Clinical trial NCT04660175: The Efficacy and Safety of Non-resistance Manual Therapy in Inpatients With Acute Neck Pain Caused by Traffic Accidents: a Randomised Controlled Trial
Official title: The Efficacy and Safety of Non-resistance Manual Therapy in Inpatients With Acute Neck Pain Caused by Traffic Accidents: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash Injury of Cervical Spine
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic

Primary outcomes:
measure: Numeric Rating Scale(NRS) of neck pain
timeFrame: Change from baseline NRS at 5 days
Secondary outcomes:
measure: Numeric Rating Scale(NRS) of neck pain
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
measure: Visual Analogue Scale (VAS) of neck pain
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days
measure: Visual Analogue Scale (VAS) of arm pain
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
measure: Numeric Rating Scale(NRS) of arm pain
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
measure: Range of movement (ROM) of flexion
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
measure: Range of movement (ROM) of extension
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
measure: Range of movement (ROM) of left lateral flexion
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
measure: Range of movement (ROM) of right lateral flexion
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
measure: Range of movement (ROM) of left rotation
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
measure: Range of movement (ROM) of right rotation
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
measure: Neck Disability Index (NDI)
timeFrame: baseline(day2), day5, day of Discharge(up to 14days), week 12
measure: Patient Global Impression of Change (PGIC)
timeFrame: day5, day of Discharge(up to 14days), week 12
measure: 12-item Short-Form Health Survey (SF-12)
timeFrame: baseline(day 2), day5, day of Discharge(up to 14days), week 12
measure: Credibility and Expectancy
timeFrame: baseline(day 2)
measure: Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
timeFrame: baseline(day 2), day5, day of Discharge(up to 14days), week 12
measure: Drug Consumption
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
measure: Adverse events
timeFrame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
References:
citation: Kim S, Kyeong DH, Kim MK, Kim CY, Lee YJ, Lee J, Ha IH, Park KS. The efficacy and safety of non-resistance manual therapy in inpatients with acute neck pain caused by traffic accidents: A randomized controlled trial. Medicine (Baltimore). 2022 Jun 3;101(22):e29151. doi: 10.1097/MD.0000000000029151.