PCT of Pharmacopuncture for Chronic Neck Pain

NCT ID: NCT06520462

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-11

Study Completion Date

2025-12-31

Brief Summary

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A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain

Detailed Description

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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

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Neck Pain Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pharmacopuncture group

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.

Group Type EXPERIMENTAL

Pharmacopuncture

Intervention Type PROCEDURE

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.

Acupuncture group

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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.

Interventions

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Pharmacopuncture

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.

Intervention Type PROCEDURE

Acupuncture

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with neck pain persisting for more than 3 months
2. Patients with a Numeric Rating Scale (NRS) score of 5 or higher for neck pain
3. Patients aged between 19 and 70 years
4. Patients who agree to participate in the clinical study and provide a written informed consent form

Exclusion Criteria

1. 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)
2. Patients exhibiting progressive neurological deficits or severe neurological symptoms
3. Patients whose pain originates from soft tissue disorders rather than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout)
4. 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)
5. Patients currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that could affect the study results
6. Patients for whom pharmacopuncture treatment is inappropriate or unsafe: those with bleeding disorders, those undergoing anticoagulant therapy, and severe diabetic patients with infection risks
7. 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
8. Pregnant women, those planning to become pregnant, or those currently breastfeeding
9. Patients who have undergone cervical spine surgery within the past 3 months
10. 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
11. Patients who find it difficult to provide informed consent for participation
12. Other cases where the researcher deems participation in the clinical study to be difficult
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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In-Hyuk Ha

Role: STUDY_DIRECTOR

Jaseng Medical Foundation

Locations

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Kyung Hee University Korean Medicine Hospital

Seoul, Dongdaemun-gu, South Korea

Site Status RECRUITING

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, Gangdong-gu, South Korea

Site Status RECRUITING

Dongguk University Bundang Oriental Hospital

Seongnam, GGyeonggi-do, South Korea

Site Status RECRUITING

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, South Korea

Site Status RECRUITING

Haeundae Jaseng Hospital of Korean Medicine

Busan, , South Korea

Site Status RECRUITING

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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In-Hyuk Ha, Dr

Role: CONTACT

1577-0007

Facility Contacts

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Dongwoo Nam, Professor

Role: primary

Yeoncheol Park, Professor

Role: primary

Eunjung Kim, Professor

Role: primary

Yeonsun Lee, KMD, M.Sc.

Role: primary

01034466314

Hyun-Woo Cho, KMD

Role: primary

Sunah Kim, KMD

Role: primary

+82-42-1577-0007

Other Identifiers

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JS-CT-2024-01

Identifier Type: -

Identifier Source: org_study_id

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