Chronic Pain, Neck Pain
Conditions
Keywords
Chuna therapy, Manual therapy, Chronic neck pain
Brief summary
This study is a pragmatic randomized controlled study that assessed 250 subjects complaining of chronic bothersome neck pain with mild discomfort in a 1:1 ratio: chuna maintenance therapy group (125 subjects, 1 time/2 weeks, total 20 weeks) and lifestyle management & self-exercise group (125 subjects, exercise method education 1 time/4 weeks, total 20 weeks).
Interventions
PROCEDUREChuna Maintenance Therapy
it is conducted every two weeks for a total of 20 weeks for individuals. The technique follows the guidelines of the Society of Chuna Manual Medicine and is based on Chuna Medicine (2.5th edition), which is utilized as a textbook in Korean Medicine colleges. The treatment is selectively administered based on the clinical judgment of the practitioner.
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
* Inclusion Criteria: 1. Aged 19 or older but under 70. 2. Neck pain with pain duration of 12 months or longer 3. NRS of neck pain over the past month is 2 or more but less than 4 4. Patients who have agreed to trial participation and provided written informed consent *
Exclusion criteria
1. Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation) 2. Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury 3. Patients whose pain is due to soft tissue disease not the spine (e.g. tumors, fibromyalgia, rheumatoid arthritis, gout) 4. Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcome (e.g. stroke and myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy) 5. Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results 6. Pregnant patients or patients with plans of pregnancy or lactating patients 7. Patients within 3 months after cervical surgery 8. Patients with experience of participating in another clinical study within 1 month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the participation date 9. Patients having difficult to completing the written informed consent 10. Patients who are deemed unsuitable by the researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS (Numeric rating scale) | Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 | Ranging 0-10 likert scale (higher=worse) |
| NDI (Neck disability index) | Wk 1, 5, 9, 13, 17, 21, 25 | Each of the 10 items scores from 0 to 5, The maximum score is 50 (higher=worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS(Visual analogue scale) for pain | Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 | Ranging 0-10cm scale (higher=worse) |
| Number of days with bothersome neck pain | Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 | — |
| Recurrence | Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 | — |
| PGIC (Patient Global Impression of Change) | Wk 21, 25 | PGIC is a 7 point scale depicting a patient's rating of overall improvement (higher=worse) |
| EQ-5D-5L( The 5-level EuroQol-5) | Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 | 5 items for self-rating of overall health (lower=worse) |
| HINT-8 (health-related quality of life instrument-8) | Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 | 8 items for self-rating of overall health (lower=worse) |
| Rating for Credibility and Expectancy of the treatment | Once at screening procedure | Ranging 1-9 likert scale (higher=more credible, positive results are expected) |
| Drug consumption history | Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 | Whether medication was used (Y/N) |
Countries
South Korea
Outcome results
None listed