Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEPC Education s.r.o.
About this trial
Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain treatment, including the method optimization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Axial low back pain (with or without lateral component).
Presence of Modic type I or II changes at ≥ 1 level.
Age over 18 years.
Duration of pain ≥ 6 months.
Disqualifiers
Coagulation disorders.
Platelet abnormalities.
Lack of informed consent.
Generalized solid tumor.
Trial design
Design model
Single group
Treatments tested in this trial
BVN ablation
Procedure/Surgeryintraosseal monopolar basivertebral nerve ablation
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: BVN ablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Oswestry Disability Index (ODI)
Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.
Time frame
6 weeks, and 3, 6, 12 monthsSecondary outcomes
1
Numeric Rating Scale (NRS) for Pain
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
Time frame
6 weeks, and 3,6,12 months2
EQ-5D standardized questionnaire used to measure health-related quality of life
Scale 0 - 100; where 0 (state equivalent to death) and 100 (full health)
Time frame
6 weeks, and 3, 6 12 months3
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)
Time frame
6 weeks, and 3, 6 12 months4
Global Rating of Change (GRC)
retrospective assessesment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement).
Time frame
6 weeks, and 3, 6 12 monthsSponsors and contacts
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Source ClinicalTrials.gov