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Completed

NCT Number: NCT05816824

The Effect of Clinical Monitoring Software on 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.

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Key information

Conditions

Musculoskeletal Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muğla Sıtkı Koçman Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symptom monitoring software via visual feedback

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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