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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic spinal pain patients attending public health rehabilitation pathways |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with nonspecific spinal pain waiting for rehabilitation in public health pathways.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Cecchi | Contact | +39 05573931 | fcecchi@dongnocchi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi, Firenze | Recruiting | Florence | FI | 50124 | Italy |
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| 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 |
| 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 |