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

ZHANG PENG

Status: Not yet enrolling

Conditions: Lateral Epicondylitis (Tennis Elbow)

Treatments: Device: Shock wave therapy for the CC points and the lateral epicondyle; Device: Standard extracorporeal shock wave therapy; Device: CC points shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07131423

2025ZDSYLL214

Details and patient eligibility

About

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.

Enrollment: 123 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Persistent pain at the lateral epicondyle of the humerus for ≥ 3 months
2. Pain is palpable at the lateral epicondyle of the humerus during examination
3. 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)
4. 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)
5. Pain occurs during resisted extension of the index finger
6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 3 patient groups

Group A

Active Comparator group

Description:

Group A (Local ESWT): ESWT (2,500 impulses/session) at the lateral epicondyle point of maximal tenderness.

Treatment:

Device: Standard extracorporeal shock wave therapy

Group B

Experimental group

Description:

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.

Treatment:

Device: CC points shock wave therapy

Group C

Experimental group

Description:

Group C (Combined): Hybrid ESWT: 1,000 impulses at the epicondyle + 1,500 impulses at three FM-identified CCs.

Treatment:

Device: Shock wave therapy for the CC points and the lateral epicondyle