Clinical trial NCT06520462: PCT of Pharmacopuncture for Chronic Neck Pain
Official title: Clinical Research of Comparative Effectiveness of Pharmacopuncture Therapy and Acupuncture Therapy for Chronic Neck Pain: A Pragmatic Randomized Strategy Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Chronic Pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Neck pain Numeric Rating Scale, NRS
timeFrame: Week 5
Secondary outcomes:
measure: Neck and arm pain Numeric Rating Scale
timeFrame: Week 1,2,3,4,5,8,12
measure: Neck and arm pain Visual Analogue Scale
timeFrame: Week 1,2,3,4,5
measure: Northwick Park Questionnaire
timeFrame: Week 1,5,8,12
measure: Neck disability index
timeFrame: Week 1,5,8,12
measure: Patient Global Impression of Change
timeFrame: Week 5,8,12
measure: Health-related Quality of Life Instrument with 8 Items
timeFrame: Week 1,5,8,12
measure: 5-Level EuroQol-5 Dimension
timeFrame: Week 1,5,8,12
measure: Adverse events
timeFrame: Week 1,2,3,4,5,8,12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital at Gangdong
state: Gangdong-gu
city: Seongnam
country: Korea, Republic of
facility: Dongguk University Bundang Oriental Hospital
state: GGyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha
role: STUDY_DIRECTOR
References: