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
CRIS Registration Number |
KCT0002258 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Comprehensive & Integrative Medicine Institute |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Daegu Oriental Hospital of Daegu Haany University |
Organization Type | Medical Institute |
7. Study Summary
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). |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M54.22)Cervicalgia, cervical region |
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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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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) |
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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) |
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Secondary Outcome(s) 3 | ||
Outcome | Patient Global Impression of Change(PGIC) |
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Timepoint | week 1, 2, 3 (primary end point), and 7 (4 weeks after treatment completion) |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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