Remote Fu's Subcutaneous Needling for Patients With Chronic Neck Pain
Effect on Symptomatic Release and Sleep Quality of Remote Fu's Subcutaneous Needling on Patients With Chronic Neck Pain
1 other identifier
interventional
90
1 country
1
Brief Summary
This is a randomized controlled trial to compare the efficacy of Fu's subcutaneous needle (FSN) and Transcutaneous electrical nerve stimulation (TENS) on chronic neck pain by using more objective assessment tools such as Neck Disability Index, Visual Analog Scales, Pressure Pain Threshold and Myotone of MTrPs of Upper Trapezius Muscles, Range of Motion of Stretch of Upper Trapezius Muscle, and Pittsburgh sleep quality index.
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
May 9, 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 12, 2019
CompletedJuly 30, 2018
July 1, 2018
10 months
May 9, 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 (4)
Neck Disability Index
1 week
Pressure Pain Threshold
1day
Myotone of MTrPs
1day
Pittsburgh sleep quality index
1 week
Study Arms (2)
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.
Transcutaneous electrical 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:
- Having chronic neck pain for more than 2 months and subjective subjective pain intensity (VAS) greater than 5 points.
- Patients with myofascial pain diagnosed with unilateral upper trapezius muscle.
- This pain is not effective for previous medication or physical therapy.
You may not qualify if:
- Contraindications for general treatment, such as serious medical problems, recent trauma, or pregnancy.
- 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.
- People with central or peripheral nerve disease.
- Cognitive dysfunction cannot be matched with the experimenter.
- People with cardiac pacemakers, epilepsy, etc. cannot place electrode patches on the skin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 999079, Taiwan
Related Publications (1)
Huang CH, Tsai LH, Sun MF, Fu Z, Sun J, Chou LW. Rapid Improvement in Neck Disability, Mobility, and Sleep Quality with Chronic Neck Pain Treated by Fu's Subcutaneous Needling: A Randomized Control Study. Pain Res Manag. 2022 Sep 30;2022:7592873. doi: 10.1155/2022/7592873. eCollection 2022.
PMID: 36247101DERIVED
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
May 9, 2018
First Posted
July 30, 2018
Study Start
May 1, 2018
Primary Completion
February 28, 2019
Study Completion
April 12, 2019
Last Updated
July 30, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share