RecruitingNot Applicable

Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy.

Italy200 participantsStarted 2023-10-30

Plain-language summary

The aim of this study is to investigate the predictive value of various biopsychosocial variables on the outcomes of subjects with chronic spinal pain undergoing public health rehabilitation pathways. Secondly, the study aims to assess the reliability of certain questionnaires, classified as Patient-Reported Outcome Measures (PROMs), which are frequently used in the evaluation of spinal pain but whose metric properties have not yet been established. These objectives will be pursued through two comprehensive assessment sessions (before and after rehabilitation), a re-test session immediately before rehabilitation (to evaluate the reliability of the questionnaires in stable subjects), and two follow-up assessments at 3 and 6 months after discharge.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age of majority; * Medical diagnosis of nonspecific low back pain or nonspecific neck pain; * Chronic symptoms, present for at least 6 months; * Waiting for rehabilitation in a public health pathways * Signature of informed consent to participate in the study and processing of personal data. Exclusion Criteria: * Subjects with cognitive impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neck Disability Index

Timeframe: Second sessions (T1), after 3 month from enrollment

Roland and Morris Disability Questionnaire

Timeframe: Third session (T2), after 6 months from enrollment

Neck Disability Index

Timeframe: Third session (T2), after 6 months from enrollment

Roland and Morris Disability Questionnaire

Timeframe: Second sessions (T1), after 3 month from enrollment

Neck Disability Index

Timeframe: T0, at the enrollment

Roland and Morris Disability Questionnaire

Timeframe: T0, at the enrollment

TAMPA SCALE of KINESIOPHOBIA

Timeframe: re-test at baseline

Trial details

NCT IDNCT06915896

SponsorFondazione Don Carlo Gnocchi Onlus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-01

Contact for this trial

Francesca Cecchi

+39 05573931 fcecchi@dongnocchi.it

View on ClinicalTrials.gov More Chronic Non-Specific Low Back Pain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Neck Disability Index

Timeframe: Second sessions (T1), after 3 month from enrollment

Roland and Morris Disability Questionnaire

Timeframe: Third session (T2), after 6 months from enrollment

Neck Disability Index

Timeframe: Third session (T2), after 6 months from enrollment

Roland and Morris Disability Questionnaire

Timeframe: Second sessions (T1), after 3 month from enrollment

Neck Disability Index

Timeframe: T0, at the enrollment

Roland and Morris Disability Questionnaire

Timeframe: T0, at the enrollment

TAMPA SCALE of KINESIOPHOBIA

Timeframe: re-test at baseline