The Impact of Perineural Injection Therapy for Adhesive Capsulitis.

NCT07134010 | Recruiting DMC

• 1 other identifier: REC/06/2025 (PG/FB/26)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Keywords

Perineural injection therapy in treating Adhesive Capsulitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Functional Outcome

  Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).

• Adverse Reactions

  Monitored throughout the 6-week intervention

Other Outcomes (1)

• Frequency of Analgesic Use

  Recorded weekly from baseline until the 3-month follow-up.

Study Arms (2)

Intervention group

EXPERIMENTAL

Perineural injection Therapy

Other: perineural injection; Other: Physiotherapy

Conventional group

SHAM COMPARATOR

Physiotherapy

Other: Physiotherapy

Interventions

perineural injection OTHER

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.

Also known as: Perineural injection therapy, PIT

Intervention group

Physiotherapy OTHER

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.

Conventional group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Teknologi Mara: lead

Study Sites (1)

Hospital Al-Sultan Abdullah, UiTM Puncak Alam

Kuala Selangor, Selangor, 42300, Malaysia

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Noor Hafizah Samsudin Bahari, MD(UKM)

  Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus

  PRINCIPAL INVESTIGATOR

• Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehabMed(UM)

  Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus

  PRINCIPAL INVESTIGATOR

• Assoc. Prof. Dr. Nadia Mohd Mustafah, MD(UPM), MRehabMed(UM)

  Faculty of Medicine, Universiti Teknologi MARA, Sg Buloh Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noor Hafizah Samsudin Bahari, MD(UKM)

CONTACT

+60333963395; 2023204074@student.uitm.edu.my

Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehabMed(UM)

CONTACT

+60333963395; aniefarhana@uitm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: This study is a prospective, single-center, two-arm, parallel-group, randomized controlled pilot trial conducted to assess the impact of Perineural Injection Therapy (PIT) on pain, shoulder mobility, and function in patients with adhesive capsulitis. Participants will be randomly assigned in a 1:1 ratio to either: Intervention Group: PIT plus conventional therapy (physiotherapy and analgesics excluding NSAIDs) Control Group: Conventional therapy alone (physiotherapy and analgesics including NSAIDs) Randomization will be implemented using a computer-generated random sequence prepared in advance and managed by an independent staff nurse not involved in treatment or outcome assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. Due to the procedural nature of PIT, blinding is not feasible for participants and treating physicians. However, outcome assessors (physiotherapists) will be blinded to group assignments to reduce bias.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-06

Locations

MY (1)