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Recruiting NCT06915896

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

— Observational Chronic Non-Specific Low Back Pain Chronic Non-specific Neck Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Non-Specific Low Back Pain, Chronic Non-specific Neck Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy: Multicenter Prospective Study

Overview

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.

Primary outcome measures

  • Neck Disability Index [Time frame: Second sessions (T1), after 3 month from enrollment]
  • Roland and Morris Disability Questionnaire [Time frame: Third session (T2), after 6 months from enrollment]
  • Neck Disability Index [Time frame: Third session (T2), after 6 months from enrollment]
  • Roland and Morris Disability Questionnaire [Time frame: Second sessions (T1), after 3 month from enrollment]
  • Neck Disability Index [Time frame: T0, at the enrollment]
  • Roland and Morris Disability Questionnaire [Time frame: T0, at the enrollment]
  • TAMPA SCALE of KINESIOPHOBIA [Time frame: re-test at baseline]
  • PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE [Time frame: re-test at baseline]
  • PITTSBURGH SLEEP QUALITY INDEX [Time frame: re-test at baseline]
  • TAMPA SCALE of KINESIOPHOBIA [Time frame: re-test at baseline]
Secondary outcome measures (12)
  • Pain Intensity [Time frame: T0, at the enrollment]
  • Pain Intensity [Time frame: Second sessions (T1), after 3 month from enrollment]
  • Pain Intensity [Time frame: Third session (T2), after 6 months from enrollment]
  • Health Related Quality of Life [Time frame: T0, at the enrollment]
  • Self-reported change [Time frame: Third session (T2), after 6 months from enrollment]
  • Self-reported change [Time frame: Second sessions (T1), after 3 month from enrollment]
  • Self-reported change [Time frame: T0, at the enrollment]
  • Medication Use [Time frame: Third session (T2), after 6 months from enrollment]
  • Medication Use [Time frame: Second sessions (T1), after 3 month from enrollment]
  • Medication Use [Time frame: T0, at the enrollment]
  • Pain Frequency [Time frame: Third session (T2), after 6 months from enrollment]
  • Pain Frequency [Time frame: Second sessions (T1), after 3 month from enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Fondazione Don Carlo Gnocchi, Firenze — Florence

Identifiers

NCT: NCT06915896 · PRE-CBP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗