Clinical trial NCT05816824: The Effect of Clinical Monitoring Software on Symptoms in Patients With Chronic Low Back Pain
Official title: The Effect of Visual Feedback Based Clinical Monitoring Software on Clinical and Psychosocial Symptoms in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Change from Baseline Visual Analog Scale at 8 weeks
measure: Nottingham Health Profile
timeFrame: Change from Baseline Nottingham Health Profile at 8 weeks
measure: Pain Catastrophising Scale
timeFrame: Change from Baseline Pain Catastrophising Scale at 8 weeks
measure: Oswestry Disability Index
timeFrame: Change from Baseline Oswestry Disability Index at 8 weeks
Secondary outcomes:
measure: Telehealth Usability Questionnaire
timeFrame: Change from Baseline Telehealth Usability Questionnaire at 8 weeks
measure: Telemedicine Satisfaction Questionnaire
timeFrame: Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks
measure: Exercise Adherence Rating Scale
timeFrame: Change from Exercise Adherence Rating Scale at 8 weeks
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman Training and Research Hospital
state: Menteşe
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Halic University
name: Bekir Güçlü, MSc
role: STUDY_CHAIR
affiliation: Süleyman Demirel University
name: İsmet Tümtürk, MSc
role: STUDY_CHAIR
affiliation: Muğla Sıtkı Koçman University
name: Ahmet İmerci, MD
role: STUDY_CHAIR
affiliation: Muğla Sıtkı Koçman University
name: Baki Umut Tuğay, PhD
role: STUDY_CHAIR
References: