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Clinical Trials/NCT06469502
NCT06469502
Not Yet Recruiting
N/A

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

Istanbul University1 site in 1 country56 target enrollmentJuly 1, 2024
ConditionsFrozen Shoulder

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frozen Shoulder
Sponsor
Istanbul University
Enrollment
56
Locations
1
Primary Endpoint
NPRS
Status
Not Yet Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
August 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Derya Celik

Professor

Istanbul University

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)

Outcomes

Primary Outcomes

NPRS

Time Frame: 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

Time Frame: 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 Outcomes

  • ASES(baseline, after 6 weeks and 6 weeks follow up)
  • Shoulder Range of Motion (ROM)(baseline, after 6 weeks and 6 weeks follow up)
  • BPI-SF(baseline, after 6 weeks and 6 weeks follow up)
  • PCS(baseline, after 6 weeks and 6 weeks follow up)

Study Sites (1)

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