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Clinical Trials/NCT04270422
NCT04270422
Completed
Not Applicable

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

Iran University of Medical Sciences2 sites in 1 country70 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain, Mechanical
Sponsor
Iran University of Medical Sciences
Enrollment
70
Locations
2
Primary Endpoint
Pain intensity(questionnaire): Numeric Rating Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
January 22, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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).

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).

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).

Secondary Outcomes

  • Change of Forward flexion range of motion (ROM)(At 4 months)
  • Kinesiophobia(At 6 weeks, after 12 treatment sessions in 38 days)
  • Change of Quality of Life(At 4 months)
  • Change of Fear Avoidance Believes(At 4 months)
  • Change of Brain function(At 4 months)
  • Pain Catastrophizing(At baseline)
  • Brain function(At baseline)
  • Quality of Life assessment(At baseline)
  • Fear Avoidance Believes(At baseline)
  • Disability(At baseline)
  • Forward flexion range of motion (ROM)(At baseline)
  • Change in Quality of Life(At 6 weeks, after 12 treatment sessions in 38 days)
  • Change of Pain Catastrophizing(At 4 months)
  • Change of Disability(At 4 months)
  • Change of Kinesiophobia(At 4 months)

Study Sites (2)

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