PCT of Pharmacopuncture for Chronic Neck Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain; Neck Pain

• Registration Number: NCT06520462
• Lead Sponsor: Jaseng Medical Foundation

Brief Summary

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 Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-09-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neck pain Numeric Rating Scale, NRS	Week 5	Change from baseline to Week 5 on the Numeric Rating Scale of neck pain

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change	Week 5,8,12	The subject's subjective improvement
Northwick Park Questionnaire	Week 1,5,8,12	A self-reported questionnaire consisting of 9 items related to the impact of neck pain on daily activities
Neck disability index	Week 1,5,8,12	The degree of neck disability in daily life
Health-related Quality of Life Instrument with 8 Items	Week 1,5,8,12	A tool developed to measure the health-related quality of life in Koreans
5-Level EuroQol-5 Dimension	Week 1,5,8,12	A tool that evaluates health status from multiple perspectives, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Neck and arm pain Numeric Rating Scale	Week 1,2,3,4,5,8,12	The pain intensity of neck and arm over the past week
Neck and arm pain Visual Analogue Scale	Week 1,2,3,4,5	The pain intensity of neck and arm over the past week
Adverse events	Week 1,2,3,4,5,8,12	An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study.

Trial Locations

Locations (6)

Kyung Hee University Korean Medicine Hospital; 🇰🇷 Seoul, Dongdaemun-gu, Korea, Republic of

Kyung Hee University Korean Medicine Hospital at Gangdong; 🇰🇷 Seoul, Gangdong-gu, Korea, Republic of

Dongguk University Bundang Oriental Hospital; 🇰🇷 Seongnam, GGyeonggi-do, Korea, Republic of

Bucheon Jaseng Hospital of Korean Medicine; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of

Haeundae Jaseng Hospital of Korean Medicine; 🇰🇷 Busan, Korea, Republic of

Daejeon Jaseng Hospital of Korean Medicine; 🇰🇷 Daejeon, Korea, Republic of