The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567758
• Other study ID #: 09.2020.518
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Telerehabilitation
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.
• Conventional 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: 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

Locations

Country	Name	City	State
Turkey	Mugla Sitki Koçman University	Mugla	Kötekli

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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 MINUTES
Secondary	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
Secondary	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