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

Not Applicable

Not yet recruiting

• Conditions: Frozen Shoulder
• Interventions: Procedure: Stretching Exercises; Procedure: Strengthening Exercises

• Registration Number: NCT06469502
• Lead Sponsor: Istanbul University

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).

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Study Start: 2024-07-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1-Stretching Group	Stretching Exercises	Exercise program consisting of supervised stretching exercises
Group 2-Strengthening Group	Strengthening Exercises	Exercise program consisting of supervised strengthening exercises

Primary Outcome Measures

Name	Time	Method
NPRS	baseline, after 6 weeks and 6 weeks follow up	Numeric Pain Rating Scale: The pain was measured using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)
Quick DASH	baseline, after 6 weeks and 6 weeks follow up	Quick Disabilities of the Arm, Shoulder, and Hand: The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).

Secondary Outcome Measures

Name	Time	Method
ASES	baseline, after 6 weeks and 6 weeks follow up	The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment: The ASES score ranges from 0-100. Higher scores indicate better functional ability
Shoulder Range of Motion (ROM)	baseline, after 6 weeks and 6 weeks follow up	Shoulder ROM measurements of forward flexion, abduction, and scapular plane external -internal rotation were taken using a standard goniometer. Pain-free active ROM and passive ROM were assesment.
BPI-SF	baseline, after 6 weeks and 6 weeks follow up	Brief Pain Inventory-Short Form: The BPI is a two-factor instrument that measures pain severity and pain interference. The pain severity factor has four items, all rated on a 0-to-10 Likert scale: 0 corresponds to "no pain" and 10 corresponds to "pain as bad as you can imagine". The pain interference factor has seven items, all rated on a 0-to-10 Likert scale: 0 corresponds to "does not interfere" and 10 corresponds to "interferes completely".
PCS	baseline, after 6 weeks and 6 weeks follow up	Pain Catastrophizing Scale: Each item is scored from 0 (never) to 4 (always), giving a total score ranging from 0 to 52. Higher scores indicate higher levels of pain catastrophizing.

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey