Clinical trial NCT03605563: Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis
Official title: Changes in the Muscle Tone of Affected Muscle After Fu's Subcutaneous Needling on the Myofascial Trigger Points - a Sample of Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Fu's subcutaneous needling (FSN)
Myofascial trigger point
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scales
timeFrame: 1 day
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: 1 day
measure: Myotone of MTrPs
timeFrame: 1 day
measure: Pain-free grip test
timeFrame: 1day
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Li-Wei Chou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang CH, Lin CY, Sun MF, Fu Z, Chou LW. Efficacy of Fu's Subcutaneous Needling on Myofascial Trigger Points for Lateral Epicondylalgia: A Randomized Control Trial. Evid Based Complement Alternat Med. 2022 Mar 14;2022:5951327. doi: 10.1155/2022/5951327. eCollection 2022.