Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy. (PRE-CBP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Non-specific Neck Pain; Chronic Non-Specific Low Back Pain

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Francesca Cecchi; Phone Number: +39 05573931; Email: fcecchi@dongnocchi.it

Study Locations

• Italy
  • FI
    • Firenze, FI, Italy, 50124
      • Recruiting
      • IRCCS Fondazione Don Carlo Gnocchi, Firenze
      • Contact: Francesca Cecchi; Phone Number: +39 05573931; Email: fcecchi@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with nonspecific spinal pain waiting for rehabilitation in public health pathways.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic spinal pain patients attending public health rehabilitation pathways

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index	The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities. For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity. In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain. (only on neck pain patients)	Second sessions (T1), after 3 month from enrollment
Roland and Morris Disability Questionnaire	The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes. For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24. (only on low back pain patients)	Third session (T2), after 6 months from enrollment
Neck Disability Index	The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities. For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity. In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain. (only on neck pain patients)	Third session (T2), after 6 months from enrollment
Roland and Morris Disability Questionnaire	The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes. For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24. (only on low back pain patients)	Second sessions (T1), after 3 month from enrollment
Neck Disability Index	The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities. For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity. In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain. (only on neck pain patients)	T0, at the enrollment
Roland and Morris Disability Questionnaire	The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes. For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24. (only on low back pain patients)	T0, at the enrollment
TAMPA SCALE of KINESIOPHOBIA	test-retest relative reliability (intraclass correlation coefficient) of TAMPA SCALE of KINESIOPHOBIA (only on neck pain patients). It's a self-report questionnaire designed to assess pain beliefs and pain-related fear of movement in subjects with musculoskeletal disorders	re-test at baseline
PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE	test-retest relative reliability (intraclass correlation coefficient) of PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE (only on neck pain patients). It is a self-report questionnaire to measure attention to pain	re-test at baseline
PITTSBURGH SLEEP QUALITY INDEX	test-retest relative reliability (intraclass correlation coefficient) of PITTSBURGH SLEEP QUALITY INDEX (only on neck pain patients). It is a rating scale developed for the purpose of providing a reliable, valid and standardized measure of sleep quality.	re-test at baseline
TAMPA SCALE of KINESIOPHOBIA	test-retest absolute reliability (minimal detectable change (mdc) 95) of TAMPA SCALE of KINESIOPHOBIA (only on neck pain patients). It's a self-report questionnaire designed to assess pain beliefs and pain-related fear of movement in subjects with musculoskeletal disorders.	re-test at baseline
PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE	test-retest absolute reliability (minimal detectable change (mdc) 95) of PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE (only on neck pain patients). It is a self-report questionnaire to measure attention to pain	re-test at baseline
PITTSBURGH SLEEP QUALITY INDEX	test-retest absolute reliability (minimal detectable change (mdc) 95) of PITTSBURGH SLEEP QUALITY INDEX (only on neck pain patients). It is a rating scale developed for the purpose of providing a reliable, valid and standardized measure of sleep quality.	re-test at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Numeric Pain Raiting scale 0-10	T0, at the enrollment
Pain Intensity	Numeric Pain Raiting scale 0-10	Second sessions (T1), after 3 month from enrollment
Pain Intensity	Numeric Pain Raiting scale 0-10	Third session (T2), after 6 months from enrollment
Health Related Quality of Life	Short-Form 12 (SF12)	T0, at the enrollment
Self-reported change	Global rating of Change Scale	Third session (T2), after 6 months from enrollment
Self-reported change	Global rating of Change Scale	Second sessions (T1), after 3 month from enrollment
Self-reported change	Global rating of Change Scale	T0, at the enrollment
Medication Use	yes/no	Third session (T2), after 6 months from enrollment
Medication Use	yes/no	Second sessions (T1), after 3 month from enrollment
Medication Use	yes/no	T0, at the enrollment
Pain Frequency	0-7 in a week	Third session (T2), after 6 months from enrollment
Pain Frequency	0-7 in a week	Second sessions (T1), after 3 month from enrollment
Pain Frequency	0-7 in a week	T0, at the enrollment
Health Related Quality of Life	Short-Form 12 (SF12)	Third session (T2), after 6 months from enrollment
Health Related Quality of Life	Short-Form 12 (SF12)	Second sessions (T1), after 3 month from enrollment
Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is a measurement scale based on a 13-item self-completion questionnaire designed to assess catastrophizing pain-related thoughts in adults with or without chronic pain. (only for patients with cervicalgia)	T0, at the enrollment
Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is a measurement scale based on a 13-item self-completion questionnaire designed to assess catastrophizing pain-related thoughts in adults with or without chronic pain. (only for patients with cervicalgia)	Second sessions (T1), after 3 month from enrollment
Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is a measurement scale based on a 13-item self-completion questionnaire designed to assess catastrophizing pain-related thoughts in adults with or without chronic pain. (only for patients with cervicalgia)	Third session (T2), after 6 months from enrollment

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Neck Pain
• Other Study ID Numbers: PRE-CBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No