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Completed

NCT Number: NCT03756740

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

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Haifa

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

telerehabilitation and physical therapy

Other

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

Control

Other

subjects will receive the LBP exercises as printed pictures on paper

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 3 months

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

  2. 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. 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

  4. Survey Health Form Short

    Time frame: 3 months

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

Secondary outcomes

  1. Global rating of change

    Time frame: 3 months

    a 15-point Likert scale ranging to assess treatment success

  2. A questionnaire regarding treatment satisfaction

    Time frame: 3 months

    a 5-point Likert scale to assess patient satisfaction from treatment

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Maccabi Healthcare Services, Israel

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2018
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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