The Effect of Clinical Monitoring Software on Symptoms in Patients With Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The aim of this randomised controlled trial is to compare the effectiveness of two different telerehabilitation assessment methods in patients with chronic low back pain. The control group will receive a video exercise-based rehabilitation protocol with telerehabilitation. The intervention group will be followed up with the same protocol plus symptom monitoring software called PhysioAnalyst which provides visual feedback. The evaluation of outcome measures will be performed on the control group through the PhysioAnalist programme without visual feedback and on the intervention group through the PhysioAnalist programme with visual feedback.

Detailed Description
-----------------
Individuals with chronic low back pain will be divided into 2 groups by randomisation software (https://ctrandomization.cancer.gov/tool/). The control group will be given video exercises on the online platform. Initial, interim and final evaluations will be performed by filling in the patient-reported outcome measures through the PhysioAnalyst programme without patient feedback. The intervention group will be given the video exercise programme on the same online platform. Initial, intermediate and final assessments will be performed with our self-developed PhysioAnalyst software using visual feedback tools. The video exercises given to the participants will include Williams, McKenzie exercises and core strengthening exercises. Visual Analogue Scale pain score, Nottingham Health Profile, Pain Catastrophising Scale, Oswestry Disability Index, Telehealth Usability Questionnaire, Telemedicine Satisfaction Questionnaire, Exercise Adherence Rating Scale will be applied.

Official Title
-----------------
The Effect of Visual Feedback Based Clinical Monitoring Software on Clinical and Psychosocial Symptoms in Patients With Chronic Low Back Pain

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Other: Symptom monitoring software via visual feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with low back pain for more than 3 months and diagnosed with chronic low back pain Adult patients aged between 18 and 65 years Individuals without a radicular symptom Patients who can understand and respond to verbal commands and who do not have hearing or speech problems or psychiatric problems that may prevent communication Patients who have devices with sufficient requirements to receive the exercise programme and assessments offered by telerehabilitation Exclusion Criteria: Spinal surgery history Presence of malignancy Presence of other orthopaedic and/or neurological diseases that may affect the assessment and treatment Pregnant women or women with suspected pregnancy Patients who did not sign the consent form required for participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptom Monitoring Telerehabilitation (Intervention) Group<br>The intervention group will be followed up with the same protocol plus symptom monitoring software called PhysioAnalyst which provides visual feedback. The video exercises given to the participants will include Williams, McKenzie exercises and core strengthening exercises. | Other: Symptom monitoring software via visual feedback<br>* With PhysioAnalyst software, individuals are evaluated using clinical tools (questionnaire, scale). These evaluations provide visual feedback to individuals in the form of tables and graphs. In this way, patients can observe the changes in their clinical status.<br>|
| Active Comparator: Telerehabilitation (Control) Group<br>The control group will receive video exercise-based rehabilitation protocol with telerehabilitation without visual feedback. The video exercises given to the participants will include Williams, McKenzie exercises and core strengthening exercises. | Other: Symptom monitoring software via visual feedback<br>* With PhysioAnalyst software, individuals are evaluated using clinical tools (questionnaire, scale). These evaluations provide visual feedback to individuals in the form of tables and graphs. In this way, patients can observe the changes in their clinical status.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | On a 10 cm straight line or numerical and visual scale, the patient is asked to mark the pain felt (0: no pain, 10: unbearable pain). | Change from Baseline Visual Analog Scale at 8 weeks | 
| Nottingham Health Profile | The measure consists of six different subcategories testing physical activity, energy, pain, social isolation, sleep and emotional responses. Scores range from 0 to 100 for each subcategory. Low scores indicate a low impact of the complaint and high scores indicate a high impact of the complaint. | Change from Baseline Nottingham Health Profile at 8 weeks | 
| Pain Catastrophising Scale | Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation. | Change from Baseline Pain Catastrophising Scale at 8 weeks | 
| Oswestry Disability Index | The Oswestry Disability Index consists of 10 questions measuring functional status. Each question is evaluated between 0 and 5 points and the total maximum score is 50. Higher score indicates more disability. | Change from Baseline Oswestry Disability Index at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telehealth Usability Questionnaire | The survey addresses six factors; usability, ease of use and learnability, interface quality, interaction quality, reliability and satisfaction. Total score is ranged between 21 to 147. A higher score indicates better usability. | Change from Baseline Telehealth Usability Questionnaire at 8 weeks | 
| Telemedicine Satisfaction Questionnaire | Treatment of patients or other remote level of satisfaction with the software or system from which they receive rehabilitation services is being evaluated. The total score ranges between 14-70. A higher score indicates better satisfaction. | Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks | 
| Exercise Adherence Rating Scale | Exercise Adherence Rating Scale is a self-report measure that is composed of six items that directly assess adherence behavior. Higher scores indicating greater adherence (0 to 24). | Change from Exercise Adherence Rating Scale at 8 weeks |