Clinical trial NCT03605576: Remote Fu's Subcutaneous Needling for Patients With Chronic Neck Pain
Official title: Effect on Symptomatic Release and Sleep Quality of Remote Fu's Subcutaneous Needling on Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Neck Pain
Sleep Quality
Keywords: Fu's subcutaneous needle
Transcutaneous electrical nerve stimulation
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: 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.

Detailed description: Neck pain combining limited range of motion is very common. Lasting for only a few days, it will taper off without any treatment. If the neck pain symptoms persist for more than two months without any improvement, it will be categorized as chronic neck pain causing not only pain but also functional impact, even in daily life, working, and sleep quality.

Fu's subcutaneous needling is utilized in treating disease related with myofascial trigger point, including soft tissue pain, joint pain, even some internal problems. Indeed it reduce pain immediately with no obvious side effects. There were some clinical articles of subjective symptoms description published lacking scientific accessment of efficacy.

Research team leading by Professor Chang-Zern Hong has already prove that excitability can be reduced by distal acupuncture. Needling TE5 and LI11 can reduce pain intensity and average amplitude of MTrPs end plate in upper trapezium m., and increase pain pressure threshold.

Comparing to traditional acupuncture, whether safer and pain-less Fu's subcutaneous needle also has the distal treatment effect or not still needs more scientific experiment to prove. This is a randomized controlled trial to compare the efficacy of Transcutaneous electrical nerve stimulation and Fu's subcutaneous needle 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Scales
timeFrame: 1 day
Secondary outcomes:
measure: Neck Disability Index
timeFrame: 1 week
measure: Pressure Pain Threshold
timeFrame: 1day
measure: Myotone of MTrPs
timeFrame: 1day
measure: Pittsburgh sleep quality index
timeFrame: 1 week
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, 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.