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

Recruiting

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

• Registration Number: NCT06915896
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-02-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TAMPA SCALE of KINESIOPHOBIA	re-test at baseline	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.
PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE	re-test at baseline	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
PITTSBURGH SLEEP QUALITY INDEX	re-test at baseline	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.
Neck Disability Index	T0, at the enrollment	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)
Roland and Morris Disability Questionnaire	T0, at the enrollment	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)

Secondary Outcome Measures

Name	Time	Method
Pain Intensity	Third session (T2), after 6 months from enrollment	Numeric Pain Raiting scale 0-10
Health Related Quality of Life	Second sessions (T1), after 3 month from enrollment	Short-Form 12 (SF12)
Self-reported change	T0, at the enrollment	Global rating of Change Scale
Medication Use	T0, at the enrollment	yes/no
Pain Frequency	T0, at the enrollment	0-7 in a week
Pain Catastrophizing Scale (PCS)	Third session (T2), after 6 months from enrollment	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)

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi, Firenze; 🇮🇹 Firenze, FI, Italy