Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,

Not Applicable

Completed

• Conditions: Frozen Shoulder
• Interventions: Drug: Corticosteroid; Other: Exercise

• Registration Number: NCT05212740
• Lead Sponsor: Istanbul University

Brief Summary

The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.

Detailed Description

After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double blind manner in a 1:1 (participant and investigator) to oral corticosteroids or exercise.

Study Timeline

• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-01-16
• Study Start: 2022-01-25
• Study First Posted: 2022-01-28
• Status Verified: 2022-10
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-20
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. between ages 18-60 years
2. loss of passive motion of the glenohumeral joint greater than 25% or 30 in at least 2 directions (flexion, external rotation, and internal rotation) compared with the contralateral side
3. The pain VAS more than 7 (10 in total)

Exclusion Criteria

1. bilateral frozen shoulder
2. rotator cuff tear
3. previous corticosteroid injection at the affected shoulder within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid	Corticosteroid	The participants will receive prednisolone for four weeks.
Exercise	Exercise	The participants will receive joint mobilization techniques, stretching and home exercise.

Primary Outcome Measures

Name	Time	Method
Change from baseline in function on DASH at 6th and 12th week	Baseline,6th week and 12th week	The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in function on ASES at 6th and 12th week	Baseline,6th week and 12th week	The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.
Change from baseline in range of motion (ROM) at 6th and 12th week	Baseline,6th week and 12th week	The joint's range of motion is the distance that the joint can extend.
Change from baseline in depression and anxiety on HADS at 6th and 12th week	Baseline,6th week and 12th week	HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring.
Change from baseline in pain on VAS at 6th and 12th week	Baseline,6th week and 12th week	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

Trial Locations

Locations (2)

Istanbul Faculty Medicine; 🇹🇷 Istanbul, Fatih, Turkey

İÜC Sağlık Bilimleri Fakültesi; 🇹🇷 Istanbul, Turkey