The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Chronic Low-back Pain

Intervention / Treatment
-----------------
* Other: Telerehabilitation
* Other: Conventional Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation (TR) Group<br>The TR group will be followed up through the video-based exercise software within the 8-week home exercise program. | Other: Telerehabilitation<br>* 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.<br>* Other names: TR;|
| Active Comparator: Conventional Rehabilitation (CR) Group<br>The CR group will be trained face-to-face with conventional methods before the 8-week home exercise program, and an exercise program will be prescribed with a visual information form. | Other: Conventional Rehabilitation<br>* 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<br>* Other names: CR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | 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 minutes | 
| Five Repeated Sit-to-Stand Test | 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. | 5 minutes | 
| Timed Up and Go Test | 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. | 5 minutes | 
| Oswestry Disability Index (ODI) | 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 minutes | 
| Tampa Kinesiophobia Scale (TSK) | 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. | 5 minutes | 
| Short Form-36 (SF-36) | 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. | 5 minutes | 
| System Usability Scale (SUS) | 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. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Adherence Rating Scale (EARS) | 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. | 5 MİNUTES | 
| Exercise Diary | 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. | 2 minutes | 
| Expectation and satisfaction assessment | 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. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Low-back Pain, Telerehabilitation, Pain, Quality of Life, Motivation, Expectation, Patient Satisfaction