Clinical trial NCT04833309: Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
Official title: Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2021-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.

Detailed description: This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific type and volume of pharmacopuncture and physical therapy.

Eligibility criteria: Inclusion Criteria:

1. low back pain for more than 6 months
2. Numeric rating scale (NRS) score for low back pain 5 or more
3. 19-70 years old
4. participants who agreed and signed informed consent form

Exclusion Criteria:

1. Spine metastasis of cancer, acute fracture of spine, or spine dislocation
2. Progressive neurologic deficits or severe neurologic deficits
3. Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
4. Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
5. Concurrent use of steroids, immunosuppressants, or psychotropic medications
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 lumbar 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: Numeric rating scale (NRS) of low-back pain
timeFrame: week 6
Secondary outcomes:
measure: Numeric rating scale (NRS) of low-back pain
timeFrame: week 1, 2, 3, 4, 5, 6, 13, 25
measure: Numeric rating scale (NRS) of radiating pain in lower extremities
timeFrame: week 1, 2, 3, 4, 5, 6, 13, 25
measure: Visual analogue scale (VAS) of leg radiating pain
timeFrame: week 1, 2, 3, 4, 5, 6, 13, 25
measure: Visual analogue scale (VAS) of low-back pain
timeFrame: week 1, 2, 3, 4, 5, 6, 13, 25
measure: Oswestry Disability Index (ODI)
timeFrame: week 1, 6, 13, 25
measure: Korean version of the Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: week 1, 6, 13, 25
measure: Patient Global Impression of Change (PGIC)
timeFrame: week 6, 13, 25
measure: Short Form-12 Health Survey version 2 (SF-12 v2)
timeFrame: week 1, 6, 13, 25
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: week 1, 6, 13, 25
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, KMD,Ph.D
role: STUDY_DIRECTOR
References:
citation: Park KS, Kim S, Seo JY, Cho H, Lee JY, Lee YJ, Lee J, Kim MJ, Choi YE, Yang CS, Han CH, Ha IH. Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Protocol for a Pragmatic Randomized Controlled Trial. J Pain Res. 2022 Sep 1;15:2629-2639. doi: 10.2147/JPR.S375231. eCollection 2022.