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NCT05646173
Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Patients With Chronic Low Back Pain
NA trial testing vagus stimülation device in Low Back Pain in 60 participants. Completed in 27 March 2023.
8 February 2023
Quick facts
| Lead sponsor | Istanbul Medipol University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 11 November 2022 |
| Primary completion | 8 February 2023 |
| Estimated completion | 27 March 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- vagus stimülation device
- Electrophysical agents
- home exercise program
Conditions studied
- Low Back Pain — all drugs for Low Back Pain →
Sponsor
Istanbul Medipol University Hospital
Who can join
Eligibility, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of our study is to compare the effectiveness of auricular vagus nerve stimulation and conventional physical therapy in patients with Chronic Low Back Pain (CBA). 60 patients, aged between 18 and 60, with persistent low back pain for the last 3 months and who voluntarily agreed to participate in the study will be included in the study. Patients will be randomly divided into two groups as conventional therapy (Group I) and auricular vagus stimulation therapy (Group II). Patient Identification Form, Oswestry Disability Index, Lumbal Region Joint Range of Motion and Mobility (Inclinometer, Modified Schober Test, Hand Finger-Ground Distance Test), muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer and Lafayette manual muscle strength measuring device) in the evaluation of patients with CKD and endurance tests, postural control and balance assessment (BBS, Biodex Medical Systems), Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Scale (PUKÖ). After the measurements on the 1st day, 15 sessions of application and the measurements will be repeated the day after the last session. A home exercise program will be created for the patients in both groups. Statistical analysis will be calculated using SPSS for Windows 22 program.
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 NCT05646173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Istanbul Medipol University Hospital trials
Trials by the same sponsor.
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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 NCT05646173 (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 Medipol University Hospital
- Last refreshed: 11 April 2023
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/NCT05646173.
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