The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in RCRSP

Istanbul University - Cerrahpasa (IUC)

Status: Enrolling

Conditions: Shoulder Pain; Subacromial Pain Syndrome; Rotator Cuff Syndrome of Shoulder and Allied Disorders

Treatments: Behavioral: Patient Education; Behavioral: Exercise Therapy; Behavioral: Cold Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06449534

2150060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

The enriched therapeutic environment group (Group 1)

Experimental group

Description:

Group 1 will receive treatment in a physiotherapy unit which has following characteristics ; enlightened with sunlight, has a view of green trees and includes other participants exercising. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will listen to classical music pieces selected by us during 15 minutes of cold application.

Treatment:

Behavioral: Cold Application

Behavioral: Exercise Therapy

Behavioral: Patient Education

The isolated therapeutic environment group (Group 2).

Experimental group

Description:

Group 2 will receive treatment in a quiet single room. The room is illuminated by artificial light, curtains are closed so that patients cannot see outside view. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest silently for 15 minutes of cold application.

Treatment:

Behavioral: Cold Application

Behavioral: Exercise Therapy

Behavioral: Patient Education