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Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04270422
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Iran University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Other: Multidimensional physiotherapy Other: Usual physiotherapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Multidimensional physiotherapy
Multidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions
Other: Multidimensional physiotherapy
Multidimensional physiotherapy based on biopsychosocial approach

Active Comparator: Usual physiotherapy
Usual evidence based physiotherapy, twice a week, 12 sessions
Other: Usual physiotherapy
Usual evidence based physiotherapy




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270422


Contacts
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Contact: Sanaz Bemani 09123955284 ext 0098 bemani_sanaz@yahoo.com
Contact: Shohreh Noorizadeh 09123723797 ext 0098 Noorizadeh.sh@iums.ac.ir

Locations
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Iran, Islamic Republic of
Iran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 1545913487
Contact: Javad Sarrafzadeh    09123098562 ext 0098    sarrafzadeh.j@iums.ac.ir   
Sponsors and Collaborators
Iran University of Medical Sciences
Investigators
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Principal Investigator: Javad Sarrafzadeh IIran University of Medical Sciences

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Responsible Party: Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04270422    
Other Study ID Numbers: IranUMS
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data or results of the present study will present in an article that will be published after completing the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 8 months after completing the study
Access Criteria: Data access requests will be reviewed by the Corresponding Author will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iran University of Medical Sciences:
Pain
Disability
Pain catastrophising
Quality of life
Fear of movement
Chronic non specific low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms