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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2012/12/28
    • Registered Date : 2013/01/10
    • Last Updated Date : 2013/02/01
Background Information
1.Background  
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
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Kwon Eui Hong  
- Title Doctor 
- Telephone  
- 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  
Status
4. Status Status  
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 Site Daejeon Korean Medicine Hospital of Daejeon University 
- Recruitment Status Recruiting  
- Date of First Enrollment 2013-02-11 , Anticipated
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Korea Institute of Oriental Medicine 
- Organization Type Research Institute  
- Project ID K12010 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Korea Institute of Oriental Medicine 
- Organization Type Research Institute  
Study Summary
7. Study Summary  
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.  
Study Design 정보
8. Study Design  
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
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. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the musculo-skeletal system and connective tissue
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 65 Year
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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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  
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration