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

Jaseng Medical Foundation

Status: Completed

Conditions: Chronic Low-back Pain

Treatments: Procedure: physical therapy; Procedure: pharmacopuncture therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04576520

JS-CT-2020-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

pharmacopuncture therapy

Experimental group

Description:

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

Treatment:

Procedure: pharmacopuncture therapy

physical therapy

Active Comparator group

Description:

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

Treatment:

Procedure: physical therapy