Clinical trial NCT04270422: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: Pain
Disability
Pain catastrophising
Quality of life
Fear of movement
Chronic non specific low back pain
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity(questionnaire): Numeric Rating Scale
timeFrame: At baseline
measure: Change of Pain intensity (questionnaire): Numeric Rating Scale
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Change of Pain intensity (questionnaire): Numeric Rating Scale
timeFrame: At 1 month
measure: Change of Pain intensity(questionnaire): Numeric Rating Scale
timeFrame: At 4 months
Secondary outcomes:
measure: Quality of Life assessment
timeFrame: At baseline
measure: Fear Avoidance Believes
timeFrame: At baseline
measure: Kinesiophobia
timeFrame: At baseline
measure: Pain Catastrophizing
timeFrame: At baseline
measure: Disability
timeFrame: At baseline
measure: Forward flexion range of motion (ROM)
timeFrame: At baseline
measure: Brain function
timeFrame: At baseline
measure: Change in Quality of Life
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Change of Fear Avoidance Believes
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Kinesiophobia
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Change of Pain Catastrophizing
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Change of Disability
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Change of Forward flexion range of motion (ROM)
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Change of Brain function
timeFrame: At 6 weeks, after 12 treatment sessions in 38 days
measure: Change of Quality of Life
timeFrame: At 1 months
measure: Change of Fear Avoidance Believes
timeFrame: At 1 months
measure: Change of Kinesiophobia
timeFrame: At 1 months
measure: Change of Pain Catastrophizing
timeFrame: At 1 months
measure: Change of Disability
timeFrame: At 1 months
measure: Change of Forward flexion range of motion (ROM)
timeFrame: At 1 months
measure: Change of Brain function
timeFrame: At 1 months
measure: Change of Quality of Life
timeFrame: At 4 months
measure: Change of Fear Avoidance Believes
timeFrame: At 4 months
measure: Change of Kinesiophobia
timeFrame: At 4 months
measure: Change of Pain Catastrophizing
timeFrame: At 4 months
measure: Change of Disability
timeFrame: At 4 months
measure: Change of Forward flexion range of motion (ROM)
timeFrame: At 4 months
measure: Change of Brain function
timeFrame: At 4 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iran University of Medical Sciences
city: Tehran
country: Iran, Islamic Republic of
facility: School of Rehabilitation Sciences, Iran University of Medical Sciences
Study officials:
affiliation: IIran University of Medical Sciences
name: Javad Sarrafzadeh
role: PRINCIPAL_INVESTIGATOR
References:
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.