Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

Low Back Pain, Mechanical Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270422
• Other study ID #: IranUMS
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 22, 2023

Study information

• Verified date: September 2023
• Source: Iran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 22, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Other:
• Multidimensional physiotherapy
Multidimensional physiotherapy based on biopsychosocial approach
• Usual physiotherapy
Usual evidence based physiotherapy

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iran University of Medical Sciences	Tehran
Iran, Islamic Republic of	School of Rehabilitation Sciences, Iran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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