Clinical trial NCT05240586: Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
Official title: Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Herniation
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 herniation.

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' conditions, respectively.

Eligibility criteria: Inclusion Criteria:

1. Symptoms of cervical disc herniation for less than 12 months
2. Numeric Rating Scale (NRS) of neck pain is more than 5
3. Symptoms of neuromuscular disease in one or both upper limbs (pain, pull, numbness, sensory abnormalities, motor abnormalities)
4. Discrimination findings above protusion, which can explain clinical symptoms on Cervical spine MRI or CT
5. 19-69 years old
6. participants who agreed and wrote informed consents

Exclusion Criteria:

1. 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)
2. Progressive neurologic deficits or severe neurologic deficits
3. Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.)
4. Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
5. Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
6. Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
7. Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
8. Pregnant, planning to get pregnant or lactating women
9. Participants who had undergone cervical surgery within 3 months
10. 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
11. Participants who can not write informed consent
12. Participants who is difficult to participate in the trial according to investigator's decision

Primary outcomes:
measure: Numeric rating scale (NRS) of neck pain
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
Secondary outcomes:
measure: Numeric rating scale (NRS) of radiating arm pain
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
measure: Visual analogue scale (VAS) of neck pain and radiating arm pain
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
measure: Neck Disability Index (NDI)
timeFrame: Week 1, 7, 13, 25
measure: Northwick Park Questionnaire (NPQ)
timeFrame: Week 1, 7, 13, 25
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 7, 13, 25
measure: Short Form-12 Health Survey version 2 (SF-12 v2)
timeFrame: Week 1, 7, 13, 25
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Week 1, 7, 13, 25
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital at Gangdong
state: Gangdong-gu
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
city: Seongnam
country: Korea, Republic of
facility: Dongguk University Bundang Oriental Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, Ph.D.
role: STUDY_DIRECTOR
References: