Remote Fu's Subcutaneous Needling for Patients With Chronic Neck Pain

China Medical University

Status: Unknown

Conditions: Chronic Neck Pain; Sleep Quality

Treatments: Procedure: Transcutaneous electrical nerve stimulation; Procedure: Fu's subcutaneous needling

Study type: Interventional

Funder types: Other

Identifiers

NCT03605576

CMUH107-REC2-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Fu's subcutaneous needling

Experimental group

Description:

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.

Treatment:

Procedure: Fu's subcutaneous needling

Transcutaneous electrical nerve stimulation

Active Comparator group

Description:

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.

Treatment:

Procedure: Transcutaneous electrical nerve stimulation