Health TrialsbyHealthPanel

Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU)

ConditionLumbago
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorConsorci Sanitari de Terrassa

About this trial

High-intensity focused ultrasound (HIFU) is an emerging technology that allows for the targeted thermal ablation of deep tissues in a non-invasive manner, by concentrating acoustic energy on the target nerve, whilst preserving adjacent structures. Recently, open clinical studies have confirmed the feasibility, safety and efficacy of HIFU in patients with lumbar facet syndrome, with clinical response rates similar to those of RFA and no significant complications.

This observational, prospective, non-interventional study aims to evaluate the clinical efficacy of lumbar medial branch ablation using this technique at 1, 3 and 6 months, as well as to assess patient satisfaction with the procedure. Only clinical data from patients undergoing the procedure in routine clinical practice will be collected.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years of age.

Signed informed consent for data collection.

Mechanical low back pain with a positive diagnostic block (>30% pain reduction) of the lumbar medial ramus with local anaesthetic.

Disqualifiers

Presence of pain with mixed characteristics or suspected multiple aetiology of the low back pain (e.g. sacroiliac joint involvement).

Active systemic infection.

Pregnancy.

History of spinal surgery at the level of treatment.

Trial population

Patients with mechanical low back pain without any other associated clinical features (neuropathic pain characteristics or significant suspicion of pain in other anatomical regions that may be causing the low back pain) who undergo lumbar medial branch ablation using the HIFU technique.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • High-Intensity Focused Ultrasound of the medial lumbar branch

    Procedure/Surgery

    Focal exposure, with a duration of 50 seconds and an energy output of 1000 joules. Monitoring of temperature and the patient's response is essential to avoid collateral damage. The objective is to achieve temperatures of 80-85 °C at the focus to induce thermal necrosis of the nerve.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Pacients with mechanical lumbalgia1 intervention

Trial outcomes

Primary outcomes

1

Verbal Numerical Rate Scale

0 - 10 Verbal Numerical Rate Scale

Time frame
1, 3, 6 months

Secondary outcomes

1

Oswestry Scale

Time frame
1, 3 and 6 months
2

Catastrophisme scale

Time frame
1, 3, 6 months
3

Brief Pain Inventory

Time frame
1, 3, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consorci Sanitari de Terrassa

Lead sponsor

Hospital Clinic of Barcelona

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: