<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03756740</url>
  </required_header>
  <id_info>
    <org_study_id>196/18</org_study_id>
    <nct_id>NCT03756740</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain</brief_title>
  <official_title>The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maccabi Healthcare Services, Israel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Haifa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain (LBP), a common disorder, causes disability, functional decline and high health&#xD;
      care costs. Patient care programs include specific exercises for promoting function and&#xD;
      improving health. Self-practice and adherence to treatment are important for treatment&#xD;
      success and better outcomes. Telerehabilitation (TR) might improve patient symptoms,&#xD;
      compliance to treatment and reduce patient symptoms, however, its effectiveness in treating&#xD;
      LBP, still needs further investigation.&#xD;
&#xD;
      The overall aim of this study will be to examine the effectiveness of combining&#xD;
      telerehabilitation within physical therapy treatments for patients with LBP&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 60 patients complaining of chronic nonspecific LBP over a 6 month&#xD;
      period of time and referred for physical therapy treatment. They will undergo a routine&#xD;
      physical examination and be assigned a personal treatment (manual therapy and electrotherapy)&#xD;
      and exercise program in accordance with their condition. Participants will receive a total of&#xD;
      8 treatments over a 4-week period (twice a week).&#xD;
&#xD;
      The sample will be randomly divided into 2 groups: a. research group A will receive a video&#xD;
      of the exercises via e-mails or to their cellphones; b. a control group will receive the&#xD;
      exercises printed on paper.&#xD;
&#xD;
      The exercises will be recorded and be supplemented by a verbal explanation and instructions&#xD;
      as to how to correctly perform the exercises. In total, there will be ten videos, found to be&#xD;
      important and effective for LBP patients. From these videos, a physical therapist will choose&#xD;
      the most suitable exercises for the patients after each treatment meeting (face to face). The&#xD;
      patients will be assessed at baseline, at the end of treatment and at a 3 month follow-up&#xD;
      telephone assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Sixty patients diagnosed with chronic LBP referred for physical therapy to one of the 5 outpatient clinics of Maccabi Health Services in the Haifa metropolitan area, Israel, will be recruited for this study. each subject will undergo a baseline examination including answering several questionnaires/self-reported outcome measures, a history of present or any past LBP and a physical examination routinely conducted during physical therapy assessment and treatments.&#xD;
Following the physical examination, the physical therapist will decide on the appropriate physical therapy modalities for the specific patients. These techniques will include only manual therapy (soft tissue mobilization and vertebrae segmental mobilization) and interferential electrotherapy. Furthermore, the subject will receive an appropriate exercise program which will performed at home.&#xD;
Each subject will be randomly referred to one of the research groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will not know the intervention in other groups or the research aim in details. they will only know that it is a research for low back pain treatment.&#xD;
The physical therapists performing the examination pre and post intervention will be blinded to the participants group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>3 months</time_frame>
    <description>level of pain on an 11-point numeric pain rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Oswestry Disability Index</measure>
    <time_frame>3 months</time_frame>
    <description>questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear-Avoidance Beliefs Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>questionnaire to assess the subject's beliefs as to the potential harm of several physical and work-related activities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survey Health Form Short</measure>
    <time_frame>3 months</time_frame>
    <description>questionnaire to assess the subject's belief as to his/her health-related quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global rating of change</measure>
    <time_frame>3 months</time_frame>
    <description>a 15-point Likert scale ranging to assess treatment success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A questionnaire regarding treatment satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>a 5-point Likert scale to assess patient satisfaction from treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Telerehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After each face to face session the patient will receive the exercises ordered by the physical therapist to perform at home.&#xD;
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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>telerehabilitation and physical therapy</intervention_name>
    <description>subject will receive the LBP exercises as a video to his/her mobile or e-mail</description>
    <arm_group_label>Telerehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>subjects will receive the LBP exercises as printed pictures on paper</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Main complaint of nonspecific LBP over a 3 month period&#xD;
&#xD;
          -  Possess a smartphone, e-mail and the understanding of using these tools for viewing&#xD;
             videos.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs or symptoms of possible malignancy are present, such as unexplained weight loss,&#xD;
             slight or no reduction of pain while in a recumbent position or subjects were not&#xD;
             screened prior to referral to physical therapy.&#xD;
&#xD;
          -  two or more of the following signs are present on physical examination: lower&#xD;
             extremity weakness in a myotome distribution, decreased sensation in a dermatomal&#xD;
             distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a&#xD;
             positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test.&#xD;
&#xD;
          -  Symptoms began immediately after a significant trauma (motor vehicle accident, fall&#xD;
             from a height) and subjects were not been screened for possible fractures.&#xD;
&#xD;
          -  Physical therapy or chiropractic treatment for LBP was provided during the 6 months&#xD;
             prior to participation in the study or are currently being treated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gali Dar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Haifa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Haifa</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 12, 2021</last_update_submitted>
  <last_update_submitted_qc>November 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Haifa</investigator_affiliation>
    <investigator_full_name>Gali Dar</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>telerehabilitation, exercises, video, physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>following study completion, a paper will be submitted to international professional journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>6 months following end of study</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756740
org study id: 196/18
nct id: NCT03756740
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Sixty patients diagnosed with chronic LBP referred for physical therapy to one of the 5 outpatient clinics of Maccabi Health Services in the Haifa metropolitan area, Israel, will be recruited for this study. each subject will undergo a baseline examination including answering several questionnaires/self-reported outcome measures, a history of present or any past LBP and a physical examination routinely conducted during physical therapy assessment and treatments.
Following the physical examination, the physical therapist will decide on the appropriate physical therapy modalities for the specific patients. These techniques will include only manual therapy (soft tissue mobilization and vertebrae segmental mobilization) and interferential electrotherapy. Furthermore, the subject will receive an appropriate exercise program which will performed at home.
Each subject will be randomly referred to one of the research groups.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will not know the intervention in other groups or the research aim in details. they will only know that it is a research for low back pain treatment.
The physical therapists performing the examination pre and post intervention will be blinded to the participants group.
measure: Numeric Pain Rating Scale
time frame: 3 months
description: level of pain on an 11-point numeric pain rating scale
measure: Modified Oswestry Disability Index
time frame: 3 months
description: questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP
measure: Fear-Avoidance Beliefs Questionnaire
time frame: 3 months
description: questionnaire to assess the subject's beliefs as to the potential harm of several physical and work-related activities
measure: Survey Health Form Short
time frame: 3 months
description: questionnaire to assess the subject's belief as to his/her health-related quality of life
measure: Global rating of change
time frame: 3 months
description: a 15-point Likert scale ranging to assess treatment success
measure: A questionnaire regarding treatment satisfaction
time frame: 3 months
description: a 5-point Likert scale to assess patient satisfaction from treatment
arm group label: Telerehabilitation
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Active Comparator
description: 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
intervention type: Other
intervention name: telerehabilitation and physical therapy
description: subject will receive the LBP exercises as a video to his/her mobile or e-mail
arm group label: Telerehabilitation
intervention type: Other
intervention name: control
description: subjects will receive the LBP exercises as printed pictures on paper
arm group label: Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gali Dar, PhD
role: Principal Investigator
affiliation: University of Haifa
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: University of Haifa
investigator full name: Gali Dar
investigator title: principal investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: following study completion, a paper will be submitted to international professional journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 6 months following end of study