Clinical trial NCT05969288: Low Back Pain and Osteopathy in Italian Young People
Official title: Presence of Low Back Pain and Willingness to Osteopathic Cures in Italian Young People
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Keywords: Low back pain
Gnathology
Orthodontics
Osteopathy
Young people
Behavioral Medicine
Lead sponsor: International Institute of Behavioral Medicines
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young people with low back pain and gnathological/orthodontics disorders.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: NRS
timeFrame: At the moment of the assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Calosso
country: Italy
facility: Barbara Rocca
Study officials:
References:
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.
citation: 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.