RecruitingNot ApplicableNCT07134010

The Impact of Perineural Injection Therapy for Adhesive Capsulitis.

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

Sponsor

Universiti Teknologi Mara

Enrollment

24 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Adhesive Capsulitis

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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.

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Interventions

OTHERperineural 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.

OTHERPhysiotherapy

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.