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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833309
• Other study ID #: JS-CT-2021-02
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: February 26, 2022

Study information

• Verified date: December 2022
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 26, 2022
• Est. primary completion date: February 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi Province
Korea, Republic of	Haeundae Jaseng Hospital of Korean Medicine	Busan
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (2)

Lead Sponsor	Collaborator
Jaseng Medical Foundation	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 low-back pain	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'.	week 6
Secondary	Numeric rating scale (NRS) of low-back pain	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'.	week 1, 2, 3, 4, 5, 6, 13, 25
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 a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.	week 1, 2, 3, 4, 5, 6, 13, 25
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, 13, 25
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, 13, 25
Secondary	Oswestry Disability Index (ODI)	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).	week 1, 6, 13, 25
Secondary	Korean version of the Roland-Morris Disability Questionnaire (RMDQ)	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).	week 1, 6, 13, 25
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, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)	week 6, 13, 25
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, 6, 13, 25
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, 6, 13, 25