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

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• Tennis Elbow 284

Keywords

• Fascial Manipulation
• Extracorporeal Shockwave Therapy
• Lateral Epicondylitis

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's planned enrollment of 123 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Lead sponsor

This is the only study on the registry with ZHANG PENG as lead sponsor.

Study arms

• Active comparator
  Group A

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

  Device: Standard extracorporeal shock wave therapy

• Experimental
  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.

  Device: CC points shock wave therapy

• Experimental
  Group C

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

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

Interventions

• DeviceStandard 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.

• DeviceCC 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.

• DeviceShock 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.

Primary outcomes

1. Grip strength

   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.

   Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

2. VAS(visual analogue scale)

   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.

   Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

3. PRTEE(Patient-Rated Tennis Elbow Evaluation)

   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.

   Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

4. PPT(pressure pain threshold)

   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.

   Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

Secondary outcomes

1. Quick-DASH66

   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.

   Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

2. Ultrasound shear wave elastography

   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.

   Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.

3. Participant satisfaction

   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".

   Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treanments.