Musculoskeletal PainNCT05816824

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

A study testing Symptom monitoring software via visual feedback in people with Musculoskeletal Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Musculoskeletal Pain
What is being tested?: Symptom monitoring software via visual feedback
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 30 Apr 2023to 5 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Muğla Sıtkı Koçman Training and Research Hospital
Muğla, Menteşe, 48000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Visual Feedback Based Clinical Monitoring Software on Clinical and Psychosocial 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.

Read the 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.

Conditions: Musculoskeletal Pain
Being tested: Symptom monitoring software via visual feedback
Medical subject headings: Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Symptom monitoring software via visual feedbackOther
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.

Study groups in NCT05816824
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Symptom monitoring software via visual feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline Oswestry Disability Index at 8 weeks

Secondary outcomes (3)

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.
Measured: Change from Baseline Telehealth Usability Questionnaire at 8 weeks
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.
Measured: Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks
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).
Measured: Change from Exercise Adherence Rating Scale at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 20235 Aug 2023

First posted18 Apr 2023
Study start30 Apr 2023
Primary completion5 Jul 2023
Study completion5 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05816824
Sponsor's protocol ID: Fizyoanalist
Status last verified: Aug 2023
First submitted: 22 Mar 2023
Last updated: 8 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ozden F, Guclu B, Tumturk I, Dogrukok ON, Imerci A, Tugay BU. The effect of visual feedback-based clinical monitoring application in patients with chronic low back pain: a randomized controlled trial. Eur Spine J. 2024 Feb;33(2):505-516. doi: 10.1007/s00586-023-08098-1. Epub 2024 Jan 6.
PubMed 38182853

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Musculoskeletal Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Visual Feedback Based Clinical Monitoring Software on Clinical and Psychosocial Symptoms in Patients With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT05816824
Acronym / sponsor ID: Fizyoanalist
Conditions: Musculoskeletal Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Muğla Sıtkı Koçman UniversityUniversity, hospital or other
Study start: 30 Apr 2023 (actual)
Primary completion: 5 Jul 2023 (actual)
Study completion: 5 Aug 2023 (actual)
First posted: 18 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Symptom Monitoring Telerehabilitation (Intervention) Group	Experimental	Other: Symptom monitoring software via visual feedbackThe 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.
Telerehabilitation (Control) Group	Active comparator	Other: Symptom monitoring software via visual feedbackThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Symptom monitoring software via visual feedbackWith 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.	Other	Symptom Monitoring Telerehabilitation (Intervention) Group, Telerehabilitation (Control) Group

Primary outcome

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).
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.
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.
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.

3 secondary outcomes

Telehealth Usability Questionnaire
Time frame: Change from Baseline Telehealth Usability Questionnaire at 8 weeks
Telemedicine Satisfaction Questionnaire
Time frame: Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks
Exercise Adherence Rating Scale
Time frame: Change from Exercise Adherence Rating Scale at 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
Derived from this study: PubMed 38182853Ozden F, Guclu B, Tumturk I, Dogrukok ON, Imerci A, Tugay BU. The effect of visual feedback-based clinical monitoring application in patients with chronic low back pain: a randomized controlled trial. Eur Spine J. 2024 Feb;33(2):505-516. doi: 10.1007/s00586-023-08098-1. Epub 2024 Jan 6.
Individual participant dataSharing planned: No

Related trials for Musculoskeletal Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
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Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
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Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fatih Özden, PhD principal investigator

Muğla Sıtkı Koçman University

Bekir Güçlü, MSc study chair

Istanbul Halic University

İsmet Tümtürk, MSc study chair

Süleyman Demirel University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Symptom monitoring software via visual feedback in people with Musculoskeletal Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: Change from Baseline Visual Analog Scale at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05816824, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.