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

Primary Purpose

Chronic Neck Pain, Sleep Quality

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fu's subcutaneous needling
Transcutaneous electrical nerve stimulation
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Fu's subcutaneous needle, Transcutaneous electrical nerve stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fu's subcutaneous needling

Transcutaneous electrical nerve stimulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neck Disability Index
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
Pressure Pain Threshold
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.
Myotone of MTrPs
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.
Pittsburgh sleep quality index
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

Full Information

First Posted
May 9, 2018
Last Updated
July 26, 2018
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03605576
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
April 12, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain, Sleep Quality
Keywords
Fu's subcutaneous needle, Transcutaneous electrical nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fu's subcutaneous needling
Arm Type
Experimental
Arm 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.
Arm Title
Transcutaneous electrical nerve stimulation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Fu's subcutaneous needling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scales
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
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
Time Frame
1 week
Title
Pressure Pain Threshold
Description
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.
Time Frame
1day
Title
Myotone of MTrPs
Description
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.
Time Frame
1day
Title
Pittsburgh sleep quality index
Description
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
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Wei Chou, PhD
Phone
+886 22052121-2381
Email
chouliwe@mail.cmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Hsuan Huang, MD
Phone
+886 978310050
Email
lauren8.huang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, PhD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
999079
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chou Li-Wei, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@mail.cmuh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36247101
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.
Results Reference
derived

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

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