NCT05969288

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

July 16, 2023

Last Update Submit

February 5, 2024

Conditions

Low Back Pain

Keywords

Low back painGnathologyOrthodonticsOsteopathyYoung peopleBehavioral Medicine

Outcome Measures

Primary Outcomes (1)

  • NRS

    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

Interventions

Behavioral surveyOTHER

Behavioral survey by administering a short self-administered questionnaire (read more in the "Detailed description" section).

Eligibility Criteria

Age11 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Rocca

Calosso, 14052, Italy

RECRUITING

Related Publications (2)

  • Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.

    PMID: 15207508RESULT

  • Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.

    PMID: 35507483RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director

Study Record Dates

First Submitted

July 16, 2023

First Posted

August 1, 2023

Study Start

September 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)