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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Other: Multidimensional physiotherapy; Other: Usual 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanaz Bemani; Phone Number: 0098 09123955284; Email: bemani_sanaz@yahoo.com
• Study Contact Backup: Name: Shohreh Noorizadeh; Phone Number: 0098 09123723797; Email: Noorizadeh.sh@iums.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1545913487
    • Iran University of Medical Sciences
  • Tehran, Iran, Islamic Republic of
    • School of Rehabilitation Sciences, Iran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At baseline
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).	At 6 weeks, after 12 treatment sessions in 38 days
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).	At 1 month
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).	At 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline
Fear Avoidance Believes	Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.	At baseline
Kinesiophobia	Self reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement.	At baseline
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).	At baseline
Disability	Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.	At baseline
Forward flexion range of motion (ROM)	Forward flexion ROM measure by meter	At baseline
Brain function	Relative power and absolute power of the frequency spectrum of EEG	At baseline
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.	At 6 weeks, after 12 treatment sessions in 38 days
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.	At 6 weeks, after 12 treatment sessions in 38 days
Kinesiophobia	Change of Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.	At 6 weeks, after 12 treatment sessions in 38 days
Change of Pain Catastrophizing	Self reported pain Catastrophizing based on Pain Catastrophizing Scale	At 6 weeks, after 12 treatment sessions in 38 days
Change of Disability	Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.	At 6 weeks, after 12 treatment sessions in 38 days
Change of Forward flexion range of motion (ROM)	Forward flexion ROM measure by meter	At 6 weeks, after 12 treatment sessions in 38 days
Change of Brain function	Relative power and absolute power of the frequency spectrum of EEG	At 6 weeks, after 12 treatment sessions in 38 days
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.	At 1 months
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.	At 1 months
Change of Kinesiophobia	Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.	At 1 months
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).	At 1 months
Change of Disability	Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.	At 1 months
Change of Forward flexion range of motion (ROM)	Forward flexion ROM measure by meter	At 1 months
Change of Brain function	Relative power and absolute power of the frequency spectrum of EEG	At 1 months
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.	At 4 months
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.	At 4 months
Change of Kinesiophobia	Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.	At 4 months
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).	At 4 months
Change of Disability	Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.	At 4 months
Change of Forward flexion range of motion (ROM)	Forward flexion ROM measure by meter	At 4 months
Change of Brain function	Relative power and absolute power of the frequency spectrum of EEG	At 4 months

Collaborators and Investigators

• Sponsor: Iran University of Medical Sciences
• Investigators: Principal Investigator: Javad Sarrafzadeh, IIran University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): January 22, 2023

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Disability; Fear of movement; Pain catastrophising; Chronic non specific low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IranUMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No