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

Muğla Sıtkı Koçman University

Status: Completed

Conditions: Musculoskeletal Pain

Treatments: Other: Symptom monitoring software via visual feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05816824

Fizyoanalist

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Symptom Monitoring Telerehabilitation (Intervention) Group

Experimental group

Description:

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.

Treatment:

Other: Symptom monitoring software via visual feedback

Telerehabilitation (Control) Group

Active Comparator group

Description:

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.

Treatment:

Other: Symptom monitoring software via visual feedback