Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis
Changes in the Muscle Tone of Affected Muscle After Fu's Subcutaneous Needling on the Myofascial Trigger Points - a Sample of Lateral Epicondylitis
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2019
CompletedJuly 30, 2018
July 1, 2018
10 months
July 18, 2018
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scales
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.
1 day
Secondary Outcomes (3)
Pressure Pain Threshold
1 day
Myotone of MTrPs
1 day
Pain-free grip test
1day
Study Arms (2)
FSN: Fu's subcutaneous needling
EXPERIMENTALIn 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
ACTIVE COMPARATORIn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \. Subjects older than 20 years of age who can cooperate with the experimental volunteers.
- \. Suffering from epicondylitis of the humerus for more than one month, and subjective pain intensity (VAS) greater than 5 points.
- \. 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.
- \. 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.
You may not qualify if:
- \. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
- \. There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 999079, Taiwan
Related Publications (1)
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.
PMID: 35321501DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Wei Chou, PhD
China Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Minister of Rehabilitation
Study Record Dates
First Submitted
July 18, 2018
First Posted
July 30, 2018
Study Start
May 1, 2018
Primary Completion
February 28, 2019
Study Completion
April 28, 2019
Last Updated
July 30, 2018
Record last verified: 2018-07