Low Back Pain and Osteopathy in Italian Young People

Sponsor
International Institute of Behavioral Medicines (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05969288
Collaborator
(none)
30
4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Behavioral survey

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Presence of Low Back Pain and Willingness to Osteopathic Cures in Italian Young People
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. NRS [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • International Institute of Behavioral Medicines

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barbara Rocca, Scientific Director, International Institute of Behavioral Medicines
ClinicalTrials.gov Identifier:
NCT05969288
Other Study ID Numbers:
  • 2023-004
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Barbara Rocca, Scientific Director, International Institute of Behavioral Medicines
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023