Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,

Frozen Shoulder Clinical Trial

Official title:

Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212740
• Other study ID #: Istanbul University-Cerrahpasa
• Status: Completed
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: October 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 20, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Drug:
• Corticosteroid
The treatment will initiate with a dose of 0.5 mg/kg/day prednisolone for two weeks and the dose will halve in the next two weeks.

Other:
• Exercise
The exercise program will be performed two times per week for six weeks for 12 sessions.

Locations

Country	Name	City	State
Turkey	Istanbul Faculty Medicine	Istanbul	Fatih
Turkey	IÜC Saglik Bilimleri Fakültesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in function on DASH at 6th 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.	Baseline,6th week and 12th week
Secondary	Change from baseline in function on ASES at 6th 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.	Baseline,6th week and 12th week
Secondary	Change from baseline in range of motion (ROM) at 6th and 12th week	The joint's range of motion is the distance that the joint can extend.	Baseline,6th week and 12th week
Secondary	Change from baseline in depression and anxiety on HADS at 6th 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.	Baseline,6th week and 12th week
Secondary	Change from baseline in pain on VAS at 6th 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.	Baseline,6th week and 12th week