search
Back to results

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

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Doin (conduction exercise)
Acupuncture
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Neck Pain, Disability Evaluation, Costs and Cost Analysis, Doin Exercise Therapy, Acupuncture

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jaseng Medical Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Doin with Acupuncture

Acupuncture

Arm Description

An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise (rotation) as needed.

An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels).

Outcomes

Primary Outcome Measures

Change in Northwick Park Neck Pain Questionnaire (NPQ)
Change in pain and functional disability questionnaire

Secondary Outcome Measures

Northwick Park Neck Pain Questionnaire (NPQ)
Pain and functional disability questionnaire
Numeric rating scale (NRS) of neck and arm pain
Pain scale
Visual analogue scale (VAS) of neck and arm pain
Pain scale
Neck Disability Index (NDI)
Functional disability questionnaire
EuroQol-5 Dimension (EQ-5D)
Health-related quality of life questionnaire
Patient Global Impression of Change (PGIC)
Global, patient-reported outcome
Short Form Health Survey 12 (SF-12)
Health-related quality of life questionnaire
Cost per QALY (quality-adjusted life year)
Economic evaluation
Cost per NRS
Economic evaluation
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)
Adverse events
Safety outcome

Full Information

First Posted
December 28, 2016
Last Updated
November 6, 2018
Sponsor
Jaseng Medical Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03009071
Brief Title
Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
Official Title
The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
August 23, 2017 (Actual)
Study Completion Date
August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Neck Pain, Disability Evaluation, Costs and Cost Analysis, Doin Exercise Therapy, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doin with Acupuncture
Arm Type
Experimental
Arm Description
An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise (rotation) as needed.
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels).
Intervention Type
Procedure
Intervention Name(s)
Doin (conduction exercise)
Other Intervention Name(s)
Doin Exercise, Do-in Exercise, Conduction Exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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 Outcome Measure Information:
Title
Change in Northwick Park Neck Pain Questionnaire (NPQ)
Description
Change in pain and functional disability questionnaire
Time Frame
6 weeks from baseline
Secondary Outcome Measure Information:
Title
Northwick Park Neck Pain Questionnaire (NPQ)
Description
Pain and functional disability questionnaire
Time Frame
Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Title
Numeric rating scale (NRS) of neck and arm pain
Description
Pain scale
Time Frame
Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
Title
Visual analogue scale (VAS) of neck and arm pain
Description
Pain scale
Time Frame
Baseline (Week 1), Week 2, 3, 4, 5, 6
Title
Neck Disability Index (NDI)
Description
Functional disability questionnaire
Time Frame
Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Title
EuroQol-5 Dimension (EQ-5D)
Description
Health-related quality of life questionnaire
Time Frame
Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Title
Patient Global Impression of Change (PGIC)
Description
Global, patient-reported outcome
Time Frame
Week 4, 6, 9, 17, 29, 53
Title
Short Form Health Survey 12 (SF-12)
Description
Health-related quality of life questionnaire
Time Frame
Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Title
Cost per QALY (quality-adjusted life year)
Description
Economic evaluation
Time Frame
Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Title
Cost per NRS
Description
Economic evaluation
Time Frame
Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Title
Drug Consumption
Description
Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)
Time Frame
Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Title
Adverse events
Description
Safety outcome
Time Frame
Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, KMD, MPH
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Medical Foundation
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs