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

NCT03756740 | Completed

• 1 other identifier: 196/18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Keywords

telerehabilitation, exercises, video, physical therapy

Outcome Measures

Primary Outcomes (4)

• Numeric Pain Rating Scale

  level of pain on an 11-point numeric pain rating scale

  3 months

• 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

  3 months

• Fear-Avoidance Beliefs Questionnaire

  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

  questionnaire to assess the subject's belief as to his/her health-related quality of life

  3 months

Secondary Outcomes (2)

• Global rating of change

  3 months

• A questionnaire regarding treatment satisfaction

  3 months

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

telerehabilitation and physical therapy OTHER

subject will receive the LBP exercises as a video to his/her mobile or e-mail

Telerehabilitation

control OTHER

subjects will receive the LBP exercises as printed pictures on paper

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Haifa: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

University of Haifa

Haifa, Israel

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Telerehabilitation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Gali Dar, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 28, 2018
• Study Start: November 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months following end of study

Locations

IL (1)