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

NCT ID: NCT04833309

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-02-26

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pharmacopuncture therapy

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.

Group Type: EXPERIMENTAL

pharmacopuncture therapy

Intervention Type: 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.

Physical therapy

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.

Group Type: ACTIVE_COMPARATOR

physical therapy

Intervention Type: 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.

Interventions

pharmacopuncture therapy

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.

Intervention Type: PROCEDURE

physical therapy

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: collaborator

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha, KMD

Director of Jaseng Spine and Joint Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Hyuk Ha, KMD,Ph.D

Role: STUDY_DIRECTOR

Jaseng Medical Foundation

Locations

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, South Korea

Haeundae Jaseng Hospital of Korean Medicine

Busan, , South Korea

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 36072909 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JS-CT-2021-02

Identifier Type: -

Identifier Source: org_study_id