Status:
COMPLETED
Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
Lead Sponsor:
Jaseng Medical Foundation
Conditions:
Cervical Disc Herniation
Eligibility:
All Genders
19-69 years
Phase:
NA
Brief Summary
This is pilot study for a 3-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy, acupunture therapy and physical therapy, medication(prn) for cervical disc he...
Detailed Description
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture, the type and number of acupuncture and the type and time of physical therapy according to participants' ...
Eligibility Criteria
Inclusion
- Symptoms of cervical disc herniation for less than 12 months
- Numeric Rating Scale (NRS) of neck pain is more than 5
- Symptoms of neuromuscular disease in one or both upper limbs (pain, pull, numbness, sensory abnormalities, motor abnormalities)
- Discrimination findings above protusion, which can explain clinical symptoms on Cervical spine MRI or CT
- 19-69 years old
- participants who agreed and wrote informed consents
Exclusion
- Case of being diagnosed with a specific serious disease that may cause neck pain(Migration of cancer reaching to spine, acute fracture of spine, spine dislocation)
- Progressive neurologic deficits or severe neurologic deficits
- Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.)
- Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
- Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
- Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
- Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
- Pregnant, planning to get pregnant or lactating women
- Participants who had undergone cervical surgery within 3 months
- Participants who had participated in other clinical trial within 1 month, had participated in other study within 6 months from the date of selection, 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05240586
Start Date
April 20 2022
End Date
September 26 2023
Last Update
March 14 2025
Active Locations (7)
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1
Kyung Hee University Korean Medicine Hospital
Seoul, Dongdaemun-gu, South Korea, 130-701
2
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea, 05278
3
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 135-896
4
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, South Korea, 14598