beta
Trial Radar AI
Clinical Trial NCT07134010 (PIT; AC) for Adhesive Capsulitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

The Impact of Perineural Injection Therapy for Adhesive Capsulitis. (PIT; AC) 24 Home-Based Exercise-Based

Recruiting
Clinical Trial NCT07134010 (PIT; AC) is an interventional study for Adhesive Capsulitis that is recruiting. It started on 3 June 2025 with plans to enroll 24 participants. Led by Universiti Teknologi Mara, it is expected to complete by 1 June 2026. The latest data from ClinicalTrials.gov was last updated on 4 September 2025.
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 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 whe...

Show More
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 capsulitis, commonly known as "frozen shoulder," is a painful condition that limits shoulder movement and affects daily activities such as dressing, reaching overhead, or lifting objects. It often affects adults between the ages...

Show More
Official Title

The Impact of Perineural Injection Therapy for Adhesive Capsulitis at a Single Centre University Hospital in Selangor: A Pilot Study

Conditions
Adhesive Capsulitis
Other Study IDs
  • PIT; AC
  • REC/06/2025 (PG/FB/26)
NCT ID Number
NCT07134010
Start Date (Actual)
2025-06-03
Last Update Posted
2025-09-04
Completion Date (Estimated)
2026-06-01
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Perineural injection therapy in treating Adhesive Capsulitis
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention group
Perineural injection Therapy
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 t...Show More
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.
Sham ComparatorConventional group
Physiotherapy
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Numerical Rating Scale
Participants will rate their shoulder pain on a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain."
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Shoulder Range of Motion (ROM)
Tool: Goniometer (standardized physical measurement) Passive ROM will be measured in four directions: forward flexion, abduction, internal rotation, and external rotation. Values will be recorded in degrees.
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Functional Outcome
Tool: Shoulder Pain and Disability Index (SPADI) - validated English and Malay versions A self-reported questionnaire with 13 items divided into two subscales: 5 for pain and 8 for functional disability. Each item is scored from 0 (no pain/disability) to 10 (worst pain/disability), with higher scores indicating greater impairment.
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Adverse Reactions
Tool: Adverse Event Reporting Form and Patient Diary Description: Side effects will be classified into: Mild: Local pain, bruising, or redness Moderate: Transient numbness, swelling, or prolonged discomfort Severe: Infection or allergic reaction
Monitored throughout the 6-week intervention
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Universiti Teknologi Mara logoUniversiti Teknologi Mara
Study Responsible Party
Noor Hafizah Binti Samsudin Bahari, Principal Investigator, Medical Doctor, Universiti Teknologi Mara
Study Central Contact
Contact: Noor Hafizah Samsudin Bahari, MD(UKM), +60333963395, [email protected]
Contact: Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehabMed(UM), +60333963395, [email protected]
1 Study Locations in 1 Countries

Selangor

Hospital Al-Sultan Abdullah, UiTM Puncak Alam, Kuala Selangor, Selangor, 42300, Malaysia
Noor Hafizah Samsudin Bahari, MD(UKM), Contact, +60333963395, [email protected]
Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehab(UM), Contact, +60333963395, [email protected]
Assoc. Prof. Dr. Nadia Mohd Mustafah, MD(UPM)MRehab(UM), Sub-Investigator
Recruiting