MedPath

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

Not Applicable
Not yet recruiting
Conditions
Lateral Epicondylitis (Tennis Elbow)
Registration Number
NCT07131423
Lead Sponsor
ZHANG PENG
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
123
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Grip strengthBaseline, 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)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)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)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.

Secondary Outcome Measures
NameTimeMethod
Quick-DASH66Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

This questionnaire consists of eleven questions and uses a 5-point scale for scoring, similar to that of DASH. The total score and the scores of each module will be calculated on a 100-point scale, with higher scores indicating a worse condition. The reported minimum clinically important difference is 15.91 points.

Ultrasound shear wave elastographyBaseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

Each patient was required to sit in front of the examiner, with the elbows flexed at 90°, the thumb pointing upwards, and to maintain a relaxed forearm position throughout the measurement process. The transducer was placed vertically on the skin surface at the lateral epicondyle of the humerus, in contact with the skin surface slightly using a coupling agent to avoid compression effects. The CET attached to the lateral epicondyle of the humerus was scanned in the longitudinal plane (parallel to the direction of the CET fibers) to obtain standardized images.

Participant satisfactionBaseline, one week after all treatments, six weeks after all treatments, three months after all treanments.

The participants' satisfaction level with the progress of their condition will be determined using a validated 4-point Likert scale, ranging from "very satisfied", "somewhat satisfied", "somewhat dissatisfied" to "very dissatisfied".

Trial Locations

Locations (1)

Zhongda Hospital Southeast University

🇨🇳

Nanjin, Jiangsu, China

Zhongda Hospital Southeast University
🇨🇳Nanjin, Jiangsu, China

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.