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Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04270422
Enrollment
70
Registered
2020-02-17
Start date
2020-12-01
Completion date
2023-01-22
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Mechanical

Keywords

Pain, Disability, Pain catastrophising, Quality of life, Fear of movement, Chronic non specific low back pain

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.

Interventions

OTHERMultidimensional physiotherapy

Multidimensional physiotherapy based on biopsychosocial approach

Usual evidence based physiotherapy

Sponsors

Iran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity(questionnaire): Numeric Rating ScaleAt baselineSelf 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 ScaleAt 6 weeks, after 12 treatment sessions in 38 daysSelf 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 ScaleAt 4 monthsSelf reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Secondary

MeasureTime frameDescription
Pain CatastrophizingAt baselineSelf 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).
DisabilityAt baselineSelf reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Forward flexion range of motion (ROM)At baselineForward flexion ROM measure by meter
Brain functionAt baselineRelative power and absolute power of the frequency spectrum of EEG
Change in Quality of LifeAt 6 weeks, after 12 treatment sessions in 38 daysSelf-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 BelievesAt 6 weeks, after 12 treatment sessions in 38 daysSelf reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Quality of Life assessmentAt baselineSelf-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 DisabilityAt 6 weeks, after 12 treatment sessions in 38 daysSelf reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Change of Forward flexion range of motion (ROM)At 6 weeks, after 12 treatment sessions in 38 daysForward flexion ROM measure by meter
Change of Brain functionAt 6 weeks, after 12 treatment sessions in 38 daysRelative power and absolute power of the frequency spectrum of EEG
Change of Quality of LifeAt 1 monthsSelf-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 KinesiophobiaAt 1 monthsSelf reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Change of Pain CatastrophizingAt 6 weeks, after 12 treatment sessions in 38 daysSelf reported pain Catastrophizing based on Pain Catastrophizing Scale
Fear Avoidance BelievesAt baselineSelf reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
KinesiophobiaAt baselineSelf reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026