Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain, Mechanical
• Interventions: Other: Multidimensional physiotherapy; Other: Usual physiotherapy

• Registration Number: NCT04270422
• Lead Sponsor: Iran University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-12-01
• Primary Completion: 2022-11-01
• Study Completion: 2023-01-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multidimensional physiotherapy	Multidimensional physiotherapy	Multidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions
Usual physiotherapy	Usual physiotherapy	Usual evidence based physiotherapy, twice a week, 12 sessions

Primary Outcome Measures

Name	Time	Method
Pain intensity(questionnaire): Numeric Rating Scale	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	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	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 Outcome Measures

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

Trial Locations

Locations (2)

School of Rehabilitation Sciences, Iran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of

Iran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of