Clinical trial NCT06086899: 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
Overall status: RECRUITING
Phase: NA
Conditions: Radiating Pain in the Upper Extremity
Keywords: Motion Style Acupuncture Treatment
Radiating pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Pragmatic randomized controlled trial
Primary purpose: TREATMENT

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)."

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.

Primary outcomes:
measure: Numeric Rating Scale(NRS) of radiating pain
timeFrame: Screening, Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
Secondary outcomes:
measure: Location of Radiating pain
timeFrame: Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
measure: VAS of Radiating pain
timeFrame: Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
measure: C-SPINE MRI
timeFrame: Taken within ±14 days of hospitalization
measure: NRS of Neck pain
timeFrame: Baseline(day2), day3, day4, day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
measure: NDI
timeFrame: Baseline(day2), day5, Discharge 1 day, 1month after enrollment, 3month after enrollment
measure: EQ-5D
timeFrame: Baseline(day2), day5, Discharge 1 day, 1month after enrollment, 3 months after enrollment
measure: PGIC
timeFrame: day5, Discharge 1 day, 1month after enrollment, 3 months after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, phD
role: PRINCIPAL_INVESTIGATOR
References: