The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

NCT04567758 | Completed

• 1 other identifier: 09.2020.518
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Exercise Adherence Rating Scale (EARS)

  5 MİNUTES

• Exercise Diary

  2 minutes

• Expectation and satisfaction assessment

  5 minutes

Study Arms (2)

Telerehabilitation (TR) Group

EXPERIMENTAL

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

Other: Telerehabilitation

Conventional Rehabilitation (CR) Group

ACTIVE COMPARATOR

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

Telerehabilitation 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.

Also known as: TR

Telerehabilitation (TR) Group

Conventional Rehabilitation 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

Also known as: CR

Conventional Rehabilitation (CR) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Muğla Sıtkı Koçman University

Muğla, Kötekli, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Patient Satisfaction

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Zübeyir Sarı, PT, PhD

  Marmara University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants, outcomes assessor, and the analyzer of the statistics of the study will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blind randomized controlled trial

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: December 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)