Clinical trial NCT06449534: The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in RCRSP
Official title: The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in Rotator Cuff Related Shoulder Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Subacromial Pain Syndrome
Rotator Cuff Syndrome of Shoulder and Allied Disorders
Keywords: Therapeutic Environment
Contextual Factors
Exercise Therapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Brief Summary

The aim of this randomized controlled study is to reveal the short-term effects of physical and social factors in different therapeutic environments on patients with rotator cuff related shoulder pain following the same exercise program. The main questions it aims answer are:

* Is there any difference in terms of pain levels among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.
* Is there any difference in terms of functionality and self-efficacy among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.

Detailed description: The investigators will include patients who applied to the physiotherapy clinic of Kadikoy Florence Nightingale Medical Center with the complaint of shoulder pain. 46 individuals who volunteer to participate in the study will be included. Participants will be randomised through a computer-based randomization program into two groups; the enriched therapeutic environment group (Group 1) and the isolated therapeutic environment group (Group 2). The same treatment including patient education, exercise therapy and ice application will be performed to both groups. Participants will receive a total of 15 sessions of treatment, 3 sessions per week. Before the treatment, 3rd week, 6th week and 12th week, the following evaluations will be made to both groups; Numerical Pain Rating Scale (NPRS) to asses pain, Arm, Shoulder, Hand Problems Quick Survey (Quick-DASH) and Western Ontario Rotator Cuff Index (WORC) to asses functionality, Pain Self-Efficacy Questionnaire (PSEQ) to asses self efficacy and Global Scale of Change (GRC) to asses the effectiveness of the treatment.

Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* diagnosed with impingement syndrome, subacromial bursitis, rotator cuff tendinopathy or partial rotator cuff tear
* pain level between 3-7 according to visual analog scale
* pain persisted for at least 3 months

Exclusion Criteria:

* 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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 3rd week, 6th week
Secondary outcomes:
measure: Quick - The Disabilities of the Arm, Shoulder and Hand (Quick DASH) Questionnaire
timeFrame: Baseline, 3rd week, 6th week, 12th week
measure: Western Ontario Rotator Cuff (WORC) Index
timeFrame: Baseline, 3rd week, 6th week, 12th week
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, 3rd week, 6th week, 12th week
measure: Global Rating of Change, GRC
timeFrame: Baseline, 3rd week, 6th week, 12th week
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul University Cerrahpasa Faculty of Health Sciences
Study officials:
References: