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

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Procedure: physical therapy; Procedure: pharmacopuncture therapy

• Registration Number: NCT04576520
• Lead Sponsor: Jaseng Medical Foundation

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-10-04
• Study First Posted: 2020-10-06
• Study Start: 2020-10-13
• Primary Completion: 2021-03-26
• Study Completion: 2021-03-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical therapy	physical therapy	The physicians will choose the type and time of physical therapy according to participants' conditions.
pharmacopuncture therapy	pharmacopuncture therapy	The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) of low back pain	Change from baseline VAS at week 6	Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) of leg radiating pain	Week 1, 2, 3, 4, 5, 6, 10, 16	Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Numeric rating scale (NRS) of low back pain and leg radiating pain	Week 1, 2, 3, 4, 5, 6, 10, 16	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'.
Oswestry Disability Index (ODI)	Week 1, 6, 10, 16	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).
Patient Global Impression of Change (PGIC)	Week 6, 10, 16	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.)
Korean version of the Roland-Morris Disability Questionnaire (RMDQ)	Week 1, 6, 10, 16	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).
Short Form-12 Health Survey version 2 (SF-12 v2)	Week 1, 6, 10, 16	The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
EuroQol-5 Dimension (EQ-5D-5L)	Week 1, 6, 10, 16	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)

Trial Locations

Locations (4)

Bucheon Jaseng Hospital of Korean Medicine; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of

Haeundae Jaseng Hospital of Korean Medicine; 🇰🇷 Busan, Korea, Republic of

Daejeon Jaseng Hospital of Korean Medicine; 🇰🇷 Daejeon, Korea, Republic of