Low Back Pain and Osteopathy in Italian Young People

February 5, 2024 updated by: Barbara Rocca, International Institute of Behavioral Medicines

Presence of Low Back Pain and Willingness to Osteopathic Cures in Italian Young People

This is a behavioral observational study aimed at evaluating the presence of low back pain in young people and the intention to undertake osteopathic treatments. It consists of a short self-administered questionnaire which will be given to adolescents with gnathological/orthodontics disorders to complete. Relationships between low back pain of young individuals' answers with the intention to undertake osteopathic treatments will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a behavioral observational study aimed at evaluating the presence of low back pain in young people and the intention to undertake osteopathic treatments.

Literature found out that low back pain is a common occurrence in young people. Adolescents develop frequently gnathological/orthodontics disorders. In Italy, young individuals with low back pain and gnathological/orthodontics disorders are frequently referred to osteopaths.

In Literature there are not studies which correlate low back pain, osteopathic cures and gnathological/orthodontics disorders as for young persons.

The study consists of a short self-administered questionnaire which will be given to young people to complete. In more details, the survey is made of 8 questions collecting information on presence/intensity of low back pain, intention to have osteopathic treatments, and (in that case) the satisfaction after the cures. Further, participants will have to complete a self-administered pain intensity numerical rating scale.

Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. Statistical correlations between adolescents' answers and the pain intensity numerical rating scale will be also evaluated.

This study investigates the relationships among low back pain, gnathological/orthodontics disorders, and osteopathic cures.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Young people with low back pain and gnathological/orthodontics disorders.

Description

Inclusion Criteria:

  • common low back pain
  • ability to read and understand the Italian language

Exclusion Criteria:

  • any diagnosable cause of low back pain
  • previous spinal surgery
  • cognitive impairment
  • refusal to adhere

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS
Time Frame: At the moment of the assessment
Pain intensity Numerical Rating Scale: it a self-reported 11-point scale which evaluates pain intensity, varying from 0 (no pain at all) to 10 (the worst imaginable pain)
At the moment of the assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Institute of Behavioral Medicines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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