Chronic Neck PainNCT03009071
Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
A study testing Doin (conduction exercise) and Acupuncture in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Doin (conduction exercise) and Acupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Feb 2017to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Doin (conduction exercise), Acupuncture
- Keywords
- Neck Pain, Disability Evaluation, Costs and Cost Analysis, Doin Exercise Therapy, Acupuncture
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doin (conduction exercise)Procedure or surgery
Also called Doin Exercise, Do-in Exercise, 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.
AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Doin with Acupuncture | Experimental | 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. Receives: Procedure: Doin (conduction exercise); Device: Acupuncture |
| Acupuncture | Active comparator | 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). Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Northwick Park Neck Pain Questionnaire (NPQ)
Change in pain and functional disability questionnaire
Measured: 6 weeks from baseline
Secondary outcomes (11)
Northwick Park Neck Pain Questionnaire (NPQ)
Pain and functional disability questionnaire
Measured: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Numeric rating scale (NRS) of neck and arm pain
Pain scale
Measured: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
Visual analogue scale (VAS) of neck and arm pain
Pain scale
Measured: Baseline (Week 1), Week 2, 3, 4, 5, 6
Neck Disability Index (NDI)
Functional disability questionnaire
Measured: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
EuroQol-5 Dimension (EQ-5D)
Health-related quality of life questionnaire
Measured: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Patient Global Impression of Change (PGIC)
Global, patient-reported outcome
Measured: Week 4, 6, 9, 17, 29, 53
Short Form Health Survey 12 (SF-12)
Health-related quality of life questionnaire
Measured: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Cost per QALY (quality-adjusted life year)
Economic evaluation
Measured: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Cost per NRS
Economic evaluation
Measured: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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)
Measured: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Adverse events
Safety outcome
Measured: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start27 Feb 2017
- Primary completion23 Aug 2017
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, KMD, MPH, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009071
- Sponsor's protocol ID
- JS-CT-2016-18
- Status last verified
- Nov 2018
- First submitted
- 28 Dec 2016
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03009071
- Acronym / sponsor ID
- JS-CT-2016-18
- Conditions
- Chronic Neck Pain
- Keywords
- Neck Pain, Disability Evaluation, Costs and Cost Analysis, Doin Exercise Therapy, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doin with Acupuncture | Experimental | Procedure: Doin (conduction exercise), Device: AcupunctureAn 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. |
| Acupuncture | Active comparator | Device: AcupunctureAn 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). |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doin (conduction exercise)Also: Doin Exercise, Do-in Exercise, Conduction ExerciseDoin (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. | Procedure or surgery | Doin with Acupuncture |
| AcupunctureAcupuncture 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. | Device | Acupuncture, Doin with Acupuncture |
Primary outcome
Change in Northwick Park Neck Pain Questionnaire (NPQ)
Time frame: 6 weeks from baseline
Change in pain and functional disability questionnaire
11 secondary outcomes
Northwick Park Neck Pain Questionnaire (NPQ)
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Numeric rating scale (NRS) of neck and arm pain
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
Visual analogue scale (VAS) of neck and arm pain
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6
Neck Disability Index (NDI)
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
EuroQol-5 Dimension (EQ-5D)
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Patient Global Impression of Change (PGIC)
Time frame: Week 4, 6, 9, 17, 29, 53
Short Form Health Survey 12 (SF-12)
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Cost per QALY (quality-adjusted life year)
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Cost per NRS
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Drug Consumption
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Adverse events
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, KMD, MPH principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doin (conduction exercise) and Acupuncture in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Northwick Park Neck Pain Questionnaire (NPQ) (time frame: 6 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.