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

NCT05816824 | Completed

• 1 other identifier: Fizyoanalist
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale

  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).

  Change from Baseline Visual Analog Scale at 8 weeks

• Nottingham Health Profile

  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.

  Change from Baseline Nottingham Health Profile at 8 weeks

• Pain Catastrophising Scale

  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.

  Change from Baseline Pain Catastrophising Scale at 8 weeks

• Oswestry Disability Index

  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.

  Change from Baseline Oswestry Disability Index at 8 weeks

Secondary Outcomes (3)

• Telehealth Usability Questionnaire

  Change from Baseline Telehealth Usability Questionnaire at 8 weeks

• Telemedicine Satisfaction Questionnaire

  Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks

• Exercise Adherence Rating Scale

  Change from Exercise Adherence Rating Scale at 8 weeks

Study Arms (2)

Symptom Monitoring Telerehabilitation (Intervention) Group

EXPERIMENTAL

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.

Other: Symptom monitoring software via visual feedback

Telerehabilitation (Control) Group

ACTIVE COMPARATOR

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.

Other: Symptom monitoring software via visual feedback

Interventions

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.

Symptom Monitoring Telerehabilitation (Intervention) Group; Telerehabilitation (Control) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Sıtkı Koçman Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatih Özden, PhD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• Bekir Güçlü, MSc

  Istanbul Halic University

  STUDY CHAIR

• İsmet Tümtürk, MSc

  Süleyman Demirel University

  STUDY CHAIR

• Ahmet İmerci, MD

  Muğla Sıtkı Koçman University

  STUDY CHAIR

• Baki Umut Tuğay, PhD

  Muğla Sıtkı Koçman University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 18, 2023
• Study Start: April 30, 2023
• Primary Completion: July 5, 2023
• Study Completion: August 5, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)