Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

Jaseng Medical Foundation

Status: Completed

Conditions: Cervical Disc Herniation

Treatments: Procedure: acupuncture therapy; Procedure: pharmacopuncture therapy; Procedure: physical therapy, medication(prn)

Study type: Interventional

Funder types: Other

Identifiers

NCT05240586

JS-CT-2021-13

Details and patient eligibility

About

This is pilot study for a 3-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy, acupunture therapy and physical therapy, medication(prn) for cervical disc herniation.

Full description

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

Enrollment: 84 patients

Sex: All

Ages: 19 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Symptoms of cervical disc herniation for less than 12 months
2. Numeric Rating Scale (NRS) of neck pain is more than 5
3. Symptoms of neuromuscular disease in one or both upper limbs (pain, pull, numbness, sensory abnormalities, motor abnormalities)
4. Discrimination findings above protusion, which can explain clinical symptoms on Cervical spine MRI or CT
5. 19-69 years old
6. participants who agreed and wrote informed consents

Exclusion criteria

1. Case of being diagnosed with a specific serious disease that may cause neck pain(Migration of cancer reaching to spine, acute fracture of spine, spine dislocation)
2. Progressive neurologic deficits or severe neurologic deficits
3. Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.)
4. Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
5. Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
6. Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
7. Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
8. Pregnant, planning to get 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, had participated in other study within 6 months from the date of selection, 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

---

84 participants in 3 patient groups

pharmacopunture therapy

Experimental group

Description:

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

Treatment:

Procedure: pharmacopuncture therapy

acupuncture therapy

Active Comparator group

Description:

The physicians will choose the type and number of acupuncture therapy according to participants' conditions.

Treatment:

Procedure: acupuncture therapy

physical therapy, medication(prn)

Active Comparator group

Description:

The physicians will choose the type and time of physical therapy according to participants' conditions. According to clinical judgment, clinicians can prescribe analgesics and muscle relaxants if necessary.

Treatment:

Procedure: physical therapy, medication(prn)