Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

Cervical Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05240586
• Other study ID #: JS-CT-2021-13
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 31, 2024
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Hernia
• Intervertebral Disc Displacement

Intervention

Procedure:
• pharmacopuncture therapy
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
• acupuncture therapy
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)
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.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi Province
Korea, Republic of	Haeundae Jaseng Hospital of Korean Medicine	Busan
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon
Korea, Republic of	Dongguk University Bundang Oriental Hospital	Seoul	Bundang-gu, Seongnam-si
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu
Korea, Republic of	Kyung Hee University Korean Medicine Hospital	Seoul	Dongdaemun-gu
Korea, Republic of	Kyung Hee University Korean Medicine Hospital at Gangdong	Seoul	Gangdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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