Back to resultsEffectiveness of Pharmacopuncture for Chronic Neck Pain
Primary Purpose
Chronic Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pharmacopuncture therapy
Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Neck pain more than 6 months
- VAS of neck pain more than 5
- Age between 17 and 70 years old
- Participants who wrote informed consent
Exclusion Criteria:
- Migration of cancer reaching to spine, fracture of spine
- Progressive neurologic deficits or severe neurologic deficits
- Cancer, fibromyalgia, RA, or goat
- Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
- Participants taking steroid, immunosuppressant, or psychotropic medication
- Hemorrhagic disease, severe diabetes or taking anticoagulant drug
- Participants who took NSAIDs or pharmacopuncture within 1 week
- Pregnant or lactating women
- Participants who had undergone cervical surgery within 3 months
- Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
- Participants who can not write informed consent
- Participants who is difficult to participate in the trial according to investigator's decision
Sites / Locations
- Jaseng Hospital of Korean Medicine
- Bucheon Jaseng Hospital of Korean Medicine
- Haeundae Jaseng Hospital of Korean Medicine
- Daejeon Jaseng Hospital of Korean Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pharmacopuncture therapy
physical therapy
Arm Description
The physicians will select one or more pharmacopuncture therapy for each participants. The physicians will also decide dosage and frequency of treatment according to the participant's status.
The physicians will select one or more physical therapy for each participants. The physicians will also decide intensity and frequency of treatment according to the participant's status.
Outcomes
Primary Outcome Measures
Visual analogue scale of neck pain
Minimum 0, Maximum 100. Higher values represent a worse outcome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04035018
Brief Title
Effectiveness of Pharmacopuncture for Chronic Neck Pain
Official Title
A Study on the Effectiveness of Pharmacopuncture for Chronic Neck Pain: A Protocol for a Pragmatic Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this study, the investigators will evaluate the efficacy and safety of pharmacopuncture therapy for chronic neck pain compared to physical therapy.
Detailed Description
This study is prgmatic RCT of pharmacopuncture therapy for chronic neck pain compared to physical therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pharmacopuncture therapy
Arm Type
Experimental
Arm Description
The physicians will select one or more pharmacopuncture therapy for each participants. The physicians will also decide dosage and frequency of treatment according to the participant's status.
Arm Title
physical therapy
Arm Type
Active Comparator
Arm Description
The physicians will select one or more physical therapy for each participants. The physicians will also decide intensity and frequency of treatment according to the participant's status.
Intervention Type
Procedure
Intervention Name(s)
pharmacopuncture therapy
Intervention Description
The participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Intervention Description
The participants in the control group will be receive one or more physical therapy according to the physician's decision.
Primary Outcome Measure Information:
Title
Visual analogue scale of neck pain
Description
Minimum 0, Maximum 100. Higher values represent a worse outcome
Time Frame
week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Neck pain more than 6 months
VAS of neck pain more than 5
Age between 17 and 70 years old
Participants who wrote informed consent
Exclusion Criteria:
Migration of cancer reaching to spine, fracture of spine
Progressive neurologic deficits or severe neurologic deficits
Cancer, fibromyalgia, RA, or goat
Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
Participants taking steroid, immunosuppressant, or psychotropic medication
Hemorrhagic disease, severe diabetes or taking anticoagulant drug
Participants who took NSAIDs or pharmacopuncture within 1 week
Pregnant or lactating women
Participants who had undergone cervical surgery within 3 months
Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
Participants who can not write informed consent
Participants who is difficult to participate in the trial according to investigator's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha
Organizational Affiliation
Jaseng Hospital of Korean Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi Province
ZIP/Postal Code
14598
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
ZIP/Postal Code
48102
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
ZIP/Postal Code
35262
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35011752
Citation
Park KS, Kim S, Kim C, Seo JY, Cho H, Kim SD, Lee YJ, Lee J, Ha IH. A Comparative Study of the Effectiveness of Pharmacopuncture Therapy for Chronic Neck Pain: A Pragmatic, Randomized, Controlled Trial. J Clin Med. 2021 Dec 21;11(1):12. doi: 10.3390/jcm11010012.
Results Reference
derived
Learn more about this trial
Effectiveness of Pharmacopuncture for Chronic Neck Pain
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