Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,

NCT ID: NCT05212740

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2022-10-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Frozen Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Corticosteroid

The participants will receive prednisolone for four weeks.

Group Type EXPERIMENTAL

Corticosteroid

Intervention Type DRUG

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.

Exercise

The participants will receive joint mobilization techniques, stretching and home exercise.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Zeynal YASACI

Research Assistant; Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya Çelik

Role: STUDY_DIRECTOR

Istanbul University

Locations

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Istanbul Faculty Medicine

Istanbul, Fatih, Turkey (Türkiye)

Site Status

İÜC Sağlık Bilimleri Fakültesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Istanbul Unıversity-Cerrahpasa

Identifier Type: -

Identifier Source: org_study_id

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