The Impact of Perineural Injection Therapy for Adhesive Capsulitis.
ConditionAdhesive Capsulitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversiti Teknologi Mara
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
perineural injection
Other interventionIntervention 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.
Physiotherapy
Other interventionPatients 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 2 interventions
Group B: Conventional groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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."
Time frame
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).2
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.
Time frame
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).Secondary outcomes
1
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.
Time frame
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).2
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
Time frame
Monitored throughout the 6-week interventionOther outcomes
1
Frequency of Analgesic Use
Tool: Patient Diary (self-recorded) Description: Participants will log each use of pain medication (type and frequency) throughout the study period.
Time frame
Recorded weekly from baseline until the 3-month follow-up.Sponsors and contacts
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Source ClinicalTrials.gov