Pragmatic randomized controlled trial of pharmacopuncture therapy for chronic low back pai

Not Applicable

Recruiting

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0006088
• Lead Sponsor: Jaseng Medical Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 November 2021

Recruitment & Eligibility

• Status: Recruiting
• 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ow back pain numeric rating scale, NRS

Secondary Outcome Measures

Name	Time	Method
umeric rating scale (NRS) of radiating pain in lower extremities;Visual analogue scale (VAS) of low back pain;Visual analogue scale (VAS) of leg radiating pain;Oswestry Disability Index, ODI;Korean version of the Roland-Morris Disability Questionnaire (RMDQ);Patient Global Impression of Change (PGIC);Short Form-12 Health Survey version 2 (SF-12 v2);EuroQol-5 Dimension (EQ-5D-5L)