Optimizing therapeutic exercise for shoulder overuse syndrome: effects on edema reduction, range of motion, and pain relief using data-driven approaches
| ISRCTN | ISRCTN15463594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15463594 |
- Submission date
- 31/08/2025
- Registration date
- 18/09/2025
- Last edited
- 12/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Shoulder pain is a common problem in older adults, affecting their ability to perform daily tasks like lifting, reaching, and carrying. This study will provide valuable information about whether exercise therapy is more effective than standard physiotherapy in improving both pain and function in elderly patients. Understanding the impact of these interventions will help to find better treatments that can help older adults live more comfortably. This study aims to investigate the effects of exercise therapy on pain reduction, shoulder range of motion, and pectoralis minor muscle length in elderly patients with chronic shoulder pain. Participants will be assessed for their pain levels, shoulder mobility, and muscle length at the beginning of the study and after completing the 6-week treatment program.
Who can participate?
The study involves elderly patients (aged 60 and above) who have chronic shoulder pain (lasting for at least 3 months).
What does the study involve?
The study compares two treatments:
Exercise therapy: A structured program of stretching and strengthening exercises designed to improve shoulder movement and reduce pain.
Physiotherapy (Placebo): A common physiotherapy treatment using methods like infrared therapy, ultrasound, and TENS (transcutaneous electrical nerve stimulation), but without the specific therapeutic exercises targeted at improving shoulder function.
Participants will be randomly assigned to one of two groups: one group will receive exercise therapy and the other will receive physiotherapy (placebo). Both groups will receive treatments for 18 sessions over the course of 6 weeks. Pain reduction will be measured using the Visual Analog Scale (VAS), a simple scale where patients rate their pain from 0 (no pain) to 10 (worst possible pain). Shoulder mobility will be assessed through measuring the range of motion in shoulder abduction and external rotation. Pectoralis minor muscle length will be measured using ultrasound to evaluate any changes in muscle flexibility.
At the end of the 6 weeks, participants will be reassessed, and their improvements in pain levels, shoulder movement, and muscle flexibility will be compared between the two groups. This will allow us to determine whether exercise therapy offers significant benefits over traditional physiotherapy.
What are the possible benefits and risks of participating?
The results of this study could potentially lead to improved treatment protocols for elderly patients suffering from chronic shoulder pain, helping them to regain mobility and reduce pain more effectively.
The risks involve temporary muscle soreness or discomfort following exercise sessions, and a potential for minor musculoskeletal strain if exercises are performed incorrectly.
All interventions were supervised by qualified professionals to ensure safety and correct technique.
Where is the study run from?
Tri-Chandra Multiple Campus, Tribhuvan University, Nepal
When is the study starting and how long is it expected to run for?
May 2025 to July 2025
Who is funding the study?
Ultimate Medical Technology Co., China
Who is the main contact?
Dr Bhishma Karki, bhishma.karki@trc.tu.edu.np
Contact information
Public, Scientific, Principal Investigator
Tri-Chandra Multiple Campus, Tribhuvan University
Kathmandu
44600
Nepal
 ORCID ID |
0000-0003-4351-8099 |
|---|---|
| Phone | +9779851014005 |
| bhishma.karki@trc.tu.edu.np |
Study information
| Study design | Single-blind parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Scientific title | Effects of exercise therapy on pain reduction, range of motion, and pectoralis minor muscle length in elderly patients with shoulder pain: A randomized controlled trial comparing exercise therapy to a placebo intervention |
| Study acronym | E-PRIME |
| Study objectives | Primary Objective: To assess the effects of exercise therapy (stretching and strengthening exercises) on pain reduction, range of motion (ROM), and pectoralis minor muscle length in elderly patients with chronic shoulder pain. Secondary Objectives: To compare the effectiveness of exercise therapy with a placebo intervention on reducing shoulder pain intensity (measured by the Visual Analog Scale). To evaluate the improvement in range of motion (abduction and external rotation) in patients undergoing exercise therapy versus those receiving a placebo. To examine the changes in pectoralis minor muscle length after a period of exercise therapy compared to placebo treatment. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | An Ethical Review Waiver on 25/05/2025 confirms that the Institutional Ethics Committee of Tribhuvan University reviewed the study and determined that it did not require formal ethical approval under the university’s guidelines. |
| Health condition(s) or problem(s) studied | Chronic shoulder pain in elderly patients |
| Intervention | This study is a single-blind, parallel-group, randomized controlled trial (RCT) conducted at a tertiary care rehabilitation center. Randomization was achieved using a computer-generated sequence, with block randomization (block size of 4) to ensure balanced allocation between two groups. Participants were randomly assigned in a 1:1 ratio to one of two intervention arms: Exercise Therapy (ET): A structured program involving stretching and strengthening exercises aimed at improving shoulder mobility, reducing pain, and enhancing muscle length. The program includes exercises targeting the scapular stabilization and shoulder strengthening. Physiotherapy (Placebo): A control intervention consisting of standard physiotherapy modalities including infrared therapy, ultrasound therapy, and transcutaneous electrical nerve stimulation (TENS), with no active therapeutic benefit to the shoulder's functional capacity. Both groups received their allocated intervention for 18 sessions across the 6-week period, with all sessions supervised. There were no changes to the trial design after commencement, and the study followed the pre-defined methods throughout. Outcomes were assessed at baseline and post-intervention (immediately after the 6-week program). The single-blind aspect refers to the outcome assessment, where the evaluator measuring outcomes was blinded to group allocation. Participants were also unaware of the existence of the other treatment arm to minimize bias. |
| Intervention type | Mixed |
| Primary outcome measure | Pain reduction as measured by the Visual Analog Scale (VAS) for shoulder pain intensity at baseline and post-intervention (immediately after the 6-week program) |
| Secondary outcome measures | The secondary outcome measures were assessed at baseline and post-intervention (immediately after the 6-week program): 1. Range of Motion (ROM): Improvement in shoulder abduction and external rotation range of motion, measured using a goniometer 2. Pectoralis Minor Muscle Length: Changes in the pectoralis minor muscle length, measured using ultrasound or muscle length measurement techniques |
| Overall study start date | 15/01/2023 |
| Completion date | 16/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 66 |
| Key inclusion criteria | 1. Age: Participants aged 60 years or older. 2. Chronic Shoulder Pain: Participants with chronic shoulder pain lasting at least 3 months. 3. Diagnosis: Participants with a diagnosis of shoulder impingement syndrome, rotator cuff tendinopathy, or other musculoskeletal disorders causing shoulder pain. 4. Range of Motion: Participants with limited shoulder range of motion (abduction or external rotation). 5. Pain Level: Participants with a Visual Analog Scale (VAS) pain score of at least 4 (moderate pain) at baseline. |
| Key exclusion criteria | 1. Acute Shoulder Injury: Participants with recent shoulder injuries (less than 3 months) or acute trauma to the shoulder. 2. Surgical History: Participants who have had shoulder surgery in the past 6 months. 3. Severe Shoulder Dysfunction: Participants with severe loss of shoulder function or contraindications to physical activity. 4. Other Medical Conditions: Participants with neurological, cardiovascular, or musculoskeletal conditions that affect the shoulder or prevent participation in the intervention. 5. Pregnancy: Female participants who are pregnant or planning to become pregnant during the study period. 6. Uncontrolled Health Conditions: Participants with uncontrolled diabetes, rheumatoid arthritis, or any other systemic illness that could interfere with participation. 7. Non-compliance: Participants who are unable or unwilling to comply with the study protocol or follow-up visits. |
| Date of first enrolment | 15/01/2023 |
| Date of final enrolment | 05/05/2023 |
Locations
Countries of recruitment
- Nepal
Study participating centre
Kathmandu, Bagmati Pradesh
44613
Nepal
Sponsor information
Industry
Building 6, 4th Floor, No. 368 Jinpeng Street, Xihu District
Hangzhou, Zhejiang Province
310000
China
| Phone | +8617798058752 |
|---|---|
| yanfeng-yan@outlook.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 25/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Peer-Reviewed Journal Publication: Primary Target Journal: The results of this study will be submitted for publication in a peer-reviewed scientific journal. The primary target journal will be one that focuses on rehabilitation, pain management, or geriatrics. Secondary Journals: Depending on the focus of the findings (e.g., shoulder pain, physiotherapy, or exercise therapy), we will consider additional journals in the fields of musculoskeletal disorders, geriatrics, and physical therapy. Dissemination to Healthcare Providers: After publication in academic journals, we will distribute summary reports of the study results to clinicians, physiotherapists, and rehabilitation centers involved in the care of elderly patients with chronic pain. This will help practitioners stay informed about new evidence on effective treatments. We will also reach out to local hospitals, geriatric care providers, and rehabilitation clinics to share the findings and encourage the adoption of exercise therapy for chronic shoulder pain management. Public Dissemination: We will prepare an accessible summary of the study results for distribution to the general public, especially for the participants of the study and their families, to ensure that they are informed about the benefits of the interventions tested in the study. Additionally, we plan to share the findings via social media platforms, particularly targeting audiences interested in chronic pain management, older adult health, and rehabilitation. Follow-up Studies: We will also consider conducting a follow-up study based on the results of this research, focusing on exploring long-term benefits of exercise therapy and its impact on quality of life in elderly patients, potentially leading to new clinical trials or longitudinal studies. |
| IPD sharing plan | This study is committed to making the individual participant data (IPD) available to the research community to promote transparency and allow for further analysis. 1. Data Storage and Repository: The datasets generated during this study will be stored in a publicly available repository such as: Open Science Framework (OSF) or Zenodo, ensuring the data is accessible to researchers globally. Link to be provided after study publication. 2. Type of Data to be Shared: The following data will be shared: Demographic information (age, gender, etc.) Pain scores (measured by the Visual Analog Scale, VAS) Range of motion measurements (abduction and external rotation) Pectoralis minor muscle length measurements (using ultrasound) 3. Data Availability Timeline: The IPD will be made publicly available 12 months after the study’s publication. The data will be stored in a publicly accessible repository (OSF/Zenodo), and links to the data will be shared in the publication's supplementary materials. 4. Access Criteria: The data will be available to researchers upon request for non-commercial academic research purposes only. Requests for data will be submitted via a formal contact (e.g., study PI or designated team member) and will require a research proposal that meets ethical and scientific criteria. Contact for Data Requests: Dr Bhishma Karki, bhishma.karki@trc.tu.edu.np 5. Mechanism of Data Sharing: Data will be shared via a secure online repository (e.g., OSF or Zenodo) where datasets will be anonymized and made available through a public link. Data will be made available with appropriate anonymization to ensure participant confidentiality and comply with GDPR or relevant data protection laws. 6. Consent from Participants: Informed consent was obtained from all study participants prior to enrollment. The consent forms include clauses about the use of anonymized data for research purposes. 7. Ethical and Legal Restrictions: Ethical approval was obtained from the Ethics Committee of Tribhuvan University (Kathmandu, Nepal). The shared data will be anonymized and will not include any personally identifiable information (PII). Data will not be shared with any commercial entities unless participants' explicit consent is obtained. 8. Comments on Data Anonymization: All shared data will be fully anonymized by removing participant identifiers such as names, addresses, or any direct identifiers. Only aggregated, de-identified data will be available to ensure that participants' privacy is maintained. 9. Exceptions: In case of unforeseen circumstances or legal restrictions (e.g., specific local laws or data protection issues), access to data may be restricted, but we will provide a clear rationale for any such limitations. 10. Long-term Availability: The dataset will remain accessible for at least 5 years after the publication date, allowing researchers to explore the data for further studies or meta-analyses. |
Editorial Notes
12/09/2025: Study's existence confirmed by the Institutional Ethics Committee of Tribhuvan University, Nepal.
