Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

September 11, 2023 updated by: Iran University of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At baseline
Change of Pain intensity (questionnaire): Numeric Rating Scale
Time Frame: At 6 weeks, after 12 treatment sessions in 38 days
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
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).
At 1 month
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).
At 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life assessment
Time Frame: 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.
At baseline
Fear Avoidance Believes
Time Frame: At baseline
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
At baseline
Kinesiophobia
Time Frame: At baseline
Self reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement.
At baseline
Pain Catastrophizing
Time Frame: 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).
At baseline
Disability
Time Frame: At baseline
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
At baseline
Forward flexion range of motion (ROM)
Time Frame: At baseline
Forward flexion ROM measure by meter
At baseline
Brain function
Time Frame: At baseline
Relative power and absolute power of the frequency spectrum of EEG
At baseline
Change in Quality of Life
Time Frame: 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.
At 6 weeks, after 12 treatment sessions in 38 days
Change of Fear Avoidance Believes
Time Frame: At 6 weeks, after 12 treatment sessions in 38 days
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
Time Frame: 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.
At 6 weeks, after 12 treatment sessions in 38 days
Change of Pain Catastrophizing
Time Frame: At 6 weeks, after 12 treatment sessions in 38 days
Self reported pain Catastrophizing based on Pain Catastrophizing Scale
At 6 weeks, after 12 treatment sessions in 38 days
Change of Disability
Time Frame: At 6 weeks, after 12 treatment sessions in 38 days
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)
Time Frame: At 6 weeks, after 12 treatment sessions in 38 days
Forward flexion ROM measure by meter
At 6 weeks, after 12 treatment sessions in 38 days
Change of Brain function
Time Frame: At 6 weeks, after 12 treatment sessions in 38 days
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
Time Frame: At 1 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.
At 1 months
Change of Fear Avoidance Believes
Time Frame: At 1 months
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
Time Frame: At 1 months
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
At 1 months
Change of Pain Catastrophizing
Time Frame: At 1 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).
At 1 months
Change of Disability
Time Frame: At 1 months
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)
Time Frame: At 1 months
Forward flexion ROM measure by meter
At 1 months
Change of Brain function
Time Frame: At 1 months
Relative power and absolute power of the frequency spectrum of EEG
At 1 months
Change of Quality of Life
Time Frame: 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.
At 4 months
Change of Fear Avoidance Believes
Time Frame: At 4 months
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
Time Frame: At 4 months
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
At 4 months
Change of Pain Catastrophizing
Time Frame: 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).
At 4 months
Change of Disability
Time Frame: At 4 months
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)
Time Frame: At 4 months
Forward flexion ROM measure by meter
At 4 months
Change of Brain function
Time Frame: At 4 months
Relative power and absolute power of the frequency spectrum of EEG
At 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Javad Sarrafzadeh, IIran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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