Records View
홈 아이콘 이미지
Search
Search
Search

Acupuncture for lateral epicondylitis (tennis elbow): a Randomized, Practitioner-Assessor blinded, Controlled Pilot Clinical Trial

Status Approved

  • First Submitted Date

    2012/12/28

  • Registered Date

    2013/01/10

  • Last Updated Date

    2013/11/21

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    		 KCT0000628
    Unique Protocol ID KI1210
    Public/Brief Title Acupuncture for lateral epicondylitis (tennis elbow): a Randomized, Practitioner-Assessor blinded, Controlled Pilot Clinical Trial
    Scientific Title Acupuncture for lateral epicondylitis (tennis elbow): a Randomized, Practitioner-Assessor blinded, Controlled Pilot Clinical Trial
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    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 djomc-100-1
    Approval Date 2013-01-14
    Institutional Review Board Name Institutional Review Board of Oriental Hospital of Daejeon University
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No

  • 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 Kwon Eui Hong
    Title Doctor
    Telephone +82-42-223-2951
    Affiliation Daejeon Korean Medicine Hospital of Daejeon University
    Address
    Contact Person for Public Queries
    Name Kyungmin Shin
    Title Doctor
    Telephone +82-42-223-4051
    Affiliation Korea Institute of Oriental Medicine
    Address
    Contact Person for Updating Information
    Name Kyungmin Shin
    Title Doctor
    Telephone +82-42-223-4051
    Affiliation Korea Institute of Oriental Medicine
    Address

  • 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 Recruiting
    Date of First Enrollment 2013-02-11 Anticipated
    Target Number of Participant 45
    Primary Completion Date 2013-11-29 , Anticipated
    Study Completion Date 2013-11-29 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Daejeon Korean Medicine Hospital of Daejeon University
    Recruitment Status Recruiting
    Date of First Enrollment 2013-02-11 ,

  • 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 Korea Institute of Oriental Medicine
    Organization Type Research Institute
    Project ID K12010

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    This is a pilot study comparing the efficacy of of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis, to assess the efficacy of contralateral acupuncture. This study is a parallel design pilot study with random assignment and practitioner-examiner blind tests.

  • 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 Single
    Blinded Subject Investigator, Outcome Accessor
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description 
    Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. All 3 groups receive 10 acupuncture treatments over 4 weeks.
    Number of Arms 3
    Arm 1

    Arm Label

    ipsilateral acupuncture group

    Target Number of Participant

    15

    Arm Type

    Experimental

    Arm Description

    Acupuncture treatment will be given 10 times in total for 4 weeks.  Ipsilateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points and the needles will be maintained for 20 minutes.
    Arm 2

    Arm Label

    Contralateral acupuncture group

    Target Number of Participant

    15

    Arm Type

    Active comparator

    Arm Description

    The contralateral acupuncture groupreceived the same frequency, duration, and total number of treatments as the ipsilateral acupuncture group . Needles are inserted at the same acupoints of the unaffected side by using the same manual technique and acupuncture duration.
    Arm 3

    Arm Label

    sham aupuncture group

    Target Number of Participant

    15

    Arm Type

    Sham comparator

    Arm Description

    For the control group, the acupoints used are unrelated to the treatment of tennis elbow(BL13, Bl14, Bl15 and Bl16) and non-invasive techniques will be used for 20 min.

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M77.1)Lateral epicondylitis 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~65Year

    Description

    1. Individuals between the ages of 19 and 65 years with tennis elbow on one arm and pain persisting for at least 4 weeks.
2. Individuals with tenderness limited to the elbow joint and surrounding area.
3. Individuals reporting pain under resisted extension of the middle finger and wrist.
4. Individuals with an average pain of 4 or more (0-10) on the numeric rating scale (NRS) in the week prior to the screening visit.
5. Individuals who volunteered to participate in the study and who signed a consent form.
    Exclusion Criteria 
    1. Individuals whose radiological examinations show abnormalities such as calcification, arthritis, and inflammatory arthropathy of the tennis elbow.
2. Individuals with a history of trauma, ligament damage, fracture, tumor, or surgery of the elbow joint.
3. Individuals who have been diagnosed with or treated for cervical radiculopathy or herniation of intervertebral disc.
4. Individuals who have received injections for tennis elbow during the last 6 months
5. Individuals who have received treatments such as non-steroidal anti-inflammatory drugs (NSAIDs), acupuncture, physiotherapy for tennis elbow during the last 2 weeks 
6. Individuals who as per the clinical research coordinator were considered as unsuitable for participation, such as those with mental disorders, who are pregnant, or with other acute or chronic disorders.
    Healthy Volunteers No

  • 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 
    100mm Pain VAS(Visual analogue Scale)
    Timepoint 
    after the completion of the treatment
    Secondary Outcome(s) 1
    Outcome 
    100mm Pain VAS(Visual analogue Scale)
    Timepoint 
    8 weeks and 12 weeks after the random assignment
    Secondary Outcome(s) 2
    Outcome 
    Patient-rated tennis elbow evaluation (PRTEE)
    Timepoint 
    after the completion of the treatment, 8 weeks and 12 weeks after the random assignment
    Secondary Outcome(s) 3
    Outcome 
    Pain-free/maximum grip strength (Dynamometer)
    Timepoint 
    after the completion of the treatment, 8 weeks and 12 weeks after the random assignment
    Secondary Outcome(s) 4
    Outcome 
    Patient global assessment
    Timepoint 
    after the completion of the treatment, 8 weeks and 12 weeks after the random assignment
    Secondary Outcome(s) 5
    Outcome 
    EuroQol-5 Dimension (EQ-5D)
    Timepoint 
    after the completion of the treatment, 8 weeks and 12 weeks after the random assignment
    Secondary Outcome(s) 6
    Outcome 
    Southampton Needle Sensation Questionnaire
    Timepoint 
    after the completion of the treatment, 8 weeks and 12 weeks after the random assignment
    Secondary Outcome(s) 7
    Outcome 
    Pressure pain threshold (Pressure Algometer)
    Timepoint 
    after the completion of the treatment, 8 weeks and 12 weeks after the random assignment
    Secondary Outcome(s) 8
    Outcome 
    Clinically relevant improvement
    Timepoint 
    after the completion of the treatment, 8 weeks and 12 weeks after the random assignment

  • 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
Move list page Move to top
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동