Keywords
Shoulder pain, Rotator cuff, Tendon injuries, Rehabilitation, Exercise Therapy.
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Alnuaimi N, Muthukrishnan R, Alshaali AS et al. Single exercise into pain versus symptom modification mediated exercises in people with rotator cuff-related shoulder pain: a pragmatic randomized controlled trial. [version 1; peer review: 1 not approved]. F1000Research 2025, 14:574 (https://doi.org/10.12688/f1000research.164912.1)
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Research Article
Single exercise into pain versus symptom modification mediated exercises in people with rotator cuff-related shoulder pain: a pragmatic randomized controlled trial.
[version 1; peer review: 1 not approved]
PUBLISHED 10 Jun 2025
OPEN PEER REVIEW
REVIEWER STATUS
Abstract
Corresponding author:
Ramprasad Muthukrishnan
Competing interests:
No competing interests were disclosed.
Grant information:
This study was supported by GMU and TPTR hospitals.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2025 Alnuaimi N et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Alnuaimi N, Muthukrishnan R, Alshaali AS et al. Single exercise into pain versus symptom modification mediated exercises in people with rotator cuff-related shoulder pain: a pragmatic randomized controlled trial. [version 1; peer review: 1 not approved]. F1000Research 2025, 14:574 (https://doi.org/10.12688/f1000research.164912.1)
First published: 10 Jun 2025, 14:574 (https://doi.org/10.12688/f1000research.164912.1)
Latest published: 10 Jun 2025, 14:574 (https://doi.org/10.12688/f1000research.164912.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Introduction
Shoulder pain is the third most prevalent and disabling musculoskeletal condition, accounting for one-third of outpatient services requiring physical therapy.1 Most people experience recurrence and persistent symptoms, with 40–50% reported continuing symptoms after 6–12 months and 14% reporting persistent symptoms after 2 years.2 The term RCRSP (Rotator cuff-related shoulder pain) was proposed to replace the inaccurate pathoanatomical diagnosis such as subacromial impingement/pain syndrome, rotator cuff partial and full thickness tears, and rotator cuff tendinopathy and provides a more generic and inclusive diagnostic approach.3 Emerging evidence has shown promising results for exercise therapy that not only target tendon related problems but overall function in the management of RCRSP.4 No program has yet demonstrated superiority over the others. The SUMS (Shape Up My Shoulder) rehabilitation program is a staged exercise program that may be considered for the movement and functional rehabilitation of musculoskeletal conditions involving the shoulder. It involves different stages, namely, SSMP (Shoulder Symptom Modification Procedure), eccentric and heavy slow resistance (HSR), and a functional program. The Shoulder Symptom Modification Procedure (SSMP) is one of the major components of shape-up-my shoulder (SUMS) rehabilitation.5 The Shoulder Symptom Modification Procedure (SSMP) is a structured set of techniques used by physiotherapists to evaluate and address shoulder pain or dysfunction. It focuses on analyzing how adjustments in posture, movement patterns, or muscle activation influence a patient’s symptoms. The SSMP has three major components: thoracic, scapular, and humeral head procedures. The SSMP has gained widespread use among physiotherapists, even though there is limited published evidence.6 It has been shown to reduce symptoms in approximately 70 percent of individuals reporting RCRSP.5 Other components of SUMS include a detailed muscle performance program, that is, an eccentric and heavy slow resistance exercise program, followed by a functional program. The second stage involves a muscle performance program culminating in early isometrics and eccentric progressive loading exercise (EPL), which is a gradual increase in muscle length with progressive production of tension. Eccentric contractions targeting the series of elastic components of muscle during the EPL phase showed improvements and appeared to confer therapeutic benefits by improving pain and function in the short term.7,8 HSR is a combination of eccentric and concentric exercises that have demonstrated a reduction in pain and functional improvement in lower-limb tendon-related symptoms.9 With HSR training, muscles contract slowly and progressively, during eccentric and concentric phases.10,11 HSR using a faster eccentric and concentric phase is hypothesized to target the contractile component and improve the mechanical strength of the muscle.11 Reason for giving Eccentric progressive loading before HSR is, as eccentrics makes tendons stiffer and lower the risk of tendon injuries by encouraging the production and proper arrangement of collagen. Conversely, during periods of increased loading, such as slow resistance training as tendon cells increase the production of collagen and cross-linking enzymes, which helps in improving the strength of tendon.12 By providing pain-free and replicating PIC movement patterns early in the rehabilitation phase, the SSMP may amplify functional mobility and neuromuscular efficiency, enabling the expedited implementation of the intervention.
In contrast, the Single Exercise for Shoulder Pain (SEiSP) involves the application of isometrics, followed by eccentric and then eccentric-concentric exercises for a single painful shoulder movement. The main reason for incorporating a single exercise into pain is to trigger exercise-induced hypoalgesia, in which the body releases endogenous opioids and activates spinal inhibitory mechanisms to reduce pain. It also activates conditioned pain modulation, promotes pain reduction, and helps patients overcome fear and avoid movement.13 A single Exercise for shoulder pain reproduces the patient's tolerable, lowest shoulder pain, is performed at low intensity, and gradually increases over time. SEiSP aims to desensitize pain receptors, exploit tissue irritability through graded exposure to the painful shoulder range, and gradually extend to other ranges by enhancing pain tolerance, supported by moderate quality of evidence studies.14,15 The effectiveness of SEiSP has yet to be investigated in patients with RCRSP. The role of gradual tendon load, SEiSP-mediated pain modulation, and their distinct contributions to achieving pain-free shoulder function warrants further investigation. Although shoulder-specific exercises generally improve pain, range of motion, and function in various shoulder conditions, the effects of functional activity on shoulder cuff tendinopathies have been less consistently reported in the literature. A functional program refers to a method of returning a patient to perform complex shoulder exercises, combined movements, and exercises aimed at improving shoulder function.5,16 Hence, reducing the risk of future recurrent injuries, along with the ability to restore an individual to their best shoulder physical fitness and preserve shoulder ranges.
In the current trial, structured exercise approaches such as the SEiSP and SUMS were applied in the earlier stages of rehabilitation to facilitate recovery and enable a smooth transition into a functional exercise or program. By offsetting pain through exercise or symptom modification and introducing calibrated muscle contractions or loads, early loading of shoulder tendons can be optimized. This creates a stable foundation for progression, preserves the shoulder functional range of motion, and facilitates a smooth transition to a functional program.
Aims & Objectives
This study aimed to compare the effectiveness of two novel exercise regimes in the management of RCRSP. This study aimed to investigate the effectiveness of SEiSP and SUMS rehabilitation programs followed by a functional program in individuals with RCRSP. Specifically, this study evaluated pain under various conditions, disability levels, and the transition rate of participants into a functional program. This study adopted an equivalence trial design to investigate whether the two interventions would produce comparable results within a predetermined range of pain and functional outcomes. The study further posited that the SUMS group would demonstrate an expedited rate of transition into the functional program compared with the SEiSP group.
Methods
Study design
This study utilized a pragmatic, adaptive equivalence trial design to compare the clinical effectiveness of two treatment modalities for shoulder pain, namely, SEiSP and SUMS, both combined with tendon loading and resistance exercises. In addition, pragmatic trial principles were applied to reflect real-world clinical settings by allowing flexibility in the implementation of treatments and the management of participants. This study evaluated the overall treatment strategies for managing rotator cuff-related shoulder pain (RCRSP) within a structured shoulder exercise program, focusing on patient-centered outcomes, such as pain relief and functional improvement, without changing individual exercise components.
Adaptive and pragmatic features
A flexible trial design was used to adjust the treatment to the needs of each participant’s exercise load adaptation and maximize treatment effectiveness. If participants experienced worsening symptoms during the trial, they received active Transcutaneous Electrical Nerve Stimulation (TENS) in addition to their originally assigned exercise treatment.17 The pragmatic approach of pain treatment was prefixed before starting the trial and provided ethical and patient-centered care enabling exercise adherence and introduced modifications based on real-time patient experience derived form new exercise strategies. Number and percentage of patients, symptom status before the next exercise session, and triggers that necessitated TENS treatment were documented.
The trial had elements of pragmatism provided by including a broader inclusion of participants, by referral, and conducting research in different locations, i.e., Outpatient department of University Hospital, Rehabilitation Hospital, affiliated hospital at territory centers and emphasizing wider reach and opportunity for the selection of participants. Shoulder workshops for therapists were conducted to ensure smooth implementation and piloting of SUMS and SEiPS exercise regimes from 7th June 2022. Based on the lessons learned, pragmatic exercise progressions were permitted and adjusted based on the clinical judgment of the treating therapists. For example, a halt was provided if the rest was required between sessions. However, the halted sessions were re-administered to reach equal levels in both the groups. In keeping with the pragmatic approach, placebo treatments were not used because the study aimed to evaluate real-world effectiveness in typical clinical settings.
Study setting and participants
A single-center, parallel-group, pragmatic randomized controlled equivalence trial following CONSORT guidelines with parallel allocation was conducted at the TPTR hospital and affiliated sites by the trial coordinator. The study protocol was approved by the Institutional Review Board, and the protocols were implemented on a trial basis before the trial in physiotherapy outpatient departments of affiliated settings. After ethical approval, participants were recruited from 1st August 2022 for the trial and informed consent was obtained prior to participation. A total of 66 participants (35 men and 31 women; aged–25-54 years) diagnosed with rotator cuff-related shoulder pain by a specialist in orthopaedics were recruited. Participants were screened based on the following criteria: atraumatic onset, insidious pain, symptom exacerbation with overhead activity, and pain experienced at night.
Inclusion criteria were defined based on
• Age between 25-55 years.
• Consistent shoulder tendon pain with resisted shoulder subacromial impingement related cuff muscle tests such as the posterior impingement test, Neer impingement test, and Hawkins-Kennedy test.18
• Loss of active ROM (Range Of Motion) with relative preservation of passive ROM.
• Confirmed rotator cuff tendinitis, tendinopathy, impingement syndrome by orthopaedic specialist.
Exclusion criteria included restriction of both passive and active ROM with indicated full-thickness (FTTs) rotator cuff tears, rotator cuff muscles strength less than grade three based on the Medical Research Council - Muscle Strength Grading Scale (MMT), adhesive capsulitis, history of unstable fractures/dislocations in the upper extremities, referred pain from other areas, shoulder and neck surgeries, comorbid neurological disorders or carcinoma, communication difficulties, metabolic syndrome including diabetes, inflammatory arthritis, and thyroid disease, and cervical spine pathology associated with symptoms.
Topographical assessment of tendons
To assess tendon loading capacity, resisted isometric contractions were performed by experienced sports physiotherapists in the following muscle-tendon groups: the supraspinatus using the Jobe or Full-Can Test, infraspinatus using the Infraspinatus Isolation Test, teres minor using the Infraspinatus Isolation Test or Patte Test, subscapularis using the Gerber Lift Off or Push-with-Force Test, and long head of the biceps using the Speed Test.19Any tendon that tested positive in the above assessments and exhibited muscle strength below grade three on the Manual Muscle Test (MMT) was excluded as a precaution. We also assessed the inter-rater reliability of the two physiotherapists in identifying tendon-specific shoulder pain.
Sample size calculation
The detailed participant recruitment strategy and analysis are shown in Figure 1. The sample size calculation resulted in 29 participants in each group, for a total of 58, with an expected difference of 4 in the Numeric Pain Rating Scale (NPRS) scores obtained from study,20 a 1:1 ratio, and without dropout rate. A sampling frame of 32 participants per group was prepared, accounting for a 10% dropout rate, and was calculated using https://riskcalc.org/samplesize/.
Figure 1. Consort flow chart.
Participants’ allocation-randomization and blinding
The participants were randomly assigned to two groups using a computer-generated randomization sequence. A block of 10 participants underwent a randomization process to ensure an equal probability of assignment to Group A (SEiSP) or Group B (SUMS). Allocation to groups was performed by a trial coordinator who was not involved in any other aspects of the study, thereby maintaining allocation concealment and minimizing potential bias. Blinding was implemented at the assessor level to reduce outcome assessment bias; the outcome accessor was blinded to group allocation throughout the study.
Interventions
After obtaining written informed consent, participants in both groups were provided with a detailed explanation of their respective interventions and the right to withdraw at any point or return to standard care. Baseline outcome measurements were taken before the intervention, and both groups attended physiotherapy sessions three times a week for 45 min in the first six weeks and 45 min, twice a week for the following six weeks, with a total of 30 sessions. Outcome variables were assessed at the 6th and 12th weeks after the intervention.
Group A received a single exercise in the pain program, that is, introducing a single painful movement, as identified using a positive-resisted isometric contraction procedure. Either abduction or flexion or internal or external rotation movements within the personal tolerable limit, but not exceeding 4/10 on the NRPS during movement execution, were used. These exercises were guided by therapists initiated with isometrics of single movement and progressed into the maximal eccentric contraction phase, and later into the equal eccentric-concentric phase guided by unprovoked symptoms. The framework was adapted from Littlewood et al. and Smith et al.14,15 A precaution was that no more than a single movement was introduced at any one of the sessions before entering into the functional program. Additional movements were performed on the basis of pain tolerance and irritability.
Group B underwent SUMS, that is, the shoulder symptom modification procedure (SSMP) for pain management using patient-identified concern of movement (PIC) by stepwise repositioning of the thoracic spine, scapula, and humeral head procedures. Worst or unchanged responses or movements with repositioning were discarded, and better responses or movements were preceded by exercise. Non-responders to PICs of SSMP were posted into isometric exercise programs before being introduced into a modified early stage exercise regime which as described below.9
The exercises were started with isometrics, EPL, and HSR. Isometric exercises on PIC movements started with 50% of their maximal force compared to the contralateral side, progressed to 80-90% or, as tolerated, were holding of contraction increased from 3 s to 20 s, up to 2 to 5 sets.9 Primarily, external and internal rotation, abduction, and flexion ranges were identified as symptomatic movement or PIC. PIC-specific muscles were first placed into eccentric contractions with a count of 5 seconds with a metronome. When one repetition was completed, the arm was assisted or passively returned to the starting position with minimal load to enhance the functionality. Optimal eccentric control progressed at a speed of 3 beats and progressed into a higher or accepted load without any exacerbation of pain. Later exercises with slow and heavier (HSR), that is, 70% of 1 RM concentric contractions, were introduced. Tempo was adjusted to equal eccentric and concentric contractions at the end phase of EPL and for HSR exercise sets. All exercises were individualized for the participants. This framework was adapted from Fernandez and Lewis and proposed by Lewis, version 8 of the SUMS.9
In the SUMS group, the participants were classified as non-responders if they did not experience symptom improvement or if their symptoms worsened. These non-responding participants transitioned to a modified early stage exercise regimen that included ball rolling exercises and the introduction of a non-immersive Virtual Reality exercise, adapted from the work of Lewis.9 The participants who underwent a modified early stage exercise regime were additionally introduced into isometric exercise, which was further followed by EPL and HSR.
The patient-identified concern of movement (n = 31, SUMS Group) and movements that exhibited positive signs of tendon pain from resisted isometric contraction for all participants (n = 66) were documented.
In both groups,the patients were asked about night pain and pain experienced on the previous day using the NPRS before beginning the next session. The Progress and phase of concentric or eccentric contractions were monitored using a metronome for slow to faster phases of contractions, and progressive load and repetitions were pragmatically personalized without provoking symptoms as far as possible and gauged by self-reporting of night pain or any pain felt during the session.
Any increase in pain after the sessions pragmatically dealt with reduced speed, load, and repetitions. Graduated eccentric exercise and HSR exercises with a minimum of three sets of five repetitions, and for isometric exercise, hold of 3–20 s, up to 2–5 sets were followed for the initial weeks until the first transition for both groups. Any pain reporting above 3/10 in the NPRS was treated with TENS to induce an analgesic effect after the patient consensus in both groups and documented for further review.
Participants were transitioned into the shoulder functional program within 12 week period based on the set criteria; that is, the functional program for both groups began when participants reported minimal 80–90% pain reduction on the Numeric Pain Rating Scale (NPRS). The participants’ point of entry into the functional program at each week for 45 minutes, which involved a brief warm-up up to 5 minutes, cardiovascular training with a bicycle or treadmill for up to 10 minutes, followed by video game-based exercise upper extremity specific regimes incorporated with core stabilization control trunk exercises with SKI and FLY screen options with holding theraband balls at chest level or freely in both hands extended up to 30 minutes. The screen-based exercise was performed using an exergaming approach available in TecnoBody D-WALL, as explained in detail in the outcomes section below. Functional program exercises were personalized by physiotherapists for every participant, predominantly for strength, motor control, and endurance gains. The final stages of the functional program in the study included upper extremity specific chaotic challenges limited to a) incremental multistage lawn mower exercise and b) throwing-catching ball.9 Intention-to-treat (ITT) analysis was used to account for potential dropouts.
Outcomes
The primary outcome measure was the Shoulder Pain and Disability Index (SPADI) to assess function and pain. The assessment comprised 13 items categorized into pain and function subscales. Participants provided responses using a 10-point scale, with higher scores indicating increased levels of pain and disability. The SPADI has shown high reliability and responsiveness to change.21 The NPRS also serves as a primary measure to assess pain. Patients were asked to indicate their pain levels on an 11-point numerical scale ranging from zero to ten, with higher scores indicating more intense pain. The NPRS has shown strong reliability and sensitivity for detecting changes in pain levels.22
Range of motion (ROM) of the shoulder was assessed using a 3D digital videographic and feedback system by TecnoBody D-WALL-ELITE.23 This system with playstations included a digital mirror that provided real-time analysis of the glenohumeral joint range of motion using a 3D camera to coordinate with 16 body segments. This digital wall allowed immediate biofeedback on performance outcomes using TecnoBody D-WALL-ELITE-2019 during exercise sessions.23 The Patient Global Impression of Change (PGICS) was used to assess the patients' overall improvement and changes in symptoms. It utilizes a 7-point scale for patients to evaluate their progress and is reported to show high reliability.24 Participants’ entry to the functional program phase week-wise was counted as the transition rate for progression.
Statistical analysis
Friedman test and pairwise comparison using Wilcoxon signed ranks test for NPRS and SPADI, Chi-square test for using frequency distribution for PGICS, Repeated measure ANOVA and post-hoc analysis for shoulder ranges of motions, and frequency distribution for transition rates were computed using SPSS V21 software. The researcher analyzed the data and was blinded to the interventions. Inter-rater reliability was measured using Cohen’s kappa for pain identification in the shoulder tendons.
Results
Seventy-two participants who reported undergoing RCSRP were assessed for eligibility. Finally, 66 participants who met the eligibility criteria were recruited and randomly assigned to the SUMS or SEiSP group.
PIC and resisted isometric contraction pain-positive results matched 67% of patients in both groups. No adverse events or dropouts occurred during the study. The demographic characteristics of the groups are presented in Table 1.
Table 1. Demographic characteristics of study participants.
| Variable | SUMS (n = 31) | SEiSP (n = 35) | p value |
|---|---|---|---|
| Age (years, Mean ± SD) | 39.16 ± 14.01 | 38.647 ± 11.09 | 0.85 |
| Body mass index (kg/m2) Mean ± SD | 25.948 ± 3.63 | 25.11 ± 3.72 | 0.33 |
| Gender n (%) | |||
| Male | 15 (48.4%) | 16 (45.7) | 0.79 |
| Female | 16 (51.6%) | 19 (54.3%) | |
| Duration of symptoms in months | |||
| <3 months | 18 (58.1%) | 20 (57.1%) | 0.17 |
| 3-12 months | 7 (22.6%) | 8 (22.9%) | |
| ≥24 months | 6 (19.4%) | 1 (2.9%) | |
| Dominant side affected | |||
| Yes | 30 (96%) | 33 (94.3%) | 0.04* |
| No | 1 (3.2%) | 2 (5.7%) | |
| Bilateral shoulder pain | |||
| Yes | 0 | 0 | 0.02* |
| No | 31 (100%) | 35 (100%) | |
| Sick leave at the baseline | |||
| Yes | 0 | 1 (2.9%) | 0.04* |
| No | 31 (100%) | 34 (97.1%) | |
| Workload, present occupation (0: Light, 10 to 10 physically heavy) | |||
| ≤5 | 5 (16.1%) | 8 (22.9%) | 0.04* |
| 6-8 | 23 (74.2%) | 22 (62.9%) | |
| 9-10 | 3 (9.7%) | 5 (14.3%) | |
| Working nature | |||
| Full time | 21 (67.7%) | 23 (65.7%) | 0.10 |
| Part time | 4 (12.9) | 11.4 (11.4%) | |
| Home maker | 6 (19.4) | 8 (22.9%) | |
| Corticosteroid injection at the baseline | |||
| Yes | 4 (12.9%) | 4 (11.4%) | 0.03* |
| No | 27 (87%) | 31 (88%) | |
| Use of analgesic drugs | |||
| Yes | 11 (35%) | 26 (74.3%) | 0.07 |
| No | 20 (64%) | 9 (25.7%) | |
| Use of analgesic: No. per exercises session | |||
| 0 | 21 (67.7%) | 28 (80%) | 0.31 |
| 0-1 | 10 (32.3%) | 6 (17.1%) | |
| 1-2 | 0 | 1 (2.9%) | |
| Adverse events after Cortico-steroid injection | |||
| Yes | 0 | 0 | 0.02* |
| No | 31 (100%) | 31 (100%) | |
| Comorbidity | |||
| Diabetes | 2 (6.4%) | 1 (2.8%) | |
| Hypertension | 4 (12.9%) | 3 (8.5%) | 0.05* |
| Diabetes and Hypertension | 0 | 2 (5.7%) | |
Supraspinatus pain was the most frequent pain in both groups, but it was more prevalent in the SUMS group (77.4%) than in the SEIPS group (62.9%). Pain in the infraspinatus was significantly more common in the SEIPS group (25.7%) than in the SUMS group (9.7%). Subscapularis pain was observed only in the SUMS group, with 6.5% involvement. The teres Minor pain was low and equal in both the groups (n = 2) (see Table 2).
Table 2. Tendon pain distribution for SUMS and SEIPS groups.
| Tendon/Muscle involvement | SUMS n(%) | SEIPS n(%) |
|---|---|---|
| Supraspinatus (Total) | 24 (77.4%) | 22 (62.9%) |
| Isolated | 15 (62.5%) | 13 (59.1%) |
| *With Infraspinatus | 6 (25.0%) | 7 (31.8%) |
| *With Biceps | 3 (12.5%) | 4 (18.2%) |
| *With Scapula Winging | 6 (25.0%) | 9 (40.9%) |
| Infraspinatus (Total) | 3 (9.7%) | 9 (25.7%) |
| Subscapularis (Total) | 2 (6.5%) | 2 (5.7%) |
| *With Biceps | 2 (100.0%) | 2 (100.0%) |
| *Teres Minor | 2 (6.5%) | 2 (5.7%) |
Inter-group comparisons for SPADI and NPRS scores did not show any significant differences after 12 weeks of intervention, which is in line with the equivalence trial design. Intra-group comparisons revealed significant improvements in pain at rest, activity, night, maximum activity level, disability, and shoulder ROM (P < 0.0001).
Numerical Pain Rating Scale (NPRS)
Significant differences were observed in Groups A and B for the following outcomes: Pain measured during rest, activity, night, and maximum level of pain at baseline, at the sixth week, and post-intervention after the 12th week (p < 0.0001) ( Table 3) and ( Table 4) were significantly reduced. Paired comparison using the Wilcoxon signed ranks test showed significant improvements within groups while comparing any pain conditions such as rest, activity, night, or maximum pain at baseline to 6 weeks, and 6 to 12 weeks (p < 0.0001). The median differences between weeks 1 versus and 12th week for the above four conditions were 5,4,4 & 5 for SUMS, 4,5,4 &5 for the SEiSP group with a significance level of p < 0.0001. This significant difference persisted in any weekly time point comparisons within groups, that is, baseline to 6th week or 6 versus 12th week. The rank-biserial correlation also known as effect size were 0.9 to 1 indicating large effect size across intra-group comparisons of week-wise time-points using post-hoc analysis. The partial eta squared was calculated to determine the effect size.
Table 3. Analysis of NPRS scores of rest, activity, night and maximum level of pain during baseline, 6 weeks and 12 weeks for SUMS group.
| Outcome: Group | Pain conditions | Mean rank (Median, Median absolute deviation) | χ2 ANOVA (df = 2) | p value* | ||
|---|---|---|---|---|---|---|
| Baseline | 6 weeks | 12 weeks | ||||
| NPRS::SUMS (n = 31) | Rest | 3 (5,1) | 1.98 (2,1) | 1.02 (0,0) | 61.51 | <0.0001 |
| Activity | 3 (6,1) | 2 (4,1) | 1 (2,0) | 62 | <0.0001 | |
| Night | 2.97 (4,1) | 2 (2,1) | 1.03 (0,0) | 60 | <0.0001 | |
| Maximum | 3 (7,1) | 2 (4,1) | 1 (2,0) | 62 | <0.0001 | |
Table 4. Analysis of NPRS scores of rest, activity, night and maximum level of pain during baseline, 6 weeks and 12 weeks for SEiSP group.
| Outcome: Group | Pain conditions | Mean rank (Median, Median absolute deviation) | χ2 ANOVA (df = 2) | p value* | ||
|---|---|---|---|---|---|---|
| Baseline | 6 weeks | 12 weeks | ||||
| NPRS::SEiSP (n = 35) | Rest | 3 (5,1) | 1.99 (3,1) | 1.01 (1,1) | 69.51 | <0.0001 |
| Activity | 3 (7,1) | 1.99 (4,1) | 1.01 (2,1) | 69.51 | <0.0001 | |
| Night | 3 (5,1) | 1.94 (2,1) | 1.06 (1,1) | 68.17 | <0.0001 | |
| Maximum | 3 (7,1) | 2 (4,1) | 1 (2,1) | 70 | <0.0001 | |
Shoulder Pain and Disability Index (SPADI)
Significant differences were observed between Groups A and B in both inter-and intra-group comparisons of SPADI scores at baseline, in the sixth week, and post-intervention in the third month (12th week) (p < 0.0001) ( Table 5).
Table 5. Analysis of SPADI scores during baseline, 6 weeks, and 12 weeks for SUMS and SEiSP group.
| Group | Mean rank (Median-median absolute deviation) | χ2 ANOVA (df ) | Sig* p value | ||
|---|---|---|---|---|---|
| Baseline | 6 weeks | 12 weeks | |||
| SUMS (n = 31) | 3 (66-7) | 2 (30.70-4.3) | 1 (10-4) | 62 (2) | <0.0001 |
| SEiSP (n = 35) | 3 (66-7) | 2 (34-7) | 1 (16-3.5) | 70 (2) | <0.0001 |
| Post-hoc analysis | 1 vs 6 week | 1 vs 12 week | 6 vs 12 week | p value | Effect size§ |
| Median difference (SUMS) | 35.30* | 56* | 20.70* | 0.0001† | 1 |
| Median difference (SEiSP) | 32* | 50* | 18* | ||
Global impression of change scale
Intra-group comparisons using the chi-square test on satisfaction frequency responses of PGICS values revealed that there was a statistically significant difference in both groups (SUMS:x2 = 18.41, p < 0.0003; SEiSP:x2 = 21.42, p < 0.0002), which implies that both groups at the end of treatment reported significant improvements in terms of satisfaction. However, inter-group comparisons of satisfaction responses revealed no significant difference (p=0.689).
Functional shoulder range of motion measured by D-wall
Between group comparisons, there was a statistically significant difference within subjects in the main effect at all tested functional ranges of the glenohumeral joint in patients with RCRSP for both groups between the time points of repeated measures ( Table 6). However, the interaction effect among the groups was similar and non-significant for all tested ranges of motion, except for the extension range of motion (p < 0.001). Hence, the no exercise regime was more effective at certain points in time than the other.
Table 6. Analysis of within-Subjects effects of shoulder functional range of motion at the baseline, 6 weeks, and 12 weeks of training using repeated measures ANOVA analysis.
Within group: Intra-group comparisons using two related samples, Wilcoxon signed-rank test, across timelines (i.e., baseline to 6th week and 12th week for shoulder range of motion) revealed that there was a statistically significant difference across time checkpoints with a large effect size above 0.7, except for a moderate effect size for extension.
Transition rate to functional program
Frequency distribution was presented as the percentage of transition of RCRSP participants into the functional program from Groups A and B cumulatively, as well as within weeks ( Table 7). Blinded raters reported 6.1%, 21.2%, 12.6%, and 9.1% transitioned during weeks 6, 7, 8, and 9, respectively, from Group A. 16.7%, 12.1%, 10.6%, and 7.6% transitioned during weeks 5, 6, 8, and 9 respectively from Group B out of cumulative 66 participants.
Table 7. Transition rates (%) of RCRSP participants into shoulder functional rehabilitation program in SEiSP and SUMS groups.
| Group | (SEiSP, n = 35) | (SUMS, n = 31) | (SEiSP, n = 35) | (SUMS, n = 31) |
|---|---|---|---|---|
| Weeks | Week-wise* (n(%)) | Cumulative of weeks (n (%)) | ||
| 5 | 0 (0) | 11 (16.7) | 0/(0) | 11/(35.48) |
| 6 | 4 (6.1) | 8 (12.1) | 4/(11.43) | 19/(61.29) |
| 7 | 14 (21.2) | 7 (10.6) | 18/(51.42) | 26/(83.87) |
| 8 | 9 (12.6) | 5 (7.6) | 27/(77.14) | 31/(100) |
| 9 | 6 (9.1) | - | 33/(94.29) | - |
| 11 | 1 (1.5) | - | 34/(97.15) | - |
| 12 | 1 (1.5) | - | 35/(100) | - |
Reliability analysis using the Pearson correlation coefficient for the shoulder functional range of motion measures obtained by the D-wall revealed a significant positive correlation across timelines (p < 0.05). The range of r values was flexion (r = 0.60-0.72), extension (0.70-0.89), abduction (0.34-0.59), adduction (0.30-0.39), internal rotation (0.10-0.64) and external rotation (0.10-0.85).
Both SEiSP and SUMS resulted in significant improvements in clinical outcomes. Among all findings, the transition rate into functional programs at the 5th and 8th weeks was significantly higher for the SUMS group than for the SEiSP group, with reported values of 0% and 35.48% against 77.14% and 100%, respectively. In the SUMS group, 27 (87%) out of 31 responded to SSMP and 4 participants were classified as non-respondents (13%), exhibited no symptom improvement or experienced symptom exacerbation using SSMP, and preceded with modified early stage exercise regimen incorporating ball rolling exercises and the introduction of a non-immersive virtual reality exercise followed by isometric contractions as a bridge to EPL and HSR.
The SEiSP group also had higher conventional transcutaneous electrical nerve stimulation (TENS) (15/35) than the SUMS group (5/31), chi squared (χ2) = 5.56, p = 0.018. An adaptive trial approach was utilized, incorporating TENS treatment for participants who developed worsening symptoms, reflecting patient-centric care. Pain was the major trigger within the first 4 weeks, and pain reduction by more than 70% was achieved before the next exercise session in both groups. In the SEiSP group, nine participants underwent three TENS sessions and six participants underwent two sessions in the first four weeks. In the SUMS group, 5 participants underwent 2 sessions of TENS from 2nd week till 4th week.
In this equivalence trial, both Shoulder Symptom Modification Procedure (SSMP) interventions and SEiSP demonstrated clinically meaningful improvements, exceeding the predetermined thresholds of 10 points on the Shoulder Pain and Disability Index (SPADI) and 35% reduction in Numeric Pain Rating Scale (NPRS) scores. Statistical analysis confirmed that the two interventions were clinically equivalent, indicating that both approaches are valid and effective for managing shoulder pain within the defined clinical criteria.
Inter-rater reliability for tendon pain identification between two physiotherapists
The inter-rater reliability for tendon pain identification between the two physiotherapists is provided below: for the supraspinatus tendon, the agreement between the two physiotherapists was moderate (κ (kappa) = 0.51), and for the infraspinatus tendon, the agreement was high (κ = 0.90) to identify the tendon pain; for the Subscapularis and Teres Minor tendons, there was substantial agreement (κ = 0.74), reflecting a strong consistency in the assessment of these tendons between the two therapists.
Discussion
The findings of the present study revealed that both groups with RCRSP transitioned well into functional programs or pain-free functional activity and yielded significant positive clinical outcomes, that is, reduced pain and shoulder disability, improved global satisfaction, and shoulder kinematics associated with increased functional range of the shoulder complex. In patients diagnosed with RCRSP, different approaches of exercise therapy were effective in improving functional ranges and controlling pain.25–29 In our study, the reported conditions of pain during activity, night, and maximum (NPRS) were above the Minimal Clinically Important Difference (MCID) values in the SEiSP group. The only NPRS score difference below the MCID values was from baseline to six weeks at rest in the SEiSP. This may be due to working in painful shoulder ranges of motion. Similarly, the SUMS group showed pain reduction above the MCID at rest and maximum pain conditions measured at 6 and 12 weeks. However, the SUMS group had immediate pain control in the first week compared to the SEiSP group, which was delayed but achieved in later weeks. This highlights the importance of symptom control at earlier stages of RCRSP treatment and underscores the need for pain modulation to introduce load-based activity-specific exercises. The SEiSP group demonstrated marginally higher pain reduction in the 12th week, as measured under both activity and maximum pain conditions, with a median difference of 1. This finding suggests a potential, albeit non-significant, unidentified neurophysiological or biological mechanism that benefits pain. All functional ranges of motions, that is, flexion, abduction, internal rotation, and external rotation, were similarly and concurrently improved over time in both groups. It was evident that the interaction effects among the groups were non-significant and similar for all ranges of motion studied, except for the extension range of motion, indicating that extension was least affected among participants.
The MDC (Minimal Detectable Change) value of the SPADI was 18, and the MCID ranged between 8 and 13 for patients with shoulder pain.30 In our study, the difference between baseline and weeks 6th and 12th was well above the reported MDC and MCID. This improvement might be attributed to improvements in pain-free functional ranges. In our study, the SEiSP group received isometric and eccentric contractions of the shoulder muscles, followed by a functional program. The other possible neurophysiological reasons might be exercise-induced hypoalgesia, conditioned pain, and improvements in collagen-related muscle stiffness and strength associated with the eccentric exercise of the SEiSP regime.31 Similar to our study, another study used a single exercise approach, that is, three weeks of single prone horizontal abduction exercise in a pain-free range and reported significant clinical outcomes in terms of pain and strength using electromyography.32 Another study used pain-free isometric abduction and progressed to isotonic abduction for 3–12 weeks compared to the control and reported no statistically significant difference between groups on SPADI and ShortForm-36.14 In the above study, exercises were applied in the pain-free shoulder range without modifying symptoms or into pain or addressing contributing factors to the symptomatic movement via exercise interventions.
Our study observed the effect of SUMS in reducing pain between baseline and six weeks of intervention on SPADI and NPRS scores. This significant symptom modulation might have served as a platform for transitioning the participants into pain-free EPL and HSR phases in the SUMS group. A recent study reported that an eccentric intervention yielded positive results in alleviating pain, enhancing functionality, and improving active shoulder range of motion.33 Similarly, Jonsson, Wahlstrom, Ohberg, and Alfredson (2006) reported that individuals with symptoms of RCRSP experienced reduced pain and improved performance following a 12-week eccentric training program.34 Another study reported a 12-week eccentric training program for the rotator cuff that has proven to be successful in reducing pain and improving functionality in individuals experiencing symptoms of rotator cuff-related shoulder pain.35 Based on our study results, the SEiSP and SUMS groups showed significantly improved perception of pain and function, and as both regimes had eccentric exercise programs. These results were in line with those obtained by Vallés-Carrascosa et al. (2018) and Jonsson, Wahlstrom, Ohberg, and Alfredson (2006) on pain scores.33,34 However, our results are not consistent with those reported by Bernhardsson, Klintberg, and Wendt (2011), and reported that the pain of some participants did not significantly improve. This could be due to the characteristics of the protocol used, that is, only the eccentric form of daily exercise had little opportunity to modulate pain factors while allowing higher load on tendons.35 This lacuna was carefully negotiated in our study exercise protocol with effects such as isometric induced hypoalgesia in the SEiSP group and alleviating patient identified concern or shoulder movement in the SUMS group. Further progressive graduated loading opportunities were created in both regimes, and TENS was selectively used for pain and discomfort. Although minimal, this TENS effect was reflected in PGICS, with 43% (15/35) reporting definite and great deal improvement categories in SEiSP compared to SUMS (39%; 12/31), contrary to the transition rates to functional programs higher in SUMS. In our study, all participants had a reduction in pain at rest, activity, night, and maximum NPRS and SPADI scores at baseline, six weeks, and 13 weeks.
Heavy training program reported similar clinical outcomes i.e., functional range of motion, and pain in RCRSP people improved after 12 weeks.34 A study applied HSR for 12 weeks, resulting in a 15% higher gain in abduction strength without an improvement in the pain score recorded on the SPADI.20 This study underscore the importance of pain modulation used as the initial treatment. This aspect also highlights the progressive model of muscle loading adapted in our study, in contrast to other studies that used heavy load eccentric training without considering pain factors.20,35,36
Video games, such as skiing or flying, utilized in the functional program phase of our study, enhanced exercise adherence owing to their gaming nature. This playful approach may have played a role in bridging interconnected movement patterns between postural stability and force transfers to the upper extremity, thereby optimizing shoulder function and reducing pain through neurobiological mechanisms.37 Recent studies revealed that a minimum of 12 weeks of exercise-based interventions along with functional rehabilitation for individuals with massive rotator cuff tears improved functional outcomes, which also emphasized the need to incorporate functional programs in clinical settings.38 Functional program principles were primarily adapted from Sciascia et al. (2012) and integrated with the functional program proposed by Lewis’ SUMS (2022).9,37 This framework was aimed at eliminating kinetic chain deficits, integrated with upper and lower extremities with postural control exercises using video feedback and reward-based exergaming approaches available in TecnoBody D-WALL named SKI and FLY game interface. This could have facilitated positive outcomes for PGICS in both groups. Two participants from Group A (SEiSP) missed one week of intervention sessions after 9 weeks and continued until the 12th week of intervention due to medical issues not related to exercise and reported lack of time. Four participants followed the isometric exercise protocol as a pre-set strategy in the SUMS group because of unidentified PIC movement; however, the intention to treat any of the above scenarios was preserved for analysis. PIC and resisted isometric contraction pain-positive results matched 67% of patients in both groups. This may be due to the involvement of multiple overlapping tendons. This study has several strengths. This study stands out as one of the limited numbers of research attempts that have examined the collective impacts of sequentially or progressively loading calibrated muscular contractions for tendons and muscles, transitioning into high-intensity exercises, and pragmatically leading to functional movements among individuals with RCRSP.
The culmination of intervention protocols used in this study was based on the best practice clinical evidence reported in previous studies, and no adverse effects, such as DOMS (Delayed Onset Muscle Soreness) were reported. Additionally, certified practitioners with extensive sports rehabilitation experience performed the SUMS and SEiSP techniques.
Limitations
However, this study has certain limitations. Therapist awareness, personalized exercise interventions, and video-play-based exercises may have influenced participant outcomes after the functional program phase entry, which may require sequential analysis and reporting. The possible contamination of the intervention in Group B might be due to the use of pre-set isometric exercises for participants who did not respond to symptom modulation techniques. This was mitigated by independent outcome measures conducted by uninvolved therapists. The findings of this study were limited to a single clinical site, thereby limiting the generalizability of the results. No control or sham exercise group was included, and long-term follow-up beyond 12 weeks was not performed. Future studies can use electromyography and force plates to analyze recruitment patterns and postural control, respectively, in patients with RCRSP after symptom control or when transitioning to a functional program. It is crucial to ensure that the observed biomechanical changes translate into clinical benefits and vice versa across various shoulder pathologies.
Conclusion
Introducing a symptom modification approach alongside exercise programs for patients with RCRSP resulted in a beneficial additional effect on faster prognosis into functional activities. Specifically, patients in the SUMS-mediated exercise programs achieved an earlier return to pain-free shoulder function compared to the SEiSP group per se, although both groups showed improvement in pain reduction, functional impairment, range of motion, global satisfaction, and disability after 6 and 12 weeks of intervention. The SEiSP group showed a modest advantage over the global satisfaction scores at the end of the final follow-up. The equivalence criteria were defined as a clinically meaningful improvement exceeding 10 points on the Shoulder Pain and Disability Index (SPADI) and a 35% reduction in Numeric Pain Rating Scale (NPRS) scores. Both interventions surpassed these predefined thresholds, indicating that they were not only effective but also clinically equivalent in reducing shoulder pain and disability.
Ethical considerations
The study protocol was approved by the Institutional Review Board (IRB/COHS/STD/06/Jan-2022) of Gulf Medical University (GMU), Ajman, United Arab Emirates. Following ethical approval in January 2022, from June to July 2022, workshops were conducted to train physiotherapists for new exercise protocol at GMU affiliated Thumbay Physical Therapy and Rehabilitation Hospital. The participants were enrolled in the trial from August 2022 till January 2023. Ethical principles aligned with the Declaration of Helsinki were followed.
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Alnuaimi N, Muthukrishnan R, Alshaali AS et al. Single exercise into pain versus symptom modification mediated exercises in people with rotator cuff-related shoulder pain: a pragmatic randomized controlled trial. [version 1; peer review: 1 not approved]. F1000Research 2025, 14:574 (https://doi.org/10.12688/f1000research.164912.1)
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Mazuquin B. Reviewer Report For: Single exercise into pain versus symptom modification mediated exercises in people with rotator cuff-related shoulder pain: a pragmatic randomized controlled trial. [version 1; peer review: 1 not approved]. F1000Research 2025, 14:574 (https://doi.org/10.5256/f1000research.181491.r391557)
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Reviewer Report 22 Aug 2025
Bruno Mazuquin,
Manchester Metropolitan University (Ringgold ID: 5289), Manchester, England, UK
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Mazuquin B. Reviewer Report For: Single exercise into pain versus symptom modification mediated exercises in people with rotator cuff-related shoulder pain: a pragmatic randomized controlled trial. [version 1; peer review: 1 not approved]. F1000Research 2025, 14:574 (https://doi.org/10.5256/f1000research.181491.r391557)
The direct URL for this report is:
https://f1000research.com/articles/14-574/v1#referee-response-391557
https://f1000research.com/articles/14-574/v1#referee-response-391557
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