Pragmatic randomized controlled trial of non-pharmacological treatment for lumbar disc herniation : A pilot study

Not Applicable

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0006113
• Lead Sponsor: Jaseng Hospital of Korean Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-28
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
2. Onset time of radiating pain occurred within 12 weeks.
3. Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
4. 19-70 years old
5. 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, orpsychotropic medications or any other medication that can interrupt the study result
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
umeric rating scale (NRS) of radiating pain in lower extremities

Secondary Outcome Measures

Name	Time	Method
umeric rating scale (NRS) of low-back pain;low back pain and radiating leg pain visual analogue scale, VAS;Oswestry Disability Index (ODI);Fear-Avoidance Beliefs Questionnaire (FABQ);Patient Global Impression of Change (PGIC);Short Form-12 Health Survey version 2 (SF-12 v2);EuroQol-5 Dimension (EQ-5D-5L);Credibility and Expectancy