Whiplash Injury of Cervical SpineNCT04660175

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

A study testing non-resistance therapy, acupuncture and chuna in people with Whiplash Injury of Cervical Spine, run by Jaseng Medical Foundation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 19 to 70 years
Conditions the study is for: Whiplash Injury of Cervical Spine
What is being tested?: non-resistance therapy, acupuncture and chuna
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteSouth Korea
Study dates: 30 Nov 2020to 26 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262

Other trials in South Korea

About this study

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).

Conditions: Whiplash Injury of Cervical Spine
Being tested: non-resistance therapy, acupuncture, chuna, pharmacoacupuncture, Korean herbal medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.
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.
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.
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.

Study groups in NCT04660175
Study group	Role	What they receive
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. Receives: Other: non-resistance therapy; Other: acupuncture; Other: chuna; Other: pharmacoacupuncture; Drug: 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. Receives: Other: acupuncture; Other: chuna; Other: pharmacoacupuncture; Drug: Korean herbal medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

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'.
Measured: Change from baseline NRS at 5 days

Secondary outcomes (17)

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'
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
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.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days
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.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
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.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Range of movement (ROM) of flexion
Range of movement (ROM) of flexion is measured.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of extension
Range of movement (ROM) of extension is measured.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of left lateral flexion
Range of movement (ROM) of left lateral flexion is measured.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of right lateral flexion
Range of movement (ROM) of right lateral flexion is measured.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of left rotation
Range of movement (ROM) of left rotation is measured.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of right rotation
Range of movement (ROM) of right rotation is measured.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
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)
Measured: baseline(day2), day5, day of Discharge(up to 14days), week 12
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.
Measured: day5, day of Discharge(up to 14days), week 12
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.
Measured: baseline(day 2), day5, day of Discharge(up to 14days), week 12
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)
Measured: baseline(day 2)
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.
Measured: baseline(day 2), day5, day of Discharge(up to 14days), week 12
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.
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Adverse events
Safety outcome
Measured: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202026 Jul 2022

First posted9 Dec 2020
Study start30 Nov 2020
Primary completion13 May 2022
Study completion26 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Whiplash Injury of Cervical SpineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04660175
Sponsor's protocol ID: JS-CT-2020-13
Status last verified: May 2023
First submitted: 24 Nov 2020
Last updated: 15 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41298158
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.
PubMed 35665724

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04660175
Acronym / sponsor ID: JS-CT-2020-13
Conditions: Whiplash Injury of Cervical Spine
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Jaseng Medical FoundationUniversity, hospital or other
Study start: 30 Nov 2020 (actual)
Primary completion: 13 May 2022 (actual)
Study completion: 26 Jul 2022 (actual)
First posted: 9 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Non-resistance therapy	Experimental	Other: non-resistance therapy, Other: acupuncture, Other: chuna, Other: pharmacoacupuncture, Drug: Korean herbal medicineFrom 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.
Oriental medicine integrated treatment	Active comparator	Other: acupuncture, Other: chuna, Other: pharmacoacupuncture, Drug: Korean herbal medicineThe control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Who may qualify

Ages: 19 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
non-resistance therapyThe 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.	Other	Non-resistance therapy
acupunctureAccording 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.	Other	Non-resistance therapy, Oriental medicine integrated treatment
chunaChuna 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.	Other	Non-resistance therapy, Oriental medicine integrated treatment
pharmacoacupunctureThis 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.	Other	Non-resistance therapy, Oriental medicine integrated treatment
Korean herbal medicineFormulated 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.	Drug	Non-resistance therapy, Oriental medicine integrated treatment

Primary outcome

Numeric Rating Scale(NRS) of neck pain
Time frame: Change from baseline NRS at 5 days
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'.

17 secondary outcomes

Numeric Rating Scale(NRS) of neck pain
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Visual Analogue Scale (VAS) of neck pain
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days
Visual Analogue Scale (VAS) of arm pain
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Numeric Rating Scale(NRS) of arm pain
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Range of movement (ROM) of flexion
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of extension
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of left lateral flexion
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of right lateral flexion
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of left rotation
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Range of movement (ROM) of right rotation
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days)
Neck Disability Index (NDI)
Time frame: baseline(day2), day5, day of Discharge(up to 14days), week 12
Patient Global Impression of Change (PGIC)
Time frame: day5, day of Discharge(up to 14days), week 12
12-item Short-Form Health Survey (SF-12)
Time frame: baseline(day 2), day5, day of Discharge(up to 14days), week 12
Credibility and Expectancy
Time frame: baseline(day 2)
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
Time frame: baseline(day 2), day5, day of Discharge(up to 14days), week 12
Drug Consumption
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12
Adverse events
Time frame: baseline(day2), day3, day4, day5, day of Discharge(up to 14days), week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
Derived from this study: PubMed 41298158Choi 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.
Derived from this study: PubMed 35665724Kim 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing non-resistance therapy, acupuncture and chuna in people with Whiplash Injury of Cervical Spine, run by Jaseng Medical Foundation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale(NRS) of neck pain (time frame: Change from baseline NRS at 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660175, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.