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Multifidus PET Scan Study

NCT04327817 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-20

No results posted yet for this study

Summary

The study involves investigating phenotypic changes (ie metabolic activity in brain pain matrix areas, metabolic activity and textural analysis of multifidus muscle) following multifidus stimulation and establishing relationship with the change in pain, functionality and quality of life.

Conditions

  • Low Back Pain

Interventions

DEVICE

Multifidus stimulator

Patient eligible for the study and have provided consent will have a baseline PET scan. Multifidus ReActiv8 Stimulator will be inserted using standard treatment for lumbar pain at Barts Health NHS Hospitals. All patients who receive the Reactiv8 system will continue to receive multifidus stimulation 20Hz for the next 6 months as per standard of care of multifidus stimulation; at the end of this period, the patients will undergo PET scanning and questionnaires. Thereafter, stimulation will continue and 3rd PET scan will be performed at 1year post implant.

Sponsors & Collaborators

  • Mainstay Medical

    collaborator INDUSTRY

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Vivek H Mehta · Barts & The London NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2025-03-17
Completion
2025-03-17
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327817 on ClinicalTrials.gov