Back to resultsThe Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
telerehabilitation and physical therapy
control
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring telerehabilitation, exercises, video, physical therapy
Eligibility Criteria
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.
Sites / Locations
- University of Haifa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telerehabilitation
Control
Arm 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.
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
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale
level of pain on an 11-point numeric pain rating scale
Modified Oswestry Disability Index
questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP
Fear-Avoidance Beliefs Questionnaire
questionnaire to assess the subject's beliefs as to the potential harm of several physical and work-related activities
Survey Health Form Short
questionnaire to assess the subject's belief as to his/her health-related quality of life
Secondary Outcome Measures
Global rating of change
a 15-point Likert scale ranging to assess treatment success
A questionnaire regarding treatment satisfaction
a 5-point Likert scale to assess patient satisfaction from treatment
Full Information
NCT ID
NCT03756740
First Posted
November 27, 2018
Last Updated
November 12, 2021
Sponsor
University of Haifa
Collaborators
Maccabi Healthcare Services, Israel
1. Study Identification
Unique Protocol Identification Number
NCT03756740
Brief Title
The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain
Official Title
The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Maccabi Healthcare Services, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
telerehabilitation, exercises, video, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation
Arm Type
Experimental
Arm 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 Title
Control
Arm Type
Active Comparator
Arm 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(s)
telerehabilitation and physical therapy
Intervention Description
subject will receive the LBP exercises as a video to his/her mobile or e-mail
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
subjects will receive the LBP exercises as printed pictures on paper
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
level of pain on an 11-point numeric pain rating scale
Time Frame
3 months
Title
Modified Oswestry Disability Index
Description
questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP
Time Frame
3 months
Title
Fear-Avoidance Beliefs Questionnaire
Description
questionnaire to assess the subject's beliefs as to the potential harm of several physical and work-related activities
Time Frame
3 months
Title
Survey Health Form Short
Description
questionnaire to assess the subject's belief as to his/her health-related quality of life
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Global rating of change
Description
a 15-point Likert scale ranging to assess treatment success
Time Frame
3 months
Title
A questionnaire regarding treatment satisfaction
Description
a 5-point Likert scale to assess patient satisfaction from treatment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
following study completion, a paper will be submitted to international professional journal
IPD Sharing Time Frame
6 months following end of study
Learn more about this trial
The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain
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