Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,

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

Study Overview

• Status: Completed
• Conditions: Frozen Shoulder
• Intervention / Treatment: Drug: Corticosteroid; Other: Exercise

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İÜC Sağlık Bilimleri Fakültesi
  • Fatih
    • Istanbul, Fatih, Turkey, 34147
      • Istanbul Faculty Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Corticosteroid; The participants will receive prednisolone for four weeks.	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.
ACTIVE_COMPARATOR: Exercise; The participants will receive joint mobilization techniques, stretching and home exercise.	Other: Exercise; The exercise program will be performed two times per week for six weeks for 12 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2022
• Primary Completion (ACTUAL): October 10, 2022
• Study Completion (ACTUAL): October 20, 2022

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (ACTUAL): January 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: exercise; corticosteroid; adhesive capsulitis; frozen shoulder
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: Istanbul Unıversity-Cerrahpasa

Drug and device information, study documents

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