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Efficacy and safety of miniscalpel acupuncture, NSAIDs or combined treatment for chronic neck pain : an assessor-blinded randomized controlled pilot study

Status Approved

  • First Submitted Date

    2017/02/06

  • Registered Date

    2017/03/09

  • Last Updated Date

    2017/10/16

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002258
    Unique Protocol ID DHUMC-D-17001
    Public/Brief Title Efficacy and safety of miniscalpel acupuncture, NSAIDs or combined treatment for chronic neck pain : an assessor-blinded randomized controlled pilot study
    Scientific Title Efficacy and safety of miniscalpel acupuncture, NSAIDs or combined treatment for chronic neck pain : an assessor-blinded randomized controlled pilot study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DHUMC-D-17001-ANS-01
    Approval Date 2017-02-03
    Institutional Review Board Name Institutional Review Board of Daegu Oriental Hospital of Daegu Hanny University
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jae-soo Kim
    Title an associate profess
    Telephone +82-53-770-2108
    Affiliation Daegu Haany University
    Address 136, Sincheondong-ro, Suseong-gu, Daegu, Korea
    Contact Person for Public Queries
    Name Jae-soo Kim
    Title an associate profess
    Telephone +82-53-770-2108
    Affiliation Daegu Haany University
    Address 136, Sincheondong-ro, Suseong-gu, Daegu, Korea
    Contact Person for Updating Information
    Name Jae-soo Kim
    Title an associate profess
    Telephone +82-53-770-2108
    Affiliation Daegu Haany University
    Address 136, Sincheondong-ro, Suseong-gu, Daegu, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-02-25 Actual
    Target Number of Participant 36
    Primary Completion Date 2017-08-26 , Actual
    Study Completion Date 2017-09-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Daegu Oriental Hospital of Daegu Haany University
    Recruitment Status Completed
    Date of First Enrollment 2017-02-25 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Comprehensive & Integrative Medicine Institute
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daegu Oriental Hospital of Daegu Haany University
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Chronic neck pain is a common musculoskeletal disease during the lifespan of an individual. With an increase in dependence on computer technology, the prevalence of chronic neck pain is expected to rise, and this can lead to socioeconomic problems. We have designed the current pilot study to evaluate the efficacy and safety of miniscalpel acupuncture treatment combined with nonsteroidal anti-inflammatory drugs in patients with chronic neck pain. 
    This 7-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms. Thirty-six patients will be recruited and randomly allocated to three treatment groups: miniscalpel acupuncture treatment, nonsteroidal anti-inflammatory drugs, and miniscalpel acupuncture treatment combined with nonsteroidal anti-inflammatory drugs. Patients in the miniscalpel acupuncture and combined treatment groups will receive three session of miniscalpel acupuncture over a 3-week period. Patients in the NSAIDs and combined treatment groups will receive zaltoprofen (one oral tablet, three times a day for 3 weeks). 
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug, Medical Device  
    Intervention Description
    This 7-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms. Thirty-six patients will be recruited and randomly allocated to three treatment groups: miniscalpel acupuncture treatment, nonsteroidal anti-inflammatory drugs, and miniscalpel acupuncture treatment combined with nonsteroidal anti-inflammatory drugs. Patients in the miniscalpel acupuncture and combined treatment groups will receive three session of miniscalpel acupuncture over a 3-week period. Patients in the NSAIDs and combined treatment groups will receive zaltoprofen (one oral tablet, three times a day for 3 weeks).
    Number of Arms 3
    Arm 1

    Arm Label

    miniscalpel acupuncture group

    Target Number of Participant

    12

    Arm Type

    Active comparator

    Arm Description

    Patients from the miniscalpel acupuncture will be treated with miniscalpel acupuncture for three sessions over a three week period.
    Arm 2

    Arm Label

    combined treatment group of miniscalpel acupuncture and NSAIDs

    Target Number of Participant

    12

    Arm Type

    Experimental

    Arm Description

    Patients from the combined group will be treated with miniscalpel acupuncture for three sessions over a three week period. Patients from the combined treatment group will be prescribed Zaltoprofen (one tablet to be taken orally, three times a day for three weeks. 
    Arm 3

    Arm Label

    NSAIDs group

    Target Number of Participant

    12

    Arm Type

    Active comparator

    Arm Description

    Patients from the NSAIDs group will be prescribed Zaltoprofen (one tablet to be taken orally, three times a day for three weeks). 
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M54.22)Cervicalgia, cervical region 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~75Year

    Description

    1) men or women aged 19-75 years
    2) symptoms such as neck pain and stiffness in the neck lasting for 3 months or more
    3) a baseline score of ≥4 on the visual analog scale (VAS) for pain
    4) provision of written informed consent
    Exclusion Criteria
    1) subjects with abnormalities in neurological functions such as cervical nerve function, deep tendon reflexes, and muscle and sensory functions
    2) those with serious sensory or motor disorders requiring surgical treatment;
    3) those with a history of spinal surgery or those with procedures scheduled during the study
    4) those with spinal disorders, including vertebral fracture, spinal infection, inflammatory spondylitis, and malignancy, on computed tomography or magnetic resonance imaging
    5) those who are pregnant, planning pregnancy, breast feeding, or refusing to consume certain forms of contraceptives
    6) those with other chronic diseases that can affect the outcomes of the study interventions, including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia, and epilepsy
    7) those with other severe musculoskeletal problems in areas other than the neck
    8) those with serious psychiatric or psychological disorders
    9) those using aspirin or anticoagulant medications
    10) those with abnormal findings in blood tests for renal or hepatic function
    11) those deemed ineligible by the recruiting researcher will be excluded.
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Visual Analogue Scale(VAS)  
    Timepoint
    screening, week 0 (baseline), 1, 2, 3 (primary end point), and 7 (4 weeks after treatment completion)
    Secondary Outcome(s) 1
    Outcome
    Neck Disability Index(NDI)
    Timepoint
    week 0 (baseline), 1, 2, 3 (primary end point), and 7 (4 weeks after treatment completion)
    Secondary Outcome(s) 2
    Outcome
    EuroQol five dimensions questionnaire (EQ-5D)
    Timepoint
    week 0 (baseline), 1, 2, 3 (primary end point), and 7 (4 weeks after treatment completion)
    Secondary Outcome(s) 3
    Outcome
    Patient Global Impression of Change(PGIC)
    Timepoint
    week 1, 2, 3 (primary end point), and 7 (4 weeks after treatment completion)
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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