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NCT05969288 Clinical Trial

Low Back Pain and Osteopathy in Italian Young People

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05969288
Other study ID # 2023-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date June 30, 2024

Study information
Verified date February 2024
Source International Institute of Behavioral Medicines
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 11 Years to 30 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Barbara Rocca Calosso

Sponsors (1)
Lead Sponsor Collaborator
International Institute of Behavioral Medicines

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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