Cervical Injury SpineNCT06938828
Treatment of Patients With Neck Pain After a Commuting Accident
An observational study of Cervical Injury Spine, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Introduction. Neck pain is one of the main causes of incapacity for work. The economic impact of neck pain is considerable due to the cost of medical treatment and physiotherapy. Accidents in itinere, those that occur on the way between home and the workplace, can cause pain and functional impairment. Objective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Injury Spine
- What is being tested?
- Observational cohort group
- How many people
- 204 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2025to 15 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have suffered a traffic accident while traveling to or from work between 2022 and 2024.
Who may be able to join
- Patients of both sexes
- Persons aged 18 to 65
- Patients with a medical diagnosis of neck pain secondary to traffic accidents while commuting
- Persons without a medical diagnosis of another associated pathology
- Patients whose accident occurred between 2022 and 2024.
Who cannot join
- Patients who have received physiotherapy treatment at another centre during the process
- Patients who requested voluntary discharge for whatever reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy in the Treatment of Patients With Neck Pain After a Commuting Accident; a Retrospective Cohort Study
Introduction. Neck pain is one of the main causes of incapacity for work. The economic impact of neck pain is considerable due to the cost of medical treatment and physiotherapy. Accidents in itinere, those that occur on the way between home and the workplace, can cause pain and functional impairment.
Objective. To analyze the relationship between the time off work following accidents on the way to and from work and the type of treatment received.
Material and method. Multicenter retrospective cohort study. Data will be collected from 146 patients. The primary variable of the study will be the time on sick leave (in days), with the type of intervention received (manual therapy or not) being the dependent variable. The secondary variables, estimated as modifying or confounding, will be the intensity of the pain (visual analog scale), sex, age, occupational cervical strain, type of contract (salaried/self-employed) and the number of physiotherapy sessions received.
- Conditions
- Cervical Injury Spine
- Being tested
- Observational cohort group
- Keywords
- neck pain, physiotherapy, accidents in itinere, Incapacity for work
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohort groupOther
As this is an observational cohort study, there will be no intervention. In this study, only retrospective data will be collected for subsequent analysis. Similarly, the aim is to assess the relationship between the time on sick leave and the type of physiotherapy treatment received by patients. As this is an observational and retrospective cohort study, there is no risk derived from the development of the study for the subjects whose data form part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Data will be collected from medical records of a mutual insurance company that collaborates with the Social Security. The data will be from patients of both sexes with a medical diagnosis of neck pain secondary to traffic accidents while commuting and without a medical diagnosis of associated traffic pathology, between the years 2022 and 2024. The patients had received a physiotherapy intervention with and without manual therapy. Receives: Other: Observational cohort group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of time off work
The dependent variable, time off work, will be measured in days.
Measured: Screening visit
Secondary outcomes (7)
Measurement of type of intervention received
The secondary variable, type of intervention received, will be evaluated with a dichotomous coding: manual therapy or no manual therapy.
Measured: Screening visit
Measurement of pain intensity at the time of medical discharge
The secondary variable, pain intensity at the time of medical discharge, will be collected with the recording of the visual analog scale (range 0-10)
Measured: Screening visit
Measurement of the number of physiotherapy sessions received
The secondary variable, number of physiotherapy sessions received, will be measured quantitatively (in days of treatment administration). This value will be collected from the physiotherapy record
Measured: Screening visit
Measurement of the type of employment contract of the patients
The secondary variable, type of employment contract of the patients, will be collected in a dichotomous qualitative variable (salaried/self-employed)
Measured: Screening visit
Measuring the age of the patients
The secondary variable, age of the patients, will be collected in a quantitative variable of completed years (measured in days)
Measured: Screening visit
Measurement of patients' occupational cervical strain
The secondary variable, patients' cervical strain , will be collected in a qualitative variable (Yes/No) depending on the type of work of the patients, their daily work may or may not require cervical strain.
Measured: Screening visit
Measuring the gender of patients
The secondary variable, the gender of patients, will be collected in a qualitative variable (Female/Male).
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start22 Apr 2025
- Primary completion13 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Injury 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938828
- Sponsor's protocol ID
- Itinere
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy in the Treatment of Patients With Neck Pain After a Commuting Accident; a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06938828
- Acronym / sponsor ID
- Itinere
- Conditions
- Cervical Injury Spine
- Keywords
- neck pain, physiotherapy, accidents in itinere, Incapacity for work
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 13 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 22 Apr 2025 (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.
Introduction. Neck pain is one of the main causes of incapacity for work. The economic impact of neck pain is considerable due to the cost of medical treatment and physiotherapy. Accidents in itinere, those that occur on the way between home and the workplace, can cause pain and functional impairment.
Objective. To analyze the relationship between the time off work following accidents on the way to and from work and the type of treatment received.
Material and method. Multicenter retrospective cohort study. Data will be collected from 146 patients. The primary variable of the study will be the time on sick leave (in days), with the type of intervention received (manual therapy or not) being the dependent variable. The secondary variables, estimated as modifying or confounding, will be the intensity of the pain (visual analog scale), sex, age, occupational cervical strain, type of contract (salaried/self-employed) and the number of physiotherapy sessions received.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Observational cohort groupData will be collected from medical records of a mutual insurance company that collaborates with the Social Security. The data will be from patients of both sexes with a medical diagnosis of neck pain secondary to traffic accidents while commuting and without a medical diagnosis of associated traffic pathology, between the years 2022 and 2024. The patients had received a physiotherapy intervention with and without manual therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have suffered a traffic accident while traveling to or from work between 2022 and 2024.
Key inclusion criteria (5 listed)
- Patients of both sexes
- Persons aged 18 to 65
- Patients with a medical diagnosis of neck pain secondary to traffic accidents while commuting
- Persons without a medical diagnosis of another associated pathology
- Patients whose accident occurred between 2022 and 2024.
Key exclusion criteria (2 listed)
- Patients who have received physiotherapy treatment at another centre during the process
- Patients who requested voluntary discharge for whatever reason.
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 |
|---|---|---|
| Observational cohort groupAs this is an observational cohort study, there will be no intervention. In this study, only retrospective data will be collected for subsequent analysis. Similarly, the aim is to assess the relationship between the time on sick leave and the type of physiotherapy treatment received by patients. As this is an observational and retrospective cohort study, there is no risk derived from the development of the study for the subjects whose data form part of the study. | Other | Observational group |
Primary outcome
Measurement of time off work
Time frame: Screening visit
The dependent variable, time off work, will be measured in days.
7 secondary outcomes
Measurement of type of intervention received
Time frame: Screening visit
Measurement of pain intensity at the time of medical discharge
Time frame: Screening visit
Measurement of the number of physiotherapy sessions received
Time frame: Screening visit
Measurement of the type of employment contract of the patients
Time frame: Screening visit
Measuring the age of the patients
Time frame: Screening visit
Measurement of patients' occupational cervical strain
Time frame: Screening visit
Measuring the gender of patients
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Cervical Injury Spine, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measurement of time off work (time frame: Screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.