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CompletedNCT04567758Updated Jul 6, 2021

The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

An interventional study of Telerehabilitation and Conventional Rehabilitation in Chronic Low-back Pain, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-06.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Low-back Pain

Keywords

  • Chronic Low-back Pain
  • Telerehabilitation
  • Pain
  • Quality of Life
  • Motivation
  • Expectation
  • Patient Satisfaction
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Telerehabilitation (TR) Group

    The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.

    Other: Telerehabilitation

  • Active comparator
    Conventional Rehabilitation (CR) Group

    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

Interventions

  • OtherTelerehabilitation

    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.

    Also known as: TR

  • OtherConventional Rehabilitation

    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

    Also known as: CR

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 5 minutes

Secondary outcomes

  1. 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.

    Time frame: 5 MİNUTES

  2. 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.

    Time frame: 2 minutes

  3. 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.

    Time frame: 5 minutes

07

Study locations

1 site
  • Muğla Sıtkı Koçman University
    Muğla, Kötekli 48000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04567758
Lead sponsor
Marmara University
Responsible party
Fatih ÖZDEN (Principal Investigator, Marmara University) — Principal investigator
First posted
Sep 28, 2020
Start date
Dec 1, 2020
Primary completion
May 1, 2021
Completion
Jun 1, 2021
Last update
Jul 6, 2021

Study contacts

Zübeyir Sarı, PT, PhD
study chair · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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