- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06938828
- Original Trial
Treatment of Patients With Neck Pain After a Commuting Accident
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Murcia, Spain, 33006
- Universidad Católica San Antonio de Murcia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who have received physiotherapy treatment at another centre during the process
- Patients who requested voluntary discharge for whatever reason.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of time off work
Time Frame: Screening visit
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The dependent variable, time off work, will be measured in days.
|
Screening visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of type of intervention received
Time Frame: Screening visit
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The secondary variable, type of intervention received, will be evaluated with a dichotomous coding: manual therapy or no manual therapy.
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Screening visit
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Measurement of pain intensity at the time of medical discharge
Time Frame: Screening visit
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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)
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Screening visit
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Measurement of the number of physiotherapy sessions received
Time Frame: Screening visit
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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
|
Screening visit
|
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Measurement of the type of employment contract of the patients
Time Frame: Screening visit
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The secondary variable, type of employment contract of the patients, will be collected in a dichotomous qualitative variable (salaried/self-employed)
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Screening visit
|
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Measuring the age of the patients
Time Frame: Screening visit
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The secondary variable, age of the patients, will be collected in a quantitative variable of completed years (measured in days)
|
Screening visit
|
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Measurement of patients' occupational cervical strain
Time Frame: Screening visit
|
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.
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Screening visit
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Measuring the gender of patients
Time Frame: Screening visit
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The secondary variable, the gender of patients, will be collected in a qualitative variable (Female/Male).
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Screening visit
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Itinere
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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