Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis

Not Applicable

• Conditions: Lateral Epicondylitis
• Interventions: Procedure: Fu's subcutaneous needling; Procedure: Transcutaneous electrical nerve stimulation

• Registration Number: NCT03605563
• Lead Sponsor: China Medical University Hospital

Brief Summary

Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The symptoms can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.

This is a randomized study, the investigators will evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling on the patients suffering with lateral epicondylitis.

Detailed Description

Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The major mechanism is overuse of the flexors, extensors and supination muscles in the wrist, causing micro-trauma in the muscles attachment to the lateral epicondyle of the elbow. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Patients often describe pain at the lateral aspect of the elbow. Pain can be further elicited with passive wrist flexion and by resisting active wrist extension. Symptoms also include weakness in the grip strength and limitation of elbow motion. Therefore, it can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.

Fu's subcutaneous needling (FSN), as one of the dry needle treatments, performed by swaying a disposable Fu's subcutaneous needle parallel to the underlying muscles after penetrating the skin to the subcutaneous fascia. With the reperfusion activities, myofascial pain and soft tissue pain caused by myofascial trigger points can be decreased effective simultaneously. So far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet.

The investigators will conduct the randomized experiment to evaluate the immediate, short-term, and long-term effect of FSN. The outcome measures include visual analog scale, patient-rated tennis elbow evaluation questionnaire, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluaton of the common extensor tendon.

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30
• Primary Completion: 2019-02-28
• Study Completion: 2019-04-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 1. Subjects older than 20 years of age who can cooperate with the experimental volunteers.

  2. Suffering from epicondylitis of the humerus for more than one month, and subjective pain intensity (VAS) greater than 5 points.

  3. There is a local tender point at the upper elbow of the elbow, and the isometric resistance test of the forearm to make a spin will induce pain.

  4. Under soft tissue ultrasound, the thickness of the common tendon of the extensor carpi muscles is more than 0.15 mm greater than that of the healthy side.

Exclusion Criteria

• 1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.

  2. There has been a history of drug abuse (including excess alcohol) that affects pain assessors.

  3. Have received neck, upper back, or upper and lower limb surgery. 4. People with central or peripheral nerve disease. 5. Cognitive impairment, unable to cooperate with the experimenter. 6. Patients currently receiving other treatments for epicondylitis of the humerus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FSN: Fu's subcutaneous needling	Fu's subcutaneous needling	In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.
TENS: Transcutaneous Electric Nerve Stimulation	Transcutaneous electrical nerve stimulation	In this arm, the subjects will receive the intervention of TENS on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scales	1 day	The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

Secondary Outcome Measures

Name	Time	Method
Pain-free grip test	1day	The pain-free grip (PFG) test is used to measure the amount of force that the patient generates to the onset of pain; when there is no pain the test result could be regarded as maximum grip strength. It is commonly performed in patients with lateral epicondylalgia (LE). LE is characterised by the presence of pain over the lateral humeral epicondyle which is provoked by at least two of: gripping, resisted wrist or middle finger extension, or palpation (Stratford et al 1993) in conjunction with reduced PFG over the affected side (Stratford et al 1993; Vicenzino et al 1996; Vicenzino et al 1998).
Pressure Pain Threshold	1 day	Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom.
Myotone of MTrPs	1 day	Muscle tone is the muscle's resistance to passive stretch during resting state. Myotone will help the investigators to get muscle parameters such as tone, elasticity and stiffness.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan