Pain Neuroscience Education Plus Exercise Versus Exercise Alone in the Management of Chronic Rotator Cuff Tendinopathy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Change in pain intensity
Study Overview
Brief Summary
The aim of this randomized controlled trial is to evaluate the combined effects of pain neuroscience education plus exercise to exercise alone in the management of patients with chronic rotator cuff tendinopathy regarding pain, function, strength, kinesiophobia, and pain catastrophizing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Researchers involved in recording outcome measures will not be aware of treatment allocation. Patients will be encouraged to not tell the evaluators about the received treatment.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Shoulder pain due to rotator cuff tendinopathy lasting more than 6 months.
- •Internal Rotation Resisted Strength Test positive.
- •Test Item Cluster (Hawkins-Kennedy, painful arc, and infraspinatus test) positive.
Exclusion Criteria
- •History of: tumors, metastasis, osteoporosis, shoulder fractures, shoulder luxation and/or instability, previous shoulder surgery, cervical radiculopathy, full-thickness rotator cuff tears, glenohumeral joint degeneration, inflammatory arthropathy, acromioclavicular joint arthrosis, and rotator cuff calcifications.
- •Being treated by other physical therapy or medical treatment for their shoulder pain at the time of recruitment.
Outcomes
Primary Outcomes
Change in pain intensity
Time Frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)
Secondary Outcomes
- Catastrophism change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)
- Shoulder disability change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)
- Kinesiophobia change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)
- Strength change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)
Investigators
Ruben Fernandez Matias
Clinical Professor
University of Alcala