Neck Pain, Chronic Pain
Conditions
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).
Interventions
PROCEDUREPharmacopuncture
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.
PROCEDUREAcupuncture
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.
Sponsors
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck pain Numeric Rating Scale, NRS | Week 5 | Change from baseline to Week 5 on the Numeric Rating Scale of neck pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
| Patient Global Impression of Change | Week 5,8,12 | The subject's subjective improvement |
| Neck disability index | Week 1,5,8,12 | The degree of neck disability in daily life |
Countries
South Korea
Contacts
STUDY_DIRECTORIn-Hyuk Ha
Jaseng Medical Foundation
Outcome results
None listed