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Completed

NCT Number: NCT05212740

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.

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Key information

Conditions

Frozen Shoulder Behavior Bursitis Joint Diseases Motor Activity Musculoskeletal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Faculty Medicine, Istanbul, Fatih, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between ages 18-60 years
  • 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
  • The pain VAS more than 7 (10 in total)

Exclusion criteria

  • bilateral frozen shoulder
  • rotator cuff tear
  • previous corticosteroid injection at the affected shoulder within 3 months

Treatment and study plan

Corticosteroid

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

Other

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

Primary outcomes

  1. Change from baseline in function on DASH at 6th and 12th week

    Time frame: 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 outcomes

  1. Change from baseline in function on ASES at 6th and 12th week

    Time frame: 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.

  2. Change from baseline in range of motion (ROM) at 6th and 12th week

    Time frame: Baseline,6th week and 12th week

    The joint's range of motion is the distance that the joint can extend.

  3. Change from baseline in depression and anxiety on HADS at 6th and 12th week

    Time frame: 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.

  4. Change from baseline in pain on VAS at 6th and 12th week

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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