PCT of Pharmacopuncture for Chronic Neck Pain

NCT06520462 | Completed

• 1 other identifier: JS-CT-2024-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Neck Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Neck pain Numeric Rating Scale, NRS

  Change from baseline to Week 5 on the Numeric Rating Scale of neck pain

  Week 5

Secondary Outcomes (8)

• Neck and arm pain Numeric Rating Scale

  Week 1,2,3,4,5,8,12

• Neck and arm pain Visual Analogue Scale

  Week 1,2,3,4,5

• Northwick Park Questionnaire

  Week 1,5,8,12

• Neck disability index

  Week 1,5,8,12

• Patient Global Impression of Change

  Week 5,8,12

Study Arms (2)

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.

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.

Procedure: Acupuncture

Interventions

Pharmacopuncture 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.

Pharmacopuncture group

Acupuncture 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.

Acupuncture group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (6)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, Daejeon, 35262, South Korea

Location

Kyung Hee University Korean Medicine Hospital

Seoul, Dongdaemun-gu, 130-701, South Korea

Location

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

Location

Dongguk University Bundang Oriental Hospital

Seongnam, GGyeonggi-do, 13601, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• In-Hyuk Ha

  Jaseng Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 25, 2024
• Study Start: September 11, 2024
• Primary Completion: April 4, 2025
• Study Completion: November 10, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)