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

NCT04576520 | Completed DMC

• 1 other identifier: JS-CT-2020-09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Visual analogue scale (VAS) of leg radiating pain

  Week 1, 2, 3, 4, 5, 6, 10, 16

• Numeric rating scale (NRS) of low back pain and leg radiating pain

  Week 1, 2, 3, 4, 5, 6, 10, 16

• Oswestry Disability Index (ODI)

  Week 1, 6, 10, 16

• Korean version of the Roland-Morris Disability Questionnaire (RMDQ)

  Week 1, 6, 10, 16

• Patient Global Impression of Change (PGIC)

  Week 6, 10, 16

Study Arms (2)

pharmacopuncture therapy

EXPERIMENTAL

The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

Procedure: pharmacopuncture therapy

physical therapy

ACTIVE COMPARATOR

The physicians will choose the type and time of physical therapy according to participants' conditions.

Procedure: physical therapy

Interventions

pharmacopuncture therapy PROCEDURE

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

pharmacopuncture therapy

physical therapy PROCEDURE

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

physical therapy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain for more than 6 months
• Visual Analogue Scale (VAS) of low back pain is more than 5
• years old
• participants who agreed and wrote informed consents

You may not qualify if:

• Migration of cancer reaching to spine, fracture of spine
• Progressive neurologic deficits or severe neurologic deficits
• Cancer, fibromyalgia, RA, or goat
• Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
• Participants taking steroid, immunosuppressant, or psychotropic medication
• Hemorrhagic disease, severe diabetes or taking anticoagulant drug
• Participants who took NSAIDs or pharmacopuncture within 1 week
• Pregnant or lactating women
• Participants who had undergone cervical surgery within 3 months
• 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
• Participants who can not write informed consent
• Participants who is difficult to participate in the trial according to investigator's decision

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (4)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• In-Hyuk Ha, Ph.D

  Jaseng Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 6, 2020
• Study Start: October 13, 2020
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

KR (4)