Effectiveness of Extracorporeal Shockwave Therapy Based on Fascial Manipulation Theory for Lateral Epicondylitis

Overview

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.

Interventions

• Device Standard extracorporeal shock wave therapy
  ESWT was performed using the Swiss DolorClast Master ESWT device in accordance with the guidelines of the International Society of Medical Shockwave Therapy. The treatment was carried out by a physical therapist with at least 5 years of ESWT experience. The patient sat with the shoulder abducted at 45°, the elbow flexed at 90°, and the forearm supinated. The shock waves were delivered in a circular motion, targeting the 2-3 most painful tender points within a 3 cm radius centered on the lateral
• Device CC points shock wave therapy
  The assessment was conducted by a 5-year or more experienced FM therapist, following the standard procedure of the FM organization. The process included conducting interviews, filling out assessment forms, performing movement checks, and conducting palpation. Four CC points covering the entire upper limb, including the shoulder area, were selected. The points were ranked based on the severity of the dense touch. The blackboard pen was used to mark the points on the patient's body. The same ESWT
• Device Shock wave therapy for the CC points and the lateral epicondyle
  Carry out the same process as Group B, but only select the three most severe CC points for shock therapy. Also, rank them according to the severity of the touch examination-induced densification. The most severe point receives 600 pulses, the second most severe receives 500 pulses, and the third most severe receives 400 pulses. At the same time, treat the lateral epicondylitis pain area in the same way as Group A. Apply 1000 pulses to the pain area. The total number of shocks for all treatments

Primary outcome measures

• Grip strength [Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.]
• VAS(visual analogue scale) [Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.]
• PRTEE(Patient-Rated Tennis Elbow Evaluation) [Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.]
• PPT(pressure pain threshold) [Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.]

Secondary outcome measures (3)

• Quick-DASH66 [Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.]
• Ultrasound shear wave elastography [Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.]
• Participant satisfaction [Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treanments.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Zhongda Hospital Southeast University — Nanjin

Identifiers

NCT: NCT07131423 · 2025ZDSYLL214

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗