search
Back to results

The 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 with acupuncture
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

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis)
  • Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
  • 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)
  • 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

  • Bucheon Jaseng Hospital of Korean Medicine
  • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon Jaseng Hospital of Korean Medicine
  • Jaseng Hospital of Korean Medicine
  • Kyung Hee University Oriental Medicine Hospital at Gangdong

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 a total 6-12 acupoints in the upper and middle trapezius areas (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 as indicated.

An acupuncture physician will administer acupuncture at a total 6-12 acupoints in the upper and middle trapezius areas (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

Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.

Secondary Outcome Measures

Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
The NDI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to neck pain.
Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
The NPQ evaluates functional impairment for the past 3 days in this study and is a patient reported outcome of subjective neck pain and pain reduction. The NPQ is a 9-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 5 levels, each representing a score of 0-4. Higher scores indicate greater limitation relating to neck pain.
Patient Global Impression of Change (PGIC)
PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
Physical examination
Pain upon movement in cervical range of motion (ROM) will be assessed.
Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters.
Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
SF-12 is a simplified version of SF-36. SF-12 assesses health-related quality of life (HRQoL) across 8 domains with 1-2 items per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Higher scores indicate better HRQoL.
Economic evaluation (medical costs)
Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
Economic evaluation (time-related costs)
Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
Economic evaluation (lost productivity costs)
Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
Credibility and Expectancy Questionnaire
The credibility and expectancy questionnaire will be used to assess treatment expectation on a 9-point Likert scale. Participants will be asked to select an answer to the following questions on their first visit of Week 1 (1='not at all'; and 5='somewhat'; to 9='very much'): "How much do you expect that treatment will alleviate your symptoms during the study period?"
Drug Consumption (drug type)
The drug type of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
Drug Consumption (drug dose)
The drug dose of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
Other treatments (treatment type)
The type of other treatments received (e.g. physical therapy, injections) will be recorded.
Other treatments (treatment frequency)
The frequency of other treatments received (e.g. physical therapy, injections) will be recorded.
Adverse events
Physicians will monitor and record any unexpected or unintended patient reaction to Chuna or usual care at each visit. Adverse events (AEs) associated with Chuna will include, but not be limited to, AEs anticipated from previous reports of manual therapy, and will stay open to all possibilities taking into consideration other potential, unknown AEs.

Full Information

First Posted
June 1, 2018
Last Updated
January 8, 2020
Sponsor
Jaseng Medical Foundation
Collaborators
Kyung Hee University Hospital at Gangdong
search

1. Study Identification

Unique Protocol Identification Number
NCT03558178
Brief Title
The 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 Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation
Collaborators
Kyung Hee University Hospital at Gangdong

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 multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain
Detailed Description
A multi-center randomized controlled, parallel, assessor-blinded full-scale trial will be conducted based on the results of the pilot study to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Doin with Acupuncture
Arm Type
Experimental
Arm Description
An acupuncture physician will administer acupuncture at a total 6-12 acupoints in the upper and middle trapezius areas (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 as indicated.
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
An acupuncture physician will administer acupuncture at a total 6-12 acupoints in the upper and middle trapezius areas (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 with acupuncture
Other Intervention Name(s)
Doin Exercise with acupuncture, Do-in Exercise with acupuncture, Conduction Exercise with acupuncture
Intervention Description
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 as indicated. Doin sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).
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 (total 10 sessions).
Primary Outcome Measure Information:
Title
Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
Description
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Time Frame
Week 5 post-baseline (screening)
Secondary Outcome Measure Information:
Title
Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Description
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Time Frame
Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
Title
Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
Description
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Description
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
Description
The NDI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to neck pain.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
Description
The NPQ evaluates functional impairment for the past 3 days in this study and is a patient reported outcome of subjective neck pain and pain reduction. The NPQ is a 9-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 5 levels, each representing a score of 0-4. Higher scores indicate greater limitation relating to neck pain.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Patient Global Impression of Change (PGIC)
Description
PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
Time Frame
Week 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Physical examination
Description
Pain upon movement in cervical range of motion (ROM) will be assessed.
Time Frame
Week 1, 6 post-baseline (screening)
Title
Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
Description
EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
Description
EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
Description
SF-12 is a simplified version of SF-36. SF-12 assesses health-related quality of life (HRQoL) across 8 domains with 1-2 items per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Higher scores indicate better HRQoL.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Economic evaluation (medical costs)
Description
Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Economic evaluation (time-related costs)
Description
Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
Time Frame
Week 2 post-baseline (screening)
Title
Economic evaluation (lost productivity costs)
Description
Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Credibility and Expectancy Questionnaire
Description
The credibility and expectancy questionnaire will be used to assess treatment expectation on a 9-point Likert scale. Participants will be asked to select an answer to the following questions on their first visit of Week 1 (1='not at all'; and 5='somewhat'; to 9='very much'): "How much do you expect that treatment will alleviate your symptoms during the study period?"
Time Frame
Week 1 post-baseline (screening)
Title
Drug Consumption (drug type)
Description
The drug type of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Drug Consumption (drug dose)
Description
The drug dose of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Other treatments (treatment type)
Description
The type of other treatments received (e.g. physical therapy, injections) will be recorded.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Other treatments (treatment frequency)
Description
The frequency of other treatments received (e.g. physical therapy, injections) will be recorded.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Adverse events
Description
Physicians will monitor and record any unexpected or unintended patient reaction to Chuna or usual care at each visit. Adverse events (AEs) associated with Chuna will include, but not be limited to, AEs anticipated from previous reports of manual therapy, and will stay open to all possibilities taking into consideration other potential, unknown AEs.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (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: Neck area pain duration of 6 months or longer Current Numeric Rating Scale (NRS) for neck area pain of 5 or higher Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent Exclusion Criteria: Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis) Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness) 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) 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, Ph.D
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
Country
Korea, Republic of
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
ZIP/Postal Code
06110
Country
Korea, Republic of
Facility Name
Kyung Hee University Oriental Medicine Hospital at Gangdong
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31079083
Citation
Lee SH, Lee J, Lee YJ, Kim MR, Cho JH, Kim KW, Ha IH. Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial. BMJ Open. 2019 May 10;9(5):e026632. doi: 10.1136/bmjopen-2018-026632.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs