Chronic Non-Specific Low Back Pain, Chronic Non-specific Neck Pain
Conditions
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.
Interventions
None listed
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index | Second sessions (T1), after 3 month from 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 | Third session (T2), after 6 months from 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) |
| TAMPA SCALE of KINESIOPHOBIA | re-test at baseline | 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 |
| PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE | re-test at baseline | 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 |
| PITTSBURGH SLEEP QUALITY INDEX | re-test at baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | T0, at the enrollment | Numeric Pain Raiting scale 0-10 |
| Pain Catastrophizing Scale (PCS) | T0, at the 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) |
| Health Related Quality of Life | T0, at the enrollment | Short-Form 12 (SF12) |
| Self-reported change | Third session (T2), after 6 months from enrollment | Global rating of Change Scale |
| Medication Use | Third session (T2), after 6 months from enrollment | yes/no |
| Pain Frequency | Third session (T2), after 6 months from enrollment | 0-7 in a week |
Countries
Italy
Contacts
Primary ContactFrancesca Cecchi
Outcome results
None listed