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

Primary Purpose

Whiplash Injury of Cervical Spine

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
non-resistance therapy
acupuncture
chuna
pharmacoacupuncture
Korean herbal medicine
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injury of Cervical Spine

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Daejeon Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-resistance therapy

Oriental medicine integrated treatment

Arm 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.

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

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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'
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.
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.
Numeric Rating Scale(NRS) of arm pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10.
Range of movement (ROM) of flexion
Range of movement (ROM) of flexion is measured.
Range of movement (ROM) of extension
Range of movement (ROM) of extension is measured.
Range of movement (ROM) of left lateral flexion
Range of movement (ROM) of left lateral flexion is measured.
Range of movement (ROM) of right lateral flexion
Range of movement (ROM) of right lateral flexion is measured.
Range of movement (ROM) of left rotation
Range of movement (ROM) of left rotation is measured.
Range of movement (ROM) of right rotation
Range of movement (ROM) of right rotation is measured.
Neck Disability Index (NDI)
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)
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.
12-item Short-Form Health Survey (SF-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
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)
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
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.
Drug Consumption
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
Safety outcome

Full Information

First Posted
November 24, 2020
Last Updated
May 12, 2023
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04660175
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injury of Cervical Spine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-resistance therapy
Arm Type
Experimental
Arm 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.
Arm Title
Oriental medicine integrated treatment
Arm Type
Active Comparator
Arm Description
The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Intervention Type
Other
Intervention Name(s)
non-resistance therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
chuna
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
pharmacoacupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Korean herbal medicine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of neck pain
Description
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 Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of neck pain
Description
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
Title
Visual Analogue Scale (VAS) of neck pain
Description
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
Title
Visual Analogue Scale (VAS) of arm pain
Description
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)
Title
Numeric Rating Scale(NRS) of arm pain
Description
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Title
Range of movement (ROM) of flexion
Description
Range of movement (ROM) of flexion is measured.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Title
Range of movement (ROM) of extension
Description
Range of movement (ROM) of extension is measured.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Title
Range of movement (ROM) of left lateral flexion
Description
Range of movement (ROM) of left lateral flexion is measured.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Title
Range of movement (ROM) of right lateral flexion
Description
Range of movement (ROM) of right lateral flexion is measured.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Title
Range of movement (ROM) of left rotation
Description
Range of movement (ROM) of left rotation is measured.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Title
Range of movement (ROM) of right rotation
Description
Range of movement (ROM) of right rotation is measured.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Title
Neck Disability Index (NDI)
Description
Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 100 (worse outcome)
Time Frame
baseline(day2), day5, day of Discharge(up to 14days), week 12
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
day5, day of Discharge(up to 14days), week 12
Title
12-item Short-Form Health Survey (SF-12)
Description
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.
Time Frame
baseline(day 2), day5, day of Discharge(up to 14days), week 12
Title
Credibility and Expectancy
Description
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)
Time Frame
baseline(day 2)
Title
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
Description
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.
Time Frame
baseline(day 2), day5, day of Discharge(up to 14days), week 12
Title
Drug Consumption
Description
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.
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Title
Adverse events
Description
Safety outcome
Time Frame
baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
ZIP/Postal Code
35262
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35665724
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.
Results Reference
derived

Learn more about this trial

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

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