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 Type
OBSERVATIONAL
Enrollment
200
IRCCS Fondazione Don Carlo Gnocchi, Firenze
Florence, FI, Italy
RECRUITINGNeck 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: re-test at baseline
Pain Intensity
Numeric Pain Raiting scale 0-10
Time frame: T0, at the enrollment
Pain Intensity
Numeric Pain Raiting scale 0-10
Time frame: Second sessions (T1), after 3 month from enrollment
Pain Intensity
Numeric Pain Raiting scale 0-10
Time frame: Third session (T2), after 6 months from enrollment
Health Related Quality of Life
Short-Form 12 (SF12)
Time frame: T0, at the enrollment
Self-reported change
Global rating of Change Scale
Time frame: Third session (T2), after 6 months from enrollment
Self-reported change
Global rating of Change Scale
Time frame: Second sessions (T1), after 3 month from enrollment
Self-reported change
Global rating of Change Scale
Time frame: T0, at the enrollment
Medication Use
yes/no
Time frame: Third session (T2), after 6 months from enrollment
Medication Use
yes/no
Time frame: Second sessions (T1), after 3 month from enrollment
Medication Use
yes/no
Time frame: T0, at the enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pain Frequency
0-7 in a week
Time frame: Third session (T2), after 6 months from enrollment
Pain Frequency
0-7 in a week
Time frame: Second sessions (T1), after 3 month from enrollment
Pain Frequency
0-7 in a week
Time frame: T0, at the enrollment
Health Related Quality of Life
Short-Form 12 (SF12)
Time frame: Third session (T2), after 6 months from enrollment
Health Related Quality of Life
Short-Form 12 (SF12)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Third session (T2), after 6 months from enrollment