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Clinical Trials/NCT05816824
NCT05816824
Completed
N/A

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

Muğla Sıtkı Koçman University1 site in 1 country44 target enrollmentApril 30, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Musculoskeletal Pain
Sponsor
Muğla Sıtkı Koçman University
Enrollment
44
Locations
1
Primary Endpoint
Visual Analog Scale
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2023
End Date
August 5, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Muğla Sıtkı Koçman University
Responsible Party
Principal Investigator
Principal Investigator

Fatih Ozden

Assistant Professor

Muğla Sıtkı Koçman University

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

Outcomes

Primary Outcomes

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).

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.

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.

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.

Secondary Outcomes

  • Exercise Adherence Rating Scale(Change from Exercise Adherence Rating Scale at 8 weeks)
  • Telehealth Usability Questionnaire(Change from Baseline Telehealth Usability Questionnaire at 8 weeks)
  • Telemedicine Satisfaction Questionnaire(Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks)

Study Sites (1)

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