PCT of Pharmacopuncture for Chronic Neck Pain

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neck Pain
• Intervention / Treatment: Procedure: Pharmacopuncture; Procedure: Acupuncture

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea
    • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon
    • Daejeon, Daejeon, South Korea, 35262
      • Daejeon Jaseng Hospital of Korean Medicine
  • Dongdaemun-gu
    • Seoul, Dongdaemun-gu, South Korea, 130-701
      • Kyung Hee University Korean Medicine Hospital
  • GGyeonggi-do
    • Seongnam, GGyeonggi-do, South Korea, 13601
      • Dongguk University Bundang Oriental Hospital
  • Gangdong-gu
    • Seoul, Gangdong-gu, South Korea, 05278
      • Kyung Hee University Korean Medicine Hospital at Gangdong
  • Gyeonggi Province
    • Bucheon-si, Gyeonggi Province, South Korea, 14598
      • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacopuncture group; 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.; 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; 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck pain Numeric Rating Scale, NRS	Change from baseline to Week 5 on the Numeric Rating Scale of neck pain	Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck and arm pain Numeric Rating Scale	The pain intensity of neck and arm over the past week	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	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	Week 1,5,8,12
Neck disability index	The degree of neck disability in daily life	Week 1,5,8,12
Patient Global Impression of Change	The subject's subjective improvement	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	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.	Week 1,5,8,12
Adverse events	An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study.	Week 1,2,3,4,5,8,12

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: In-Hyuk Ha, Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Neck Pain; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: JS-CT-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No