An observational study in Chronic Non-Specific Low Back Pain and Chronic Non-specific Neck Pain, sponsored by Fondazione Don Carlo Gnocchi Onlus. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Observational
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with nonspecific spinal pain waiting for rehabilitation in public health pathways.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: 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
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Feb 2026, 27 months after the start.
Of 175 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 27 months is above that.
Counting every sponsor, half of 185 studies reached it within 24 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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