Actively Recruiting
The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in Rotator Cuff Related Shoulder Pain
Led by Istanbul University - Cerrahpasa · Updated on 2024-10-03
34
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to investigate how different therapeutic environments affect pain, function, self-efficacy, and satisfaction in patients with rotator cuff related shoulder pain. The study focuses on whether treating patients in enriched versus isolated settings leads to differences in pain levels, shoulder functionality, and patients' confidence in managing their pain. It is a randomized controlled study involving adults diagnosed with shoulder conditions such as impingement syndrome and rotator cuff tendinopathy. Participants will be randomly assigned to one of two groups: an enriched therapeutic environment group or an isolated therapeutic environment group. Both groups will receive the same treatment program including patient education, exercise therapy, and cold application over 15 sessions, conducted three times a week. The enriched group will receive treatment in a sunlit room with a view of green trees and will listen to classical music during cold application, while the isolated group will be treated in a quiet, artificially lit room with closed curtains and rest silently during cold application. Participants will undergo evaluations before treatment and at weeks 3, 6, and 12 using several tools to measure pain intensity, shoulder function, self-efficacy, and overall treatment effectiveness. Assessments include the Numeric Pain Rating Scale, Quick-DASH, Western Ontario Rotator Cuff Index, Pain Self-Efficacy Questionnaire, and Global Rating of Change. The study will monitor changes over time to understand the short-term effects of the different therapeutic settings on patients' shoulder pain and related outcomes.
CONDITIONS
Brief Title
The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in RCRSP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-75 years old
- Diagnosed with impingement syndrome, subacromial bursitis, rotator cuff tendinopathy, or partial rotator cuff tear
- Pain level between 3 and 7 according to visual analog scale
- Pain has persisted for at least 3 months
You will not qualify if you...
- Having a full-thickness or massive rotator cuff tear
- History of shoulder surgery
- Having a musculoskeletal disease that prevents exercise
- Having a neurological disease or psychological disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive 15 sessions of treatment including patient education, exercise therapy, and cold application over 6 weeks. Sessions occur 3 times per week, each lasting approximately 60 minutes. Group 1 receives treatment in an enriched environment with sunlight, greenery, and classical music during cold application, while Group 2 receives treatment in a quiet single room with artificial lighting and silent cold application.
3 sessions per week for a total of 15 sessions (in-person)
Duration - Up to 12 weeks from baseline
Participants undergo evaluations of pain, functionality, self-efficacy, and treatment effectiveness at baseline, 3rd week, 6th week, and 12th week to assess progress.
4 visits (in-person) at baseline, week 3, week 6, and week 12
Trial Site Locations
Total: 1 location
1
İstanbul University Cerrahpasa Faculty of Health Sciences
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
M
Merve KOYUNCU CENİKLİ, Research asistant
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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