NCT04660175

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

November 24, 2020

Last Update Submit

May 12, 2023

Conditions

Whiplash Injury of Cervical Spine

Outcome Measures

Primary Outcomes (1)

  • 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'.

    Change from baseline NRS at 5 days

Secondary Outcomes (17)

  • Numeric Rating Scale(NRS) of neck pain

    baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12

  • Visual Analogue Scale (VAS) of neck pain

    baseline(day2), day3, day4, day5, day of Discharge(up to 14days

  • Visual Analogue Scale (VAS) of arm pain

    baseline(day2), day3, day4, day5, day of Discharge(up to 14days)

  • Numeric Rating Scale(NRS) of arm pain

    baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12

  • Range of movement (ROM) of flexion

    baseline(day2), day3, day4, day5, day of Discharge(up to 14days)

  • +12 more secondary outcomes

Study Arms (2)

Non-resistance therapy

EXPERIMENTAL

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.

Other: non-resistance therapyOther: acupunctureOther: chunaOther: pharmacoacupunctureDrug: Korean herbal medicine

Oriental medicine integrated treatment

ACTIVE COMPARATOR

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

Other: acupunctureOther: chunaOther: pharmacoacupunctureDrug: Korean herbal medicine

Interventions

non-resistance therapyOTHER

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.

Non-resistance therapy
acupunctureOTHER

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.

Non-resistance therapyOriental medicine integrated treatment
chunaOTHER

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.

Non-resistance therapyOriental medicine integrated treatment
pharmacoacupunctureOTHER

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.

Non-resistance therapyOriental medicine integrated treatment
Korean herbal medicineDRUG

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.

Non-resistance therapyOriental medicine integrated treatment

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Related Publications (2)

  • Choi SW, Kim KH, Yoon JY, Lee SW, Park JW, Hong HW, Kyeong DH, Kim MK, Kim SN, Kim CY, Lee YJ, Lee JH, Kim JY, Ha IH. Effectiveness and safety of manual therapy for inpatients with traffic accident-induced acute neck pain: A randomized controlled trial. J Integr Med. 2026 Jan;24(1):81-89. doi: 10.1016/j.joim.2025.10.008. Epub 2025 Nov 1.

    PMID: 41298158DERIVED

  • 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.

    PMID: 35665724DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 9, 2020

Study Start

November 30, 2020

Primary Completion

May 13, 2022

Study Completion

July 26, 2022

Last Updated

May 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)