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

NCT ID: NCT07131423

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2027-08-01

Brief Summary

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.

Conditions

Lateral Epicondylitis (Tennis Elbow)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Standard extracorporeal shock wave therapy

Intervention Type: DEVICE

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 epicondyle. A total of 2,500 pulses were administered per session (0.2 to 2 bar, 8 Hz, 2,500 pulses, with intensity adjusted according to the patient's tolerance). All patients received a total of 4 ESWT sessions, once every 5 days, over a period of 3 weeks.

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.

Group Type: EXPERIMENTAL

CC points shock wave therapy

Intervention Type: DEVICE

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 therapist as in Group A used the same shock wave treatment instrument to treat the four CC points. The most severe point received 800 shocks, the second most received 700 shocks, and the remaining two points each received 500 shocks. A total of 2,500 pulses (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity adjusted according to the depth of the point and the patient's tolerance) were administered. This treatment was performed once every 5 days for 3 weeks.

Group C

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

Group Type: EXPERIMENTAL

Shock wave therapy for the CC points and the lateral epicondyle

Intervention Type: DEVICE

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 is 2500 (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity is adjusted according to the depth of the point and the patient's tolerance). The therapist performing the treatment is the same as those in Group A and Group B. The treatment is carried out once every 5 days for 3 weeks.

Interventions

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 epicondyle. A total of 2,500 pulses were administered per session (0.2 to 2 bar, 8 Hz, 2,500 pulses, with intensity adjusted according to the patient's tolerance). All patients received a total of 4 ESWT sessions, once every 5 days, over a period of 3 weeks.

Intervention Type: 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 therapist as in Group A used the same shock wave treatment instrument to treat the four CC points. The most severe point received 800 shocks, the second most received 700 shocks, and the remaining two points each received 500 shocks. A total of 2,500 pulses (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity adjusted according to the depth of the point and the patient's tolerance) were administered. This treatment was performed once every 5 days for 3 weeks.

Intervention Type: 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 is 2500 (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity is adjusted according to the depth of the point and the patient's tolerance). The therapist performing the treatment is the same as those in Group A and Group B. The treatment is carried out once every 5 days for 3 weeks.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: collaborator

ZHANG PENG

OTHER

Sponsor Role: lead

Responsible Party

ZHANG PENG

Chief Therapist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

MING MA

Role: STUDY_DIRECTOR

Zhongda Hospital

Peng 张

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital Southeast University

Nanjin, Jiangsu, China

Countries

China

Central Contacts

Peng Zhang

Role: CONTACT

502772262@qq.com

+8615952087298

Other Identifiers

2025ZDSYLL214

Identifier Type: -

Identifier Source: org_study_id