Multi-joint Strength Exercises and Proprioceptive Somatosensory Stimulation on Pain, Function, Quality of Life, Sleep Quality, and Psychosocial Factors in Patients Over 60 Years of Age With Chronic Rotator Cuff-related Shoulder Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Brief Pain Inventory - Short Form (BPI-SF)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Visual disturbances that cannot be corrected with glasses, contact lenses, or surgery.
- •Being enrolled in another physical exercise or treatment program during the study.
Arms & Interventions
Control Group
A control group (CG) will be evaluated in the pre- and post-study phases. Participants assigned to this group will continue their usual conventional treatment in the rehabilitation service to which they are assigned. They will also receive general advice on the positive effects of regular physical activity on their therapeutic process, based on the World Health Organization guidelines for those over 60 years of age.
Experimental Group
The experimental group will participate in a 12-week therapeutic exercise program designed to complement conventional treatment. Following an initial evaluation and informed consent, participants will attend two supervised group sessions per week, each lasting 50-60 minutes. These sessions will combine proprioceptive somatosensory exercises, multi-joint strength training, and specific complementary movements. Exercise loads will be carefully individualized, taking into account each participant's pain threshold, physical characteristics, clinical stage, and symptoms. A structured progression will be ensured by applying progressive overload through systematic changes in repetitions, external resistance, and range of motion. To reinforce the supervised training, participants will also carry out two to three additional home sessions per week, supported with educational materials, a personal logbook, and an adherence diary to encourage continuity and engagement throughout the intervention.
Intervention: Shoulder Exercise & Proprioceptive Training Program (Other)
Outcomes
Primary Outcomes
Brief Pain Inventory - Short Form (BPI-SF)
Time Frame: Up to twelve weeks
The BPI-SF is a self-administered questionnaire that evaluates pain severity and pain interference with daily activities. It complements the NPRS by covering affective and functional dimensions of the pain experience.
Numerical Pain Rating Scale (NPRS)
Time Frame: Up to twelve weeks
The NPRS is an 11-point numeric scale (0-10) used to assess pain intensity. Participants indicate their current level of pain, with 0 representing "no pain" and 10 representing "worst imaginable pain." It will be applied to capture the sensory-discriminative dimension of pain.
Algometry (Pressure Pain Thresholds)
Time Frame: Up to twelve weeks
Pressure algometry will be used to determine pain thresholds to pressure stimuli. It allows the quantification of mechanical sensitivity and the evaluation of changes in pain perception.
Pain Catastrophizing Scale (PCS)
Time Frame: Up to twelve weeks
The PCS is a validated questionnaire that measures catastrophic thinking related to pain through three subscales: rumination, magnification, and helplessness. Higher scores indicate greater pain catastrophizing.
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Up to twelve weeks
The FABQ evaluates fear-avoidance beliefs regarding physical activity and work. It identifies how fear of pain may influence behavior and functional limitations.
Pain Vigilance and Awareness Questionnaire (PVAQ-9)
Time Frame: Up to twelve weeks
The PVAQ-9 assesses hypervigilance and attentional focus on pain sensations. It quantifies the degree to which individuals monitor, detect, and are alert to pain-related stimuli.
Tampa Scale for Kinesiophobia (TSK-11)
Time Frame: Up to twelve weeks
The TSK-11 short version is a self-reported questionnaire measuring kinesiophobia, i.e., the fear of movement due to pain or risk of injury. It captures cognitive and emotional aspects of avoidance behavior.
Shoulder Rating Questionnaire (SRQ)
Time Frame: Up to twelve weeks
The SRQ is a disease-specific tool validated in Spanish that measures functional disability related to shoulder pain. It evaluates domains such as pain, daily activity limitations, and overall shoulder function.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Up to twelve weeks
The PSQI is a widely used questionnaire to assess sleep quality over the previous month. It includes seven components (subjective sleep quality, latency, duration, efficiency, disturbances, medication use, and daytime dysfunction), providing a global score of sleep quality.
Back Scratch Test
Time Frame: Up to twelve weeks
The Back Scratch Test evaluates shoulder flexibility and range of motion by measuring the distance between the hands behind the back. It is a simple field test for functional shoulder mobility.
Goniometry (Shoulder Range of Motion)
Time Frame: Up to twelve weeks
A goniometer will be used to measure active range of motion in flexion, abduction, and rotations of the shoulder. The inclinometer option will ensure precise angular assessment.
Handheld Dynamometry
Time Frame: Up to twelve weeks
Isometric muscle strength of the main shoulder movements (flexion, abduction, rotation) and handgrip strength will be measured with a handheld dynamometer, providing objective data on functional capacity.
Secondary Outcomes
No secondary outcomes reported
Investigators
Agustín Aibar Almazán
Principal investigator
University of Jaén