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

NCT06449534 | Recruiting DMC

• 1 other identifier: 2150060
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Therapeutic Environment; Contextual Factors; Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  Participants' pain at rest, at night and during activity was measured using the NPRS. The NPRS is an 11-point scale that can be scored from 0 to 10. A score of zero (0) indicates "no pain" and 10 indicates score defines "the most severe pain". The patient will be asked to mark shoulder pain on the scale

  Baseline, 3rd week, 6th week

Secondary Outcomes (4)

• Quick - The Disabilities of the Arm, Shoulder and Hand (Quick DASH) Questionnaire

  Baseline, 3rd week, 6th week, 12th week

• Western Ontario Rotator Cuff (WORC) Index

  Baseline, 3rd week, 6th week, 12th week

• Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline, 3rd week, 6th week, 12th week

• Global Rating of Change, GRC

  Baseline, 3rd week, 6th week, 12th week

Study Arms (2)

The enriched therapeutic environment group (Group 1)

EXPERIMENTAL

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.

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

The isolated therapeutic environment group (Group 2).

EXPERIMENTAL

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.

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

Interventions

Patient Education BEHAVIORAL

It includes evaluation of the treatment process and past sessions. Simple shoulder biomechanics, function, and what caused the injury were explained to the patients. In order to increase patients' participation in treatment, it was emphasized what the treatment does and that the patient should cooperate in order to heal. During their treatment, patients are instructed to regulate their daily living activities, avoid overhead and repetitive movements of the arm, bags weighing more than 2-3 kg, etc. It was recommended not to carry them. Patients were informed about alternative sleeping positions.

The enriched therapeutic environment group (Group 1); The isolated therapeutic environment group (Group 2).

Exercise Therapy BEHAVIORAL

Participants in both groups were included in a structured exercise program consisting of exercises recommended in the literature. This exercise program includes joint range of motion exercises, stretching exercises and strengthening exercises and was carried out under the supervision of a physiotherapist for 6 weeks. Joint range of motion and strengthening exercises are recommended as 3 sets of 10 repetitions, and stretching exercises are recommended as 5 repetitions for 20 seconds. Exercises appropriate to the patients' clinical conditions and progression were selected by the physiotherapist and included in the program.

The enriched therapeutic environment group (Group 1); The isolated therapeutic environment group (Group 2).

Cold Application BEHAVIORAL

Following each exercise treatment, cold-pack will be applied for 15 minutes. During col-pack application, patients in the Group 1 group will listen to classical music selected by us, while patients in the Group 2 will rest quietly. There are a total of 40 songs by Bach, Mozart, Beethoven and Andre Rieu on our CD player, and patients have the right to choose and listen to the song they want.

The enriched therapeutic environment group (Group 1); The isolated therapeutic environment group (Group 2).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul University Cerrahpasa Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Patient Education as Topic; Exercise Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Merve KOYUNCU CENİKLİ, Research asistant

CONTACT

5459039585; merve.cenikli@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant, PT

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: May 6, 2024
• Primary Completion: November 15, 2024
• Study Completion: May 15, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)