Whiplash Injury of Cervical SpineNCT04113824
The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury
A study testing trapezuis motion style acupuncture treatment and other Korean medical treatment in people with Whiplash Injury of Cervical Spine and Neck Pain, Posterior, run by Jaseng Medical Foundation at 2 sites in South Korea.
Trial summary
This study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Whiplash Injury of Cervical Spine, Neck Pain, Posterior
- What is being tested?
- trapezuis motion style acupuncture treatment and other Korean medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 3 Jul 2019to 15 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
- Patients who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident
- Patients with NRS ≥ 5 for posterior neck pain
- Patients aged 19-70 years on the date they sign the consent form
- Patients who provide consent to participate in the trial and return the informed consent form
Who cannot join
- Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.
- Patients with progressive neurological deficits or with severe neurological symptoms
- Patients who have had surgery or procedures within the last three weeks
- The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
- Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
- Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
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- If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
- Patients who are pregnant or planning to become pregnant
- Patients with a serious mental illness
- Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
- Patients who are difficult to complete the research participation agreement
- Other patients whose participation in the trial is judged by a researcher to be problematic
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
Jaseng Medical Foundation
Seoul
About this study
Official title: The Efficacy and Safety of Trapezius MSAT on Inpatients With Acute Whiplash Injury Caused by Traffic Accidents: A Randomized Controlled Trials
This study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment
Read the detailed description
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.
So, we conducted a randomized controlled trials to verify the efficacy and safety of trapezuis MSAT. From July 2019 to September 2019, we collected 100 inpatients who were suffered from posterior nick pain with the numeric rating scale(NRS) over 4 after whiplash injury by acute traffic accident(TA). For experimental group(n=50), we conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except MSAT was conducted. For these two groups, we compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Nthe amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Neck Disability Index (NDI), and EuroQol 5-Dimension (EQ-5D).
- Being tested
- trapezuis motion style acupuncture treatment, other Korean medical treatment
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trapezuis motion style acupuncture treatmentProcedure or surgery
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation
other Korean medical treatmentProcedure or surgery
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
| Study group | Role | What they receive |
|---|---|---|
| trapezius motion style acupuncture treatment | Experimental | The MSAT group recieved 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience conducted the MSAT.
The MSAT group were also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Receives: Procedure: trapezuis motion style acupuncture treatment; Procedure: other Korean medical treatment |
| Korean medical treatment | Active comparator | The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Receives: Procedure: other Korean medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale(NRS) of neck pain
The extent of posterior neck pain and discomfort was assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their posterior neck pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: day 5
Secondary outcomes (9)
Visual Analogue Scale (VAS) of neck pain
VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end.
Measured: day 5
Visual Analogue Scale (VAS) of arm pain
VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end.
Measured: day 5
Numeric Rating Scale(NRS) of arm pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10.
Measured: day 5
Physical examination (Cervical range of motion)
ROM of flexion, extension, lateral flexion, rotation was measured.
Measured: day 5
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability.
Measured: day 5
EuroQol 5-Dimension (EQ-5D)
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, we will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
Measured: day 5
Patient Global Impression of Change (PGIC)
The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.
Measured: day 5
Drug Consumption
Check drug consumption change every visit
Measured: day 5
Adverse events
Check adverse events every visit
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start3 Jul 2019
- Primary completion7 Sep 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash Injury of Cervical SpineStudies 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
- Model description
- double blind, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 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, PhD, Study chair, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113824
- Sponsor's protocol ID
- JS-CT-2019-06
- Status last verified
- Mar 2020
- First submitted
- 1 Oct 2019
- Last updated
- 27 Mar 2020
- Results posted
- 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 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Trapezius MSAT on Inpatients With Acute Whiplash Injury Caused by Traffic Accidents: A Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT04113824
- Acronym / sponsor ID
- JS-CT-2019-06
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 7 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 3 Oct 2019 (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.
This study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment
Detailed description
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.
So, we conducted a randomized controlled trials to verify the efficacy and safety of trapezuis MSAT. From July 2019 to September 2019, we collected 100 inpatients who were suffered from posterior nick pain with the numeric rating scale(NRS) over 4 after whiplash injury by acute traffic accident(TA). For experimental group(n=50), we conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except MSAT was conducted. For these two groups, we compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Nthe amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Neck Disability Index (NDI), and EuroQol 5-Dimension (EQ-5D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| trapezius motion style acupuncture treatment | Experimental | Procedure: trapezuis motion style acupuncture treatment, Procedure: other Korean medical treatmentThe MSAT group recieved 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience conducted the MSAT. The MSAT group were also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. |
| Korean medical treatment | Active comparator | Procedure: other Korean medical treatmentThe control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident
- Patients with NRS ≥ 5 for posterior neck pain
- Patients aged 19-70 years on the date they sign the consent form
- Patients who provide consent to participate in the trial and return the informed consent form
Key exclusion criteria (12 listed)
- Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.
- Patients with progressive neurological deficits or with severe neurological symptoms
- Patients who have had surgery or procedures within the last three weeks
- The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
- Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
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 |
|---|---|---|
| trapezuis motion style acupuncture treatmentMotion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation | Procedure or surgery | trapezius motion style acupuncture treatment |
| other Korean medical treatmentacupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine | Procedure or surgery | Korean medical treatment, trapezius motion style acupuncture treatment |
Primary outcome
Numeric Rating Scale(NRS) of neck pain
Time frame: day 5
The extent of posterior neck pain and discomfort was assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their posterior neck pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
9 secondary outcomes
Visual Analogue Scale (VAS) of neck pain
Time frame: day 5
Visual Analogue Scale (VAS) of arm pain
Time frame: day 5
Numeric Rating Scale(NRS) of arm pain
Time frame: day 5
Physical examination (Cervical range of motion)
Time frame: day 5
Neck Disability Index (NDI)
Time frame: day 5
EuroQol 5-Dimension (EQ-5D)
Time frame: day 5
Patient Global Impression of Change (PGIC)
Time frame: day 5
Drug Consumption
Time frame: day 5
Adverse events
Time frame: day 5
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 27 Mar 2020.
- Individual participant dataSharing planned: No
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, PhD study chair
Jaseng Medical Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trapezuis motion style acupuncture treatment and other Korean medical treatment in people with Whiplash Injury of Cervical Spine and Neck Pain, Posterior, run by Jaseng Medical Foundation at 2 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 4 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 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Numeric Rating Scale(NRS) of neck pain (time frame: day 5). 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 27 Mar 2020.