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The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury

Primary Purpose

Whiplash Injury of Cervical Spine, Neck Pain, Posterior

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
trapezuis motion style acupuncture treatment
other Korean medical treatment
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 who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident
  • Patients with NRS ≥ 5 for posterior neck pain
  • Patients aged 19-70 years on the date they sign the consent form
  • 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 spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.
  • Patients with progressive neurological deficits or with severe neurological symptoms
  • Patients who have had surgery or procedures within the last three weeks
  • 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
  • If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
  • Patients who are pregnant or planning to become pregnant
  • Patients with a serious mental illness
  • Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
  • 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

  • Jaseng Hospital of Korean Medicine
  • Jaseng Medical Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

trapezius motion style acupuncture treatment

Korean medical treatment

Arm Description

The MSAT group recieved 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience conducted the MSAT. The MSAT group were also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Outcomes

Primary Outcome Measures

Numeric Rating Scale(NRS) of neck pain
The extent of posterior 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 participant is asked to report their posterior 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

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.
Physical examination (Cervical range of motion)
ROM of flexion, extension, lateral flexion, rotation was measured.
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability.
EuroQol 5-Dimension (EQ-5D)
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, we will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
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.
Drug Consumption
Check drug consumption change every visit
Adverse events
Check adverse events every visit

Full Information

First Posted
October 1, 2019
Last Updated
March 25, 2020
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04113824
Brief Title
The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury
Official Title
The Efficacy and Safety of Trapezius MSAT on Inpatients With Acute Whiplash Injury Caused by Traffic Accidents: A Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
September 7, 2019 (Actual)
Study Completion Date
December 15, 2019 (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
This study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment
Detailed Description
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment. So, we conducted a randomized controlled trials to verify the efficacy and safety of trapezuis MSAT. From July 2019 to September 2019, we collected 100 inpatients who were suffered from posterior nick pain with the numeric rating scale(NRS) over 4 after whiplash injury by acute traffic accident(TA). For experimental group(n=50), we conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except MSAT was conducted. For these two groups, we compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Nthe amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Neck Disability Index (NDI), and EuroQol 5-Dimension (EQ-5D).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind, randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trapezius motion style acupuncture treatment
Arm Type
Experimental
Arm Description
The MSAT group recieved 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience conducted the MSAT. The MSAT group were also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Arm Title
Korean medical treatment
Arm Type
Active Comparator
Arm Description
The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Intervention Type
Procedure
Intervention Name(s)
trapezuis motion style acupuncture treatment
Intervention Description
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation
Intervention Type
Procedure
Intervention Name(s)
other Korean medical treatment
Intervention Description
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of neck pain
Description
The extent of posterior 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 participant is asked to report their posterior 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
day 5
Secondary Outcome Measure Information:
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
day 5
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
day 5
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
day 5
Title
Physical examination (Cervical range of motion)
Description
ROM of flexion, extension, lateral flexion, rotation was measured.
Time Frame
day 5
Title
Neck Disability Index (NDI)
Description
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability.
Time Frame
day 5
Title
EuroQol 5-Dimension (EQ-5D)
Description
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, we will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
Time Frame
day 5
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
day 5
Title
Drug Consumption
Description
Check drug consumption change every visit
Time Frame
day 5
Title
Adverse events
Description
Check adverse events every visit
Time Frame
day 5

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 who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident Patients with NRS ≥ 5 for posterior neck pain Patients aged 19-70 years on the date they sign the consent form 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 spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc. Patients with progressive neurological deficits or with severe neurological symptoms Patients who have had surgery or procedures within the last three weeks 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 If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease Patients who are pregnant or planning to become pregnant Patients with a serious mental illness Patients who are participated in clinical trials other than observational studies without therapeutic intervention. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, PhD
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of
Facility Name
Jaseng Medical Foundation
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury

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