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

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Procedure: pharmacopuncture therapy; Procedure: physical therapy

• Registration Number: NCT04833309
• Lead Sponsor: Jaseng Medical Foundation

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.

Study Timeline

• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-06
• Study Start: 2021-06-10
• Primary Completion: 2022-02-26
• Study Completion: 2022-02-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacopuncture therapy	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.
Physical therapy	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.

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS) of low-back pain	week 6	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'.

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) of leg radiating pain	week 1, 2, 3, 4, 5, 6, 13, 25	Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Short Form-12 Health Survey version 2 (SF-12 v2)	week 1, 6, 13, 25	The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Korean version of the Roland-Morris Disability Questionnaire (RMDQ)	week 1, 6, 13, 25	The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability).
Numeric rating scale (NRS) of low-back pain	week 1, 2, 3, 4, 5, 6, 13, 25	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'.
Oswestry Disability Index (ODI)	week 1, 6, 13, 25	ODI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome).
Patient Global Impression of Change (PGIC)	week 6, 13, 25	Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
Numeric rating scale (NRS) of radiating pain in lower extremities	week 1, 2, 3, 4, 5, 6, 13, 25	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'.
EuroQol-5 Dimension (EQ-5D-5L)	week 1, 6, 13, 25	The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
Visual analogue scale (VAS) of low-back pain	week 1, 2, 3, 4, 5, 6, 13, 25	Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.

Trial Locations

Locations (4)

Bucheon Jaseng Hospital of Korean Medicine; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of

Haeundae Jaseng Hospital of Korean Medicine; 🇰🇷 Busan, Korea, Republic of

Daejeon Jaseng Hospital of Korean Medicine; 🇰🇷 Daejeon, Korea, Republic of