Low Back PainNCT05969288
Low Back Pain and Osteopathy in Italian Young People
An observational study of Low Back Pain, run by International Institute of Behavioral Medicines at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 11 to 30 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Behavioral survey
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Young people with low back pain and gnathological/orthodontics disorders.
Who may be able to join
- common low back pain
- ability to read and understand the Italian language
Who cannot join
- any diagnosable cause of low back pain
- previous spinal surgery
- cognitive impairment
- refusal to adhere
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Barbara Rocca
Calosso, 14052
Barbara Rocca, +393333653393, info.ellis.bm@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Behavioral survey
- Keywords
- Low back pain, Gnathology, Orthodontics, Osteopathy, Young people, Behavioral Medicine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral surveyOther
Behavioral survey by administering a short self-administered questionnaire (read more in the "Detailed description" section).
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the moment of the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Institute of Behavioral Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Rocca, International Institute of Behavioral Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969288
- Sponsor's protocol ID
- 2023-004
- Status last verified
- Feb 2024
- First submitted
- 16 Jul 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15207508Chiarotto 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.
PubMed 35507483
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Low Back Pain and Willingness to Osteopathic Cures in Italian Young People
- ClinicalTrials.gov ID
- NCT05969288
- Acronym / sponsor ID
- 2023-004
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Gnathology, Orthodontics, Osteopathy, Young people, Behavioral Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- International Institute of Behavioral MedicinesUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Young people with low back pain and gnathological/orthodontics disorders.
Key inclusion criteria (2 listed)
- common low back pain
- ability to read and understand the Italian language
Key exclusion criteria (4 listed)
- any diagnosable cause of low back pain
- previous spinal surgery
- cognitive impairment
- refusal to adhere
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral surveyBehavioral survey by administering a short self-administered questionnaire (read more in the "Detailed description" section). | Other | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Results publication: PubMed 15207508Salaffi 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.
- Results publication: PubMed 35507483Chiarotto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by International Institute of Behavioral Medicines at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: At the moment of the assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05969288, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.