Back to resultsThe Efficacy and Safety of Early MSAT on Radiating Pain in the Upper Extremity
Primary Purpose
Radiating Pain in the Upper Extremity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cervical motion style acupuncture treatment(Trapezius, Rhomboid, Scalene)
Korean medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Radiating Pain in the Upper Extremity focused on measuring Motion Style Acupuncture Treatment, Radiating pain
Eligibility Criteria
Inclusion Criteria: Patients aged 19-69 years on the date they sign the consent form. Patients who are suffered byradiating pain in the upper extremity that occurred within 3 days after traffic accident. Patients who are hospitalized due to traffic accident. Patients with NRS of radiating pain ≥ 5. 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 radiating pain: malignancy, spondylitis, inflammatory spondylitis, etc. Patients with progressive neurological deficits or with severe neurological symptoms. Patients with medical history of cervical surgery or thoracic surgery within the last three weeks. Patients who have radiating pain in upper extremity before the traffic accident. Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, 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 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cervical motion style acupuncture treatment(Trapezius, Rhomboid, Scalene)
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 radiating pain
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 leg 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
Location of Radiating pain
The location of radiating pain varies depending on the nerve. The assessor will ask patients where the pain occur.
VAS of Radiating 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.
C-SPINE MRI
We will examine the results of patients who underwent MRI. The investor will conduct whether or not MRI was performed, date of operation, presence of cervical disc herniation, grade of cervical disc herniation, area of cervical disc herniation, classification of disc degeneration, presence of stenosis.
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 participant is asked to report their leg pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
NDI
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 leg pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
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, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
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
Full Information
NCT ID
NCT06086899
First Posted
October 12, 2023
Last Updated
October 16, 2023
Sponsor
Jaseng Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT06086899
Brief Title
The Efficacy and Safety of Early MSAT on Radiating Pain in the Upper Extremity
Official Title
The Effect of Early MSAT Treatment on Radiating Pain in the Upper Extremity Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a double blind, randomized controlled trail. condition/disease: radiating pain in the upper extremity. 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 MSAT on radiating pain in the upper extremity. From October 2023 to December 2024, we collected 100 inpatients who were suffered from radiating pain in the upper extremity with the numeric rating scale(NRS) over 5 after 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), Neck Disability Index(NDI), C-SPINE MRI, EuroQol 5-Dimension (EQ-5D) and Patient Global Impression of Change (PGIC)."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiating Pain in the Upper Extremity
Keywords
Motion Style Acupuncture Treatment, Radiating pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Pragmatic randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cervical motion style acupuncture treatment(Trapezius, Rhomboid, Scalene)
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)
Cervical motion style acupuncture treatment(Trapezius, Rhomboid, Scalene)
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)
Korean medical treatment
Intervention Description
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of radiating pain
Description
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 leg pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Time Frame
Screening, Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
Secondary Outcome Measure Information:
Title
Location of Radiating pain
Description
The location of radiating pain varies depending on the nerve. The assessor will ask patients where the pain occur.
Time Frame
Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
Title
VAS of Radiating 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, Discharge 1 day, 1month after enrollment, 3month after enrollment
Title
C-SPINE MRI
Description
We will examine the results of patients who underwent MRI. The investor will conduct whether or not MRI was performed, date of operation, presence of cervical disc herniation, grade of cervical disc herniation, area of cervical disc herniation, classification of disc degeneration, presence of stenosis.
Time Frame
Taken within ±14 days of hospitalization
Title
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 participant is asked to report their leg 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, Discharge 1 day, 1month after enrollment, 3month after enrollment
Title
NDI
Description
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 leg 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), day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
Title
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, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
Time Frame
Baseline(day2), day5, Discharge 1 day, 1month after enrollment, 3 months after enrollment
Title
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, Discharge 1 day, 1month after enrollment, 3 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 19-69 years on the date they sign the consent form.
Patients who are suffered byradiating pain in the upper extremity that occurred within 3 days after traffic accident.
Patients who are hospitalized due to traffic accident.
Patients with NRS of radiating pain ≥ 5.
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 radiating pain: malignancy, spondylitis, inflammatory spondylitis, etc.
Patients with progressive neurological deficits or with severe neurological symptoms.
Patients with medical history of cervical surgery or thoracic surgery within the last three weeks.
Patients who have radiating pain in upper extremity before the traffic accident.
Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
In-Hyuk Ha, phD
Phone
02-2222-2740
Email
hanitata@jaseng.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, phD
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
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 Contact:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, phD
Phone
3218-2249
Ext
82
Email
hanihata@jaseng.co.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of Early MSAT on Radiating Pain in the Upper Extremity
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