Strength Training and Proprioceptive Stimulation on Pain, Function, Quality of Life, Sleep Qualit… (NCT07184242) | Clinical Trial Compass
CompletedNot Applicable
Strength Training and Proprioceptive Stimulation on Pain, Function, Quality of Life, Sleep Quality, and Psychosocial Factors in Older Adults With Shoulder Pain
Spain80 participantsStarted 2025-09-18
Plain-language summary
A single-blind randomized clinical trial with a pretest posttest design is proposed in adults over 60 years of age with chronic shoulder pain due to rotator cuff involvement. Participants will be divided into an experimental group that will receive a multi-joint strength exercise program along with proprioceptive somatosensory stimulation plus conventional treatment for 12 weeks and a control group that will only receive conventional treatment. Assessments will be performed at the beginning and end of the intervention by measuring pain with the NPRS and BPI SF scales, psychosocial factors with PCS FABQ PVAQ and TSK 11, functional disability with the Shoulder Rating Questionnaire, sleep quality with the Pittsburgh Index, and physical function with the Back Scratch Test, goniometry and inclinometer, shoulder dynamometry, and manual grip. It is expected that the combined intervention will significantly improve pain, associated psychosocial factors, quality of life, sleep, and functional capacity of participants.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* People over 60 years of age.
* Be able to understand the instructions and answer the questionnaires designed for this study, as well as participate in the established physical tests.
* People with rotator cuff-related shoulder pain (RCSRP) of at least 3 months' duration.
* Sign informed consent to participate in the study.
* Possible medical diagnoses to categorize you as RCSRP:
* Subacromial syndrome or subacromial pain syndrome.
* Subacromial impingement.
* Rotator cuff tendinopathy/tendinitis/tendinosis.
* Subdeltoid/subacromial bursitis.
* Non-traumatic partial tears of a rotator cuff tendon affecting less than 50% of the tendon thickness.
* Mild/moderate intrasubstance rotator cuff tears.
Exclusion Criteria:
* Complete/massive rotator cuff tears.
* Corticosteroid injections within the last 6 weeks.
* Recent surgery on that shoulder or planned surgery within the next 3 months.
* Bilateral shoulder pain.
* Presence of glenohumeral fractures or osteoarthritis confirmed by radiographic examination.
* Psychiatric illnesses or central or peripheral neurological disorders that make it difficult to grasp, cooperate, or follow instructions during the procedure.
* Individuals with an absolute contraindication to moderate-to-high-intensity physical exercise based on prior medical testing.
* Presence of severe difficulties with gait, balance, or functional activity, or hearing or vestibular disorders that prevent the performance of the prescribed exercises.
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numerical Pain Rating Scale (NPRS)
Timeframe: Up to twelve weeks
2
Brief Pain Inventory - Short Form (BPI-SF)
Timeframe: Up to twelve weeks
3
Algometry (Pressure Pain Thresholds)
Timeframe: Up to twelve weeks
4
Pain Catastrophizing Scale (PCS)
Timeframe: Up to twelve weeks
5
Fear-Avoidance Beliefs Questionnaire (FABQ)
Timeframe: Up to twelve weeks
6
Pain Vigilance and Awareness Questionnaire (PVAQ-9)