Clinical trial NCT03756740: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: telerehabilitation, exercises, video, physical therapy
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2018-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 3 months
measure: Modified Oswestry Disability Index
timeFrame: 3 months
measure: Fear-Avoidance Beliefs Questionnaire
timeFrame: 3 months
measure: Survey Health Form Short
timeFrame: 3 months
Secondary outcomes:
measure: Global rating of change
timeFrame: 3 months
measure: A questionnaire regarding treatment satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Gali Dar, PhD
role: PRINCIPAL_INVESTIGATOR
References: