Effectiveness of Acupuncture in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial Comparing Kinesiotape, Orthosis, and Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity From Baseline to Month 3
研究概览
简要总结
Lateral epicondylitis, commonly known as tennis elbow, can cause pain and reduced hand and wrist function. This study evaluated whether adding acupuncture to a conservative rehabilitation program provides additional benefits for adults with lateral epicondylitis.
Participants were randomly assigned to one of two treatment groups. One group received acupuncture in addition to kinesio taping, a wrist orthosis, and a home exercise program. The other group received the same kinesio taping, wrist orthosis, and exercise program without acupuncture. Acupuncture was applied twice weekly for three weeks, for a total of six sessions.
Participants were assessed before treatment, at the end of the third week, and at three months. Outcomes included pain intensity, active wrist flexion and extension range of motion, pinch strength, and hand grip strength. The study aimed to determine whether acupuncture provides additional benefits when combined with standard conservative rehabilitation for lateral epicondylitis.
详细描述
This was a prospective, single-center, two-arm randomized controlled clinical trial designed to evaluate the additional effects of acupuncture when combined with a standardized conservative rehabilitation program in adults with lateral epicondylitis.
Eligible adults aged 18 to 65 years with a clinical diagnosis of lateral epicondylitis and symptoms lasting at least six weeks were randomly allocated in a 1:1 ratio to two parallel treatment groups using a computer-generated randomization sequence. Allocation was concealed using sequentially numbered, opaque, sealed envelopes. Outcome assessments were performed by a blinded assessor.
The intervention group received acupuncture in addition to kinesio taping, a custom low-temperature thermoplastic volar wrist orthosis, and a home-based exercise program. Acupuncture was administered twice weekly for three weeks, for a total of six sessions. The acupuncture protocol included local, regional, and distal points and was performed by a physician trained in acupuncture.
Both groups received kinesio taping once weekly for three weeks, a custom volar wrist orthosis positioned at approximately 15-20 degrees of wrist extension for six weeks, and a home exercise program emphasizing eccentric wrist extensor strengthening and progressive grip exercises. Exercise performance and adherence were reviewed during follow-up visits.
Assessments were performed at baseline, at the end of week 3, and at month 3. The primary outcome was pain intensity measured using a 0-10 Visual Analog Scale. Secondary outcomes included active wrist flexion and extension range of motion measured with a goniometer, pinch strength measured with a pinch gauge, and hand grip strength measured with a Jamar hydraulic dynamometer. Adverse events related to acupuncture, kinesio taping, orthosis use, and exercise were also monitored throughout the study.
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)
盲法说明
Outcome assessors were blinded to group allocation. Participants and treating clinicians could not be blinded because of the nature of the interventions, including visible acupuncture needling, kinesio taping, orthosis fitting, and supervised exercise.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years. Clinical diagnosis of lateral epicondylitis. Symptoms of lateral epicondylitis lasting at least 6 weeks.
排除标准
- •Steroid injection to the affected elbow within the previous 6 months.
- •Previous elbow surgery. Neurological disease affecting the tested upper limb. Active cervical radiculopathy. Systemic inflammatory disease. Pregnancy. Inability to comply with the study protocol or follow-up assessments.
研究组 & 干预措施
Arm 1
Participants received acupuncture in addition to kinesio taping, a custom volar wrist orthosis, and a home-based exercise program.
干预措施: Acupuncture (Procedure)
Arm 1
Participants received acupuncture in addition to kinesio taping, a custom volar wrist orthosis, and a home-based exercise program.
干预措施: Kinesio Taping (Procedure)
Arm 1
Participants received acupuncture in addition to kinesio taping, a custom volar wrist orthosis, and a home-based exercise program.
干预措施: Volar Wrist Orthosis (Device)
Arm 1
Participants received acupuncture in addition to kinesio taping, a custom volar wrist orthosis, and a home-based exercise program.
干预措施: Home-Based Exercise Program (Behavioral)
Arm 2
Participants received kinesio taping, a custom volar wrist orthosis, and a home-based exercise program without acupuncture.
干预措施: Kinesio Taping (Procedure)
Arm 2
Participants received kinesio taping, a custom volar wrist orthosis, and a home-based exercise program without acupuncture.
干预措施: Volar Wrist Orthosis (Device)
Arm 2
Participants received kinesio taping, a custom volar wrist orthosis, and a home-based exercise program without acupuncture.
干预措施: Home-Based Exercise Program (Behavioral)
结局指标
主要结局
Change in Pain Intensity From Baseline to Month 3
时间窗: Baseline and Month 3
Pain intensity was assessed using a 0-10 Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. The primary endpoint was the between-group difference in change in VAS pain from baseline to Month 3.
次要结局
- Change in Active Wrist Flexion Range of Motion(Baseline, Week 3, and Month 3)
- Change in Active Wrist Extension Range of Motion(Baseline, Week 3, and Month 3)
- Change in Pinch Strength(Baseline, Week 3, and Month 3)
- Change in Hand Grip Strength(Baseline, Week 3, and Month 3)
研究者
Enver Guven
Assistant Professor
Ankara University
