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Completed

NCT Number: NCT04567758

The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

Telerehabilitation enables patients to easily adapt to home exercise programs and to be monitored remotely by their clinicians. The aim of this study is to investigate the effectiveness of the home exercise program, which is integrated into 8-week remote asynchronous video telerehabilitation sessions, on clinical status in terms of pain, functionality, quality of life parameters, as well as patient expectation, motivation, and satisfaction levels.

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Key information

Conditions

Chronic Low-back Pain Behavior Health Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muğla Sıtkı Koçman University

Muğla, Kötekli, 48000, Turkey (Türkiye)

About this study

Low back pain is symptomatic pathology in the region between the twelve ribs and lower gluteal line defined as the lumbar region and sometimes accompanied by radicular symptoms spreading to the lower extremity, but it is not considered as a pathology alone. They are evaluated and treated on the basis of symptom duration, potential cause, the presence or absence of radicular symptoms, and the corresponding anatomical or radiographic abnormalities. Exercise is considered an essential element in the management of physical therapy and rehabilitation in patients with chronic low back pain. However, it has been found in the studies that improvements after physical therapy and rehabilitation applications are not preserved in the long term, and recurrence of chronic low back pain is common. In order to prevent this, physiotherapists need to follow their patients for a long time and to participate in the rehabilitation process. With a more cost-effective treatment model such as telerehabilitation, patients can be followed up more efficiently during home exercise. The aim of this study is to investigate the effectiveness of the home exercise program, which is integrated into 8-week remote asynchronous video telerehabilitation sessions, on clinical status in terms of pain, functionality, quality of life parameters, as well as patient expectation, motivation, and satisfaction levels.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients aged 18-65
  • Patients who have complained of low back pain for at least 3 months
  • Pain and numbness that does not spread to the legs

Exclusion criteria

  • Patients with cognitive disorders or communications problems to complete assessments or treatment interventions.
  • Individuals who have undergone surgical operations on the spine and/or extremities
  • Specific pathological conditions (e.g. malignancy, fracture, systemic rheumatoid disease)
  • Orthopedic and neurological problems that prevent evaluation and/or treatment
  • Complaints of pain and numbness spreading to the lower extremities
  • Individuals with a diagnosed psychiatric illness
  • Individuals who have received physiotherapy in the last 6 months
  • Individuals who use another treatment method during the study
  • Individuals with musculoskeletal pain in any other part of the body during work
  • Pregnancy

Treatment and study plan

telerehabilitation

Other

The home exercise program includes the following exercises:

  • Lumbar region and lower extremity stretching exercises;
  • Exercises to strengthen the abdominal muscles;
  • Exercises to strengthen the lumbar muscles;
  • Bridging, spine mobility exercise, McKenzie extension, and Williams flexion exercises

A web-based telerehabilitation platform (Fizyoweb) will be used to deliver the exercise program. Using the Fizyoweb web application, exercises will be presented to the patients in the form of audio-video and detailed instructions with explanations. The exercise program to be given will be prescribed specifically with slight changes according to the patient's condition. The exercise protocol will be the same as in the conventional rehabilitation group. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.

Other names: TR

conventional rehabilitation

Other

The home exercise program, which will be given with conventional rehabilitation, will be educated to the patient in the clinic on the first day. Exercise information form including explanation and picture of the exercises will be given to the patients. The exercise program to be given will be prescribed specifically with slight changes according to the patient's condition. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.

The home exercise program includes the following exercises:

  • Lumbar region and lower extremity stretching exercises;
  • Exercises to strengthen the abdominal muscles;
  • Exercises to strengthen the lumbar muscles;
  • Bridging, spine mobility exercise, McKenzie extension, and Williams flexion exercises

Other names: CR

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 2 minutes

    Visual Analogue Scale (VAS): The patients will be asked to mark their pain feelings for rest and activity on a 10 cm numerical line (0: no pain, 10: unbearable pain). It is planned to use numerical VAS in our study. The cut-off values for chronic musculoskeletal pain will be classified as the severity of pain according to VAS as follows:

    <3.4 centimeters: mild pain, 3.5-7.4 centimeters: moderate pain, > 7.5 centimeters: severe pain.

  2. Five Repeated Sit-to-Stand Test

    Time frame: 5 minutes

    In the starting position, the participant will be asked to sit in a chair without a standard armrest, with his back flat, feet shoulder-width apart and soles flat on the floor, with his arms crossed in front of the chest. With the "start" command, the participant is asked to stand up straight from the chair and return to the starting position without disturbing the arm position. Up to 5 repetitions are recorded in seconds.

  3. Timed Up and Go Test

    Time frame: 5 minutes

    The patient stands up from a sitting position, walks on a 3-meter line, turns back and sits on the chair again. The duration of the performance is recorded in seconds.

  4. Oswestry Disability Index (ODI)

    Time frame: 5 minutes

    ODI is a questionnaire consisting of 10 questions measuring the functional status. Each question is evaluated between 0-5 points and the total maximum score is 50. As the total score increases, functionality decreases and disability increases.

  5. Tampa Kinesiophobia Scale (TSK)

    Time frame: 5 minutes

    TSK is a questionnaire consisting of 17 questions and used in the evaluation of kinesiophobia (fear of movement). 4-point Likert scale (1 = Strongly disagree, 4 = Strongly agree) is used. The scale is scored between 17-68. The high score the person gets on the scale indicates that his kinesiophobia is also high.

  6. Short Form-36 (SF-36)

    Time frame: 5 minutes

    SF-36 consists of thirty-six items. These provide measurements of eight dimensions. Subscales evaluate health between 0-100 points; '0' indicates poor health, '100' indicates good health.

  7. System Usability Scale (SUS)

    Time frame: 5 minutes

    SUS is an evaluation tool developed to evaluate systems or software in terms of usability, expectation, and satisfaction. The SUS, which is a 5-point Likert-type scale, includes 10 items in total. At the end of the scale, a score between 0 and 100 is obtained.

Secondary outcomes

  1. Exercise Adherence Rating Scale (EARS)

    Time frame: 5 MİNUTES

    EARS provides a measurement of commitment to home exercise. This may facilitate the evaluation of interventions that promote self-management, for the treatment of chronic conditions.

  2. Exercise Diary

    Time frame: 2 minutes

    The patients will be asked to fill the daily exercise diary chart, whether the they have done the exercise or not in order to follow up their home exercise program.

  3. Expectation and satisfaction assessment

    Time frame: 5 minutes

    The expectation questionnaire will be conducted on the day of the start of the home exercise program, and the satisfaction questionnaire will be carried out on the day of termination from the two questionnaires prepared by the researchers of the study for the assessment of expectations and satisfaction.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Effect of Telerehabilitation on Clinical Results, Patient Expectation, Motivation and Satisfaction Level in Patients With Chronic Low Back Pain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2020
Registry last updated
Jul 6, 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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