Chronic Neck PainNCT03558178
The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
A study testing Doin with acupuncture and Acupuncture in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 5 sites in South Korea.
Trial summary
A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain 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 with acupuncture and Acupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 6 Jul 2018to 5 Dec 2019
- 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
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do
Haeundae Jaseng Hospital of Korean Medicine
Busan
Daejeon Jaseng Hospital of Korean Medicine
Daejeon
Jaseng Hospital of Korean Medicine
Seoul, 06110
Kyung Hee University Oriental Medicine Hospital at Gangdong
Seoul
About this study
Official title: The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: A Multi-center Randomized Controlled Trial
A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain
Read the 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Doin with acupuncture, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doin with acupunctureProcedure or surgery
Also called Doin Exercise with acupuncture, Do-in Exercise with acupuncture, Conduction Exercise with acupuncture
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).
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 (total 10 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Doin with Acupuncture | Experimental | 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. Receives: Procedure: Doin with acupuncture; Device: Acupuncture |
| Acupuncture | Active comparator | 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). Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 5 post-baseline (screening)
Secondary outcomes (19)
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.
Measured: Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
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'.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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'.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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.
Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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.
Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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).
Measured: Week 6, Month 3, 6, 9, 12 post-baseline (screening)
Physical examination
Pain upon movement in cervical range of motion (ROM) will be assessed.
Measured: Week 1, 6 post-baseline (screening)
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).
Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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.
Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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.
Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Economic evaluation (medical costs)
Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Economic evaluation (time-related costs)
Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
Measured: Week 2 post-baseline (screening)
Economic evaluation (lost productivity costs)
Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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?"
Measured: Week 1 post-baseline (screening)
Drug Consumption (drug type)
The drug type of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Drug Consumption (drug dose)
The drug dose of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Other treatments (treatment type)
The type of other treatments received (e.g. physical therapy, injections) will be recorded.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Other treatments (treatment frequency)
The frequency of other treatments received (e.g. physical therapy, injections) will be recorded.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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.
Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start6 Jul 2018
- Primary completion8 Jan 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, KMD, Ph.D, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558178
- Sponsor's protocol ID
- JS-CT-2018-03
- Status last verified
- Jan 2020
- First submitted
- 1 Jun 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SM, Kim SJ, Nam D, Park YC, Kim EJ, Ha IH, Lee YJ. Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs. BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.
PubMed 39725423Lee 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.
PubMed 31079083
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. 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 Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03558178
- Acronym / sponsor ID
- JS-CT-2018-03
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- 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 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.
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 with acupuncture, Device: AcupunctureAn 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. |
| Acupuncture | Active comparator | Device: AcupunctureAn 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). |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 with acupunctureAlso: Doin Exercise with acupuncture, Do-in Exercise with acupuncture, Conduction Exercise with acupunctureDoin (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). | 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 (total 10 sessions). | Device | Acupuncture, Doin with Acupuncture |
Primary outcome
Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
Time frame: Week 5 post-baseline (screening)
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.
19 secondary outcomes
Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Time frame: Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Patient Global Impression of Change (PGIC)
Time frame: Week 6, Month 3, 6, 9, 12 post-baseline (screening)
Physical examination
Time frame: Week 1, 6 post-baseline (screening)
Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Economic evaluation (medical costs)
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Economic evaluation (time-related costs)
Time frame: Week 2 post-baseline (screening)
Economic evaluation (lost productivity costs)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Credibility and Expectancy Questionnaire
Time frame: Week 1 post-baseline (screening)
Drug Consumption (drug type)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Drug Consumption (drug dose)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Other treatments (treatment type)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Other treatments (treatment frequency)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Adverse events
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (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 13 Jan 2020.
- Derived from this study: PubMed 39725423Lee SM, Kim SJ, Nam D, Park YC, Kim EJ, Ha IH, Lee YJ. Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs. BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.
- Derived from this study: PubMed 31079083Lee 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.
- 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, Ph.D principal investigator
Jaseng Medical Foundation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doin with acupuncture and Acupuncture in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 5 sites 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 13 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline (time frame: Week 5 post-baseline (screening)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558178, which also lists 2 linked publications.
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 13 Jan 2020.