Comparison of the Effectiveness of Stretching and Strengthening Exercises in Patients With Frozen Shoulder

NCT ID: NCT06469502

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-08-15

Brief Summary

The aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.

Detailed Description

Frozen shoulder is a common disorder characterized by spontaneous shoulder pain, progressive inflammation and fibrosis of the joint capsule and loss of both active and passive glenohumeral range of motion.Exercise reduces pain, increases range of motion and function in patients with frozen shoulder. When investigators examine the literature, stretching and strengthening exercises are frequently encountered in the content of multimodal exercise programs applied clinically and at home in frozen shoulder. However, they have not been compared in isolation. Stretching is known to increase flexibility, while strengthening is often used to increase strength capacity and hypertrophy.Both exercise methods produce mechanical tension, known as a factor that stimulates anabolic metabolism and increases protein synthesis.Therefore, the aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.According to the power analysis result, 56 patients will be randomized into two groups (Group 1 =28, Group 2=28). The treatment will last for a total of 6 weeks and the follow-up period will be 6 weeks. Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist. Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times per week) under the supervision of a physiotherapist. The primary outcomes are the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH) and the Numeric Pain Rating Scale (NPRS), while the secondary outcomes are the American Shoulder and Elbow Surgeons Standardized Shoulder Evaluation (ASES), Shoulder range of motion, Brief Pain Inventory-Short Form (BFI-SF) and Pain Catastrophizing Scale (PCS).

Conditions

Frozen Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1-Stretching Group

Exercise program consisting of supervised stretching exercises

Group Type: EXPERIMENTAL

Stretching Exercises

Intervention Type: PROCEDURE

Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist.

Group 2-Strengthening Group

Exercise program consisting of supervised strengthening exercises

Group Type: EXPERIMENTAL

Strengthening Exercises

Intervention Type: PROCEDURE

Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times a week) under the supervision of a physiotherapist.

Interventions

Stretching Exercises

Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist.

Intervention Type: PROCEDURE

Strengthening Exercises

Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times a week) under the supervision of a physiotherapist.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 40-65
• Clinical and radiologic diagnosis of unilateral primary frozen shoulder
• Being in frozen shoulder stages 2 and 3
• Having an ROM of less than 50% in one or more directions of shoulder flexion, abduction, external rotation compared to the unaffected shoulder
• Giving informed consent and volunteering
• To have the ability to understand evaluation scales

Exclusion Criteria

• Neurological, cardiovascular, cerebrovascular disease
• Those with severe mental illness or impaired consciousness
• Upper extremity fractures and tumors
• Rheumatic disease
• Pathologies of cervical origin
• Untreated shoulder trauma
• Severe osteoporosis
• Previous treatment for the current complaint (physiotherapy and rehabilitation, intra-articular injection, surgery)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Derya Celik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ümmü Öztürk, PhD(c)

Role: CONTACT

ummuozturk90@hotmail.com

05346749164

Derya Çelik, Professor

Role: CONTACT

ptderya@hotmail.com

05327940169

Other Identifiers

DR2024

Identifier Type: -

Identifier Source: org_study_id