CompletedNot Applicable

The Efficacy and Safety of Non-resistance Manual Therapy in Inpatients With Acute Neck Pain Caused by Traffic Accidents: a Randomised Controlled Trial

South Korea120 participantsStarted 2020-11-30

Plain-language summary

Non-resistance therapy is a combination of muscle compression relaxation technique and joint mobilization in patients with acute neck pain caused by traffic accidents. This study is to evaluate the effectiveness and safety of non-resistance therapy for pain and function problems in patients complaining of acute neck pain induced by traffic accidents. So, investigators conduct a randomized controlled trials to verify the effectiveness and safety of non-resistance therapy. From December 2020 to May 2021, investigators recruit 120 inpatients who are suffered from acute neck pain with the numeric rating scale(NRS) over 5 by traffic accident(TA). The Korean medical treatment group(n=60) receives daily acupuncture, herbal medicine, and chuna treatment as inpatient treatment from hospitalization until discharge. For the non-resistance therapy group(n=60), the korean medical treatment is performed in the same manner, but additional non-resistance therapy is performed once a day from the 2nd day to the 5th day of hospitalization. Baseline is the time point before treatment for non-resistance therapy on the second day of hospitalization, and the primary endpoint is the time point after treatment on the 5th day (v5) after hospitalization. For these two groups, investigators compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of Motion(ROM), Neck Disability Index(NDI), the 12-Item Short Form Health Survey(SF-12), and PTSD Checklist for DSM(Diagnostic and Statistical Manual of Mental Disorders, DSM)-5(PCL-5).

Who can participate

Age range

19 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 19-70 years on the date they sign the consent form * Patients with NRS ≥ 5 for neck pain * Patients who needs hospitalization due to acute neck pain that occurred within 7 days after traffic accident * Patients who provide consent to participate in the trial and return the informed consent form Exclusion Criteria: * Patients with a specific serious disease that may cause acute neck pain: malignancy, fracture of lumbar spine, etc. * Patients with progressive neurological deficits or with severe neurological symptoms * 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 * Patients who are pregnant, planning to become pregnant, or are breastfeeding * Patients who have had surgery or procedures of cervical spine within the last three weeks * Patients with a serious mental illness * Patients who has not passed one month since the end of participation in other clinical studies, or plan to participate in other clinical studies during the study participation and follow-up period within 12 weeks * Patients who are difficult to complete the rese…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numeric Rating Scale(NRS) of neck pain

Timeframe: Change from baseline NRS at 5 days

Trial details

NCT IDNCT04660175

SponsorJaseng Medical Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-13

View on ClinicalTrials.gov More Whiplash Injury of Cervical Spine trials