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

Comparison of the Effectiveness of Stretching and Strengthening Exercises on Pain, Functional Status, Range of Motion and Psychosocial Factors in Patients With Frozen Shoulder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frozen Shoulder
• Intervention / Treatment: Procedure: Stretching Exercises; Procedure: Strengthening Exercises

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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Derya Çelik, Professor; Phone Number: 05327940169; Email: ptderya@hotmail.com
• Study Contact Backup: Name: Ümmü Öztürk, PhD(c); Phone Number: 05346749164; Email: ummuozturk90@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1-Stretching Group; Exercise program consisting of supervised stretching exercises	Procedure: 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.
Experimental: Group 2-Strengthening Group; Exercise program consisting of supervised strengthening exercises	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick DASH	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).	baseline, after 6 weeks and 6 weeks follow up
NPRS	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)	baseline, after 6 weeks and 6 weeks follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES	The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment: The ASES score ranges from 0-100. Higher scores indicate better functional ability	baseline, after 6 weeks and 6 weeks follow up
Shoulder Range of Motion (ROM)	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.	baseline, after 6 weeks and 6 weeks follow up
BPI-SF	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".	baseline, after 6 weeks and 6 weeks follow up
PCS	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.	baseline, after 6 weeks and 6 weeks follow up

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: exercise; stretching; strengthening; frozen shoulder
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: DR2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No