Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
Primary Purpose
Cervical Disc Herniation
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pharmacopuncture therapy
acupuncture therapy
physical therapy, medication(prn)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- 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
- 19-69 years old
- participants who agreed and wrote informed consents
Exclusion Criteria:
- 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
Sites / Locations
- Dongguk University Bundang Oriental Hospital
- Kyung Hee University Korean Medicine Hospital
- Kyung Hee University Korean Medicine Hospital at Gangdong
- Jaseng Hospital of Korean Medicine
- Bucheon Jaseng Hospital of Korean Medicine
- Haeundae Jaseng Hospital of Korean Medicine
- Daejeon Jaseng Hospital of Korean Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
pharmacopunture therapy
acupuncture therapy
physical therapy, medication(prn)
Arm Description
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
The physicians will choose the type and number of acupuncture therapy according to participants' conditions.
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.
Outcomes
Primary Outcome Measures
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'.
Secondary Outcome Measures
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'.
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.
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).
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.
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.)
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.
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)
Full Information
NCT ID
NCT05240586
First Posted
February 13, 2022
Last Updated
April 19, 2023
Sponsor
Jaseng Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05240586
Brief Title
Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
Official Title
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pharmacopunture therapy
Arm Type
Experimental
Arm Description
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Arm Title
acupuncture therapy
Arm Type
Active Comparator
Arm Description
The physicians will choose the type and number of acupuncture therapy according to participants' conditions.
Arm Title
physical therapy, medication(prn)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
pharmacopuncture therapy
Intervention Description
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Intervention Type
Procedure
Intervention Name(s)
acupuncture therapy
Intervention Description
This is a pragmatic RCT, so the physicians will choose the type and number of acupuncture therapy according to participants' conditions.
Intervention Type
Procedure
Intervention Name(s)
physical therapy, medication(prn)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS) of neck pain
Description
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'.
Time Frame
Week 7
Secondary Outcome Measure Information:
Title
Numeric rating scale (NRS) of radiating arm pain
Description
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'.
Time Frame
Week 1, 2, 3, 4, 5, 6, 7, 13, 25
Title
Visual analogue scale (VAS) of neck pain and radiating arm pain
Description
Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Time Frame
Week 1, 2, 3, 4, 5, 6, 7, 13, 25
Title
Neck Disability Index (NDI)
Description
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).
Time Frame
Week 1, 7, 13, 25
Title
Northwick Park Questionnaire (NPQ)
Description
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.
Time Frame
Week 1, 7, 13, 25
Title
Patient Global Impression of Change (PGIC)
Description
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.)
Time Frame
Week 7, 13, 25
Title
Short Form-12 Health Survey version 2 (SF-12 v2)
Description
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Time Frame
Week 1, 7, 13, 25
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
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)
Time Frame
Week 1, 7, 13, 25
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
19-69 years old
participants who agreed and wrote informed consents
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, Ph.D.
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Dongguk University Bundang Oriental Hospital
City
Seoul
State/Province
Bundang-gu, Seongnam-si
ZIP/Postal Code
13601
Country
Korea, Republic of
Facility Name
Kyung Hee University Korean Medicine Hospital
City
Seoul
State/Province
Dongdaemun-gu
ZIP/Postal Code
130-701
Country
Korea, Republic of
Facility Name
Kyung Hee University Korean Medicine Hospital at Gangdong
City
Seoul
State/Province
Gangdong-gu
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi Province
ZIP/Postal Code
14598
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
ZIP/Postal Code
35262
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
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