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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Subjects with cognitive impairment

Trial population

Patients with nonspecific spinal pain waiting for rehabilitation in public health pathways.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Chronic spinal pain patients attending public health rehabilitation pathways

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

Pain Intensity

Numeric Pain Raiting scale 0-10

Time frame
T0, at the enrollment
2

Pain Intensity

Numeric Pain Raiting scale 0-10

Time frame
Second sessions (T1), after 3 month from enrollment
3

Pain Intensity

Numeric Pain Raiting scale 0-10

Time frame
Third session (T2), after 6 months from enrollment
4

Health Related Quality of Life

Short-Form 12 (SF12)

Time frame
T0, at the enrollment

Other outcomes

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