Clinical trial NCT06591221: The Effectiveness of Chuna Maintenance Therapy for Chronic Bothersome Neck Pain
Official title: Evaluation of the Effectiveness of Manual Maintenance Therapy (Chuna Maintenance Therapy) for Chronic Bothersome Neck Pain : a Multi-centered, Pragmatic Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Chronic Pain
Keywords: Chuna therapy
Manual therapy
Chronic neck pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 250
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: 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).


Eligibility 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

Primary outcomes:
measure: NRS (Numeric rating scale)
timeFrame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
measure: NDI (Neck disability index)
timeFrame: Wk 1, 5, 9, 13, 17, 21, 25
Secondary outcomes:
measure: VAS(Visual analogue scale) for pain
timeFrame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
measure: Number of days with bothersome neck pain
timeFrame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
measure: Recurrence
timeFrame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
measure: PGIC (Patient Global Impression of Change)
timeFrame: Wk 21, 25
measure: EQ-5D-5L( The 5-level EuroQol-5)
timeFrame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
measure: HINT-8 (health-related quality of life instrument-8)
timeFrame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
measure: Rating for Credibility and Expectancy of the treatment
timeFrame: Once at screening procedure
measure: Drug consumption history
timeFrame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
city: Haeundae
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Seoul
country: Korea, Republic of
facility: College of Korean Medicine, Kyung Hee University
city: Seoul
country: Korea, Republic of
facility: Department of Acupuncture &amp;amp; Moxibustion Medicine, College of Korean Medicine, Kyung Hee University
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
city: Yangsan
country: Korea, Republic of
facility: School of Korean Medicine, Pusan National University
Study officials:
References: