The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Being tested

Telerehabilitation, Conventional Rehabilitation

Keywords

Chronic Low-back Pain, Telerehabilitation, Pain, Quality of Life, Motivation, Expectation, Patient Satisfaction

Medical subject headings

Pain, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• TelerehabilitationOther

  Also called TR

  The home exercise program includes the following exercises:

  1. Lumbar region and lower extremity stretching exercises;
  2. Exercises to strengthen the abdominal muscles;
  3. Exercises to strengthen the lumbar muscles;
  4. 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.

• Conventional RehabilitationOther

  Also called CR

  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:

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 2 minutes

2. 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.

   Measured: 5 minutes

3. 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.

   Measured: 5 minutes

4. 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.

   Measured: 5 minutes

5. 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.

   Measured: 5 minutes

6. 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.

   Measured: 5 minutes

7. 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.

   Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Sep 2020
2. Study start1 Dec 2020
3. Primary completion1 May 2021
4. Study completion1 Jun 2021

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
• More trials run by Marmara UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.