A Study on the Effectiveness of Pharmacopuncture for Chronic Neck Pain: A Protocol for a Pragmatic Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jaseng Medical Foundation
- Enrollment
- 101
- Locations
- 4
- Primary Endpoint
- Visual analogue scale of neck pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
pharmacopuncture therapy
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.
Intervention: pharmacopuncture therapy (Procedure)
physical therapy
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: Physical therapy (Procedure)
Outcomes
Primary Outcomes
Visual analogue scale of neck pain
Time Frame: week 6
Minimum 0, Maximum 100. Higher values represent a worse outcome
Secondary Outcomes
No secondary outcomes reported
Investigators
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation