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NCT Number: NCT06915896

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

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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Key information

Conditions

Chronic Non-Specific Low Back Pain Chronic Non-specific Neck Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Don Carlo Gnocchi, Firenze

Florence, FI, 50124, Italy

Location status: Recruiting

Location contact

Francesca Cecchi

CONTACT

[email protected]

+39 05573931

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neck Disability Index

    Time frame: 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)

  2. Roland and Morris Disability Questionnaire

    Time frame: 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)

  3. Neck Disability Index

    Time frame: Third session (T2), after 6 months 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)

  4. Roland and Morris Disability Questionnaire

    Time frame: Second sessions (T1), after 3 month 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)

  5. Neck Disability Index

    Time frame: T0, at the 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)

  6. Roland and Morris Disability Questionnaire

    Time frame: T0, at the 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)

  7. TAMPA SCALE of KINESIOPHOBIA

    Time frame: 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

  8. PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE

    Time frame: 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

  9. PITTSBURGH SLEEP QUALITY INDEX

    Time frame: 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.

  10. TAMPA SCALE of KINESIOPHOBIA

    Time frame: re-test at baseline

    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.

  11. PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE

    Time frame: re-test at baseline

    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

  12. PITTSBURGH SLEEP QUALITY INDEX

    Time frame: re-test at baseline

    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.

Secondary outcomes

  1. Pain Intensity

    Time frame: T0, at the enrollment

    Numeric Pain Raiting scale 0-10

  2. Pain Intensity

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

    Numeric Pain Raiting scale 0-10

  3. Pain Intensity

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

    Numeric Pain Raiting scale 0-10

  4. Health Related Quality of Life

    Time frame: T0, at the enrollment

    Short-Form 12 (SF12)

  5. Self-reported change

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

    Global rating of Change Scale

  6. Self-reported change

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

    Global rating of Change Scale

  7. Self-reported change

    Time frame: T0, at the enrollment

    Global rating of Change Scale

  8. Medication Use

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

    yes/no

  9. Medication Use

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

    yes/no

  10. Medication Use

    Time frame: T0, at the enrollment

    yes/no

  11. Pain Frequency

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

    0-7 in a week

  12. Pain Frequency

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

    0-7 in a week

  13. Pain Frequency

    Time frame: T0, at the enrollment

    0-7 in a week

  14. Health Related Quality of Life

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

    Short-Form 12 (SF12)

  15. Health Related Quality of Life

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

    Short-Form 12 (SF12)

  16. Pain Catastrophizing Scale (PCS)

    Time frame: 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)

  17. Pain Catastrophizing Scale (PCS)

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

  18. Pain Catastrophizing Scale (PCS)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Cecchi

CONTACT

[email protected]

+39 05573931

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy: Multicenter Prospective Study

Acronym: PRE-CBP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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