Strength Training and Proprioceptive Stimulation on Pain, Function, Quality of Life, Sleep Quality, and Psychosocial Factors in Older Adults With Shoulder Pain

NCT ID: NCT07184242

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2025-12-19

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Shoulder Exercise & Proprioceptive Training Program

Intervention Type: OTHER

The study includes two intervention modalities. The experimental group will combine conventional treatment with a structured 12-week therapeutic exercise program, with two supervised group sessions per week (50-60 minutes), which will include proprioceptive somatosensory work, multi-joint strength exercises, and adapted specific movements. Progression will be individually adjusted based on each participant's pain tolerance, physical condition, and clinical progress, complemented by home activities and supporting educational materials.

The control group will receive only conventional treatment provided at their rehabilitation center and general guidelines on the benefits of physical activity according to WHO recommendations for people over 60 years of age.

Interventions

Shoulder Exercise & Proprioceptive Training Program

The study includes two intervention modalities. The experimental group will combine conventional treatment with a structured 12-week therapeutic exercise program, with two supervised group sessions per week (50-60 minutes), which will include proprioceptive somatosensory work, multi-joint strength exercises, and adapted specific movements. Progression will be individually adjusted based on each participant's pain tolerance, physical condition, and clinical progress, complemented by home activities and supporting educational materials.

The control group will receive only conventional treatment provided at their rehabilitation center and general guidelines on the benefits of physical activity according to WHO recommendations for people over 60 years of age.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Agustín Aibar Almazán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ICOT rehabilitation centers

Las Palmas de Gran Canaria, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Paulino Vico Rodríguez

Role: primary

paulino.vico@pdi.atlanticomedio.es

685613272

Other Identifiers

UUJA

Identifier Type: -

Identifier Source: org_study_id