Cervical Disc HerniationNCT05240586
Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
A study testing pharmacopuncture therapy, acupuncture therapy and physical therapy, medication(prn) in people with Cervical Disc Herniation, run by Jaseng Medical Foundation at 7 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- pharmacopuncture therapy, acupuncture therapy and physical therapy, medication(prn)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 20 Apr 2022to 26 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
Haeundae Jaseng Hospital of Korean Medicine
Busan
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, 13601
Kyung Hee University Korean Medicine Hospital
Seoul, Dongdaemun-gu, 130-701
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, 05278
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: 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.
Read the 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
- Being tested
- pharmacopuncture therapy, acupuncture therapy, physical therapy, medication(prn)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacopuncture therapyProcedure or surgery
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
acupuncture therapyProcedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| pharmacopunture therapy | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions. Receives: Procedure: pharmacopuncture therapy |
| acupuncture therapy | Active comparator | The physicians will choose the type and number of acupuncture therapy according to participants' conditions. Receives: 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. Receives: Procedure: physical therapy, medication(prn) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
Secondary outcomes (7)
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'.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.)
Measured: 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.
Measured: 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)
Measured: Week 1, 7, 13, 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start20 Apr 2022
- Primary completion26 May 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, Ph.D., Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240586
- Sponsor's protocol ID
- JS-CT-2021-13
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
- ClinicalTrials.gov ID
- NCT05240586
- Acronym / sponsor ID
- JS-CT-2021-13
- Conditions
- Cervical Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pharmacopunture therapy | Experimental | Procedure: pharmacopuncture therapyThe physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
| acupuncture therapy | Active comparator | Procedure: acupuncture therapyThe physicians will choose the type and number of acupuncture therapy according to participants' conditions. |
| physical therapy, medication(prn) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacopuncture therapyThis is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions. | Procedure or surgery | pharmacopunture therapy |
| acupuncture therapyThis is a pragmatic RCT, so the physicians will choose the type and number of acupuncture therapy according to participants' conditions. | Procedure or surgery | acupuncture therapy |
| 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. | Procedure or surgery | physical therapy, medication(prn) |
Primary outcome
Numeric rating scale (NRS) of neck pain
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
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'.
7 secondary outcomes
Numeric rating scale (NRS) of radiating arm pain
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
Visual analogue scale (VAS) of neck pain and radiating arm pain
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
Neck Disability Index (NDI)
Time frame: Week 1, 7, 13, 25
Northwick Park Questionnaire (NPQ)
Time frame: Week 1, 7, 13, 25
Patient Global Impression of Change (PGIC)
Time frame: Week 7, 13, 25
Short Form-12 Health Survey version 2 (SF-12 v2)
Time frame: Week 1, 7, 13, 25
EuroQol-5 Dimension (EQ-5D-5L)
Time frame: Week 1, 7, 13, 25
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, Ph.D. study director
Jaseng Medical Foundation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacopuncture therapy, acupuncture therapy and physical therapy, medication(prn) in people with Cervical Disc Herniation, run by Jaseng Medical Foundation at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) of neck pain (time frame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.