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The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Conventional Rehabilitation
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic Low-back Pain, Telerehabilitation, Pain, Quality of Life, Motivation, Expectation, Patient Satisfaction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muğla Sıtkı Koçman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation (TR) Group

Conventional Rehabilitation (CR) Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 23, 2020
Last Updated
July 2, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04567758
Brief Title
The Effect of Telerehabilitation in Patients With Chronic Low Back Pain
Official Title
The Effect of Telerehabilitation on Clinical Results, Patient Expectation, Motivation and Satisfaction Level in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic Low-back Pain, Telerehabilitation, Pain, Quality of Life, Motivation, Expectation, Patient Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double-blind randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Participants, outcomes assessor, and the analyzer of the statistics of the study will be blinded.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation (TR) Group
Arm Type
Experimental
Arm Description
The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.
Arm Title
Conventional Rehabilitation (CR) Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Other Intervention Name(s)
TR
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Other Intervention Name(s)
CR
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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
Title
Five Repeated Sit-to-Stand Test
Description
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
Title
Timed Up and Go Test
Description
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
Title
Oswestry Disability Index (ODI)
Description
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
Title
Tampa Kinesiophobia Scale (TSK)
Description
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
Title
Short Form-36 (SF-36)
Description
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
Title
System Usability Scale (SUS)
Description
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 Outcome Measure Information:
Title
Exercise Adherence Rating Scale (EARS)
Description
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
Title
Exercise Diary
Description
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
Title
Expectation and satisfaction assessment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zübeyir Sarı, PT, PhD
Organizational Affiliation
Marmara University
Official's Role
Study Chair
Facility Information:
Facility Name
Muğla Sıtkı Koçman University
City
Muğla
State/Province
Kötekli
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

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