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The Impact of Perineural Injection Therapy for Adhesive Capsulitis.

NCT07134010 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-04

No results posted yet for this study

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 questions it aims to answer are:

Does PIT reduce shoulder pain and improve shoulder range of motion more effectively than conventional therapy alone?

What side effects or medical problems do participants experience when receiving PIT?

Researchers will compare PIT to conventional therapy to see if PIT works better to treat adhesive capsulitis.

Participants will:

Receive either:

PIT once weekly for 6 weeks plus physiotherapy and oral analgesics (excluding NSAIDs), or

Conventional therapy only (physiotherapy and analgesics including NSAIDs)

Attend scheduled follow-up visits at Week 6, 1 month, and 3 months after treatment

Perform daily home-based shoulder exercises and record their analgesic use and any side effects in a patient diary

Conditions

  • Adhesive Capsulitis

Interventions

OTHER

perineural injection

Intervention The procedure will be performed by a rehabilitation physician who has obtained hospital-level credentialing and privileging to practice Perineural Injection Therapy (PIT). The physician has undergone hands-on training with Dr. Lyftogt-certified trainers in Malaysia. PIT will be administered weekly for six week (Total 6 sessions). In addition to this intervention, patient will also receive conventional therapy which is monthly outpatient physiotherapy with supplementary home-based exercise program, and oral analgesia (except NSAIDs). Solution: Buffered 5% dextrose. Pre injection: Chronic constriction injury points will be identified by palpation along the shoulder's cutaneous nerves - the suprascapular, supraclavicular, axillary, musculocutaneous, and radial nerves. These points will be marked to ensure precise targeting. Taking into account these nerve pathways, the maximum injection area for this research is set at 10 sites per session.

OTHER

Physiotherapy

Patients will be receiving a structured home-based exercise program and will be instructed on how to perform these exercises at home. The exercise regime will be 30 minutes, 3 times a day to enhance shoulder mobility and strength in addition to the regular monthly outpatient physiotherapy session. Oral analgesics exclude NSAIDs will be prescribed as needed to manage pain.

Sponsors & Collaborators

  • Universiti Teknologi Mara

    lead OTHER

Principal Investigators

  • Noor Hafizah Samsudin Bahari, MD(UKM) · Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus

  • Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehabMed(UM) · Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus

  • Assoc. Prof. Dr. Nadia Mohd Mustafah, MD(UPM), MRehabMed(UM) · Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2026-05-31
Completion
2026-06-01

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07134010 on ClinicalTrials.gov