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 Foundation120 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Whiplash Injury of Cervical Spine

Interventions

non-resistance therapyOTHER

The non-resistance technique, created in Jaseng Hospital, is a combination of ischemic compression and mobilization It is a treatment that improves the limited range of motion of the cervical spine and relieves pain by applying ischemic pressure to the induration of the neck and at the same time firmly supporting the patient's head to give passive joint movements and completely relax.

acupunctureOTHER

According to the judgment of the oriental medicine doctor, select acupuncture point and tender spots such as BL10, TE14, GB20, GV16, etc. to a depth of 10 mm 6 -Self needle in 12 blood spots.

chunaOTHER

Chuna treatment is administered once a day during the hospitalization period. Chuna is Korean manual therapy using methods such as joint mobilization, joint distraction, fascia relaxation and manipulation.

pharmacoacupunctureOTHER

This is an oriental medical practice in which a certain amount of a drug extracted from a specific herbal medicine is injected with an injector to treat the patient's constitution, disease state, etc., and then injected into the treatment acupuncture points and body surface reaction points. Depending on the condition of the inpatient, acupuncture is used in parallel.

Korean herbal medicineDRUG

Formulated with herbal medicinal and pack the extract in a pouch, and have the hospitalized patient take it once in the morning and afternoon for 30 minutes after meals.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Numeric Rating Scale(NRS) of neck pain

The extent of acute 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 participants are asked to report their neck pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

Time frame: Change from baseline NRS at 5 days

Secondary Outcomes

Numeric Rating Scale(NRS) of neck pain

NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participants are asked to report their neck pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'

Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12

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.

Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days

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.