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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2016/10/14
    • Registered Date : 2016/11/10
    • Last Updated Date : 2016/10/25
Background Information
1.Background  
CRIS Registration Number KCT0002137 
Unique Protocol ID M2013-03-2  
Public/Brief Title The Efficacy of Radiofrequency-Thermal Stimulation in Acupoints for Chronic Low Back Pain: A Preliminary Study of a Randomized, Patient-Blinded, Placebo Control Trial. 
Scientific Title The Efficacy of Radiofrequency-Thermal Stimulation in Acupoints for Chronic Low Back Pain: A Preliminary Study of a Randomized, Patient-Blinded, Placebo Control Trial.  
Acronym  
MFDS Regulated Study Yes
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 M2013-03-2  
Approval Date 2013-11-01 
Institutional Review Board  
- Name Daejeon University Cheonan Oriental Hospital Institutional Review Board  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Jaehui Kang 
- Title Professor 
- Telephone +82-41-521-7578 
- Affiliation Daejeon University 
- Address 62 Daehak-ro, Dong-gu, Daejeon, 34520, Republic of Korea 
Contact Person for Public Queries
- Name Jiwon Yoon 
- Title Resident 
- Telephone  
- Affiliation Cheonan Korean Medicine Hospital of Daejeon University  
- Address 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea 
Contact Person for Updating Information
- Name Boncho Ku 
- Title Senior researcher 
- Telephone +82-42-868-9589 
- Affiliation Korea Institute of Oriental Medicine 
- Address 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2013-11-04 , Actual
Target Number of Participant 56
Primary Completion Date 2013-12-13 , Actual
Study Completion Date 2013-12-13 , Actual
Recruitment Status by Participating Study Site 1 
- Name of Study Site Cheonan Korean Medicine Hospital of Daejeon University  
- Recruitment Status Completed  
- Date of First Enrollment 2013-11-04 , Actual
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 10028438 
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 The objective of this study is to assess the pain-relief efficacy of radiofrequency (RF)-thermal stimulation on acupuncture points (APs) in the treatment of patients suffering from low back pain (LBP) as a preliminary study. The study was designed as a randomized, practitioner-blinded, active control trial. A total of 56 LBP patients whose minimum pain intensity on visual analogue scale (VAS, 0-100mm) was more than 30mm were randomly allocated to either control or treatment group. The treatment group received RF thermal stimulation plus cupping therapy on four bilateral and three unilateral APs for three times a week. The active-controlled group (n=28) received false thermal stimulation but cupping therapy on the identical APs with the treatment group. All patients after randomization were required to report the case report form at baseline, all of three times of treatment periods and the follow-up period within a week after all treatments.  
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 
Allocation RCT 
Intervention Type Medical Device  
Intervention Description Intervention group
1) Treatment group: radiofrequency (RF)-thermal stimulation plus cupping therapy
2) Active controlled group: cupping therapy

Deion of Interventions
1) RF-thermal stimulation: RF of 2 MHz was applied at intervals of 2000 ms through channel 1, and the actual stimulation duration of each application was configured to 400 ms. The output power was initially set at 20 W (10% of the maximum output power). The stimulation applied on approximately six selected acupoints (APs) among five bilateral (BL23, BL24, BL25, BL30, and BL40) and three unilateral (GV3, GV4, and GV5) APs.
2) Cupping therapy: The cupping pressure with 15 kPa induced by the cup-shaped probes was applied on the identical APs with RF-thermal stimulation.

Time/Duration of Intervention: Three times of intervention over one week  
Number of Arms
Arm 1 Arm Label Radiofrequency-thermal stimulation plus cupping therapy 
Target Number of Participant 28 
Arm Type Experimental 
Arm Description Combination of radiofrequency (RF) thermal stimulation and cupping pressure on approximately six selected acupoints (APs) among five bilateral (BL23, BL24, BL25, BL30, and BL40) and three unilateral (GV3, GV4, and GV5) APs for ten minutes, three times over a week . RF of 2 MHz was applied at intervals of 2000 ms through channel 1, and the actual stimulation duration of each application was configured to 400 ms. The output power was initially set at 20 W (10% of the maximum output power), and the cupping pressure was 15 kPa.  
Arm 2 Arm Label Cupping therapy 
Target Number of Participant 28 
Arm Type Sham comparator 
Arm Description An identical negative pressure used in the treatment group was applied. All acupoints, duration of pressure, frequency and duration of treatment was identical with the treatment group. The devices used in both the treatment group and the active control group were manufactured with identical appearances, but radiofrequency irradiation output of the device used for the active control group was not operational. The practitioners were only able to identify each device according to the masked group labels.Acoustic sounds mimicking the application of RF thermal stimulation were also delivered by the devices to preserve the group blinding of the practitioners. 
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 20 Year ~ 75 Year
Description 1. Patients with a minimum pain intensity score greater than 30 mm on a visual analogue scale (VAS, 0 to 100 mm)
2. Diagnosed as the low back pain with medical evidences (e.g. previous radiographic records and independent physical examination)
3. Voluntary participation who clearly understood purpose and characteristics of the clinical trials signed informed consent form  
Exclusion Criteria 1. Patients who required the aid of medical devices or attached implantable equipment that could be affected by electromagnetic fields, such as pacemakers or hearing aids
2. Unendurable pain, bone fractures, severe disc herniation, or spinal tumours.
3. Taking drugs such as corticosteroids, anticonvulsants, or anti-inflammatory agents.
4. Pregnancy
5. Patients who experienced any adverse effects due to the physical stimulation therapy
6. Cognitive or mental dysfunction
7. Participated in other clinical trials within the last month  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Change in visual analogue scale (VAS, 100 mm) from the baseline to follow-up period 
- Timepoint Baseline, every three times of treatment over the course of one week (visit 1 to visit 3), and within one week after the end of all scheduled treatments (visit 4: follow-up). 
Secondary Outcome(s) 1 
- Outcome Change of pressure pain threshold (PPT)  
- Timepoint Every three times of treatment over the course of one week, and within one week after the end of all scheduled treatments (visit 4: follow-up). 
Secondary Outcome(s) 2 
- Outcome Change of patient's global impression of change (PGIC)  
- Timepoint Every three times of treatment over the course of one week (visit 1 to visit 3), and within one week after the end of all scheduled treatments (visit 4: follow-up). 
Secondary Outcome(s) 3 
- Outcome European Quality of Life-5 Dimensions (EQ-5D) 
- Timepoint The first time of the treatment (visit 1) and within one week after the end of all scheduled treatments (visit 4: follow-up). 
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