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Active, Not Recruiting

NCT Number: NCT06591221

The Effectiveness of Chuna Maintenance Therapy for Chronic Bothersome Neck Pain

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neck Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bucheon Jaseng Hospital of Korean Medicine, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Aged 19 or older but under 70.
  • Neck pain with pain duration of 12 months or longer
  • NRS of neck pain over the past month is 2 or more but less than 4
  • Patients who have agreed to trial participation and provided written informed consent
  • Exclusion Criteria:
  • Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
  • Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
  • Patients whose pain is due to soft tissue disease not the spine (e.g. tumors, fibromyalgia, rheumatoid arthritis, gout)
  • 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)
  • Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
  • Pregnant patients or patients with plans of pregnancy or lactating patients
  • Patients within 3 months after cervical surgery
  • 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
  • Patients having difficult to completing the written informed consent
  • Patients who are deemed unsuitable by the researchers

Treatment and study plan

Chuna Maintenance Therapy

Procedure

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.

Primary outcomes

  1. NRS (Numeric rating scale)

    Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

    Ranging 0-10 likert scale (higher=worse)

  2. NDI (Neck disability index)

    Time frame: 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 outcomes

  1. VAS(Visual analogue scale) for pain

    Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

    Ranging 0-10cm scale (higher=worse)

  2. Number of days with bothersome neck pain

    Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

  3. Recurrence

    Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

  4. PGIC (Patient Global Impression of Change)

    Time frame: Wk 21, 25

    PGIC is a 7 point scale depicting a patient's rating of overall improvement (higher=worse)

  5. EQ-5D-5L( The 5-level EuroQol-5)

    Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

    5 items for self-rating of overall health (lower=worse)

  6. HINT-8 (health-related quality of life instrument-8)

    Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

    8 items for self-rating of overall health (lower=worse)

  7. Rating for Credibility and Expectancy of the treatment

    Time frame: Once at screening procedure

    Ranging 1-9 likert scale (higher=more credible, positive results are expected)

  8. Drug consumption history

    Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

    Whether medication was used (Y/N)

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

Evaluation of the Effectiveness of Manual Maintenance Therapy (Chuna Maintenance Therapy) for Chronic Bothersome Neck Pain : a Multi-centered, Pragmatic Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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