Perineural injection therapy for frozen shoulder
The Impact of Perineural Injection Therapy for Adhesive Capsulitis at a Single Centre University Hospital in Selangor: A Pilot Study
This study will test whether perineural injection therapy (5% dextrose) plus physiotherapy helps adults with frozen shoulder have less pain and better shoulder movement than physiotherapy and painkillers alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiti Teknologi Mara Academic / other |
| Locations | 1 site (Kuala Selangor, Selangor) |
| Trial ID | NCT07134010 on ClinicalTrials.gov |
What this trial studies
This single-center randomized pilot compares weekly perineural injections of 5% dextrose for six weeks plus physiotherapy and oral analgesics (excluding NSAIDs) against conventional therapy (physiotherapy and analgesics including NSAIDs) in adults with adhesive capsulitis. Participants attend follow-up visits at week 6, one month, and three months after treatment while performing daily home exercises and keeping a diary of analgesic use and side effects. The trial measures pain, shoulder range of motion, function, and any adverse events to determine whether adding PIT improves outcomes and is safe. Results will inform whether larger trials are warranted.
Who should consider this trial
Good fit: Adults aged 18 or older with primary adhesive capsulitis for at least three months, at least 50% range-of-motion loss in three or more directions, and movement pain of 4/10 or greater who have not had recent shoulder injections or surgery are ideal candidates.
Not a fit: People with other shoulder pathologies (rotator cuff tears, fractures, tumors, neurologic deficits), recent shoulder injections or surgery, or a known allergy to dextrose are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, PIT could provide a non-surgical option that reduces pain and improves shoulder range of motion and function faster than conventional therapy alone.
How similar studies have performed: Perineural injection therapy has shown promising results for other nerve-related and musculoskeletal pain conditions, but its use specifically for adhesive capsulitis is novel and not well-studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 and above. 2. Diagnosed with primary adhesive capsulitis by a specialist. 3. 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). 4. Chronic adhesive capsulitis shoulder pain lasting for at least 3 months. 5. Pain score of at least 4/10 on the Numerical Rating Scale (NRS) during movement, indicating at least moderate pain severity. 6. Consented to the study. Exclusion Criteria: 1. 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. 2. Diagnosed with other shoulder pathology such as neurologic deficits affecting shoulder function, tumour, rotator cuff injury or fracture. 3. Has history of allergy to dextrose solution. 4. Patients receiving steroidsimmunosuppressants, psychotropic medication, or other medications that may affect, the clinical outcomes 5. Patients with haemorrhagic disease, taking anticoagulant drugs, or patients with severe diabetes mellitus having an increased risk of infection (HBA1c \>8%) 6. Do not understand Malay or English language. 7. Unable to follow a 3 steps command.
Where this trial is running
Kuala Selangor, Selangor
- Hospital Al-Sultan Abdullah, UiTM Puncak Alam — Kuala Selangor, Selangor, Malaysia (Recruiting)
Study contacts
- Principal investigator: Noor Hafizah Samsudin Bahari, MD(UKM) — Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus
- Study coordinator: Noor Hafizah Samsudin Bahari, MD(UKM)
- Email: 2023204074@student.uitm.edu.my
- Phone: +60333963395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.