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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-04-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FSN: 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.

Group Type EXPERIMENTAL

Fu's subcutaneous needling

Intervention Type PROCEDURE

Fu's Subcutaneous Needle (FSN), is an innovation for the treatment of myofascial pain and trigger points. The needle is a non-injection needle, and the fact that both needles are manipulated and act on soft connective tissue.

FSN abstains from the muscle and deep fascia layers and is confined to only the subcutaneous layer where collagen fibers are most abundant. As the subcutaneous layer is poorly innervated, pain is less than other needling therapies.

FSN is also currently being used successfully to treat non-musculoskeletal conditions.

TENS: Transcutaneous Electric 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.

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type PROCEDURE

Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.

TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (\>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (\<10 Hz) with an intensity that produces motor contraction.

Interventions

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Fu's subcutaneous needling

Fu's Subcutaneous Needle (FSN), is an innovation for the treatment of myofascial pain and trigger points. The needle is a non-injection needle, and the fact that both needles are manipulated and act on soft connective tissue.

FSN abstains from the muscle and deep fascia layers and is confined to only the subcutaneous layer where collagen fibers are most abundant. As the subcutaneous layer is poorly innervated, pain is less than other needling therapies.

FSN is also currently being used successfully to treat non-musculoskeletal conditions.

Intervention Type PROCEDURE

Transcutaneous electrical nerve stimulation

Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.

TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (\>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (\<10 Hz) with an intensity that produces motor contraction.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No