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

Chronic Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009071
• Other study ID #: JS-CT-2016-18
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

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)