Low Back Pain, Mechanical, Biofeedback, Pain, ChronicNCT03099941
The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain
A study testing Biofeedback in people with Low Back Pain, Mechanical, Biofeedback, Pain, Chronic, run by Istanbul University.
Trial summary
Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus muscles is the most important cause of the chronic nonspecific low back pain (CNLBP). Recently, applications sre developed that generates audio and vibrant stimuli in response to anteroposterior and mediolateral rotations and can be… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
- What is being tested?
- Biofeedback
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2015to 1 Jun 2016
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 25 and 65 years
- Continuous or recurrent episodes of pain in the lower back lasting for more than 12 weeks (chronic)
- No specific cause for pain complaints
- No other pathologic complaints or immobility
- Sufficient auditory and visual communication skills and
- Sufficient knowledge of the Turkish language
Who cannot join
- Any chronic disorder that may prevent exercise,
- Personal history of neurologic or rheumatologic disease,
- Pregnant or lactating women,
- Patients with malignancy or a lumbar comorbidity
- Terminal or progressive disease and any other musculoskeletal condition
- Surgery in the last 6 months and
- Any type of treatment for low back pain within past 6 months
About this study
Official title: The Comparison of the Effects of Two Different Feedback in the Core Stabilization Training for Patients With Chronic Nonspecific Low Back Pain (CNLBP): Randomized Parallel Group Trial
Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus muscles is the most important cause of the chronic nonspecific low back pain (CNLBP). Recently, applications sre developed that generates audio and vibrant stimuli in response to anteroposterior and mediolateral rotations and can be adapted according to subject-specific movement sensitivity.
Objective. The objective of this study was to compare effects of a biofeedback application that is alternative to physiotherapist feedback in core stabilization training of patients with chronic nonspecific low back pain.
Read more
Design. This study was a parallel group randomized controlled trial with outcome assessment.
Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back pain.
Interventions. Patients were randomly assigned to receive either physiotherapist feedback or Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12 sessions, 30 minutes of three weekly graded functional core education trial.
Measurements. Primary outcome measures were muscle strength (transversus abdominus and multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry Disability Index); secondary outcomes were flexibility (modified Schober test), range of motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality of life(36 Item Short-Form Health Survey questionnaire [SF-36]).
Limitations. Outcome measures for muscle strength did not include objective assesment.
Keywords. Chronic low back, core stabilization training, biofeedback, pain, function
- Being tested
- Biofeedback
- Keywords
- Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
- Medical subject headings
- Low Back Pain, Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackOther
The aim of this study is to investigate effects of a biofeedback application that is alternative to physical therapist feedback in core stabilization training of patients with CNLBP.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback group | Experimental | The biofeedback application which helps patient to understand neutral position and how to maintain it in exercises that are prescribed by the physical therapist Receives: Other: Biofeedback |
| Physical therapist feedback group | Active comparator | In physical therapist feedback group feedback applied by oral and tactile stimulation of physical therapist to helps patient to understand neutral position and how to maintain it in exercises that are prescribed Receives: Other: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Oswestry Disability Index
Disability
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start11 May 2015
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, Mechanical, Biofeedback, Pain, ChronicStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLVİN DİLAN CANAN, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099941
- Sponsor's protocol ID
- IstanbulFizyoterapi
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2017
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effects of Two Different Feedback in the Core Stabilization Training for Patients With Chronic Nonspecific Low Back Pain (CNLBP): Randomized Parallel Group Trial
- ClinicalTrials.gov ID
- NCT03099941
- Acronym / sponsor ID
- IstanbulFizyoterapi
- Keywords
- Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 11 May 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 4 Apr 2017 (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.
Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus muscles is the most important cause of the chronic nonspecific low back pain (CNLBP). Recently, applications sre developed that generates audio and vibrant stimuli in response to anteroposterior and mediolateral rotations and can be adapted according to subject-specific movement sensitivity.
Objective. The objective of this study was to compare effects of a biofeedback application that is alternative to physiotherapist feedback in core stabilization training of patients with chronic nonspecific low back pain.
Design. This study was a parallel group randomized controlled trial with outcome assessment.
Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back pain.
Interventions. Patients were randomly assigned to receive either physiotherapist feedback or Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12 sessions, 30 minutes of three weekly graded functional core education trial.
Measurements. Primary outcome measures were muscle strength (transversus abdominus and multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry Disability Index); secondary outcomes were flexibility (modified Schober test), range of motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality of life(36 Item Short-Form Health Survey questionnaire [SF-36]).
Limitations. Outcome measures for muscle strength did not include objective assesment.
Keywords. Chronic low back, core stabilization training, biofeedback, pain, function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback group | Experimental | Other: BiofeedbackThe biofeedback application which helps patient to understand neutral position and how to maintain it in exercises that are prescribed by the physical therapist |
| Physical therapist feedback group | Active comparator | Other: BiofeedbackIn physical therapist feedback group feedback applied by oral and tactile stimulation of physical therapist to helps patient to understand neutral position and how to maintain it in exercises that are prescribed |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 25 and 65 years
- Continuous or recurrent episodes of pain in the lower back lasting for more than 12 weeks (chronic)
- No specific cause for pain complaints
- No other pathologic complaints or immobility
- Sufficient auditory and visual communication skills and
Key exclusion criteria (7 listed)
- Any chronic disorder that may prevent exercise,
- Personal history of neurologic or rheumatologic disease,
- Pregnant or lactating women,
- Patients with malignancy or a lumbar comorbidity
- Terminal or progressive disease and any other musculoskeletal condition
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 |
|---|---|---|
| BiofeedbackThe aim of this study is to investigate effects of a biofeedback application that is alternative to physical therapist feedback in core stabilization training of patients with CNLBP. | Other | Biofeedback group, Physical therapist feedback group |
Primary outcome
Revised Oswestry Disability Index
Time frame: 1 month
Disability
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 6 Apr 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Low Back Pain, Mechanical, Biofeedback, Pain, Chronic, run by Istanbul University.
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 6 inclusion and 7 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Revised Oswestry Disability Index (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2017; AzTrials last refreshed its copy on 30 Oct 2026.