Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

NCT ID: NCT05240586

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2023-09-26

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.

Detailed 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.

Conditions

Cervical Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

pharmacopunture therapy

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

Group Type: EXPERIMENTAL

pharmacopuncture therapy

Intervention Type: PROCEDURE

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

acupuncture therapy

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

Group Type: ACTIVE_COMPARATOR

acupuncture therapy

Intervention Type: PROCEDURE

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

physical therapy, medication(prn)

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.

Group Type: ACTIVE_COMPARATOR

physical therapy, medication(prn)

Intervention Type: 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.

Interventions

pharmacopuncture therapy

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

Intervention Type: PROCEDURE

acupuncture therapy

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

Intervention Type: PROCEDURE

physical therapy, medication(prn)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha, KMD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Hyuk Ha, Ph.D.

Role: STUDY_DIRECTOR

Jaseng Medical Foundation

Locations

Kyung Hee University Korean Medicine Hospital

Seoul, Dongdaemun-gu, South Korea

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, Gangdong-gu, South Korea

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, South Korea

Dongguk University Bundang Oriental Hospital

Seongnam-si, Gyeonggi-do, South Korea

Haeundae Jaseng Hospital of Korean Medicine

Busan, , South Korea

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

JS-CT-2021-13

Identifier Type: -

Identifier Source: org_study_id