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Outcome comparison of intra-articular injection of hyaluronic acid with ketorolac versus ketorolac alone in adhesive capsulitis patients

Phase 1
Conditions
The patients with unilateral adhesive capsulitis who had conservative treatment more than 1 month
adhesive capsulitis, frozen shoulder
Registration Number
TCTR20230908006
Lead Sponsor
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
30
Inclusion Criteria

1.Adhesive capsulitis patients with normal radiograph of affected shoulder
2.Age 18-70 years
3.Restriction of active and passive motion greater than 25 degree in at least 2 planes compared to contralateral of shoulder
4.Conservative treatment at least 1 month and the duration of symptoms less than a year
5.Willingness to participate in research study

Exclusion Criteria

1.Previous shoulder trauma/surgery at shoulder
2.Bilateral symptoms
3.Uncontrolled diabetes mellitus (HbA1C>7%)
4.Overt hypothyroidism or hyperthyroidism
5.Previous glenohumeral joint injection
6.Full thickness rotator cuff tear
7.History of gastrointestinal bleeding
8.Allergies to injection material
9.Systemic inflammatory disease including rheumatoid arthritis, osteoarthritis of shoulder joint
10.Neurological symptoms
11.Coagulopathy disorder

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Functional shoulder score pre-treatment and 2, 6, 12, 24 post-treatment SPADI score
Secondary Outcome Measures
NameTimeMethod
Range of motion Pre-treatment and 2, 6, 12, 24 weeks post-treatment Goniometer,Pain score Pre-treatment and 2, 6, 12, 24 weeks post-treatment Visual analog scale,Dose of breakthrough pain drugs used 2, 6, 12, 24 weeks post-treatment Logbook,Adverse event 2, 6, 12, 24 weeks post-treatment Logbook
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