The Efficacy and Safety of Non-resistance Manual Therapy in Inpatients With Acute Neck Pain Caused by Traffic Accidents: a Randomised Controlled Trial
- Conditions
- Whiplash Injury of Cervical Spine
- Interventions
- Other: acupunctureOther: non-resistance therapyOther: chunaOther: pharmacoacupunctureDrug: Korean herbal medicine
- Registration Number
- NCT04660175
- Lead Sponsor
- Jaseng Medical Foundation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-resistance therapy pharmacoacupuncture 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. Non-resistance therapy Korean herbal medicine 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. Oriental medicine integrated treatment acupuncture The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Oriental medicine integrated treatment chuna The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Oriental medicine integrated treatment pharmacoacupuncture The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Oriental medicine integrated treatment Korean herbal medicine The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Non-resistance therapy non-resistance therapy 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. Non-resistance therapy acupuncture 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. Non-resistance therapy chuna 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.
- Primary Outcome Measures
Name Time Method Numeric Rating Scale(NRS) of neck pain Change from baseline NRS at 5 days 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'.
- Secondary Outcome Measures
Name Time Method Range of movement (ROM) of extension baseline(day2), day3, day4, day5, day of Discharge(up to 14days) Range of movement (ROM) of extension is measured.
Visual Analogue Scale (VAS) of neck pain baseline(day2), day3, day4, day5, day of Discharge(up to 14days 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.
Range of movement (ROM) of left rotation baseline(day2), day3, day4, day5, day of Discharge(up to 14days) Range of movement (ROM) of left rotation is measured.
Range of movement (ROM) of right rotation baseline(day2), day3, day4, day5, day of Discharge(up to 14days) Range of movement (ROM) of right rotation is measured.
Numeric Rating Scale(NRS) of neck pain baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12 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'
Visual Analogue Scale (VAS) of arm pain baseline(day2), day3, day4, day5, day of Discharge(up to 14days) 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.
Range of movement (ROM) of flexion baseline(day2), day3, day4, day5, day of Discharge(up to 14days) Range of movement (ROM) of flexion is measured.
Range of movement (ROM) of right lateral flexion baseline(day2), day3, day4, day5, day of Discharge(up to 14days) Range of movement (ROM) of right lateral flexion is measured.
Neck Disability Index (NDI) baseline(day2), day5, day of Discharge(up to 14days), week 12 Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 100 (worse outcome)
Patient Global Impression of Change (PGIC) day5, day of Discharge(up to 14days), week 12 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.
Drug Consumption baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12 During the study period, the type and dose of drugs (prescribed due to the current medical history or remedy) were observed through a questionnaire when visiting the study subjects.
Adverse events baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12 Safety outcome
Range of movement (ROM) of left lateral flexion baseline(day2), day3, day4, day5, day of Discharge(up to 14days) Range of movement (ROM) of left lateral flexion is measured.
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K) baseline(day 2), day5, day of Discharge(up to 14days), week 12 The PCL-5(The Posttraumatic Stress Disorder Checklist for DSM-5) is a 20-item, 5-point-Likert-scale, self-report questionnaire to measure the PTSD symptoms in the DSM-536 and to diagnose PTSD. A higher score (out of 80) indicates severe PTSD.
Numeric Rating Scale(NRS) of arm pain baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12 NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10.
12-item Short-Form Health Survey (SF-12) baseline(day 2), day5, day of Discharge(up to 14days), week 12 The SF-12 is a shortened version of the Short Form-36 Health Survey (SF-36), which is a widely used instrument to assess health-related quality of life. The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Credibility and Expectancy baseline(day 2) Credibility and Expectancy is a 9-point scale-likert-scale to evaluate the participants' expectations for treatment.(1 = not at all, 5 = somewhat, and 9 = very much)
Trial Locations
- Locations (1)
Daejeon Jaseng Hospital of Korean Medicine
🇰🇷Daejeon, Korea, Republic of