Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

NCT05240586 | Completed DMC

• 1 other identifier: JS-CT-2021-13
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Cervical Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) of neck 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, 7, 13, 25

Secondary Outcomes (7)

• Numeric rating scale (NRS) of radiating arm pain

  Week 1, 2, 3, 4, 5, 6, 7, 13, 25

• Visual analogue scale (VAS) of neck pain and radiating arm pain

  Week 1, 2, 3, 4, 5, 6, 7, 13, 25

• Neck Disability Index (NDI)

  Week 1, 7, 13, 25

• Northwick Park Questionnaire (NPQ)

  Week 1, 7, 13, 25

• Patient Global Impression of Change (PGIC)

  Week 7, 13, 25

Study Arms (3)

pharmacopunture therapy

EXPERIMENTAL

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

Procedure: pharmacopuncture therapy

acupuncture therapy

ACTIVE COMPARATOR

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

Procedure: acupuncture therapy

physical therapy, medication(prn)

ACTIVE COMPARATOR

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.

Procedure: physical therapy, medication(prn)

Interventions

pharmacopuncture therapy PROCEDURE

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

pharmacopunture therapy

acupuncture therapy PROCEDURE

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

acupuncture therapy

physical therapy, medication(prn) PROCEDURE

This is a pragmatic RCT, so 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.

physical therapy, medication(prn)

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Progressive neurologic deficits or severe neurologic deficits
• Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.)
• Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
• Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
• Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
• Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
• Pregnant, planning to get pregnant or lactating women
• Participants who had undergone cervical surgery within 3 months
• 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
• 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 (7)

Kyung Hee University Korean Medicine Hospital

Seoul, Dongdaemun-gu, 130-701, South Korea

Location

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

Location

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

Dongguk University Bundang Oriental Hospital

Seongnam-si, Gyeonggi-do, 13601, 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

Acupuncture Therapy; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Complementary Therapies; 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: February 13, 2022
• First Posted: February 15, 2022
• Study Start: April 20, 2022
• Primary Completion: May 26, 2023
• Study Completion: September 26, 2023
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

KR (7)