Back to Journals » Open Access Journal of Sports Medicine » Volume 15
Exercise into Pain in Chronic Rotator Cuff-Related Shoulder Pain: A Randomized Controlled Trial with 6-Month Follow-Up
Authors Cavaggion C , Luque-Suarez A , Voogt L , Juul-Kristensen B, Wollants G, Beke L, Fransen E , Struyf F
Received 27 June 2024
Accepted for publication 24 October 2024
Published 30 November 2024 Volume 2024:15 Pages 181—196
DOI https://doi.org/10.2147/OAJSM.S483272
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Prof. Dr. Andreas Imhoff
Claudia Cavaggion,1 Alejandro Luque-Suarez,2,3 Lennard Voogt,4,5 Birgit Juul-Kristensen,6 Guy Wollants,7 Lucas Beke,7 Erik Fransen,8 Filip Struyf1
1Research Group MOVANT, Department of Rehabilitation Sciences and Physiotherapy (REVAKI), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium; 2Faculty of Health Sciences, Universidad de Malaga, Malaga, Spain; 3Instituto de Investigacion Biomedica de Malaga (IBIMA), Malaga, Spain; 4Rotterdam University of Applied Sciences, Department of Physical Therapy Studies and Research Centre for Health Care Innovations, Rotterdam, the Netherlands; 5Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; 6Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark; 7Groepspraktijk Beke & Wollants, Hove, Belgium; 8Center of Medical Genetics, University of Antwerp and Antwerp University Hospital, Edegem, Belgium
Correspondence: Alejandro Luque-Suarez, Faculty of Health Sciences, Universidad de Malaga, Arquitecto Penalosa s/n, Malaga, 29002, Spain, Email [email protected]
Purpose: Exercise therapy is the first-line treatment in rotator cuff-related shoulder pain (RCRSP), and diverse types of exercise seem effective. However, it is not still clear if painful exercise should be allowed or avoided during exercises. The objective of this study was to investigate if exercise into pain is more effective than no pain in RCRSP.
Patients and Methods: A randomized controlled trial was conducted in a physiotherapy clinic in Belgium. Forty-three participants with chronic RCRSP were randomly allocated to G1 (exercising into pain) or G2 (exercising without pain) in a 12-week intervention with 6-month follow-up. Primary outcome was the Shoulder Pain and Disability Index (SPADI); secondary outcomes were pain intensity, fear-avoidance beliefs, fear of pain, quality of life, strength, and range of motion. Outcomes were measured at baseline (T0), after 9 weeks (T1), 12 weeks (T2), and 6 months (T3) from the first session and analysed with linear mixed models.
Results: No between-group difference in SPADI (time-by-group interaction, p = 0.25) up to 6 months was found, with mean difference (G1-G2) at T1 = 5.78 (CI95%: − 3.43,14.59; p = 0.33), at T2 = 0.93 (CI95%: − 7.20,9.05; p = 0.82), at T3 = 4.15 (CI95%: − 2.61,10.92; p = 0.33). No between-group differences were found for any other outcomes.
Conclusion: Pain provocation seems not to be necessary in RCRSP for achieving successful treatment effect in pain and disability reduction, fear-related beliefs, and quality of life up to 6 months.
Trial Registration: ClinicalTrials.gov NCT04553289.
Keywords: shoulder pain, rehabilitation, physical therapy modalities, shoulder impingement syndrome, exercise therapy
A Letter to the Editor has been published for this article.
A Response to Letter by Mr Ghosh has been published for this article.
Introduction
Shoulder pain is commonly reported as a musculoskeletal disorder in primary care, with a median prevalence of 16% in community settings, and higher estimates in women and high-income nations.1 Rotator cuff-related shoulder pain (RCRSP) refers to pain and limitations typically experienced during shoulder elevation and external rotation. It is an umbrella term encompassing rotator cuff tendinopathy, subacromial impingement syndrome, and symptomatic rotator cuff tears, whether partial or full-thickness.2
Exercise therapy is recommended as the first choice of treatment in RCRSP. However, there is currently no evidence to support the superiority of one exercise program over another.3 Various exercise types, from scapular-focused4 to motor control exercises,5 and various delivery modalities, from home to supervised interventions,6 seem effective. There is low evidence regarding whether a high dose (in terms of load and volume) of exercise provides greater functional benefits over a low dose.7 As different types, modalities or doses seem beneficial, the focus of research might be in other therapeutic parameters, such as pain avoidance or tolerance during exercise.
It is not clear whether pain should be avoided or allowed during exercise.8,9 Protocols involving exercise that elicit pain may be more beneficial in short term for chronic musculoskeletal disorders,10 and painful exercises can help address fears associated with movements perceived as threatening.11 Furthermore, exercise has a hypoalgesic effect, and protocols including painful exercises often involve a higher dose of exercise, resulting in increased exercise-induced hypoalgesia.10,11 Lastly, pain can serve as a triggering stimulus during the conditioned pain modulation response, which is also known as “pain inhibits pain” mechanisms.11 Conversely, pain aggravation during exercise might indicate tissue overload, hamper motor relearning, and decrease patient’s motivation.12
Exercise into pain remains under debate with conflicting indications regarding the acceptable level of pain.9 The pain monitoring model, which has been frequently used in previous studies, involves patients experiencing pain during exercise but no more than 5/10 on a Visual Analogue Scale (VAS) or Numeric Pain Rating Scale (NPRS).13,14 However, other studies used different thresholds, such as resting pain at 3/10,15 or different monitoring timings, such as pain reverting to initial levels or subsiding directly after an exercise session,16 before the next session14 or by the next morning.13 Although the pain monitoring model is widely used in research, the original low (0–2 on VAS scale), acceptable (2–5), and high (5–10) risk-zone levels were based on the clinical experience of Thomee in 1997.17 Moreover, studies usually do not report a minimal VAS or NPRS scale for treatment, even when explicitly comparing painful and non-painful eccentric exercises in RCRSP.18 These discrepancies are also evident in clinical practice, where the tolerance for pain during exercise in RCRSP varies from being acceptable to experiencing no pain or maintaining pain below a certain threshold in different countries.19–21
Consequently, the objective of this randomized controlled trial was to investigate if exercising into pain (4–7 NPRS) was more effective than non/slightly painful (0–2 NPRS) exercises on pain and disability in RCRSP. The findings could impact exercise prescription in RCRSP, and they are relevant for both health-care professionals and their patients.
Materials and Methods
Design
This study is presented following the CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments,22 and it was registered in ClinicalTrials.gov (NCT04553289). The Ethics Committee of Antwerp University Hospital approved this study (ref: B300201837376) and the study complies with the Declaration of Helsinki. All participants gave written informed consent before data collection began.
It consisted of a single-center, double-blinded (outcome assessor and patients), controlled study with a 1:1 allocation ratio, where participants were randomized into two groups (G1: exercise into pain, G2: exercise without pain). They underwent nine sessions of physiotherapy over a 12-week period, with measurements taken at 4 time points: baseline (T0), after 9 weeks (T1), 12 weeks (T2), and 6 months (T3) from the first physiotherapy session.
An independent researcher generated the randomization list with www.randomization.com (2 groups, permuted block randomization of sizes 2, 4, and 6) and prepared sequentially numbered sealed opaque envelopes, which were opened by the physiotherapist only at the first treatment session. There was a single outcome assessor (CC), who remained blinded to the group allocation until the end of data collection. Patients were informed that two treatments involving exercise therapy were compared, but they were kept unaware to the main research hypotheses. They were specifically instructed not to describe their exercises to the assessor to ensure the blinding. The physiotherapists applying treatments were aware of the group allocation, but they did not disclose it to patients or the outcome assessor to limit bias.
Participants and Setting
Adults with RCRSP were recruited at a private physiotherapy clinic in Hove (Belgium), where three physiotherapists (GW, LB, TV) included patients with: shoulder pain for minimum 3 months elicited in the antero-lateral shoulder region, age 18–65 years, resting pain at 2/10 maximum on verbal NPRS, at least 3 out of 5 provocative tests positive (Neer test, Hawkins–Kennedy test, Jobe test, painful arc between 60° and 120°, external rotation resistance test).23 The exclusion criteria were: bilateral shoulder pain, corticosteroid injections 6 weeks prior to the study, pregnancy, inability to understand spoken or written Dutch, clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test), evidence of frozen shoulder (reduction of 50% or above 30° of loss in passive external rotation),24 previous cervical, thoracic or shoulder surgery, recent fractures or dislocations on the painful shoulder, symptoms of cervical nerve root involvement, reproduction of shoulder pain with cervical rotation or axial compression, primary diagnosis of acromioclavicular pathology or shoulder instability, previous medical imaging confirming the presence of fracture or calcification larger than 5 mm, presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, mental health illness, osteoporosis, hemophilia, rheumatic polymyalgia), more than 4 h of training in sport overhead shoulder activities per week. Upon patients’ interest, the principal assessor CC confirmed their eligibility using the same criteria and collected data on demographics (age, sex, e-mail address) and other patients’ characteristics (BMI, duration of symptoms, hand dominance, working status, sport, previous treatments) one or two weeks before the first treatment session.
Intervention
Patients sought treatment for shoulder pain with a prescription for 9 or 18 sessions, as standard procedure of care in Belgium. The intervention consisted of four progressively loaded exercises conducted over a period of 12 weeks, with nine sessions supervised by two physiotherapists (GW, LB). At the end of the 12th week, additional sessions were added if deemed necessary, and they were registered as additional treatment at the end of the 6-month follow-up. All patients attended one supervised session per week and two additional unsupervised exercises per week. The first five sessions were typically planned within the first five weeks, depending on the patient’s availability. The remaining four sessions were spread out over the following seven weeks. During the unsupervised weeks, patients were instructed to exercise at home three times per week. Each supervised session was divided into 10–15 minutes of manual therapy (stretching of the posterior tissues of the shoulder performed by the physiotherapist) and 15–20 minutes of exercise therapy consisting of four exercises. The stretching of the posterior shoulder tissues was based on the presence of posterior shoulder tightness in RCRSP,25 which can create scapular maladaptations contributing to shoulder symptoms.26 Moreover, it was delivered in line with the treatment applied in the previous feasibility phase.27 There were two groups: G1 (exercising into pain) and G2 (exercising with no pain).
We previously investigated the compliance and feedback of patients and physiotherapists regarding exercise in pain (4–7 on verbal NPRS) in a feasibility study.27 A considerable proportion of patients did not adhere to exercising into pain, and compliance with home exercise was low. Therefore, we decreased the number of exercises into pain from 4 to 1, and we decided to use the rate of perceived exertion (RPE)28 in case the physiotherapists could not find exercises that provoked pain at a certain point in the treatment. G1 performed one exercise that induced pain within the range of 4–7 on the NPRS, along with three loaded exercises that caused minimal pain within the range of 0–2 on the NPRS, up until the 9th week. In the last 3 weeks, all exercises in G1 were performed within the 0–2 NPRS range. G2, on the other hand, performed all exercises without pain (max 2/10 on NPRS) throughout the entire 12-week treatment period. The choice of 4–7 and 0–2 as range reference was to make a clear distinction between exercise with or without pain, respectively, giving also a minimal value of 4 on NPRS in G1. As pain perception is rather subjective and it might fluctuate during exercise, we decided to indicate a range instead of only one number on NPRS, consistent also with the ranges given in the feasibility study.27 As neuromuscular adaption supposedly occurred in the first phase,27 all patients performed pain-free exercises after 9 weeks.
The physiotherapists selected four exercises from a predefined list of categories: two exercises in a closed kinetic chain (category 1), two exercises with an elastic band or with dumbbells/weights (category 2 and 3 respectively). Stretching exercises (category 4) were applied only if necessary. The exercises were individualized for each patient in terms of progression and repetitions to keep the pain within the predetermined range. Details on exercises are reported in Supplementary Table 1 and in Supplementary Information 1 (in Supplementary Material A), following the Consensus on Exercise Reporting Template guidelines.29 Patient education, lifestyle, and ergonomics recommendations were provided equally to both groups, following current practices in Belgium.19
Outcome Measures
Primary Outcome
The Dutch Shoulder and Pain Disability Index (SPADI) was the primary patient-reported outcome measure (PROM), as it is a highly reliable, valid, and responsive shoulder-specific questionnaire.30,31 It consists of two subscales: pain (5 items) and disability (8 items).30 Each item ranges from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult that it requires help) on NPRS. The total score is the average of the two subscales, where a higher score indicates more pain or disability. The minimal clinically important difference (MCID) of SPADI between groups previously reported was 10 points,32 while the minimal important change (MIC) was 20 points.30
Secondary Outcomes
Pain was also evaluated with the VAS% scale, which was registered during movement on the day of completing the questionnaire, in the past night, and maximal pain over the last 24 hours.33 As this RCT was comparing pain tolerance versus pain avoidance in terms of, respectively, high or low NPRS ranges during exercise, it was essential to evaluate the between-groups differences on pain-related beliefs. Therefore, fear of pain was assessed as a total score (FPQ-9 total) and as subscales (severe, minor, medical),34 together with fear-avoidance beliefs concerning physical activity (FABQ-PA) and work (FABQ-W).35 Health-related quality of life was evaluated with the EQ-5D-5L questionnaire,36 which resulted in an EQ-5D index and a VAS score. PROMs were administered via an online survey using Qualtrics (Qualtrics software, Version [2020–2022], Qualtrics, Provo, UT, USA. https://www.qualtrics.com).
Strength was also measured because we hypothesized that G1 would develop greater strength due to higher dose or difficulty of exercise to make it painful. The maximum voluntary isometric contraction was assessed in external rotation, internal rotation, and scaption using a hand-held dynamometer (MicroFet, Hoggan Health Industries Inc.) in Newtons.37 In order to evaluate the flexibility acquired during treatment, range of motion (ROM) was assessed for passive and active internal rotation, external rotation, and scaption using a gravity-referenced inclinometer (Plurimeter, Dr. Rippstein, Medidevice) in degrees.37 Details for reliability and MCID for secondary outcomes and measurement protocols of physical outcomes are reported in Supplementary Information 2. All PROMs and secondary outcomes were measured at T0, T1, T2, T3. Ultrasonographic outcomes (acromiohumeral distance, coracohumeral distance, rotator cuff tendon thickness) and scapular dyskinesis were also measured, but they are not presented in the current manuscript for the sake of clarity and brevity.
Other outcome measures were adherence, adverse effects, additional treatments, patient’s satisfaction, and recovery. Adherence was assessed separately for physiotherapy and home exercise sessions. Co-interventions were registered throughout the 12-week treatment period and between the end of the treatment at 12 weeks and the 6-month follow-up. The global perceived effect (GPE) was assessed as the amount of recovery or satisfaction after one week, nine weeks, and twelve weeks from the first physiotherapy session. Details on adherence, additional treatments, and GPE are described in Supplementary Information 2. Deviations from trial registration were present, concerning outcomes, intervention, and sample size calculation. Details are described in Supplementary Information 3.
Data Analysis
The sample size was calculated using the Edland method, R package longpower 1.0–11 considering a mixed regression model for repeated measures,38 and it was based on the following data: 10% points as MCID in SPADI at 6 months (considered as moderate effect size),32 30% for adjustment for non-linearity of the data (because of the higher decrease in SPADI in the first three months compared to six months), alpha = 5%, power = 80%. The required total sample size was 38 subjects, considering 15% drop-out rate. The variance of the residuals cannot be estimated from previous studies, but it has an extremely limited effect on the sample size. It does not change the result of the power calculation, and therefore it was not included in this analysis. The original sample size calculation did not account for inflation due to therapist effect, but therapist effect was included as a random effect in the analysis.
The difference in SPADI score as a primary outcome was estimated over a period of 6 months with 4-time points measurement (T0, T1, T2, T3). A linear mixed model was fitted with participants and physiotherapists as random effects, and group, time (as categorical variable), and group-by-time as fixed effects. Group-by-time was the primary focus of the analysis for every outcome, and significant p-values were set at 0.05. Covariates of interest were age, sex, and durations of symptoms, and they were added to the initial model for every outcome. Group-by-time and covariates were eliminated using a stepwise backwards approach starting from the least significant variable, and intention-to-treat analysis was used. Linear mixed models do not need complete cases, as long as missing data are missing at random.15 If a significant effect of time was present in the primary outcome SPADI, post-hoc analysis was conducted with Tukey HSD correction to find at which timepoint the differences were significant, also in relation to the MIC of 20 points in SPADI.30
Between-group differences were investigated with Standard Least Square Methods for every outcome of interest at T1, T2, and T3, considering significant covariates for every specific outcome. P-values were corrected for False Discovery Rate (FDR), and Effect Cohen’s d was calculated at T1, T2, T3 and considered as follows: very small if d < 0.2, small if 0.2 ≤ d < 0.5, medium if 0.5 ≤ d < 0.8 and large if d > 0.8.39 For all models fitted, the assumptions of normality of residuals and homoscedasticity were checked using a QQplot and a plot of residuals versus fitted values. Dichotomous outcomes were compared between groups with chi-square test or Fisher’s exact test. All statistical analyses were completed using JMP® (JMP Pro, Version 17, SAS Institute Inc., Cary, NC).
Results
Participants and Therapists
Between July 2020 and June 2022, 43 participants were included in the trial, while 281 were excluded (Figure 1). In G2, one participant dropped out of the study before T3. Two patients from G2 were excluded in the final analysis due to reporting exclusion criteria after their initial inclusion (mental illness condition and calcification > 5 mm). Missing data for both PROMs and physical outcomes are presented in Supplementary Table 2 (in Supplementary Material B).
There was no delay between randomization and the initiation of the intervention, as the physiotherapists opened the allocation envelopes for each patient just before the start of their first session. Two physiotherapists performed the intervention: GW treated 33 patients, LB treated 8 patients. Two patients were treated by both physiotherapists because of the unavailability of one therapist due to holidays. In six patients from G1, the physiotherapists used the RPE instead of the NPRS at one or more sessions during therapy, as they could not find a successful provocative exercise for these patients. Demographic characteristics are shown in Table 1. Scores for all PROMs and physical outcomes (strength, active and passive ROM) at different time points for both groups are presented in Supplementary Tables 3 and 4 (in Supplementary Material B).
![]() |
Table 1 Baseline Characteristics |
Patient-Reported Outcome Measures
There was no significant group-by-time interaction in the primary patient-reported outcome measure SPADI, while the treatment group did not have a significant effect (Table 2). Participants improved their function and pain (represented by SPADI total) at the end of the treatment, irrespectively of the treatment group (Figure 2). Between-group differences were not significant at any timepoint (T1, T2, T3) (Table 3). Although the effect size was medium at T1 and G1 showed higher SPADI than G2 (Table 3), this difference was not significant (FDR adjusted p-value=0.33) and the score 5.78 was inferior to the MCID of 10. Moreover, the percentage of patients who reached a significant and clinically relevant change over time in SPADI was not different between groups (n = 14, 70% in G1 and n = 16, 84% in G2, Fisher’s exact test p = 0.45). Patients showed significant improvement in time irrespectively of the group, and every pairwise comparison between different time points was significant (p < 0.005). The mean differences between T0-T1 (20.71, CI95%: 14.91; 26.51), T0-T2 (26.42, CI95% 20.71; 32.12) T0-T3 (33.21, CI95% 27.45; 38.96) exceeded the MIC of 20 points.
![]() |
Table 2 Results (p-values) of All Outcomes from Linear Mixed Models |
![]() |
Table 3 Differences Between Groups at T1, T2, T3 for All Outcomes |
Similarly, SPADI subscales (pain, function), VAS% (movement, 24 h, night), FPQ-9 (total score and subscales severe, medical, minor), quality of life (EQ-5D index, EQ-5D VAS) did not show a significant time-by-group interaction, nor a group effect. Time showed a significant effect irrespectively of the group in all PROMs, expect FPQ-9 (total score and all subscales) and FABQ-W. Duration of symptoms was a relevant covariate in FPQ-9 (total score, severe and minor subscales) (Table 2).
Physical Outcomes
There were no significant group-by-time interactions or group effects were observed for any of the strength or ROM measures (external rotation, internal rotation, scaption). All participants improved over time irrespectively of the treatment group (Table 2).
There were no significant between-groups differences in adverse effects, use of additional treatments, adherence, GPE-recovery, or GPE-satisfaction (p > 0.05). Adverse effects after physiotherapy-led sessions were similar in both groups: 10% (n = 2) had 4–7 episodes of persistent pain or fatigue. Concerning adverse effects after home-exercises, 4–7 episodes occurred in 14% (n = 3) in G1 and in 5% (n = 1) in G2. Details are presented in Supplementary Information 4.
Discussion
The findings of this RCT indicate that exercising into pain does not result in greater benefits compared to exercising without pain in RCRSP. No significant between-group differences were detected for pain or disability, fear-avoidance beliefs, fear of pain, quality of life, and for ROM. Interestingly, no between-group differences were found also in adherence, the use of additional treatments, occurrence of adverse effects, patients’ satisfaction, or perception of recovery. However, there was a substantial improvement in pain and function over time, irrespectively of the group.
Two previously randomized controlled trials were conducted in similar RCRSP population: Maenhout et al investigated the addition of a heavy-load eccentric program dosed on pain-monitoring model to a usual rotator-cuff training in a 12-week intervention,13 while Valles-Carrascosa et al compared two exercise protocols with or without painful eccentric exercise of the rotator cuff in a 4-week intervention.18 In agreement with our results in SPADI at 12 weeks, no between-group differences were found in either SPADI at 12 weeks13 or in VAS at 4 weeks18 in previous studies, although their frequency of treatment was higher, going from daily exercises13 to 5x/week.18
The physiotherapists involved in the current study adjusted the load or resistance for the exercise that induced pain in the group that exercised into pain, aiming to make it provocative. However, both groups progressed in terms of repetitions or loads in the non-provocative exercises throughout the treatment period. This suggests that the difference in treatment may not have been sufficient to produce a significant between-group difference. However, six patients in G1 (exercise into pain group) transitioned from NPRS to the RPE scale, meaning that fatigue during exercise may be a more viable option for certain patients. Moreover, based on low adherence observed in a previous feasibility study,27 increasing the number of painful exercises is not recommended.
This study aimed to improve pain and disability with one painful exercise by inducing higher exercise hypoalgesia and by enhancing fear-related beliefs while also restoring muscular strength through the other three exercises against gravity or resistance. The physiotherapists gave different types of exercises, two in a closed kinetic chain and two in an open kinetic chain (with dumbbells or elastic bands), as diverse exercises seem effective in RCRSP (ie scapular-focused, motor control, eccentric exercises).3,4,6,40 Quality and good performance were sought in all exercises and, in particular, for the three non-painful exercises, the aim was to re-train force couples in the shoulder (ie lower activity of serratus anterior and over-activation of the upper trapezius during arm elevation41), improve the function of rotator cuff muscles to center the humeral head in the glenoid, preventing excessive superior humeral head translation caused by contraction of the deltoid.42 Nevertheless, the bursal impingement under the coracoacromial arch and the status of the synovial bursa were not evaluated. However, it might give potentially useful indications (ie the presence of synovial hypertrophy with hypervascularization, exudative bursitis, adhesive bursitis),43 and it is suggested as an additional ultrasonographic measure for future studies.
As there were no between-group differences for all the outcomes but a significant effect of time up to 6 months, we can hypothesize that exercise had a hypoalgesic effect in both groups, with restored strength in three different shoulder positions and substantial decrease in FABQ-PA, perhaps mediated by a reconceptualization of pain and improved self-efficacy.44 Similarly, FABQ-PA was not different at 6 months when comparing progressive home exercises (16 weeks, up to six sessions) with best practice advice (one session),45 or when adding three additional group meetings to control intervention in RCRSP.46 This suggests that fear-avoidance beliefs on physical activity might have marginal importance in order to achieve successful treatment outcomes.
In contrast, fear-avoidance related to work and fear of pain did not seem to change over time, and the latter was significantly influenced by duration of symptoms. A combination of various factors, from neuromuscular, neuro-endocrine-immune, and psychosocial mechanisms, may have played a role.47 However, we cannot draw conclusions on the effect of exercise based on the current study, because we did not include a control group. Nevertheless, we can conclude that pain provocation during one exercise seems not to be necessary in the treatment of chronic RCRSP to achieve beneficial results.
Patients were equally reassured and motivated in both groups, and this may also explain the absence of difference in perception of recovery or satisfaction between the groups. Interestingly, the number of adverse effects, use of additional treatments, and adherence did not differ between groups. One would expect that patients training with pain in one exercise would be less compliant or experience more pain or fatigue after exercises, but this was not the case in the current study. However, closer monitoring of symptoms flares-up during home-exercises is suggested in future studies, as four patients in total had 4 to 7 episodes of increased pain after 24 h from the unsupervised exercises.
Limitations
Although we found clinical improvements over time, we did not include a control group to assess the natural course of the RCRSP. Moreover, the sample size was calculated on the primary outcome SPADI. Consequently, the results on the other outcomes should be considered exploratory in nature because type II error might be present due to a possible lack of power for the analysis of these outcomes. The research team decided to not provide a fixed set of exercises because different types of exercises seem equally effective in RCRSP.3,4,6 On the one hand, this increased the variability of exercises and progression between different patients, on the other hand, it aligns well with current clinical practice.19 Furthermore, the blinding of outcome assessors and patients decreased the risk of performance and detection bias. Only one assessor evaluated the patients using the mean of three measures, increasing the internal consistency of physical measures. The assessor was blinded to group allocation but, as being part of the research team leading the project, this could have introduced biases. Therefore, an external outcome assessor is suggested for future studies.
Only two physiotherapists working in one physiotherapy clinic participated in the study, which limits the external validity of the results but reduces variations of the intervention. Moreover, the presence of two different therapists was considered as a random effect in the statistical analysis. Lastly, only 13% of all screened patients were included. Consequently, our conclusions are limited to patients with chronic RCRSP with minimal resting pain (verbal NPRS < 2), and findings might be different in a population with higher initial irritability or in an acute phase.
Conclusion
Interventions including one exercise into pain or not are both effective in pain and disability reduction, fear-related beliefs, and quality of life up to 6 months in chronic RCRSP. This study suggests that there is a substantial improvement in pain and function over time, whether the patients with RCRSP exercise into pain or not. Increases in strength and range of motion were also present over time, irrespectively of group. Therefore, pain provocation during shoulder exercises does not seem to be necessary in the treatment of chronic RCRSP for achieving successful results.
Abbreviations
BMI, Body Mass Index; CERT, Consensus on Exercise Reporting Template; CI, Confidence Interval; CONSORT, Consolidated Standards of Reporting Trials; EQ-5D-5L, 5-level EQ-5D by EuroQol Group; FABQ-PA, Fear-Avoidance Beliefs on Physical Activity; FABQ-W, Fear-Avoidance Beliefs on Work; FDR, False Discovery Rate; GPE, Global Perceived Effect; MCID, Minimal Clinically Important Difference; MIC, Minimal Important Change; NPRS, Numeric Pain Rating Scale; NS, Non Significant; QQplot, Quantile Quantile plot; RCRSP, Rotator Cuff-Related Shoulder Pain; RCT, Randomized Controlled Trial; ROM, Range Of Motion; RPE, Rate of Perceived Exertion; SPADI, Shoulder and Pain Disability Index; VAS, Visual Analogue Scale.
Data Sharing Statement
The data used during the current study are available from the corresponding author on reasonable request.
Ethics Approval and Informed Consent
The Ethics Committee of Antwerp University Hospital approved this study (ref: B300201837376). All participants gave written informed consent before data collection began.
Consent for Publication
The person appearing in the Supplementary Information has given her written consent for publication.
Acknowledgments
We are grateful to the patients who participated in this study.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Funding
This study was funded by the Research Foundation Flanders – FWO (grant number: 1158121N). This institution had no involvement in the interpretation, writing, or in the decision to submit the article for publication.
Disclosure
The authors report no conflicts of interest in this work.
References
1. Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022;23(1):1073. doi:10.1186/s12891-022-05973-8
2. Lewis J. Rotator cuff related shoulder pain: assessment, management and uncertainties. Man Ther. 2016;23:57–68. doi:10.1016/j.math.2016.03.009
3. Pieters L, Lewis J, Kuppens K, et al. An update of systematic reviews examining the effectiveness of conservative physical therapy interventions for subacromial shoulder pain. J Orthop Sports Phys Ther. 2020;50(3):131–141. doi:10.2519/jospt.2020.8498
4. Saito H, Harrold ME, Cavalheri V, McKenna L. Scapular focused interventions to improve shoulder pain and function in adults with subacromial pain: a systematic review and meta-analysis. Physiother Theory Pract. 2018;34(9):653–670. doi:10.1080/09593985.2018.1423656
5. Lafrance S, Charron M, Dubé MO, et al. The efficacy of exercise therapy for rotator cuff related shoulder pain according to the FITT principle: a systematic review with meta-analyses. J Orthop Sports Phys Ther. 2024;54(10):1–26. doi:10.2519/jospt.2024.12618
6. Gutiérrez-Espinoza H, Araya-Quintanilla F, Cereceda-Muriel C, Álvarez-Bueno C, Martínez-Vizcaíno V, Cavero-Redondo I. Effect of supervised physiotherapy versus home exercise program in patients with subacromial impingement syndrome: a systematic review and meta-analysis. Review Physical Therapy in Sport. 2020;41:34–42. doi:10.1016/j.ptsp.2019.11.003
7. Malliaras P, Johnston R, Street G, et al. The efficacy of higher versus lower dose exercise in rotator cuff tendinopathy: a systematic review of randomized controlled trials. Arch Phys Med Rehabil. 2020;101(10):1822–1834. doi:10.1016/j.apmr.2020.06.013
8. Littlewood C, Malliaras P, Chance-Larsen K. Therapeutic exercise for rotator cuff tendinopathy: a systematic review of contextual factors and prescription parameters. Int J Rehabil Res. 2015;38(2):95–106. doi:10.1097/MRR.0000000000000113
9. Smith BE, Riel H, Vicenzino B, Littlewood C. Elephant in the room: how much pain is ok? If physiotherapy exercise RCTs do not report it, we will never answer the question. Br J Sports Med. 2019; 54(14):821–2.
10. Smith BE, Hendrick P, Smith TO, et al. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017;51(23):1679–1687. doi:10.1136/bjsports-2016-097383
11. Smith BE, Hendrick P, Bateman M, et al. Musculoskeletal pain and exercise-challenging existing paradigms and introducing new. Br J Sports Med. 2019;53(14):907–912. doi:10.1136/bjsports-2017-098983
12. Klintberg IH, Cools AMJ, Holmgren TM, et al. Consensus for physiotherapy for shoulder pain. Int Orthop. 2015;39(4):715–720. doi:10.1007/s00264-014-2639-9
13. Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013;21(5):1158–1167. doi:10.1007/s00167-012-2012-8
14. Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012;344(feb20 1):e787. doi:10.1136/bmj.e787
15. Dube MO, Desmeules F, Lewis JS, Roy JS. Does the addition of motor control or strengthening exercises to education result in better outcomes for rotator cuff-related shoulder pain? A multiarm randomised controlled trial. Br J Sports Med Apr. 2023;57(8):457–463. doi:10.1136/bjsports-2021-105027
16. Littlewood C, Bateman M, Brown K, et al. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study). Clin Rehabil. 2016;30(7):686–696. doi:10.1177/0269215515593784
17. Thomee R. A comprehensive treatment approach for patellofemoral pain syndrome in young women. Phys Ther. 1997;77(12):1690–1703. doi:10.1093/ptj/77.12.1690
18. Valles-Carrascosa E, Gallego-Izquierdo T, Jimenez-Rejano JJ, et al. Pain, motion and function comparison of two exercise protocols for the rotator cuff and scapular stabilizers in patients with subacromial syndrome. J Hand Ther. 2018;31(2):227–237. doi:10.1016/j.jht.2017.11.041
19. Pieters L, Voogt L, Bury J, et al. Rotator CUFF disorders: a survey of current physiotherapy practice in Belgium and the Netherlands. Musculoskelet Sci Pract. 2019;43:45–51. doi:10.1016/j.msksp.2019.06.001
20. Brindisino F, Matteuzzi I, Bury J, McCreesh K, Littlewood C. Rotator cuff disorders: a survey of current (2018) Italian physiotherapy practice. Physiother Pract Res. 2020;41(1):11–22.
21. Bury J, Littlewood C. Rotator cuff disorders: a survey of current (2016) UK physiotherapy practice. Shoulder Elbow. 2018;10(1):52–61. doi:10.1177/1758573217717103
22. Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, Group CN. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a consort extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167(1):40–47. doi:10.7326/M17-0046
23. Michener LA, Walsworth MK, Doukas WC, Murphy KP. Reliability and diagnostic accuracy of 5 physical examination tests and combination of tests for subacromial impingement. Arch Phys Med Rehabil. 2009;90(11):1898–1903. doi:10.1016/j.apmr.2009.05.015
24. Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009;39(2):135–148. doi:10.2519/jospt.2009.2916
25. Duzgun I, Turgut E, Cinar-Medeni O, et al. The presence and influence of posterior capsule tightness on different shoulder problems. J Back Musculoskelet Rehabil. 2017;30(2):187–193. doi:10.3233/BMR-160731
26. Cools AM, Struyf F, De Mey K, Maenhout A, Castelein B, Cagnie B. Rehabilitation of scapular dyskinesis: from the office worker to the elite overhead athlete. Br J Sports Med. 2014;48(8):692–697. doi:10.1136/bjsports-2013-092148
27. Cavaggion C, Juul-Kristensen B, Luque-Suarez A, et al. Exercise into pain in chronic rotator cuff related shoulder pain: a prospective single-group feasibility study. BMJ Open. 2023;13(10):e070698. doi:10.1136/bmjopen-2022-070698
28. Foster C, Florhaug JA, Franklin J, et al. A new approach to monitoring exercise training. J Strength Cond Res. 2001;15(1):109–115.
29. Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): explanation and Elaboration Statement. Br J Sports Med. 2016;50(23):1428–1437. doi:10.1136/bjsports-2016-096651
30. Thoomes-de Graaf M, Scholten-Peeters W, Duijn E, et al. The responsiveness and interpretability of the shoulder pain and disability index. J Orthop Sports Phys Ther. 2017;47(4):278–286. doi:10.2519/jospt.2017.7079
31. Thoomes-de Graaf M, Scholten-Peeters GG, Duijn E, Karel Y, Koes BW, Verhagen AP. The Dutch Shoulder Pain and Disability Index (SPADI): a reliability and validation study. Qual Life Res. 2015;24(6):1515–1519. doi:10.1007/s11136-014-0879-1
32. Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011;91(1):37–47. doi:10.2522/ptj.20090338
33. Delgado DA, Lambert BS, Boutris N, et al. Validation of digital visual analog scale pain scoring with a traditional paper-based visual analog scale in adults. J Am Acad Orthop Surg Glob Res Rev. 2018;2(3):e088. doi:10.5435/JAAOSGlobal-D-17-00088
34. McNeil DW, Kennedy SG, Randall CL, et al. Fear of pain questionnaire-9: brief assessment of pain-related fear and anxiety. Eur J Pain. 2018;22(1):39–48. doi:10.1002/ejp.1074
35. Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the fear-avoidance beliefs questionnaire and Tampa scale of kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010;91(7):1128–1136. doi:10.1016/j.apmr.2010.04.009
36. EQ-5D-5L. EuroQoL Research Foundation. Rotterdam, The Netherlands: www.euroqol.org; 2019.
37. Ingwersen KG, Jensen SL, Sorensen L, et al. Three months of progressive high-load versus traditional low-load strength training among patients with rotator cuff tendinopathy: primary results from the double-blind randomized controlled RoCTEx trial. Orthop J Sports Med. 2017;5(8):2325967117723292. doi:10.1177/2325967117723292
38. Diggle PJ, Heagerty PJ, Liang K, Z SL. Analysis of longitudinal data Statistical Science Series. J Anat. 2002;66(Pt 4):610617Dyar.
39. Cohen J. Statistical Power Analysis for the Behavioral Sciences.
40. Larsson R, Bernhardsson S, Nordeman L. Effects of eccentric exercise in patients with subacromial impingement syndrome: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019;20(1):446. doi:10.1186/s12891-019-2796-5
41. Kang FJ, Ou HL, Lin KY, Lin JJ. Serratus anterior and upper trapezius electromyographic analysis of the push-up plus exercise: a systematic review and meta-analysis. J Athl Train. 2019;54(11):1156–1164. doi:10.4085/1062-6050-237-18
42. Escamilla RF, Hooks TR, Wilk KE. Optimal management of shoulder impingement syndrome. Open Access J Sports Med. 2014;5:13–24. doi:10.2147/OAJSM.S36646
43. Cocco G, Ricci V, Corvino A, et al. Musculoskeletal disorders in padel: from biomechanics to sonography. J Ultrasound. 2024;27(2):335–354. doi:10.1007/s40477-023-00869-2
44. Powell JK, Lewis JS. Rotator cuff-related shoulder pain: is it time to reframe the advice, “you need to strengthen your shoulder”? J Orthop Sports Phys Ther. 2021;51(4):156–158. doi:10.2519/jospt.2021.10199
45. Hopewell S, Keene DJ, Marian IR, et al. Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 x 2 factorial, randomised controlled trial. Lancet. 2021;398(10298):416–428. doi:10.1016/S0140-6736(21)00846-1
46. Trostrup J, Frost P, Dalboge A, et al. Reducing shoulder complaints in employees with high occupational shoulder exposures: a cluster-randomised controlled study (the shoulder-cafe study). J Occup Rehabil. 2023;33(3):473–485. doi:10.1007/s10926-022-10086-z
47. Powell JK, Schram B, Lewis J, Hing W. “You have (rotator cuff related) shoulder pain, and to treat it, I recommend exercise.” A scoping review of the possible mechanisms underpinning exercise therapy. Musculoskelet Sci Pract. 2022;62:102646. doi:10.1016/j.msksp.2022.102646
© 2024 The Author(s). This work is published and licensed by Dove Medical Press Limited. The
full terms of this license are available at https://www.dovepress.com/terms.php
and incorporate the Creative Commons Attribution
- Non Commercial (unported, 3.0) License.
By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted
without any further permission from Dove Medical Press Limited, provided the work is properly
attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.