Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Disc Herniation
• Intervention / Treatment: Procedure: pharmacopuncture therapy; Procedure: acupuncture therapy; Procedure: physical therapy, medication(prn)

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In-Hyuk Ha, Ph.D.; Phone Number: 82-2-2222-2740; Email: hanihata@gmail.com

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon, Korea, Republic of, 35262
    • Daejeon Jaseng Hospital of Korean Medicine
  • Bundang-gu, Seongnam-si
    • Seoul, Bundang-gu, Seongnam-si, Korea, Republic of, 13601
      • Dongguk University Bundang Oriental Hospital
  • Dongdaemun-gu
    • Seoul, Dongdaemun-gu, Korea, Republic of, 130-701
      • Kyung Hee University Korean Medicine Hospital
  • Gangdong-gu
    • Seoul, Gangdong-gu, Korea, Republic of, 05278
      • Kyung Hee University Korean Medicine Hospital at Gangdong
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine
  • Gyeonggi Province
    • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
      • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pharmacopunture therapy; The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.	Procedure: pharmacopuncture therapy; This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Active Comparator: acupuncture therapy; The physicians will choose the type and number of acupuncture therapy according to participants' conditions.	Procedure: acupuncture therapy; This is a pragmatic RCT, so the physicians will choose the type and number of acupuncture therapy according to participants' conditions.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale (NRS) of radiating arm 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
Visual analogue scale (VAS) of neck pain and radiating arm pain	Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.	Week 1, 2, 3, 4, 5, 6, 7, 13, 25
Neck Disability Index (NDI)	NDI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome).	Week 1, 7, 13, 25
Northwick Park Questionnaire (NPQ)	NPQ measures the neck pain and the consequent patient disabilities. The questionnaire is divided in nine five-part sections. Each parameter is divided in five answer possibilities with points from 0 till 4. 0 is significant for no pain and 4 is significant for worst pain. The maximum score is 36 if all nine questions were answered and 32 if only the first eight questions were answered. The percentage ranges from 0% to 100%. The higher the percentage, the greater the disability and the pain.	Week 1, 7, 13, 25
Patient Global Impression of Change (PGIC)	Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)	Week 7, 13, 25
Short Form-12 Health Survey version 2 (SF-12 v2)	The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.	Week 1, 7, 13, 25
EuroQol-5 Dimension (EQ-5D-5L)	The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)	Week 1, 7, 13, 25

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: In-Hyuk Ha, Ph.D., Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): September 26, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: JS-CT-2021-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No