The Efficacy and Safety of Non-resistance Manual Therapy in Inpatients With Acute Neck Pain Caused by Traffic Accidents: a Randomised Controlled Trial
NCT ID: NCT04660175
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2020-11-30
2022-07-26
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
acupuncture
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.
chuna
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.
pharmacoacupuncture
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 medicine
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.
Oriental medicine integrated treatment
The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
acupuncture
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.
chuna
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.
pharmacoacupuncture
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 medicine
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.
Interventions
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non-resistance therapy
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.
acupuncture
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.
chuna
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.
pharmacoacupuncture
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 medicine
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 Criteria
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Inclusion Criteria
* 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 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
19 Years
70 Years
ALL
No
Sponsors
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Jaseng Medical Foundation
OTHER
Responsible Party
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In-Hyuk Ha, KMD
Director
Locations
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Daejeon Jaseng Hospital of Korean Medicine
Daejeon, , South Korea
Countries
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References
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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.
Other Identifiers
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JS-CT-2020-13
Identifier Type: -
Identifier Source: org_study_id
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