Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain
Primary Purpose
Low Back Pain, Mechanical
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Multidimensional physiotherapy
Usual physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Pain, Disability, Pain catastrophising, Quality of life, Fear of movement, Chronic non specific low back pain
Eligibility 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
Sites / Locations
- Iran University of Medical Sciences
- School of Rehabilitation Sciences, Iran University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multidimensional physiotherapy
Usual physiotherapy
Arm Description
Multidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions
Usual evidence based physiotherapy, twice a week, 12 sessions
Outcomes
Primary Outcome Measures
Pain intensity(questionnaire): Numeric Rating Scale
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity (questionnaire): Numeric Rating Scale
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity (questionnaire): Numeric Rating Scale
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity(questionnaire): Numeric Rating Scale
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
Quality of Life assessment
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.
Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Kinesiophobia
Self reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement.
Pain Catastrophizing
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).
Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Brain function
Relative power and absolute power of the frequency spectrum of EEG
Change in Quality of Life
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.
Change of Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Kinesiophobia
Change of Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Change of Pain Catastrophizing
Self reported pain Catastrophizing based on Pain Catastrophizing Scale
Change of Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Change of Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Change of Brain function
Relative power and absolute power of the frequency spectrum of EEG
Change of Quality of Life
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.
Change of Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Change of Kinesiophobia
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Change of Pain Catastrophizing
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).
Change of Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Change of Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Change of Brain function
Relative power and absolute power of the frequency spectrum of EEG
Change of Quality of Life
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.
Change of Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire.A higher score indicates more strongly held fear avoidance beliefs.
Change of Kinesiophobia
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Change of Pain Catastrophizing
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).
Change of Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Change of Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Change of Brain function
Relative power and absolute power of the frequency spectrum of EEG
Full Information
NCT ID
NCT04270422
First Posted
February 10, 2020
Last Updated
September 11, 2023
Sponsor
Iran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04270422
Brief Title
Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
January 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Pain, Disability, Pain catastrophising, Quality of life, Fear of movement, Chronic non specific low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multidimensional physiotherapy
Arm Type
Experimental
Arm Description
Multidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions
Arm Title
Usual physiotherapy
Arm Type
Active Comparator
Arm Description
Usual evidence based physiotherapy, twice a week, 12 sessions
Intervention Type
Other
Intervention Name(s)
Multidimensional physiotherapy
Intervention Description
Multidimensional physiotherapy based on biopsychosocial approach
Intervention Type
Other
Intervention Name(s)
Usual physiotherapy
Intervention Description
Usual evidence based physiotherapy
Primary Outcome Measure Information:
Title
Pain intensity(questionnaire): Numeric Rating Scale
Description
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
At baseline
Title
Change of Pain intensity (questionnaire): Numeric Rating Scale
Description
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Change of Pain intensity (questionnaire): Numeric Rating Scale
Description
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
At 1 month
Title
Change of Pain intensity(questionnaire): Numeric Rating Scale
Description
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
At 4 months
Secondary Outcome Measure Information:
Title
Quality of Life assessment
Description
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.
Time Frame
At baseline
Title
Fear Avoidance Believes
Description
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Time Frame
At baseline
Title
Kinesiophobia
Description
Self reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement.
Time Frame
At baseline
Title
Pain Catastrophizing
Description
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).
Time Frame
At baseline
Title
Disability
Description
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Time Frame
At baseline
Title
Forward flexion range of motion (ROM)
Description
Forward flexion ROM measure by meter
Time Frame
At baseline
Title
Brain function
Description
Relative power and absolute power of the frequency spectrum of EEG
Time Frame
At baseline
Title
Change in Quality of Life
Description
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.
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Change of Fear Avoidance Believes
Description
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Kinesiophobia
Description
Change of Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Change of Pain Catastrophizing
Description
Self reported pain Catastrophizing based on Pain Catastrophizing Scale
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Change of Disability
Description
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Change of Forward flexion range of motion (ROM)
Description
Forward flexion ROM measure by meter
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Change of Brain function
Description
Relative power and absolute power of the frequency spectrum of EEG
Time Frame
At 6 weeks, after 12 treatment sessions in 38 days
Title
Change of Quality of Life
Description
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.
Time Frame
At 1 months
Title
Change of Fear Avoidance Believes
Description
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Time Frame
At 1 months
Title
Change of Kinesiophobia
Description
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Time Frame
At 1 months
Title
Change of Pain Catastrophizing
Description
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).
Time Frame
At 1 months
Title
Change of Disability
Description
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Time Frame
At 1 months
Title
Change of Forward flexion range of motion (ROM)
Description
Forward flexion ROM measure by meter
Time Frame
At 1 months
Title
Change of Brain function
Description
Relative power and absolute power of the frequency spectrum of EEG
Time Frame
At 1 months
Title
Change of Quality of Life
Description
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.
Time Frame
At 4 months
Title
Change of Fear Avoidance Believes
Description
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire.A higher score indicates more strongly held fear avoidance beliefs.
Time Frame
At 4 months
Title
Change of Kinesiophobia
Description
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Time Frame
At 4 months
Title
Change of Pain Catastrophizing
Description
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).
Time Frame
At 4 months
Title
Change of Disability
Description
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Time Frame
At 4 months
Title
Change of Forward flexion range of motion (ROM)
Description
Forward flexion ROM measure by meter
Time Frame
At 4 months
Title
Change of Brain function
Description
Relative power and absolute power of the frequency spectrum of EEG
Time Frame
At 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javad Sarrafzadeh
Organizational Affiliation
IIran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iran University of Medical Sciences
City
Tehran
ZIP/Postal Code
1545913487
Country
Iran, Islamic Republic of
Facility Name
School of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All data or results of the present study will present in an article that will be published after completing the study.
IPD Sharing Time Frame
8 months after completing the study
IPD Sharing Access Criteria
Data access requests will be reviewed by the Corresponding Author will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
34620205
Citation
Bemani S, Dehkordi SN, Sarrafzadeh J, Talebian S, Salehi R, Zarei J. Efficacy of a multidimensional versus usual care physiotherapy on pain and electroencephalography (EEG) spectrum in chronic nonspecific low back pain: study protocol for a randomized controlled trial. Trials. 2021 Oct 7;22(1):679. doi: 10.1186/s13063-021-05580-3.
Results Reference
derived
Learn more about this trial
Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain
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