Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study

Lumbar Disc Prolapse With Radiculopathy Clinical Trial

Official title:

Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833270
• Other study ID #: JS-CT-2021-01
• Status: Completed
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: September 2022
• Source: Jaseng Hospital of Korean Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.

Description:

Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 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 intervention and dosage of pharmacological and non-pharmacological treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Prolapse With Radiculopathy
• Prolapse
• Radiculopathy

Intervention

Other:
• KM non-pharmacological treatment group
This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.
• Pharmacological treatment group
This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine	Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale (NRS) of radiating pain in lower extremities	NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.	week 9
Secondary	Numeric rating scale (NRS) of radiating pain in lower extremities	NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.	week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Secondary	Numeric rating scale (NRS) of low-back pain	NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.	week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Secondary	Visual analogue scale (VAS) of leg radiating pain	Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.	week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Secondary	Visual analogue scale (VAS) of low-back pain	Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.	week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Secondary	Oswestry Disability Index (ODI)	ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome)	week 1, 5, 9, 14, 27
Secondary	Fear-Avoidance Beliefs Questionnaire (FABQ)	FABQ is one of pateint-reported outcome questionnaire which consists of total 16 questions. Through FABQ, the investigator can evaluate fear avoidance responses, especially in physical and occupational activity domain for patients with low-back pain	week 1, 9, 14, 27
Secondary	Patient Global Impression of Change (PGIC)	Participants rate the improvement after treatment on a 7-point Likert scale(1, very much improved; 2, much improved; 3, minimally improved; 4, nochange; 5, minimally worse; 6, much worse; or 7, very much worse.)	week 9, 14, 27
Secondary	Short Form-12 Health Survey version 2 (SF-12 v2)	The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.	week 1, 5, 9, 14, 27
Secondary	EuroQol-5 Dimension (EQ-5D-5L)	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)	week 1, 5, 9, 14, 27