Neck PainNCT06520462
PCT of Pharmacopuncture for Chronic Neck Pain
A study testing Pharmacopuncture and Acupuncture in people with Neck Pain and Chronic Pain, run by Jaseng Medical Foundation at 6 sites in South Korea.
Trial summary
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Pharmacopuncture and Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 11 Sep 2024to 10 Nov 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neck pain persisting for more than 3 months
- Patients with a Numeric Rating Scale (NRS) score of 5 or higher for neck pain
- Patients aged between 19 and 70 years
- Patients who agree to participate in the clinical study and provide a written informed consent form
Who cannot join
- Patients diagnosed with serious specific diseases that could be the cause of neck pain (e.g., spinal metastasis of tumors, acute fractures, and spinal dislocations)
- Patients exhibiting progressive neurological deficits or severe neurological symptoms
- Patients whose pain originates from soft tissue disorders rather than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout)
- Patients with other chronic diseases that could interfere with the interpretation of treatment effects or outcomes (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
- Patients currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that could affect the study results
- Patients for whom pharmacopuncture treatment is inappropriate or unsafe: those with bleeding disorders, those undergoing anticoagulant therapy, and severe diabetic patients with infection risks
Show all 12Show fewer
- Patients who have taken medications that could affect pain (e.g., Non-Steroidal Anti-Inflammatory Drugs, NSAIDs) or received pharmacopuncture, acupuncture, or physical therapy within the past week
- Pregnant women, those planning to become pregnant, or those currently breastfeeding
- Patients who have undergone cervical spine surgery within the past 3 months
- Patients who have not completed participation in another clinical study within the past month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection
- Patients who find it difficult to provide informed consent for participation
- Other cases where the researcher deems participation in the clinical study to be difficult
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 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, Daejeon, 35262
Dongguk University Bundang Oriental Hospital
Seongnam, GGyeonggi-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
About this study
Official title: Clinical Research of Comparative Effectiveness of Pharmacopuncture Therapy and Acupuncture Therapy for Chronic Neck Pain: A Pragmatic Randomized Strategy Comparative Clinical Trial
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain
Read the detailed description
This study aims to confirm the comparative effectiveness of pharmacopuncture by conducting a pragmatic randomized controlled clinical trial with 128 patients suffering from chronic neck pain. The trial will compare patients treated with a pharmacopuncture-based strategy (64 patients) to those treated with an acupuncture-based strategy (64 patients). As this is a pragmatic clinical trial, participants will be randomly assigned to either the pharmacopuncture or acupuncture groups. However, the specific methods of pharmacopuncture and acupuncture to be used will not be predetermined. Instead, they will be determined based on the clinical judgment of the traditional Korean medicine doctor according to the patient's condition. All methods used will be recorded in the CRF (Case Report Form).
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Pharmacopuncture, Acupuncture
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacopunctureProcedure or surgery
The physicians will decide the specific methods of pharmacopuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.
AcupunctureProcedure or surgery
The physicians will decide the specific methods of acupuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacopuncture group | Experimental | 1. Acupoints: The selection of acupoints, depth of insertion, and other procedural details are determined based on the clinical judgment of the physicians according to the participant's symptoms, diagnostic imaging, and degree of improvement. Acupoints may include GB20, GB21, BL11, and EX-B2. However, these acupoints are not restrictive; any acupoints used for the treatment of chronic neck pain will be documented.
2. Pharmacopuncture: The type and dosage of the pharmacopuncture solution used during treatment will be selected based on the clinical judgment of the physicians performing the pharmacopuncture. The types of pharmacopuncture solutions and the total amount administered will be recorded. The choice will be based on the participant's symptoms and the clinical judgment within the range of pharmacopuncture solutions currently used in clinical practice at the trial institution, without adding new solutions specifically for this study. Receives: Procedure: Pharmacopuncture |
| Acupuncture group | Active comparator | The selection of acupoints, depth of insertion, and other procedural details are to be determined based on the clinical judgment of the physicians according to the participant's symptoms, diagnostic imaging, and degree of improvement. Acupoints may include sites such as GB21, SI9, GB20, GV14, and distal points like SI3. The number of needles used can range from 5 to 30. All acupoints treated during the procedure are to be documented. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain Numeric Rating Scale, NRS
Change from baseline to Week 5 on the Numeric Rating Scale of neck pain
Measured: Week 5
Secondary outcomes (8)
Neck and arm pain Numeric Rating Scale
The pain intensity of neck and arm over the past week
Measured: Week 1,2,3,4,5,8,12
Neck and arm pain Visual Analogue Scale
The pain intensity of neck and arm over the past week
Measured: Week 1,2,3,4,5
Northwick Park Questionnaire
A self-reported questionnaire consisting of 9 items related to the impact of neck pain on daily activities
Measured: Week 1,5,8,12
Neck disability index
The degree of neck disability in daily life
Measured: Week 1,5,8,12
Patient Global Impression of Change
The subject's subjective improvement
Measured: Week 5,8,12
Health-related Quality of Life Instrument with 8 Items
A tool developed to measure the health-related quality of life in Koreans
Measured: Week 1,5,8,12
5-Level EuroQol-5 Dimension
A tool that evaluates health status from multiple perspectives, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Week 1,5,8,12
Adverse events
An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study.
Measured: Week 1,2,3,4,5,8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start11 Sep 2024
- Primary completion4 Apr 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520462
- Sponsor's protocol ID
- JS-CT-2024-01
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Comparative Effectiveness of Pharmacopuncture Therapy and Acupuncture Therapy for Chronic Neck Pain: A Pragmatic Randomized Strategy Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06520462
- Acronym / sponsor ID
- JS-CT-2024-01
- Conditions
- Neck Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 25 Jul 2024 (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.
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain
Detailed description
This study aims to confirm the comparative effectiveness of pharmacopuncture by conducting a pragmatic randomized controlled clinical trial with 128 patients suffering from chronic neck pain. The trial will compare patients treated with a pharmacopuncture-based strategy (64 patients) to those treated with an acupuncture-based strategy (64 patients). As this is a pragmatic clinical trial, participants will be randomly assigned to either the pharmacopuncture or acupuncture groups. However, the specific methods of pharmacopuncture and acupuncture to be used will not be predetermined. Instead, they will be determined based on the clinical judgment of the traditional Korean medicine doctor according to the patient's condition. All methods used will be recorded in the CRF (Case Report Form).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacopuncture group | Experimental | Procedure: Pharmacopuncture1. Acupoints: The selection of acupoints, depth of insertion, and other procedural details are determined based on the clinical judgment of the physicians according to the participant's symptoms, diagnostic imaging, and degree of improvement. Acupoints may include GB20, GB21, BL11, and EX-B2. However, these acupoints are not restrictive; any acupoints used for the treatment of chronic neck pain will be documented. 2. Pharmacopuncture: The type and dosage of the pharmacopuncture solution used during treatment will be selected based on the clinical judgment of the physicians performing the pharmacopuncture. The types of pharmacopuncture solutions and the total amount administered will be recorded. The choice will be based on the participant's symptoms and the clinical judgment within the range of pharmacopuncture solutions currently used in clinical practice at the trial institution, without adding new solutions specifically for this study. |
| Acupuncture group | Active comparator | Procedure: AcupunctureThe selection of acupoints, depth of insertion, and other procedural details are to be determined based on the clinical judgment of the physicians according to the participant's symptoms, diagnostic imaging, and degree of improvement. Acupoints may include sites such as GB21, SI9, GB20, GV14, and distal points like SI3. The number of needles used can range from 5 to 30. All acupoints treated during the procedure are to be documented. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with neck pain persisting for more than 3 months
- Patients with a Numeric Rating Scale (NRS) score of 5 or higher for neck pain
- Patients aged between 19 and 70 years
- Patients who agree to participate in the clinical study and provide a written informed consent form
Key exclusion criteria (12 listed)
- Patients diagnosed with serious specific diseases that could be the cause of neck pain (e.g., spinal metastasis of tumors, acute fractures, and spinal dislocations)
- Patients exhibiting progressive neurological deficits or severe neurological symptoms
- Patients whose pain originates from soft tissue disorders rather than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout)
- Patients with other chronic diseases that could interfere with the interpretation of treatment effects or outcomes (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
- Patients currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that could affect the study results
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 |
|---|---|---|
| PharmacopunctureThe physicians will decide the specific methods of pharmacopuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms. | Procedure or surgery | Pharmacopuncture group |
| AcupunctureThe physicians will decide the specific methods of acupuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms. | Procedure or surgery | Acupuncture group |
Primary outcome
Neck pain Numeric Rating Scale, NRS
Time frame: Week 5
Change from baseline to Week 5 on the Numeric Rating Scale of neck pain
8 secondary outcomes
Neck and arm pain Numeric Rating Scale
Time frame: Week 1,2,3,4,5,8,12
Neck and arm pain Visual Analogue Scale
Time frame: Week 1,2,3,4,5
Northwick Park Questionnaire
Time frame: Week 1,5,8,12
Neck disability index
Time frame: Week 1,5,8,12
Patient Global Impression of Change
Time frame: Week 5,8,12
Health-related Quality of Life Instrument with 8 Items
Time frame: Week 1,5,8,12
5-Level EuroQol-5 Dimension
Time frame: Week 1,5,8,12
Adverse events
Time frame: Week 1,2,3,4,5,8,12
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 11 Feb 2026.
- Individual participant dataSharing planned: No
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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 study director
Jaseng Medical Foundation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacopuncture and Acupuncture in people with Neck Pain and Chronic Pain, run by Jaseng Medical Foundation at 6 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 4 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Neck pain Numeric Rating Scale, NRS (time frame: Week 5). 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 11 Feb 2026.