Skip to main content
OpenTrials
Completed

NCT Number: NCT03009071

Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain

A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaseng Medical Foundation

Seoul, South Korea

About this study

A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed by pain and functional disability scales, monitor its safety, and assess the feasibility of and serve as the basis for a full-scale, multicenter trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Onset of at least 6 months previous for neck area pain
  • Current neck area pain of Numeric Rating Scale (NRS) 5 or higher
  • Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent

Exclusion criteria

  • Pathologies of non-spinal or soft tissue origin or high severity which may cause neck or radiating arm pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis, fibromyalgia, rheumatic arthritis, gout)
  • Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
  • Other chronic diseases which may interfere with treatment effect or interpretation of results (e.g. cardiovascular disorder, renal disease, diabetic neuropathy, dementia, epilepsy)
  • Current intake of steroids, immunosuppressant medicine, psychiatric medicine or other medication which may interfere with treatment results
  • Patients considered unsuitable or unsafe to receive acupuncture (e.g. patients with hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, severe diabetes with high risk of infection, severe cardiovascular diseases)
  • Patients who were treated with invasive interventions such as acupuncture or injections, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
  • History of cervical surgery within the past 3 months
  • Pregnancy or plans of pregnancy
  • Severe psychopathy
  • Participation in other clinical studies
  • Inability to give written informed consent
  • Other reasons rendering trial participation inappropriate as judged by the researchers

Treatment and study plan

Doin (conduction exercise)

Procedure

Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability. Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.

Other names: Doin Exercise, Do-in Exercise, Conduction Exercise

acupuncture

Device

Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.

Primary outcomes

  1. Change in Northwick Park Neck Pain Questionnaire (NPQ)

    Time frame: 6 weeks from baseline

    Change in pain and functional disability questionnaire

Secondary outcomes

  1. Northwick Park Neck Pain Questionnaire (NPQ)

    Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

    Pain and functional disability questionnaire

  2. Numeric rating scale (NRS) of neck and arm pain

    Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53

    Pain scale

  3. Visual analogue scale (VAS) of neck and arm pain

    Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6

    Pain scale

  4. Neck Disability Index (NDI)

    Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

    Functional disability questionnaire

  5. EuroQol-5 Dimension (EQ-5D)

    Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

    Health-related quality of life questionnaire

  6. Patient Global Impression of Change (PGIC)

    Time frame: Week 4, 6, 9, 17, 29, 53

    Global, patient-reported outcome

  7. Short Form Health Survey 12 (SF-12)

    Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

    Health-related quality of life questionnaire

  8. Cost per QALY (quality-adjusted life year)

    Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

    Economic evaluation

  9. Cost per NRS

    Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

    Economic evaluation

  10. Drug Consumption

    Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)

    Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)

  11. Adverse events

    Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)

    Safety outcome

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 4, 2017
Registry last updated
Nov 7, 2018

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.

Published trials that share one or more normalized conditions with this study.