Clinical trial NCT06915896: Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy.
Official title: Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy: Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Non-Specific Low Back Pain
Chronic Non-specific Neck Pain
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with nonspecific spinal pain waiting for rehabilitation in public health pathways.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Neck Disability Index
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Roland and Morris Disability Questionnaire
timeFrame: Third session (T2), after 6 months from enrollment
measure: Neck Disability Index
timeFrame: Third session (T2), after 6 months from enrollment
measure: Roland and Morris Disability Questionnaire
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Neck Disability Index
timeFrame: T0, at the enrollment
measure: Roland and Morris Disability Questionnaire
timeFrame: T0, at the enrollment
measure: TAMPA SCALE of KINESIOPHOBIA
timeFrame: re-test at baseline
measure: PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE
timeFrame: re-test at baseline
measure: PITTSBURGH SLEEP QUALITY INDEX
timeFrame: re-test at baseline
measure: TAMPA SCALE of KINESIOPHOBIA
timeFrame: re-test at baseline
measure: PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE
timeFrame: re-test at baseline
measure: PITTSBURGH SLEEP QUALITY INDEX
timeFrame: re-test at baseline
Secondary outcomes:
measure: Pain Intensity
timeFrame: T0, at the enrollment
measure: Pain Intensity
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Pain Intensity
timeFrame: Third session (T2), after 6 months from enrollment
measure: Health Related Quality of Life
timeFrame: T0, at the enrollment
measure: Self-reported change
timeFrame: Third session (T2), after 6 months from enrollment
measure: Self-reported change
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Self-reported change
timeFrame: T0, at the enrollment
measure: Medication Use
timeFrame: Third session (T2), after 6 months from enrollment
measure: Medication Use
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Medication Use
timeFrame: T0, at the enrollment
measure: Pain Frequency
timeFrame: Third session (T2), after 6 months from enrollment
measure: Pain Frequency
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Pain Frequency
timeFrame: T0, at the enrollment
measure: Health Related Quality of Life
timeFrame: Third session (T2), after 6 months from enrollment
measure: Health Related Quality of Life
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Pain Catastrophizing Scale (PCS)
timeFrame: T0, at the enrollment
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Second sessions (T1), after 3 month from enrollment
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Third session (T2), after 6 months from enrollment
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi, Firenze
state: FI
Study officials:
References: