The Impact of Perineural Injection Therapy for Adhesive Capsulitis at a Single Centre University Hospital in Selangor: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale
研究概览
简要总结
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
详细描述
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 of 40 to 60 and can last for months or even years. For some, the condition may improve with physiotherapy and medication, but others continue to struggle with pain and stiffness.
This clinical trial aims to explore a new method of treatment called Perineural Injection Therapy (PIT). PIT involves injecting a natural sugar solution (5% dextrose) just under the skin at specific nerve areas around the shoulder. This method targets nerves that may be irritated or inflamed and helps to reduce pain and improve movement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Perineural injection Therapy
干预措施: perineural injection (Other)
Intervention group
Perineural injection Therapy
干预措施: Physiotherapy (Other)
Conventional group
Physiotherapy
干预措施: Physiotherapy (Other)
结局指标
主要结局
Numerical Rating Scale
时间窗: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Participants will rate their shoulder pain on a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain."
Shoulder Range of Motion (ROM)
时间窗: Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
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.
次要结局
- 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)
研究者
Noor Hafizah Binti Samsudin Bahari
Medical Doctor
Universiti Teknologi Mara