PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study

Chronic Low-back Pain Clinical Trial

Official title:

Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576520
• Other study ID #: JS-CT-2020-09
• Status: Completed
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: August 2021
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.

Description:

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

1. low back pain for more than 6 months

2. Visual Analogue Scale (VAS) of low back pain is more than 5

3. 19-70 years old

4. participants who agreed and wrote informed consents

Exclusion Criteria:

1. Migration of cancer reaching to spine, fracture of spine

2. Progressive neurologic deficits or severe neurologic deficits

3. Cancer, fibromyalgia, RA, or goat

4. Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy

5. Participants taking steroid, immunosuppressant, or psychotropic medication

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 cervical 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
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
• physical therapy
This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.

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 (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS) of low back pain	Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.	Change from baseline VAS at week 6
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, 10, 16
Secondary	Numeric rating scale (NRS) of low back pain and leg radiating 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, 10, 16
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, 10, 16
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, 10, 16
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, 10, 16
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, 10, 16
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, 10, 16