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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Procedure: pharmacopuncture therapy; Procedure: physical therapy

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon, Korea, Republic of, 35262
    • Daejeon Jaseng Hospital of Korean Medicine
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine
  • Gyeonggi Province
    • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
      • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pharmacopuncture therapy; The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.	Procedure: pharmacopuncture therapy; This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Active Comparator: physical therapy; The physicians will choose the type and time of physical therapy according to participants' conditions.	Procedure: physical therapy; This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: In-Hyuk Ha, Ph.D, Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 4, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: JS-CT-2020-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No