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

NCT ID: NCT05816824

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2023-08-05

Brief Summary

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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

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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.

Conditions

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Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Symptom monitoring software via visual feedback

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Symptom monitoring software via visual feedback

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Fatih Ozden

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatih Özden, PhD

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Bekir Güçlü, MSc

Role: STUDY_CHAIR

Istanbul Halic University

İsmet Tümtürk, MSc

Role: STUDY_CHAIR

Süleyman Demirel University

Ahmet İmerci, MD

Role: STUDY_CHAIR

Muğla Sıtkı Koçman University

Baki Umut Tuğay, PhD

Role: STUDY_CHAIR

Muğla Sıtkı Koçman University

Locations

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Muğla Sıtkı Koçman Training and Research Hospital

Muğla, Menteşe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Fizyoanalist

Identifier Type: -

Identifier Source: org_study_id

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