Remote Fu's Subcutaneous Needling for Patients With Chronic Neck Pain
- Conditions
- Chronic Neck PainSleep Quality
- Interventions
- Procedure: Transcutaneous electrical nerve stimulationProcedure: Fu's subcutaneous needling
- Registration Number
- NCT03605576
- Lead Sponsor
- China Medical University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcutaneous electrical nerve stimulation Transcutaneous electrical nerve stimulation 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. Fu's subcutaneous needling Fu's subcutaneous needling 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.
- Primary Outcome Measures
Name Time Method Visual Analog Scales 1 day 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.
- Secondary Outcome Measures
Name Time Method Pressure Pain Threshold 1day Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom.
Neck Disability Index 1 week The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Pittsburgh sleep quality index 1 week The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures
Myotone of MTrPs 1day Muscle tone is the muscle's resistance to passive stretch during resting state. Myotone will help the investigators to get muscle parameters such as tone, elasticity and stiffness.
Trial Locations
- Locations (1)
China Medical University Hospital
🇨🇳Taichung, Taiwan