Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial

NCT04833309 | Completed DMC

• 1 other identifier: JS-CT-2021-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) of low-back pain

  NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  week 6

Secondary Outcomes (9)

• Numeric rating scale (NRS) of low-back pain

  week 1, 2, 3, 4, 5, 6, 13, 25

• Numeric rating scale (NRS) of radiating pain in lower extremities

  week 1, 2, 3, 4, 5, 6, 13, 25

• Visual analogue scale (VAS) of leg radiating pain

  week 1, 2, 3, 4, 5, 6, 13, 25

• Visual analogue scale (VAS) of low-back pain

  week 1, 2, 3, 4, 5, 6, 13, 25

• Oswestry Disability Index (ODI)

  week 1, 6, 13, 25

Study Arms (2)

Pharmacopuncture therapy

EXPERIMENTAL

Pharmacopuncture will be administered to the subjects in the pharmacopuncture therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions.

Procedure: pharmacopuncture therapy

Physical therapy

ACTIVE COMPARATOR

Physical therapy will be applied to the subjects in the physical therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions.

Procedure: physical therapy

Interventions

pharmacopuncture therapy PROCEDURE

The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and dosage will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.

Pharmacopuncture therapy

physical therapy PROCEDURE

The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and body part will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.

Physical therapy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain for more than 6 months
• Numeric rating scale (NRS) score for low back pain 5 or more
• years old
• participants who agreed and signed informed consent form

You may not qualify if:

• Spine metastasis of cancer, acute fracture of spine, or spine dislocation
• Progressive neurologic deficits or severe neurologic deficits
• Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
• Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
• Concurrent use of steroids, immunosuppressants, or psychotropic medications
• 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 lumbar 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead
• Korea Institute of Oriental Medicine: collaborator

Study Sites (4)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, 48102, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Related Publications (2)

• Lee YS, Kim SJ, Park KS, Lee YJ, Yang C, Han CH, Ha IH. A cost-utility analysis of pharmacopuncture versus physiotherapy for chronic low back pain: A multicenter, pragmatic randomized controlled trial. Integr Med Res. 2025 Dec;14(4):101210. doi: 10.1016/j.imr.2025.101210. Epub 2025 Aug 5.

  PMID: 41497196 DERIVED

• 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.

  PMID: 36072909 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• In-Hyuk Ha, KMD,Ph.D

  Jaseng Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Jaseng Spine and Joint Research Institute

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 6, 2021
• Study Start: June 10, 2021
• Primary Completion: February 26, 2022
• Study Completion: February 26, 2022
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)