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NCT03099941
The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain
NA trial testing Biofeedback in Low Back Pain, Mechanical, Biofeedback, Pain, Chronic in 38 participants. Completed in 1 June 2016.
1 June 2016
Quick facts
| Lead sponsor | Istanbul University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 11 May 2015 |
| Primary completion | 1 June 2016 |
| Estimated completion | 1 June 2016 |
Drugs / interventions tested
- Biofeedback
Conditions studied
- Low Back Pain, Mechanical, Biofeedback, Pain, Chronic — all drugs for Low Back Pain, Mechanical, Biofeedback, Pain, Chronic →
Sponsor
Istanbul University
Who can join
Adults 25 to 65, any sex, with Low Back Pain, Mechanical, Biofeedback, Pain, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03099941
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03099941 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul University
- Last refreshed: 6 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03099941.
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