoms; (5) Conclusion: The current study proves the importance of combining ET with HT and PT. The earlier the RT is implemented, the lower the pain perception and level of disability associated with the lumbar disease. Low back pain (LBP) is a common problem in the active population, and is considered to be the second reason for visiting a physician. Besides the fact that LBP causes a substantial morbidity, being the main reason for disabilities in the active population, it also generates major expenses consisting of treatment costs, lost workdays and decreased productivity . In patiIt is known that patients with LDP prefer to start their treatment with conservative methods such as analgesics, epidural steroid injections, electrotherapy (ET) and physical therapy (PT). Lately, the updated 2021 Clinical Practice Guidelines (CPGs) for LBP focused on which intervention could be recommended for providing pain and/or disability reduction and functional improvement. Moreover, the recommendation of the 2021 LBP CPGs update focused on the type of intervention delivered by physiotherapists . Fritz eThis study helps to improve the ways rehabilitation is provided to patients with LDP. The outcomes of this study will have a positive influence on the wellbeing of patients with LDP by helping them improve mobility and strength, and decrease the pain and disability. The rehabilitation treatment proposed may be included by physiotherapists in the routines they use with patients with LDP, and some of the physiotherapy exercises can also be included by the patients in their daily routine at home. Furthermore, the rehabilitation treatment proposed may be used by physiotherapists in other research.The main objective of this study was to determine the effectiveness of the rehabilitation treatment (RT) versus ET-only intervention on pain and disability reduction, and the increase in muscle strength and mobility in patients with LDP. The second objective was to investigate if there is a correlation between early rehabilitation intervention and pain and disability.We performed a prospective cohort study, enrolling 60 patients (25 men and 35 women) aged between 26 to 76 years, diagnosed with LDP.This study complied with the principles outlined in the Helsinki Declaration and was approved by the local Ethics Committee . It was registered at Iranian Registry of Clinical Trails (IRCT20200422047172N2). All participants provided their written informed consent before being included in the study.For this study, the block randomization method was used to randomize subjects into groups that resulted in equal sample size, in order to maintain a reasonably good balance among groups. Therefore, the two groups had the same number of subjects (30 subjects) and the randomization was made taking into account the patient’s motivation or the subject’s willingness to receive not only electrotherapy treatment but also the physical exercises and hydrotherapy. In this research, a single-blinded procedure was used. Given the nature of the therapeutic intervention, , and its effects directly felt by the subjects, blinding for therapists and patients was not possible, therefore subjects were aware that they belonged to an experimental or a control group. In order to reduce bias, one team of therapists performed the therapeutic procedures, and another person who did not belong to the team performing the treatment, therefore unaware whether the patient received one type of intervention or the other, evaluated its results. STROBE checklist of items was respected in our study .n = 30) or experimental group (n = 30). The control group (Gr B) received only a classical ET program. In addition, the patients in the experimental group (Gr A) received a physical therapy (PT) program associated with hydrotherapy (HT) and ET.Patients were recruited at the Ceres Hotel Treatment Centre from Băile 1 Mai, Romania, from July 2021 to January 2022, and the study was performed over a period of six months. According to one’s personal reasons , the patients were assigned either to a control  received a 10-day inpatient rehabilitation program, once a day. Moreover, they continued the daily physical therapy exercise program after hospital discharge.All patients in Gr A attended the rehabilitation treatment consisting of: HT, PT and ET.Patients were treated with 37 °C water therapy (hydrotherapy) in a therapeutic pool for 30 min a day, five-days a week for a total duration of 10 days. In Băile 1 Mai, the thermal water used for the treatment has a mineralization that is at around 1 g/L with mainly negative ions (anions)—bicarbonates, sulfates and positive ions (cations)—calcium, sodium and magnesium. Hydrotherapy is widely used for the relief of all forms of back pain .A PT program was given to all patients for 45 min a day, five-days a week for a total duration of 10 days. The exercises consisted of active resisted movement of trunk flexion and extension, pelvic tilt, abdominal and trunk muscles strengthening, and trunk mobility exercises. The dosage and intensity of the exercises progressed over time. The program was individualized according to the patients’ specific impairments.After completing the PT program, ET was applied to each patient. The ET procedures consisted of: (1) Transcutaneous electrical nerve stimulation (TENS) in conventional mode, symmetric biphasic, 90 Hz, for 15 min; (2) Interferential current (IFC) in quadripolar mode, at 100 Hz frequency, for 10 min; (3) Magnetic field therapy in continuous form (sedative effect), for 15 min.TENS and IFC were performed using the Chattanooga Intelect Neo combined device. The magnetic field was delivered through a Physiomed MAG-Expert device with a field strength of 1–100 Gauss (adjustable in steps of one Gauss) and a frequency range from 1–100 Hz, with two completely independent channels and a treatment timer.We used TENS and IFC in order to reduce pain. We used both types of currents to insure better reactivity and compliance from the patients. The magnetic field therapy was applied to help reduce the state of psychomotor agitation induced by pain.After completing the 10 days program of RT in the treatment center, all patients received a written outline and description of the PT program and they were reminded to carry out the exercises regularly after discharge.The patients in the control group were only treated with ET, for 10 days, in a hospital. The ET protocol was the same as for the experimental group.The inclusion criteria were: LBP for more than three months, an MRI confirmed diagnosis of LDP , and ability to perform a physical therapy program. The exclusion criteria were: indication for acute surgery, previous surgery on the same lumbar spinal level, sciatica, presence of severe spinal pathology . Chronic pain relief drug users, refusal to participate in the research, neoplasms of any sort, severe comorbidities, and mental illness are also exclusionary factors.The patients presented to the rehabilitation service with the diagnosis established by the specialized doctor, based on the MRI results. In Romania, most rehabilitation centers are separate units, separate from healthcare units/hospitals, where patients come from all over the country, based on recommendations made by a specialist.There were no cases of dropout from the therapeutic program.The participants’ demographic characteristics such as age, gender, weight, height and body mass index (BMI) were recorded. In addition, the presence of radiculopathies and the elapsed period (in months) from diagnosis to the start of the treatment were noted.All assessments were made before the intervention and six months later by the same physiotherapist, who was blinded to the treatment groups.Spinal mobility was assessed using the lateral lumbar flexion (LLF) testing, index-ground (IG), lumbar Schober tests for flexion (LS), and Inverted Schober test for extension (ILS) ,26,27,28For the muscle strength evaluation, both the strength of the flexor and extensor muscles of the trunk were tested. To assess the abdominal muscle strength, the number of trunk flexions the subject could perform in a 30 s interval was recorded. In evaluating the strength of the lumbar extensor muscles, the number of correct executions of spine extensions in a 30-s interval was noted.Primary endpoints were the Oswestry Disability Index (ODI), the Short Form McGill Pain Questionnaire (SF-MPQ) and the pain level using Visual Analogue Scale (VAS) ,31,32,33Secondary outcomes included muscle strength and spinal mobility evaluation using the LLF testing, IG, LS, and ILS .SF-MPQ was used to determine the pain level ,34,35. TAdditionally, the degree of pain was evaluated using a visual analogue scale (VAS) on a 10-cm scale, with zero indicating “no pain” and 10 indicating “worst pain”.The Oswestry Disability Questionnaire (ODQ) was used to measure the limitation in everyday life activities . There iIn order to exclude subject selection bias, we respected the natural recovery potential of LDP and excluded patients with adjuvant therapies that have a major impact influencing the ability to comply with PT. Thus, only patients with LDP of more than six months were included in this study, as the natural recovery potential decreases with increasing disease duration and will eventually approach to zero. Furthermore, those subjects who found that their ability to comply with PT had been clearly influenced by the adjuvant therapies administered were excluded during the study.In order to establish the sample size, we used as primary reference the average number of patients with low back pain who came into the clinic in a month, as being the population size. We are referring to a number of 70 patients per month. We also considered the 95% confidence level, and a margin of error of 5% and an assumed population proportion of 0.5. The z score for a 95% confidence level is 1.96. In order to obtain the sample size according to these parameters, we used an online sample size calculator. The sample size for the chosen population size is 60 subjects.t-test, as we have a normal data distribution . The Chi2 test for homogeneity was conducted in order to explore whether frequency counts are distributed identically across the two groups of subjects, in terms of gender and the presence of radiculopathy.For data analysis, we used the Statistical Package for Social Sciences (SPSS) Evaluation version 15.0.0, issued by IBM SPSS.Statistic, Oradea, Romania (SPSS 15.0). For the quantitative analysis of the numerical variables, we used the mean and standard deviation, and for the categorical variables we used the percentage and mean. We analyzed the normality of data distribution using the Kolmogorov–Smirnov test. For the intergroup analysis of the initial values, we used the independent samples p ≥ 0.05). For pretest–posttest analysis for the two groups we used One-Way ANOVA with repeated measures.In order to test if there is a significant difference between the two groups for the initial and final results, we used the One-Way ANOVA between subjects, as we had a normal data distribution . The subjects below the ‘cut point’ score were excluded and then we used a logistic regression analysis to account for the differences in sample size between models using the same process, but only including patients with an initial score above the ‘cut point’.In total, 95% confidence intervals (CIs) were reported as appropriate.p ≥ 0.05). Furthermore, there is not a significant difference between experimental and control group regarding data homogeneity according to gender  and the presence of radiculopathy .The distribution of the patients’ parameters in each group was homogeneous  according to the studied variables: age, gender, body mass index, time elapsed from diagnosis and start of the treatment, presence of radiculopathies  ; SF-MPQ pain perception ; finger-to-floor distance ; Schober test ; inverted Schober test ; ODQ score ; ODQ (%) . At six months, the experimental group had improved more than the control group in regards to pain , disability  and LS scores (p < 0.05). There was no statistically significant difference between the two groups in the trunk left lateral flexion ; trunk right lateral flexion ; trunk flexion strength ; trunk extension strength    .p < 0.05]; pain intensity in the evening (VAS-M) ; in the morning; SF-MPQ pain perception ; finger-to-floor distance ; Schober test ; disability level  and percentual disability level (ODQ%) .The percentage score obtained in the assessment of disability level decreased on average by 11.93 points .The analysis within the control group proves that there are significant differences between the pretest–posttest values for pain intensity in the morning (VAS-M) ; pain intensity in the evening (VAS-E) ; SF-MPQ pain perception ; finger-to-floor distance ; Schober test ; inverted Schober test ; trunk left lateral flexion ; trunk right lateral flexion ; trunk forward flexion ; trunk extension ; disability level (ODQ)  and the percentage of disability level (ODQ%) . The percentage score obtained in the assessment of disability level decreased on average by 11.93 points .The analysis within the experimental group proves that there are significant differences between the pretest–posttest values for pain intensity in the morning (VAS-M)  nor in the control group Regarding the correlation between the time elapsed from the diagnosis to treatment administration and the level of pain in the morning, there is no significant correlation, neither in the experimental group  nor in the control group .Regarding the correlation between the time elapsed from the diagnosis to treatment administration and the level of pain in the evening, there is no significant correlation, neither in the experimental group  ≧ 10. Subjects with the baseline score already below the cutpoint for success were excluded and the N was adjusted accordingly. The dependent variable was dichotomized into successful and unsuccessful groups. A logistic regression analysis was completed to account for the differences in sample size between models using the same process, but only including patients with an initial SF-MPQ above 10 points improvement. For all regression calculations, a p value of ≤005 was considered significant.For SF-MPQ, the MCID score is a single cutpoint. In the experimental group, only 13.33% of the subjects registered a score over the cutpoint. The logistic regression model was statistically significant, x2(1) = 41.054, p < 0.0005 for the experimental group.In the experimental group, 43.33% from the patients registered a score over the 10-points improvement cutpoints for the ODI have been suggested as: 50% change [cutpoint for success were excluded and the N was adjusted accordingly. A logistic regression analysis was completed to account for the differences in sample size between models using the same process, but only including patients with an initial ODI above 30% improvement. For all regression calculations, a p value of ≤0.005 was considered significant. For ODI, the MCID score was established as a percentage-based change score from baseline. Different authors have suggested a number of MCIDs represented by a minimal change in scores that have been anchored to a patient’s perception of clinical importance. Minimal clinically important difference change score % change ; or 30% % change . Successcutpoint. In the experimental group, none of the subjects registered a score over the cutpoint. The logistic regression model was statistically significant, x2(1) = 9.654, p < 0.0005. for the experimental group, and was not statistically significant, x2(1) = 1.257, p > 0.0005 for the control groupIn the experimental group, 69% from the patients registered a score over the 10-points improvement The results of our study suggest that, in the lumbar disc disease, a combined rehabilitation program may be more effective in terms of pain and disability reduction, if it starts early after diagnosis. Similar results were reported by other authors ,55,56,57However, other authors think that the effect of early PT on pain and disability are significant, but the improvements were modest and did not last long ,56.A key strength of the present study is the complex rehabilitation treatment with an adapted and individualized physical therapy program, electrotherapy procedures correlated to the symptoms and specific hydrokinetic therapy.Another strength of this study is that the parameters considered in the study highlight the functional and symptomatologic status of patients.Clinicians need to take into account that the combination of ET, HT and adherence to an individualized PT program is of great importance for the treatment of LDP.For patients, it is important to realize that the LDP can be treated conservatively without the need for surgery and that it is very important to consult a doctor as soon as possible in order to prevent further aggravation of the pathology.It is important for researchers to remember that treatment is individualized according to the patient’s symptoms and clinical condition, and that the PT program must be tailored to the clinical condition of the patients.This study was limited by the relatively small number of patients and the short duration of the study.Our findings may stimulate further research with longer follow-up periods and larger patient groups.The current study proves the importance of combining ET with HT and PT. Patients who received this treatment combination showed an extremely significant improvement in pain relief, and reduction in functional disability after six months of treatment. The earlier the RT is implemented, the lower the pain perception and level of disability associated with the lumbar disease.


None of review has been conducted to compare the efficacy of interscalene blockade (ISB) with that of local infiltration analgesia (LIA) in patients undergoing total shoulder arthroplasty (TSA). We thus conduct a high-quality meta-analysis of randomized controlled trials (RCTs) to investigate which analgesic provides better pain relief.A comprehensive search of the published literature in PUBMED, Scopus, EMBASE, and Cochrane Library databases will be performed. Only RCTs evaluating LIA versus ISB in TSA are included in this study. The primary outcome was pain score. Secondary outcome measures included opioid consumption, postoperative adverse event, and length of stay. The Cochrane risk of bias tool is used to evaluate the risk of bias of included RCTs by 2 independent reviewers.The results of this research will be delivered in a peer-reviewed journal.This study expects to provide credible and scientific evidence for the efficacy and safety of ISB and LIA for early postoperative pain control after TSA.10.17605/OSF.IO/S3MBP.Since this study is on the basis of published or registered RCTs, ethical approval and informed consent of patients are not required. The growth rates of TSA are higher than the rates for total hip and knee procedures in the United States and were predicted to further increase by between 192% and 322% by 2015 based on 2008 numbers. However, due to the soft tissue injury and large amount of bone destruction involved, undesirable postoperative pain remains a challenge for both patients and surgeons after TSA.Currently, total shoulder arthroplasty (TSA) has been widely used in treatment for patients with degenerative arthritis and rotator-cuff-deficient conditions of the glenohumeral joint. In shoulder literature, various techniques can be used to relieve postoperative pain, including anti-inflammatory medications, opioids, epidural anesthesia, interscalene blockade (ISB), and local infiltration analgesia (LIA). The ISB allows delivery of local anesthetic in a controlled manner to the trunks of the brachial plexus between the anterior and middle scalene muscles. Compared with patients receiving only general anesthesia, patients who undergo preoperative ISB have shorter hospital stays and a reduced need for analgesics. However, ISB is also associated with risks, such as failure of nerve blockade, residual neurapraxia, displacement of the catheter postoperatively, systemic toxicity, and respiratory and neurologic complications. LIA has recently gained popularity for its potential to provide extended postoperative pain relief. It is a surgeon-controlled analgesic technique that used to reduce the pain in the early postoperative period with no influence on muscle strength. However, the possibility of LIA replacing ISB as an integral component of a multimodal clinical pathway for TSA needs to be further investigated.Pain management after TSA is an important variable in the perioperative period that can influence participation in physical therapy, discharge from the hospital or outpatient surgery center, and patient satisfaction. In addition, inadequate pain management has been shown to contribute to an increased incidence of postoperative complications.–10However, limited review has been conducted to compare the efficacy of ISB with that of LIA in patients undergoing TSA. Since several randomized controlled trials (RCTs) have been recently published, we thus conduct a high-quality meta-analysis to investigate which analgesic provides better pain relief.22.1The systematic review protocol has been registered on Open Science Framework (OSF) registries. The registration number is 10.17605/OSF.IO/S3MBP. The systematic literature review is structured to adhere to PRISMA guidelines , which include requirements deemed essential for the transparent reporting of results. We will update our protocol for any changes in the entire research process if needed.2.2The following search terms will be used in PUBMED, Scopus, EMBASE, and Cochrane Library databases on January 24, 2021, as the search algorithm:  OR  AND  OR  AND  OR . Two searchers will independently draft and carry out the search strategy, and the third member will further complete it. No time limit is given to publication date. References within included articles are reviewed to include articles that are not included within our literature search. A flow diagram explaining the literature search strategy and study selection is shown in Figure 2.3Studies included in our meta-analysis have to meet all of the following inclusion criteria in the PICOS order:(1)population: patients undergoing primary TSA;(2)intervention: ISB group;(3)comparison intervention: LIA group;(4)outcome measures: at least one of the following outcome measures is reported: postoperative pain relief, opioid consumption, functional outcome, length of stay, and postoperative adverse event;(5)study design: English RCTs. Articles with no assessment of outcomes mentioned above or no comparison of 2 groups will not be included into meta-analysis.Duplicate reports and conference abstracts will be excluded. Retrospective trials, case reports, biochemical trials, letters, and reviews will also be eliminated. Articles are exported to EndNote, and duplicates removed. Two independent authors (YC and JP) screen the titles and abstracts of potentially relevant studies to determine their eligibility based on the criteria.2.4Cochrane Handbook for Systematic Reviews of Interventions. Two independent authors (YC And JP) extract the following descriptive raw information from the selected studies: study characteristics such as author, publication year, study design; patient demographic details such as patients’ number, average age, body mass index, and gender ratio. The primary outcome is pain score. Secondary outcome measures include opioid consumption, postoperative adverse event, and length of stay. Where disagreement in the collection of data occurs, this is resolved through discussion. If the data are missing or cannot be extracted directly, we will contact the corresponding authors to ensure that the information integrated. Otherwise, we calculate them with the guideline of Cochrane Handbook for Systematic Reviews of Interventions. If necessary, we will abandon the extraction of incomplete data. A detailed description of all included studies will be listed in Table The method of data extraction will follow the approach outlined by the 2.5Q test and I2 statistic. An I2 value of <25% is chosen to represent low heterogeneity and an I2 value of >75% to indicate high heterogeneity. All outcomes are pooled on random-effect model. A P value of <.05 is considered to be statistically significant.Review Manager software  is used for the meta-analysis. Extracted data are entered into Review Manager by the first independent author and checked by the second independent author. Risk ratio with a 95% confidence interval or standardized mean difference with 95% CI are assessed for dichotomous outcomes or continuous outcomes, respectively. The heterogeneity is assessed by using the 2.6 is used to evaluate the risk of bias of included RCTs by 2 independent reviewers. The quality of RCTs is assessed by using following 7 items: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and other bias (Table The Cochrane risk of bias tool3In recent years, the use of TSA for treatment of various shoulder conditions has grown rapidly. Considering the continuously increasing number of TSA being performed, establishing a reasonable postoperative pain control program has become essential. The aim of the present study was to compare the efficacy of ISB and LIA in postoperative pain control after TSA. Hannan et al conducted a cohort study and revealed that LIA was associated with less pain, less opioid consumption, and shorter hospital stays after TSA compared with ISB. The study by Weller et al showed that LIA was associated with similar pain relief, increased opioid consumption, and fewer complications compared to ISB following TSA. However, these studies were retrospective cohort studies. With reduced opioid consumption, patients in ISB group can mitigate potential adverse events such as respiratory depression, nausea, and vomiting. Perhaps increased levels of narcotics consumed in the LIA cohort could very well offset any potential advantages over the potential complications associated with ISB.Several studies have compared the efficacy of ISB vs LIA for pain management following TSA. Angerame et al found no significant differences in mean pain level, postoperative opioid consumption, or length of stay, indicating that LIA may be as effective as ISB therapy.,16 and 2 retrospective studies,,15 Yan et al indicated that compared with ISB, LIA with liposomal bupivacaine had comparative effectiveness on reducing both pain scores and length of hospital stay. Wang et al including 4 RCTs,6,15,16 reported similar effectiveness of pain relief between ISB and LIA. However, the author mistakenly used a retrospective study as RCT in their study. In the study of Sun et al, the authors included 4 RCTs,6,16,20 and 3 retrospective studies–15 to compare ISB alone with LIA alone and found that both techniques provide similar overall pain relief and have similar opioid consumption, while patients treated with LIA experienced significantly less occurrence rate of complications after TSA. However, they contained some methodological shortcomings, data extraction, limited sample size, and high heterogeneity. Since several RCTs have been recently published, we thus conduct an updated high-quality meta-analysis to investigate which analgesic provides better pain relief. The results of this research will be delivered in a peer-reviewed journal. This study expects to provide credible and scientific evidence for the efficacy and safety of ISB and LIA for early postoperative pain control after TSA.Numerous meta-analyses have been published comparing the pain management of ISB and LIA in TSA. In a meta-analysis that included 2 RCTsConceptualization: Cheng Ji.Data curation: Yanhui Wu, Yuan Chen.Formal analysis: Yanhui Wu.Funding acquisition: Wen Ye.Investigation: Yanhui Wu, Yuan Chen.Methodology: Yuan Chen, Cheng Ji.Project administration: Wen Ye.Software: Cheng Ji.Supervision: Wen Ye.Validation: Cheng Ji.Visualization: Yuan Chen.Writing – original draft: Yanhui Wu.Writing – review & editing: Wen Ye.


P = 0.046). Pair-wise comparisons with baseline demonstrated significant differences for both groups in pain (P ≤ 0.001), disability (P ≤ 0.001), pressure-pain thresholds (P ≤ 0.044), lower limb mechanosensitivity, (P ≤ 0.047), anxiety (P ≤ 0.001), depression (P ≤ 0.001) and sleep quality (P ≤ 0.010). Patients with chronic low back pain who received a combined treatment of exercises and kinesio taping or analgesic current showed an improvement in pain, disability, anxiety, depression and sleep pattern. Moreover, exercises combined with electrotherapy produces greater improvements over these variables.Chronic low back pain it is one of the most common health problems worldwide. Usually is accompanied by a complex set of symptoms and generates significant direct and indirect socioeconomic and health costs. From a therapeutic point of view, there are a wide variety of methods to address the treatment of this pathology, however, these therapies have not been shown definitive efficacy. To investigate the effect of a mixed treatment with exercise and electrical stimulation versus exercise and kinesio taping in patients with non-specific chronic low back pain. A total of 58 patients participated in this single-blinded randomised clinical trial. Participants were assigned to the exercises- kinesio taping group, or exercises- analgesic current group, both received 12 treatment sessions. Disability, fear of movement, anxiety, depression, sleeps quality, pain, lower limb mechanosensitivity and pressure-pain thresholds were recorded at baseline and after 4 weeks of treatment. The 2 × 2 mixed analysis of covariance test showed statistically significant differences between groups for pain (Trial registration: NCT02812459. Scientific literature has demonstrated that LBP is accompanied by a complex set of symptoms such as physical functional disturbs, pain, fatigue, sleep deficits, poor quality of life, and altered emotional well-being2. The probability of being free of pain 12 months after having lumbar pain is only 42%1, so there is an urgent need for more effective treatments. In this case, the pain becomes chronic (CLBP) to the point of being considered the main cause of years lived with disability5. This pain is classified in most cases as “non-specific” pain, making it difficult to attribute it to a specific pathology6.Low back pain (LBP) has been one of the biggest public health problems, affecting up to 80% of the general population at least once in their life7, chiropractic therapy8, kinesiology9, exercise10, health counseling11, manipulative spinal therapy12, medication13 and electrotherapy14. Within the exercise program, lumbopelvic stabilization work is effective in chronic LBP, fundamentally from the point of view of the disability generated (work absenteeism)15. However, its effects are more limited in terms of subjective perception of pain. Therefore, together with the completion of these exercises, another series of complementary analgesic measures will be required15.Several treatments for LBP have been studied, including education programs17, as it provides a beneficial effect by relieving pain while not constricting movement18. Four beneficial effects of KT have been defined: normalization of muscle function, increase of lymphatic and vascular flow, reduction of pain and contribution to possible corrections of misalignments17. Although the degree to which these mechanisms contribute to some clinical effects is unknown, some studies have shown a significant beneficial effect, compared to placebo applications1. The results of its use could be contradictory when it refers to some parts of the body, but in general, the literature shows consistency regarding the benefits of the use of KT for the relief of CLBP19.Kinesio taping (KT) has been previously used as a complementary technique for the clinical management of patients with chronic pain21. Electroanalgesia with transcutaneous electrical nerve stimulation (TENS) is one of the most used for the relief of chronic and acute pain21. TENS consists in the application of low frequency electrical impulse currents through the skin to stimulates the peripheral nerves and produce various physiological effects21 which includes the affectation of the descending pathways in the cerebral cortex promoting the release of substances such as enkephalin and endorphins22 and the potential of being able to inhibit nociceptive fibbers, according to the gate control theory of pain23.Another technique used would be electrotherapyTo the best of our knowledge, there is no further previous evidence from studies based on the comparison of these treatment techniques (i.e. KT and TENS) for the control of pain and disability perception in patients with non-specific CLBP.Considering the mechanisms of action of the previously mentioned techniques and the existing evidence on the results for the relief of non-specific CLBP, we hypothesize that a combined intervention of TENS and exercise will be more effective in reducing pain and, therefore, will improve other factors such as sleep quality, than the combined application of KT and exercises.Considering this background, the purpose of this this study was to analyse the effectiveness of KT and electrical stimulation in combination with exercise in people with non-specific CLBP.A single-blind randomized clinical trial with parallel design  was conducted in patients with non-specific CLBP, who were referred to the clinical laboratory of the Physiotherapy Department of the University of Granada from a private Physiotherapy Centre in Granada, and who were studied between June 2016 and April 2018.24) for 3 months or more, not currently receiving physical therapy and a score of four points or more on the Roland Morris Disability Questionnaire (RMDQ)25. Exclusion criteria were: the presence of lumbar stenosis; any clinical signs of radiculopathy; a diagnosis of spondylolisthesis and/or fibromyalgia; treatment with corticosteroid or oral medication within the past 2 weeks; a history of spinal surgery; disease of the central or peripheral nervous system.Study inclusion eligibility criteria were: age between 25 and 65 years, presence of CLBP  on 2016 and complied with the 2013 modification of the Helsinki Declaration and Spanish legislation for clinical trials .26 for assessing disability due to CLBP, the Oswestry Disability Index (ODI)27 to check the level of functional impediment patients experienced as a result of back pain, Tampa Scale for Kinesiophobia (TSK)28 for assessing fear of movement, the Beck Depression29 and Anxiety30 Inventories, the Pittsburgh Sleep Quality Index (PSQI)31, and Numerical Pain Rating Scale (NPRS)32 for pain.Subjects provided demographic, clinical information and completed self-report measures including: the Spanish version of the RMDQ26. It is a self-administered measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability where a 2–3 point change from baseline is considered a minimum clinically important difference (MCID)25. We used the Spanish version of the questionnaire, which has been shown a good test–retest reliability (ICC: 0.87) and internal consistency (Cronbach α: 0.84–0.91)26.The primary outcome of this study was the change from baseline to post-treatment at 1 month in the RMDQ. The RMDQ is a widely used well-validated measure with good reliability for assessing disability due to LBP27, that evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0–5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0–10%), moderately disabled (20–40%), severely disabled (40–60%), crippled (60–80%), or bedbound (80–100%)27. The Spanish version of the ODI has shown good test–retest reliability (ICC: 0.92) and favorable internal consistency (Cronbach α: 0.86)27. Ostelo et al.33 reported that a change of 10 points is considered as the MCID for the ODI.The ODI28, comprising 17 items on the fear of movement or recurrent lesion, each scored on a 1–4-point Likert scale from “completely disagree” to “completely agree” where higher values reflect greater fear of (re)injury28. Test–retest reliability ranged from 0.90 to 0.96 in patients with chronic LBP28. The Spanish version has a good reliability  and validity (convergent and predictive) 28.Change from baseline in TSK30 consists of 21 items that are scored on a scale that goes from “not at all” to “severely”. The total score is interpreted according to the following classification: 0–7 indicates minimum anxiety, 8–15 mild anxiety, 16–25 moderate anxiety, and 26–63 severe anxiety. Beck’s depression inventory29 is made up of 21 items to evaluate the intensity of depression. In each of the items the subject has to choose a sentence from a set of four possible answers (punctuated with 0–1–2–3). The total score of the 21 items varies from 0 to 63. A persistent score of 17 or more indicates the possible need for professional help.Beck’s Anxiety Inventory31 contains a total of 19 questions, grouped into 10 sub-questions. The 19 questions combine to form seven areas with their corresponding score, each of them which shows a range between 0 and 3 points. In all cases, a score of “0” indicates ease, while a score of 3 indicates severe difficulty, within their respective area. The score of the seven areas is finally added to give a global score ranging from 0 to 21 points.The PSQI24, which is a Visual Analogue Scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain. It was used to assess the patients’ current level of pain and the worst and lowest level of pain experienced in the preceding 24 h32. The MCID for the NPRS in patients with CLBP has been reported to be 2.5points33.Change from baseline in the NPRS34 (SLR) and Slump Tests (ST)35. For the SLR, the degree of hip flexion was measured with a large universal goniometer placed lateral to the pelvis, with the proximal arm parallel to the patient’s trunk and the distal arm lateral to the thigh, in line with the femoral condyle34.To test the lower limb mechanosensitivity we used the Straight Leg Raise35, the degree of knee extension was measured with an universal goniometer placed with the fulcrum located on the knee, with the fixed arm  aligned with the trochanter, and the mobile arm aligned with the lateral peroneal malleolus. The ST is only considered positive if the patient experiences relief of symptoms with active cervical extension35. Kase.For the ST36. The examination was carried out twice in the same places, on the left and right sides following the protocol described by Sipko et al.36.Pressure-pain thresholds (PPT) at certain points in the lower back and along with lower limbs were determined by algometryDuring the randomisation process, concealed allocation (ratio 1:1) was performed using 58 printed cards placed in opaque envelopes. Patients were allocated to the treatment with KT or TENS group according to randomised codes. The therapist who prepared the randomisation code by using computer software (XX-X) was not involved in the rest of the study. The therapists who examined the patients (XX-X) for eligibility criteria and collected all baseline demographic and self-report variables and collected all outcome measures during the trial, were blinded to treatment assignment. Due to the nature of the study, patients and physical therapists could not be blinded to treatment assignment. All treatment interventions were carried out by 2 KT instructors with wide clinical experience who were blinded to the outcome measures and baseline examination findings but not to the treatment allocation, although they did not reveal group membership to the physical therapists who gathered outcome measures.Outcome measures were assessed before the first treatment session (baseline data), and immediately after the 4-week (1 month) intervention period by an assessor blinded to the treatment allocation of the patients.Patients in this group received the application of KT for the inhibition of lumbar paravertebral plus back exercise program. The tape used in this study was waterproof, porous and adhesive, with a width of 5 cm and a thickness of 0.5 mm.First, two black tape bands, shaped as a capital ‘I’, were placed along the paravertebral musculature, , with a length equal to that of the paravertebral musculature of the back, being necessary for the placement of the rest of the band for the patient to perform a little trunk flexion, letting the forearms rest on the treatment table, while the tension-free bands were placed “paper off”. Strips were applied by pressing and adhering the central parts before the ends Fig. . Next, aParticipants were advised to leave the tape in situ until the next session. Bandages were replaced three times a week during the 4 weeks of intervention.Patients in this group received the application of TENS plus back exercise program. The TENS were administered with a frequency of 30–50 Hz, and phase duration of 200 microseconds, in continuous mode. Four adhesive electrodes were used, which were placed in the lumbar area at a distance of 2 cm from the spinous, forming a square. The current was applied for 40 min with an intensity depending on the tolerance of each patient. The treatment lasted three weekly sessions for 4 weeks.37.In both groups, both the application of TENS and the KT bandage were carried out simultaneously a back exercise program by the patients according to the protocol described in a previous studyDiaphragmatic breathing technique (for 2–3 min).Activation of the transverse abdominal muscle (3 × 15 repetitions).Pelvic girdle (3 × 15 repetitions).Glute bridge (3 × 15 repetitions).Erector spinae strengthening (Prone Superman) (3 × 8 − 10 repetitions).Front plank (3 × 30 s).Side plank (3 × 30 s for each side).Lateral leg-raise for gluteus medius (3 × 10 − 15 repetitions).Spinal column mobility (Quadruped Cat Camel exercise) (3 × 10 repetitions).The exercise program consisted in eight different exercises according to three kinds of practices to guarantee the stability and control of motor pelvic and, trunk muscle strengthening and stretching. The sequency of the exercises performed is described below:The program was adapted according to the tolerance of the patients. The exercise program was conducted by a physical therapist. The patients performed 10–15 repetitions of each exercise in the set, once a day, three times a week for a total of 4 weeks.38, assuming a standard deviation (SD) of 2.5 points, a two-tailed test, an alpha (α) level of 0.05, and a desired power (beta) of 80%. The estimated desired sample size was calculated in 28 subjects per group.We used the Ene 3.0 software  to calculate the sample size. We based the calculations on the detection differences of 2.5 points in the RMQ Statistical analysis was performed using SPSS statistical software, version 20.0, conducted according to the intention-to-treat analysis principle.t-tests for continuous data and chi-square tests for categorical data. To test for homogeneity of variances Levene test was performed, with a 95% confidence interval.Key baseline demographic variables and self-report measures were compared between groups using independent Separate 2 × 2 mixed model ANCOVA with repeated measurements need to be conducted in order to test the effect of the treatment on disability as primary outcome and fear symptoms, anxiety, depression, sleep quality and pain as secondary outcomes with time (baseline and 4-week follow-up) as within-subject variable and group (KT or TENS) as between-subjects variable.P < 0.05 was considered significant in all tests.Changes in variable scores within and between groups were measured by means  of t-tests for paired or independent samples as appropriate. The effect size was calculated according to Cohen’s d statistic. An effect size < 0.2 reflects a negligible difference, between ≥ 0.2 and ≤ 0.5 a small difference, between ≥ 0.5 and ≤ 0.8 a moderate difference, and ≥ 0.8 a large difference. The study was approved by the bioethics committee of the University of Granada (Spain) on 2016 and complied with the 2013 modification of the Helsinki Declaration and Spanish legislation for clinical trials .Informed consent was obtained from all the participants before their involvement.Of the 62 patients recruited for the study, 58 patients with an average age of 43.41 years (SD = 17.62) met the inclusion criteria and were randomly assigned to the experimental (n = 29) or control group (n = 29). A CONSORT flow diagram of the participants throughout the study is shown in Fig. P ≥ 0.101).The baseline characteristics of participants in each group are shown in Table F = 0.21; P < 0.884), kinesiophobia  or the level of functional impediment patients experienced as a result of back pain . However differences between groups for the NPRS  were found, where the TENS group showed a greater decreased.The Group * Time interaction for the 2 × 2 mixed ANCOVA did not show significantly difference between the score of both groups in disability due to CLBP . Similar results were found in kinesio taping group (d ⩾1.65) with the exception of kinesiophobia that showed a moderate difference. Table P < 0.001), disability (P = 0.001) and kinesiophobia (P = 0.007) variables at 4 weeks post-treatment in the TENS group (P = 0.001). In the KT group only disability (P < 0.001) and pain (P < 0.001), outcomes were significant. The score change in pain was significantly greater in the TENS group (NPRS 3.55) than in the KT group (NPRS 2.11) , left SLR , right ST , left ST  scores. Also did not show significantly differences for PPT scores, in the spinal, left spinal, right gluteus medius, left gluteus medius, right sural triceps, left sural triceps, right anterior tibialis and left anterior tibialis .At the end of the 4-week treatment period, the Group * Time interaction for the 2 × 2 mixed ANCOVA for mechanosensitivity (SLR y ST), did not show significantly difference for right SLR . The TENS group showed, a moderate-large effect for right and left SLR and ST and a large effect for all the PPT. Table P < 0.001), left ST (P = 0.044), PPT scores of right L5-S1 (P = 0.048), left L5-S1 (P = 0.003), right gluteus (P = 0.001), left gluteus (P = 0.002), right sural triceps (P < 0.001), left sural triceps (P = 0.021), right anterior tibial (P = 0.044) and left anterior tibial (P = 0.001). In the TENS group the results showed significant differences in right ST (P = 0.047), PPT scores in the right L5-S1 (P < 0.001), left L5-S1 (P = 0.001), gluteus (P < 0.001), right sural triceps (P < 0.001), left sural triceps (P = 0.011) and anterior tibial (P < 0.001). The improvements in these scores before and after treatment were not significantly different between groups.  or depression . For the PSQI there were no significantly differences between total score, subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, sleeping medication or daytime dysfunction  scores.The Group * Time interaction for the 2 × 2 mixed ANCOVA did not show significantly difference between the score of both groups in anxiety , depression (P < 0.001), sleep quality (P < 0.001), subjective sleep quality (P < 0.001), sleep latency (P = 0.039), sleep duration (P = 0.010), sleep perturbation (P = 0.023), and dysfunction (P = 0.009) variables at 4 weeks post-treatment in the TENS group and for anxiety (P < 0.001), depression (P < 0.001), sleep quality (P < 0.001), subjective sleep quality (P = 0.010), sleep latency (P = 0.018), sleep perturbation (P = 0.001), medication (P = 0.010), and dysfunction (P = 0.004) scores in KT group. The improvements in these scores before and after treatment were not significantly different between groups , the administration format , and whether they were combined with other conservative treatments, therefore, the comparison of our results with other previous studies should be taken with caution45.An intervention that has been widespread in recent years is the use KT46.Although the mechanism through which KT acts on the conditions of the musculoskeletal system is still unclear, the most accepted hypothesis is that KT applies pressure to the skin or stretches the skin and that this external load can stimulate cutaneous mechanoreceptors (large fibers myelinated) and therefore inhibit pain transmission according to the theory of door control17. In fact, a decrease in pain has been reported after the specific use of KT application (origin to insertion) in different pathologies50. However, regarding the methodological quality of the selected articles, we found serious limitations in terms of the fulfilment of the defined criteria.In recent years, it has been theorized that this type of bandage can be useful to achieve an analgesic effect on the spine. A recent systematic review analysed this effect in patients with CLBP, finding statistically significant differences regarding the degree of pain between the group to which KT was applied and the group to which a placebo was applied49. TENS is a common modality for the treatment of musculoskeletal pain51. According to the door control theory23, TENS can stimulate large diameter afferent fibers, which can reduce the transmission of pain signals through the small nociceptive of afferent fibers, thus inhibiting pain discrimination and perception. In our study, it has been observed how the TENS have produced a significant improvement, in the threshold of pressure pain , in all points examined bilaterally .Concerning another of the techniques used in our study, some studies show that TENS therapy was effective in pain relief27. Our estimation of the effect of KT on disability measures on the ODI is 7.5 points, which is a relatively good score compared to the gamma of possible scores on the ODI27 and compared to the initial score of the study participants.People with LBP usually show a 6-point improvement in the ODI52, the measurement of this variable is also reflected, showing a change of 2 points at 4 weeks after applying the treatment.For the TSK questionnaire, a variation of 1.33 points has been observed in patients treated with KT. In the article by Castro-Sánchez et al.53.In both therapies, the presence of short-term placebo analgesic effects in response to the simulated control should support the use of the placebo protocol. The placebo analgesic responses are modulated through expectations regarding the treatment of pain and are regulated through responses to harmful stimuli in the spinal cord and brain, as well as the activation of descending pain by inhibitory pathwaysThe present study has some limitations. Firstly the small sample of patients, which may not be representative of the entire population of individuals with nonspecific CLBP thus affecting external validity. Secondly, we only investigated the short-term results of analgesic currents and a certain type of bandage with KT, and we could not conclude their longer-term effects, which deserve future research through randomized clinical trials. Finally, including a third group that only involves the performance of therapeutic exercise could help to better understand the individual contributions made by electroanalgesia and bandage to said therapy.In conclusion, individuals with non-specific CLBP experienced a significant improvement in pain intensity and disability after receiving 12 treatment sessions that combined a back exercises program with KT or TENS, being greater in the group treated with TENS application. More future researches are needed to evaluate the effects of KT and electrotherapy over a longer period to observe the long-term effects.