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

Jaseng Medical Foundation

Status

Completed

Conditions

Whiplash Injury of Cervical Spine

Treatments

Drug: Korean herbal medicine

Other: chuna

Other: acupuncture

Other: non-resistance therapy

Other: pharmacoacupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT04660175

JS-CT-2020-13

Details and patient eligibility

About

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).

Enrollment

120 patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Non-resistance therapy

Experimental group

Description:

From the 2nd to 5th day of hospitalization, once a day, 4 times of non-resistance therapy is administered. And non-resistance therapy group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Treatment:

Drug: Korean herbal medicine

Other: pharmacoacupuncture

Other: chuna

Other: acupuncture

Other: non-resistance therapy

Oriental medicine integrated treatment

Active Comparator group

Description:

The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Treatment:

Drug: Korean herbal medicine