Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index
研究概览
简要总结
Objective: To evaluate the efficacy of intra-articular hyaluronic acid (HA) injections for the treatment of adhesive capsulitis (AC) of the shoulder.
Design: Prospective, randomized, parallel-group interventional trial Setting: Rehabilitation department of a medical center hospital. Participants: Participants: Patients with frozen-phase primary adhesive capsulitis Interventions: The patients received intra-articular glenohumeral joint injections of HA, 60mg, once per week for 3 consecutive weeks.
Main Outcome Measures: Active and passive range of motion (ROM) of the affected shoulder; Shoulder pain and disability were measured using 2 questionnaires: the SPADI.
The patients were evaluated before treatment and were reevaluated 4, 6, 8, and 26 weeks after the beginning of the treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with frozen shoulder by a clinical physician based on the patient's medical history, physical examination, X-ray, and ultrasound or magnetic resonance imaging reports.
- •Clinical course: Patients must have a pain score of less than 3, no nighttime shoulder pain, and be in the post-freezing stage, primarily presenting restricted shoulder joint range of motion.
- •The affected shoulder joint must have at least two angles of shoulder joint movement reduced by at least 30% compared to the healthy side: shoulder flexion, abduction, and external rotation, or a single affected side abduction angle reduced by 50% relative to the healthy side.
- •Age between 40 to 70 years old.
排除标准
- •full-thickness tear or massive tear of the rotator cuff tendons or calcific tendinitis.
- •Presence of systemic rheumatic disease.
- •History of shoulder fracture or previous shoulder surgery.
- •Received shoulder injections for treatment within the last 3 months.
- •Acute cervical nerve root compression.
- •Current pregnancy or lactation.
- •Patients with shoulder instability or cancer.
- •Patients with cognitive impairment, unable to follow simple instructions, or unable to comply with the study procedures.
研究组 & 干预措施
Intra-articular Hyaluronic Acid Injection
A- Experimental Group: Intra-articular Hyaluronic Acid Injection Treatment Regimen Patients in the experimental group received ultrasound-guided intra-articular injections of hyaluronic acid (Artibest, 60 mg/3 ml, 2%, manufactured by Kang Stem Biotech, Taiwan) into the affected shoulder joint. The injections were administered once a week for three consecutive weeks, totaling three injections per patient.
The subjects were evaluated for shoulder function using the Shoulder Pain and Disability Index (SPADI) and Range of Motion (ROM) assessment at the following time points: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks and 26 weeks after the treatment.
干预措施: hyaluronic acid (Drug)
Physical Therapy
B- Control Group: Physical Therapy Patients in the control group underwent a 6-week physical therapy program, consisting of two sessions per week, with each session lasting approximately 30 minutes. The physical therapy program was conducted under the guidance and supervision of a physical therapist and included joint exercises, stretching, and muscle strengthening exercises.
The subjects were evaluated for shoulder function using the Shoulder Pain and Disability Index (SPADI) and Range of Motion (ROM) assessment at the following time points: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks and 26 weeks after the treatment.
干预措施: Physical Therapy (Other)
结局指标
主要结局
Shoulder Pain and Disability Index
时间窗: baseline, 4, 6, 8, and 26 weeks after treatment initiation
The SPADI consists of two subscales, pain, and disability, comprising a total of 13 items. Each item is rated on a scale from 0 (no pain/disability) to 10 (most severe pain/disability). Higher scores indicate greater functional impairment. The total score on the SPADI is used to determine the percentage of functional disability
次要结局
- Range of Motion(baseline, 4, 6, 8, and 26 weeks after treatment initiation)
研究者
Chih-Ya Chang
Attending Physician
Tri-Service General Hospital