The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain

November 12, 2021 updated by: Gali Dar, University of Haifa

Low back pain (LBP), a common disorder, causes disability, functional decline and high health care costs. Patient care programs include specific exercises for promoting function and improving health. Self-practice and adherence to treatment are important for treatment success and better outcomes. Telerehabilitation (TR) might improve patient symptoms, compliance to treatment and reduce patient symptoms, however, its effectiveness in treating LBP, still needs further investigation.

The overall aim of this study will be to examine the effectiveness of combining telerehabilitation within physical therapy treatments for patients with LBP

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

The study will include 60 patients complaining of chronic nonspecific LBP over a 6 month period of time and referred for physical therapy treatment. They will undergo a routine physical examination and be assigned a personal treatment (manual therapy and electrotherapy) and exercise program in accordance with their condition. Participants will receive a total of 8 treatments over a 4-week period (twice a week).

The sample will be randomly divided into 2 groups: a. research group A will receive a video of the exercises via e-mails or to their cellphones; b. a control group will receive the exercises printed on paper.

The exercises will be recorded and be supplemented by a verbal explanation and instructions as to how to correctly perform the exercises. In total, there will be ten videos, found to be important and effective for LBP patients. From these videos, a physical therapist will choose the most suitable exercises for the patients after each treatment meeting (face to face). The patients will be assessed at baseline, at the end of treatment and at a 3 month follow-up telephone assessment.

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.
30

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 Locations

  • Israel
      • Haifa, Israel
        • University of Haifa

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Main complaint of nonspecific LBP over a 3 month period
  • Possess a smartphone, e-mail and the understanding of using these tools for viewing videos.

Exclusion Criteria:

  • Signs or symptoms of possible malignancy are present, such as unexplained weight loss, slight or no reduction of pain while in a recumbent position or subjects were not screened prior to referral to physical therapy.
  • two or more of the following signs are present on physical examination: lower extremity weakness in a myotome distribution, decreased sensation in a dermatomal distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test.
  • Symptoms began immediately after a significant trauma (motor vehicle accident, fall from a height) and subjects were not been screened for possible fractures.
  • Physical therapy or chiropractic treatment for LBP was provided during the 6 months prior to participation in the study or are currently being treated.

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: Double

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: Telerehabilitation
After each face to face session the patient will receive the exercises ordered by the physical therapist to perform at home. The exercises will be sent as a video to his/her mobile or e-mail according to the subject's preference. The exercises will be previously recorded and accompanied with a verbal explanation and instructions on how to correctly perform the exercises, paying close attention to specific points. In total, there will be 10 videos of exercises found effective for LBP patients.. After each face to face meeting, the physical therapist will choose from these 10 videos suitable exercises for the patients.
Other: telerehabilitation and physical therapy
subject will receive the LBP exercises as a video to his/her mobile or e-mail
Active Comparator: Control

After each face to face session the patient will receive the exercises ordered by the physical therapist to perform at home.

subjects will receive the same exercises given to experimental group according to the results of the face to face meeting. The exercises will be shown as printed pictures on paper
Other: control
subjects will receive the LBP exercises as printed pictures on paper

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
Numeric Pain Rating Scale
Time Frame: 3 months
level of pain on an 11-point numeric pain rating scale
3 months
Modified Oswestry Disability Index
Time Frame: 3 months
questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP
3 months
Fear-Avoidance Beliefs Questionnaire
Time Frame: 3 months
questionnaire to assess the subject's beliefs as to the potential harm of several physical and work-related activities
3 months
Survey Health Form Short
Time Frame: 3 months
questionnaire to assess the subject's belief as to his/her health-related quality of life
3 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
Global rating of change
Time Frame: 3 months
a 15-point Likert scale ranging to assess treatment success
3 months
A questionnaire regarding treatment satisfaction
Time Frame: 3 months
a 5-point Likert scale to assess patient satisfaction from treatment
3 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.
University of Haifa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maccabi Healthcare Services, Israel

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: Gali Dar, PhD, University of Haifa

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.
November 1, 2019

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.
October 1, 2021

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.
October 1, 2021

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).
November 27, 2018

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.
November 27, 2018

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.
November 28, 2018

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.
November 15, 2021

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.
November 12, 2021

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.
November 1, 2021

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.
  • 196/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

following study completion, a paper will be submitted to international professional journal

IPD Sharing Time Frame

6 months following end of study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (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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