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

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Symptom monitoring software via visual feedback
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Muğla Sıtkı Koçman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Symptom Monitoring Telerehabilitation (Intervention) Group

Telerehabilitation (Control) Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.

Secondary Outcome Measures

Telehealth Usability Questionnaire
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.
Telemedicine Satisfaction Questionnaire
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.
Exercise Adherence Rating Scale
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).

Full Information

First Posted
March 22, 2023
Last Updated
August 7, 2023
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05816824
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
August 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptom Monitoring Telerehabilitation (Intervention) Group
Arm Type
Experimental
Arm 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.
Arm Title
Telerehabilitation (Control) Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Symptom monitoring software via visual feedback
Intervention Description
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 Outcome Measure Information:
Title
Visual Analog Scale
Description
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).
Time Frame
Change from Baseline Visual Analog Scale at 8 weeks
Title
Nottingham Health Profile
Description
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.
Time Frame
Change from Baseline Nottingham Health Profile at 8 weeks
Title
Pain Catastrophising Scale
Description
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.
Time Frame
Change from Baseline Pain Catastrophising Scale at 8 weeks
Title
Oswestry Disability Index
Description
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.
Time Frame
Change from Baseline Oswestry Disability Index at 8 weeks
Secondary Outcome Measure Information:
Title
Telehealth Usability Questionnaire
Description
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.
Time Frame
Change from Baseline Telehealth Usability Questionnaire at 8 weeks
Title
Telemedicine Satisfaction Questionnaire
Description
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.
Time Frame
Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks
Title
Exercise Adherence Rating Scale
Description
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).
Time Frame
Change from Exercise Adherence Rating Scale at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bekir Güçlü, MSc
Organizational Affiliation
Istanbul Halic University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Süleyman Demirel University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmet İmerci, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Baki Umut Tuğay, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Chair
Facility Information:
Facility Name
Muğla Sıtkı Koçman Training and Research Hospital
City
Muğla
State/Province
Menteşe
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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