The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

NCT ID: NCT04567758

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-06-01

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Telerehabilitation (TR) Group

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

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: OTHER

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 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.

Group Type: ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type: OTHER

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

Interventions

Telerehabilitation

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.

Intervention Type: OTHER

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:

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

Intervention Type: OTHER

Other Intervention Names

TR; CR

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Fatih ÖZDEN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zübeyir Sarı, PT, PhD

Role: STUDY_CHAIR

Marmara University

Locations

Muğla Sıtkı Koçman University

Muğla, Kötekli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2020.518

Identifier Type: -

Identifier Source: org_study_id