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Completed

NCT Number: NCT04270422

Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

This study compares the effect of multidimensional physiotherapy to usual evidence-based physiotherapy in the treatment of chronic nonspecific low back pain in adults. Half of the participants will receive multidimensional physiotherapy based on biopsychosocial approach while the other half will receive usual evidence based physiotherapy.

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Key information

Conditions

Low Back Pain, Mechanical Anxiety Disorders Back Pain Kinesiophobia Low Back Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iran University of Medical Sciences, Tehran, Iran

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About this study

multidimensional physiotherapy treatment include: psychoeducation based on cognitive behavioral therapy (CBT), education, graded exposure, postural correction exercise, lifestyle change, and electrotherapy.

usual evidence-based physiotherapy include: electrotherapy, education, and trunk general exercises.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18-50
  • Low back pain for 3 months or more
  • Disability based on Oswestry Disability Index (ODI) between 20-60
  • Fear of movement based on Tampa scale of kinesiophobia >37
  • Minimum level of education
  • Native Persian speaking

Exclusion criteria

  • Any evidence of e specific medical diagnosis
  • Rheumatoid disease,fibromyalgia, neuropathy, progressive neurological disease
  • History of headache, dizziness, nausea, epilepsy, migraines and mental disorder
  • Beck's Anxiety Inventory> 26
  • Beck's Depression Inventory II> 29
  • Pregnancy
  • Having other therapies during the present research

Treatment and study plan

Multidimensional physiotherapy

Other

Multidimensional physiotherapy based on biopsychosocial approach

Usual Physiotherapy

Other

Usual evidence based physiotherapy

Primary outcomes

  1. Pain intensity(questionnaire): Numeric Rating Scale

    Time frame: At baseline

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  2. Change of Pain intensity (questionnaire): Numeric Rating Scale

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  3. Change of Pain intensity (questionnaire): Numeric Rating Scale

    Time frame: At 1 month

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  4. Change of Pain intensity(questionnaire): Numeric Rating Scale

    Time frame: At 4 months

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Secondary outcomes

  1. Quality of Life assessment

    Time frame: At baseline

    Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.

  2. Fear Avoidance Believes

    Time frame: At baseline

    Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.

  3. Kinesiophobia

    Time frame: At baseline

    Self reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement.

  4. Pain Catastrophizing

    Time frame: At baseline

    Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).

  5. Disability

    Time frame: At baseline

    Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.

  6. Forward flexion range of motion (ROM)

    Time frame: At baseline

    Forward flexion ROM measure by meter

  7. Brain function

    Time frame: At baseline

    Relative power and absolute power of the frequency spectrum of EEG

  8. Change in Quality of Life

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.

  9. Change of Fear Avoidance Believes

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.

  10. Kinesiophobia

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Change of Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.

  11. Change of Pain Catastrophizing

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Self reported pain Catastrophizing based on Pain Catastrophizing Scale

  12. Change of Disability

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.

  13. Change of Forward flexion range of motion (ROM)

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Forward flexion ROM measure by meter

  14. Change of Brain function

    Time frame: At 6 weeks, after 12 treatment sessions in 38 days

    Relative power and absolute power of the frequency spectrum of EEG

  15. Change of Quality of Life

    Time frame: At 1 months

    Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.

  16. Change of Fear Avoidance Believes

    Time frame: At 1 months

    Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.

  17. Change of Kinesiophobia

    Time frame: At 1 months

    Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.

  18. Change of Pain Catastrophizing

    Time frame: At 1 months

    Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).

  19. Change of Disability

    Time frame: At 1 months

    Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.

  20. Change of Forward flexion range of motion (ROM)

    Time frame: At 1 months

    Forward flexion ROM measure by meter

  21. Change of Brain function

    Time frame: At 1 months

    Relative power and absolute power of the frequency spectrum of EEG

  22. Change of Quality of Life

    Time frame: At 4 months

    Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.

  23. Change of Fear Avoidance Believes

    Time frame: At 4 months

    Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire.A higher score indicates more strongly held fear avoidance beliefs.

  24. Change of Kinesiophobia

    Time frame: At 4 months

    Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.

  25. Change of Pain Catastrophizing

    Time frame: At 4 months

    Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).

  26. Change of Disability

    Time frame: At 4 months

    Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.

  27. Change of Forward flexion range of motion (ROM)

    Time frame: At 4 months

    Forward flexion ROM measure by meter

  28. Change of Brain function

    Time frame: At 4 months

    Relative power and absolute power of the frequency spectrum of EEG

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Registry information

Official study title

Effect of Multidimensional Physiotherapy Based on Biopsychosocial Approach on Clinical Findings and Electroencephalography (EEG) Spectrum in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 17, 2020
Registry last updated
Sep 13, 2023

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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