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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03009071
Other study ID # JS-CT-2016-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 27, 2017
Est. completion date August 22, 2018

Study information

Verified date November 2018
Source Jaseng Medical Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 22, 2018
Est. primary completion date August 23, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Doin (conduction exercise)
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.
Device:
Acupuncture
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.

Locations

Country Name City State
Korea, Republic of Jaseng Medical Foundation Seoul

Sponsors (1)

Lead Sponsor Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Northwick Park Neck Pain Questionnaire (NPQ) Change in pain and functional disability questionnaire 6 weeks from baseline
Secondary Northwick Park Neck Pain Questionnaire (NPQ) Pain and functional disability questionnaire Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Secondary Numeric rating scale (NRS) of neck and arm pain Pain scale Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
Secondary Visual analogue scale (VAS) of neck and arm pain Pain scale Baseline (Week 1), Week 2, 3, 4, 5, 6
Secondary Neck Disability Index (NDI) Functional disability questionnaire Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Secondary EuroQol-5 Dimension (EQ-5D) Health-related quality of life questionnaire Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Secondary Patient Global Impression of Change (PGIC) Global, patient-reported outcome Week 4, 6, 9, 17, 29, 53
Secondary Short Form Health Survey 12 (SF-12) Health-related quality of life questionnaire Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Secondary Cost per QALY (quality-adjusted life year) Economic evaluation Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Secondary Cost per NRS Economic evaluation Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Secondary Drug Consumption Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy) Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Secondary Adverse events Safety outcome Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
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