Clinical trial NCT04576520: PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
Official title: Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
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 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.

Detailed description: This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.

Eligibility criteria: Inclusion Criteria:

1. low back pain for more than 6 months
2. Visual Analogue Scale (VAS) of low back pain is more than 5
3. 19-70 years old
4. participants who agreed and wrote informed consents

Exclusion Criteria:

1. Migration of cancer reaching to spine, fracture of spine
2. Progressive neurologic deficits or severe neurologic deficits
3. Cancer, fibromyalgia, RA, or goat
4. Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
5. Participants taking steroid, immunosuppressant, or psychotropic medication
6. Hemorrhagic disease, severe diabetes or taking anticoagulant drug
7. Participants who took NSAIDs or pharmacopuncture within 1 week
8. 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, 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: Visual analogue scale (VAS) of low back pain
timeFrame: Change from baseline VAS at week 6
Secondary outcomes:
measure: Visual analogue scale (VAS) of leg radiating pain
timeFrame: Week 1, 2, 3, 4, 5, 6, 10, 16
measure: Numeric rating scale (NRS) of low back pain and leg radiating pain
timeFrame: Week 1, 2, 3, 4, 5, 6, 10, 16
measure: Oswestry Disability Index (ODI)
timeFrame: Week 1, 6, 10, 16
measure: Korean version of the Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Week 1, 6, 10, 16
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 6, 10, 16
measure: Short Form-12 Health Survey version 2 (SF-12 v2)
timeFrame: Week 1, 6, 10, 16
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Week 1, 6, 10, 16
Other outcomes:
Locations:
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: 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: