The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Other: Conventional Rehabilitation; Other: Telerehabilitation

• Registration Number: NCT04567758
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Study Start: 2020-12-01
• Status Verified: 2021-02
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-01
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Rehabilitation (CR) Group	Conventional Rehabilitation	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.
Telerehabilitation (TR) Group	Telerehabilitation	The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.

Primary Outcome Measures

Name	Time	Method
Five Repeated Sit-to-Stand Test	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.
Short Form-36 (SF-36)	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.
Oswestry Disability Index (ODI)	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.
Visual Analogue Scale (VAS)	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.
Timed Up and Go Test	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.
Tampa Kinesiophobia Scale (TSK)	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.
System Usability Scale (SUS)	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 Outcome Measures

Name	Time	Method
Expectation and satisfaction assessment	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.
Exercise Diary	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.
Exercise Adherence Rating Scale (EARS)	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.

Trial Locations

Locations (1)

Muğla Sıtkı Koçman University; 🇹🇷 Muğla, Kötekli, Turkey