Effectiveness of Extracorporeal Shockwave Therapy Based on Fascial Manipulation Theory for Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Grip strength
研究概览
简要总结
Goal:
This clinical trial aims to find out if using fascial theory to guide shockwave therapy works better for treating "tennis elbow" (pain on the outer side of the elbow) compared to standard shockwave treatment. It will also check for any side effects.
Main Questions:
Does treating fascial points (key tension areas in the arm) with shockwaves reduce pain more than just treating the elbow? Are there any temporary discomforts (like soreness or swelling) after treatment?
How It Works:
Researchers will compare three approaches:
Group A: Shockwaves applied only to the painful elbow area (standard treatment).
Group B: Shockwaves applied to 4 fascial points in the arm/shoulder (no elbow treatment).
Group C: Shockwaves applied to both the elbow and 3 fascial points.
Participants Will:
Receive 4 shockwave sessions (1 session every 5 days). Report pain levels, grip strength, and daily activities for 3 months. Attend follow-up visits to track progress.
Why It Matters:
If successful, this could lead to a more effective way to treat tennis elbow-by targeting the root cause of tension in the arm's connective tissue, not just the pain spot.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent pain at the lateral epicondyle of the humerus for ≥ 3 months
- •Pain is palpable at the lateral epicondyle of the humerus during examination
- •Positive Thompson's test (i.e., the patient reports pain when performing resisted extension while slightly extending the wrist joint, flexing the fist, extending the elbow joint, and having the forearm in an ulnar deviation position)
- •Positive Mill's test (i.e., the patient reports pain when performing resisted supination while slightly flexing the elbow joint, having the forearm in an ulnar deviation position, slightly extending the wrist joint, and flexing the fist)
- •Pain occurs during resisted extension of the index finger
- •Age between 18 and 65 years old. The participants in our study included those who were frequently active.
排除标准
- •Tendon rupture, nerve root type cervical spondylosis, cubital or carpal tunnel syndrome, local infection, pregnancy, malignant tumor, bilateral tennis elbow, carpal tunnel syndrome, medial epicondylitis, elbow arthritis or instability, having systemic inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis, cognitive impairment making it difficult to cooperate, ipsilateral shoulder dysfunction, neurological abnormalities, radial nerve compression, arrhythmia or having a cardiac pacemaker implanted, diabetes, having received physical therapy and/or corticosteroid injections in the past three months.
研究组 & 干预措施
Group A
Group A (Local ESWT): ESWT (2,500 impulses/session) at the lateral epicondyle point of maximal tenderness.
干预措施: Standard extracorporeal shock wave therapy (Device)
Group B
Group B (FM-guided ESWT): ESWT (2,500 impulses) at four Fascial Manipulation (FM)-selected Coordinating Centers (CCs) proximal to the epicondyle, with impulses weighted by tissue density.
干预措施: CC points shock wave therapy (Device)
Group C
Group C (Combined): Hybrid ESWT: 1,000 impulses at the epicondyle + 1,500 impulses at three FM-identified CCs.
干预措施: Shock wave therapy for the CC points and the lateral epicondyle (Device)
结局指标
主要结局
Grip strength
时间窗: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Participants will be required to adopt a shoulder-width stance, with their arms naturally hanging down and close to their bodies, and their elbows fully extended. The pain-free grip strength will be measured until pain occurs when the subject slowly squeezes the grip force gauge. The maximum grip strength will be measured at the maximum grip strength level. The average value of three consecutive trials will be calculated, with an interval of 20 seconds between each trial.
VAS(visual analogue scale)
时间窗: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Pain intensity over the past week (at rest, during activity, and at night) was evaluated using a 0-10 cm horizontal visual analogue scale (VAS), where 0 represented no pain and 10 represented the most severe pain imaginable.
PRTEE(Patient-Rated Tennis Elbow Evaluation)
时间窗: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Five items for pain (0 = no pain, 10 = the most severe pain imaginable) and physical function (six specific activity items and four daily activity items, 0 = no difficulty, 10 = unable to do), ranging from 0 to 100 points, with higher scores indicating more severe pain and greater functional loss.
PPT(pressure pain threshold)
时间窗: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
The PPT was evaluated at two sites, namely the lateral epicondyle of the humerus and 1 cm lateral to the lateral epicondyle. The patient was in a sitting position, with the shoulder externally rotated by 30°, the elbow flexed at 90°, and the forearm, wrist and hand supported on the table. Under this posture, the PPT measurement was conducted three times for each condition.
次要结局
- Quick-DASH66(Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.)
- Ultrasound shear wave elastography(Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.)
- Participant satisfaction(Baseline, one week after all treatments, six weeks after all treatments, three months after all treanments.)
研究者
ZHANG PENG
Chief Therapist
Zhongda Hospital