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

August 7, 2023 updated by: Fatih Ozden, Muğla Sıtkı Koçman University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Menteşe
      • Muğla, Menteşe, Turkey, 48000
        • Muğla Sıtkı Koçman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symptom Monitoring Telerehabilitation (Intervention) Group
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
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.
Active Comparator: Telerehabilitation (Control) Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Change from Baseline Visual Analog Scale at 8 weeks
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
Time Frame: Change from Baseline Nottingham Health Profile at 8 weeks
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
Time Frame: Change from Baseline Pain Catastrophising Scale at 8 weeks
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
Time Frame: Change from Baseline Oswestry Disability Index at 8 weeks
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
Time Frame: Change from Baseline Telehealth Usability Questionnaire at 8 weeks
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
Time Frame: Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks
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
Time Frame: Change from Exercise Adherence Rating Scale at 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: Fatih Özden, PhD, Muğla Sıtkı Koçman University
  • Study Chair: Bekir Güçlü, MSc, Istanbul Halic University
  • Study Chair: İsmet Tümtürk, MSc, Suleyman Demirel University
  • Study Chair: Ahmet İmerci, MD, Muğla Sıtkı Koçman University
  • Study Chair: Baki Umut Tuğay, PhD, Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

August 5, 2023

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fizyoanalist

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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