Status:
RECRUITING
The Impact of Perineural Injection Therapy for Adhesive Capsulitis.
Lead Sponsor:
Universiti Teknologi Mara
Conditions:
Adhesive Capsulitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if Perineural Injection Therapy (PIT) works to treat adhesive capsulitis (frozen shoulder) in adults. It will also learn about the safety of PIT. The main ...
Detailed Description
Study Title: The Impacts of Perineural Injection Therapy on Adhesive Capsulitis in a Single Centre Hospital in Selangor: A Randomized Controlled Trial Pilot Study Study Overview : Adhesive capsulit...
Eligibility Criteria
Inclusion
- Age 18 and above.
- Diagnosed with primary adhesive capsulitis by a specialist.
- Limitation of range of motion ≥ 50% relative to the normal side or normal reference (in patient with bilateral adhesive capsulitis) in three or more movement directions (i.e., external rotation, abduction, forward flexion, and internal rotation).
- Chronic adhesive capsulitis shoulder pain lasting for at least 3 months.
- Pain score of at least 4/10 on the Numerical Rating Scale (NRS) during movement, indicating at least moderate pain severity.
- Consented to the study.
Exclusion
- Received any shoulder pain injection within the past 6 weeks or surgical intervention such manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
- Diagnosed with other shoulder pathology such as neurologic deficits affecting shoulder function, tumour, rotator cuff injury or fracture.
- Has history of allergy to dextrose solution.
- Patients receiving steroidsimmunosuppressants, psychotropic medication, or other medications that may affect, the clinical outcomes
- Patients with haemorrhagic disease, taking anticoagulant drugs, or patients with severe diabetes mellitus having an increased risk of infection (HBA1c \>8%)
- Do not understand Malay or English language.
- Unable to follow a 3 steps command.
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07134010
Start Date
June 3 2025
End Date
June 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
Hospital Al-Sultan Abdullah, UiTM Puncak Alam
Kuala Selangor, Selangor, Malaysia, 42300