Multifidus PET Scan Study

NCT04327817 | Completed Phase 4 DMC FDA Device

• 1 other identifier: 254110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multifidus stimulation; 18F FDG PET/CT scans; Multifidus muscle

Outcome Measures

Primary Outcomes (37)

• Low Back Pain Visual Analog Scale (VAS)

  The instrument used for evaluating pain is the continuous Visual Analog Scale comprised of a horizontal line 10cm in length, anchored by 2 verbal descriptors. The scoring of the scale 0 represents no pain and 10 being the worst pain imaginable.

  Baseline

• Low Back Pain Visual Analog Scale (VAS)

  The instrument used for evaluating pain is the continuous Visual Analog Scale comprised of a horizontal line 10cm in length, anchored by 2 verbal descriptors. The scoring of the scale 0 represents no pain and 10 being the worst pain imaginable.

  3 months

• Low Back Pain Visual Analog Scale (VAS)

  The instrument used for evaluating pain is the continuous Visual Analog Scale comprised of a horizontal line 10cm in length, anchored by 2 verbal descriptors. The scoring of the scale 0 represents no pain and 10 being the worst pain imaginable.

  6 months

• Low Back Pain Visual Analog Scale (VAS)

  The instrument used for evaluating pain is the continuous Visual Analog Scale comprised of a horizontal line 10cm in length, anchored by 2 verbal descriptors. The scoring of the scale 0 represents no pain and 10 being the worst pain imaginable.

  12 months

• Low Back Pain Visual Analog Scale (VAS)

  The instrument used for evaluating pain is the continuous Visual Analog Scale comprised of a horizontal line 10cm in length, anchored by 2 verbal descriptors. The scoring of the scale 0 represents no pain and 10 being the worst pain imaginable.

  24 months

• Oswestry Disability Index (ODI)

  Oswestry Disability Index (ODI) is a disease specific assessment of the disabling effects of back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.

  Baseline

• Oswestry Disability Index (ODI)

  Oswestry Disability Index (ODI) is a disease specific assessment of the disabling effects of back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.

  3 months

• Oswestry Disability Index (ODI)

  Oswestry Disability Index (ODI) is a disease specific assessment of the disabling effects of back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.

  6 months

• Oswestry Disability Index (ODI)

  Oswestry Disability Index (ODI) is a disease specific assessment of the disabling effects of back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.

  12 months

• Oswestry Disability Index (ODI)

  Oswestry Disability Index (ODI) is a disease specific assessment of the disabling effects of back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.

  24 months

• European Quality of Life Score on Five Dimensions (EQ-5D)

  The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given to ED-5D can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

  Baseline

• European Quality of Life Score on Five Dimensions (EQ-5D)

  The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given to ED-5D can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

  3 months

• European Quality of Life Score on Five Dimensions (EQ-5D)

  The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given to ED-5D can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

  6 months

• European Quality of Life Score on Five Dimensions (EQ-5D)

  The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given to ED-5D can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

  12 months

• European Quality of Life Score on Five Dimensions (EQ-5D)

  The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given to ED-5D can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

  24 months

• Clinical Global Impression of change

  Clinical Global Impression - Global Improvement consists of a question comparing the subject's situation at baseline to that at each follow-up visit and it to be completed by the Investigator. A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 being very much improved to 7 very much worse.

  3 months

• Clinical Global Impression of change

  Clinical Global Impression - Global Improvement consists of a question comparing the subject's situation at baseline to that at each follow-up visit and it to be completed by the Investigator. A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 being very much improved to 7 very much worse.

  6 months

• Clinical Global Impression of change

  Clinical Global Impression - Global Improvement consists of a question comparing the subject's situation at baseline to that at each follow-up visit and it to be completed by the Investigator. A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 being very much improved to 7 very much worse.

  12 months

• Clinical Global Impression of change

  Clinical Global Impression - Global Improvement consists of a question comparing the subject's situation at baseline to that at each follow-up visit and it to be completed by the Investigator.

  24 months

• Pain and Sleep 3 point index (PSQ-3)

  The PSQ-3 is an instrument that measures the quality of sleep over a month. This questionnaire is based on 3 questions about sleep and marked as 10cm visual scale where 0 is no problem sleeping to 10 being always having trouble sleeping.

  Baseline

• Pain and Sleep 3 point index (PSQ-3)

  The PSQ-3 is an instrument that measures the quality of sleep over a month. This questionnaire is based on 3 questions about sleep and marked as 10cm visual scale where 0 is no problem sleeping to 10 being always having trouble sleeping.

  3 months

• Pain and Sleep 3 point index (PSQ-3)

  The PSQ-3 is an instrument that measures the quality of sleep over a month. This questionnaire is based on 3 questions about sleep and marked as 10cm visual scale where 0 is no problem sleeping to 10 being always having trouble sleeping.

  6 months

• Pain and Sleep 3 point index (PSQ-3)

  The PSQ-3 is an instrument that measures the quality of sleep over a month. This questionnaire is based on 3 questions about sleep and marked as 10cm visual scale where 0 is no problem sleeping to 10 being always having trouble sleeping.

  12 months

• Pain and Sleep 3 point index (PSQ-3)

  The PSQ-3 is an instrument that measures the quality of sleep over a month. This questionnaire is based on 3 questions about sleep and marked as 10cm visual scale where 0 is no problem sleeping to 10 being always having trouble sleeping.

  24 months

• PainDETECT Questionnaire

  The PainDETECT questionnaire (PD-Q) is a screening tool specifically designed to identify neuropathic pain in an heterogenous low back pain cohort.Scores on the nine-item painDETECT (seven pain-symptom items, one pain-course item, one pain-irradiation item) range from -1 to 38 (worst Neuropathic pain); the seven-item painDETECT scores (only pain symptoms) range from 0 to 35.

  baseline

• PainDETECT Questionnaire

  The PainDETECT questionnaire (PD-Q) is a screening tool specifically designed to identify neuropathic pain in an heterogenous low back pain cohort.Scores on the nine-item painDETECT (seven pain-symptom items, one pain-course item, one pain-irradiation item) range from -1 to 38 (worst Neuropathic pain); the seven-item painDETECT scores (only pain symptoms) range from 0 to 35.

  3 months

• PainDETECT Questionnaire

  The PainDETECT questionnaire (PD-Q) is a screening tool specifically designed to identify neuropathic pain in an heterogenous low back pain cohort.Scores on the nine-item painDETECT (seven pain-symptom items, one pain-course item, one pain-irradiation item) range from -1 to 38 (worst Neuropathic pain); the seven-item painDETECT scores (only pain symptoms) range from 0 to 35.

  6 months

• PainDETECT Questionnaire

  The PainDETECT questionnaire (PD-Q) is a screening tool specifically designed to identify neuropathic pain in an heterogenous low back pain cohort.Scores on the nine-item painDETECT (seven pain-symptom items, one pain-course item, one pain-irradiation item) range from -1 to 38 (worst Neuropathic pain); the seven-item painDETECT scores (only pain symptoms) range from 0 to 35.

  12 months

• PainDETECT Questionnaire

  The PainDETECT questionnaire (PD-Q) is a screening tool specifically designed to identify neuropathic pain in an heterogenous low back pain cohort.Scores on the nine-item painDETECT (seven pain-symptom items, one pain-course item, one pain-irradiation item) range from -1 to 38 (worst Neuropathic pain); the seven-item painDETECT scores (only pain symptoms) range from 0 to 35.

  24 months

• Percent Pain Relief

  the Subject is asked to report the percent pain relief at the time of the current visit compared to the pain at baseline. The scale is marked at 0% with no change to 100% total change.

  3 months

• Percent Pain Relief

  the Subject is asked to report the percent pain relief at the time of the current visit compared to the pain at baseline. The scale is marked at 0% with no change to 100% total change.

  6 months

• Percent Pain Relief

  the Subject is asked to report the percent pain relief at the time of the current visit compared to the pain at baseline. The scale is marked at 0% with no change to 100% total change.

  12 months

• Percent Pain Relief

  the Subject is asked to report the percent pain relief at the time of the current visit compared to the pain at baseline. The scale is marked at 0% with no change to 100% total change.

  24 months

• Subject Global Impression of Change (SGIC)

  the Subject's overall status since baseline. A 7-point scale that requires the patient to rate the severity of their illness at the time of assessment, relative to the patients's diagnosis.

  3 months

• Subject Global Impression of Change (SGIC)

  the Subject's overall status since baseline. A 7-point scale that requires the patient to rate the severity of their illness at the time of assessment, relative to the patients's diagnosis.

  6 months

• Subject Global Impression of Change (SGIC)

  the Subject's overall status since baseline. A 7-point scale that requires the patient to rate the severity of their illness at the time of assessment, relative to the patients's diagnosis.

  12 months

• Subject Global Impression of Change (SGIC)

  the Subject's overall status since baseline. A 7-point scale that requires the patient to rate the severity of their illness at the time of assessment, relative to the patients's diagnosis.

  24 months

Other Outcomes (3)

• PET/CT scans

  Baseline

• PET/CT scans

  6 months

• PET/CT scans

  12 months

Study Arms (1)

Multifidus ReActiv8 stimulator

OTHER

The Mainstay ReActiv8 is an implantable electrical stimulation system that consists of an implantable pulse generator, implantable leads, programmer, activator and magnet.

Device: Multifidus stimulator

Interventions

Multifidus stimulator DEVICE

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.

Also known as: ReActiv8 stimulator

Multifidus ReActiv8 stimulator

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥22 years, ≤75 years
• Low Back Pain VAS of ≥6.0cm and ≤9.0cm (on a 10cm scale) at the Baseline Visit.
• Oswestry Disability Index score ≥21% and ≤60% at the Baseline Visit
• Chronic Low Back Pain defined as pain and discomfort localized below the costal margin and above the inferior gluteal fold (with or without referred leg pain) that has persisted \>90 days prior to the Baseline Visit, which has resulted in pain in at least half of the days in the 12 months prior to the Baseline Visit, as reported by the Subject.
• Evidence of lumbar multifidus muscle dysfunction (for example by the Prone Instability Test (PIT)).
• Continuing low back pain despite \>90 days of medical management including:
• At least one attempt of physical therapy treatment for low back pain, which may optionally be accomplished over multiple episodes or flare-ups of low back pain.
• For Subjects with medications prescribed and used for chronic low back pain, usage shall be at a stable dose in the 30 days prior to the Baseline Visit as reported by the Subject.
• NOTE: A stable dose means the Subject reports no significant change in regular use of medications, which may include PRN use, in the 30 days prior to the Baseline Visit. Typical use must be provided
• Be willing and capable of giving Informed Consent.
• Ability to comply with the instructions for use and to operate ReActiv8, and to comply with this Clinical Investigation Plan.

You may not qualify if:

• BMI \> 35
• Back Pain characteristics:
• Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis (Cobb angle ≥25°).
• Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal \<10mm in Subjects with lower extremity pain.
• Neurological deficit possibly associated with the back pain (e.g. foot drop).
• Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
• Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia).
• Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amenable to surgery.
• Back pain due to vascular causes such as aortic aneurysm and dissection.
• Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
• Source of pain is the sacroiliac joint as determined by the Investigator.
• Drug use per Subject report as follows:
• a. Current baseline use of \>120mg oral morphine equivalent per day of opioids. b. Current use of breakthrough dose of \>60mg oral morphine equivalent per day. c. Current requirement of opioids for treatment of a condition other than low back pain.
• d. History of any substance abuse at any time in the five years prior to the Baseline Visit.
• e. Currently taking \>15mg Diazepam per day or equivalent.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Mainstay Medical: collaborator

Study Sites (1)

Barts Health NHS Trust

London, EC1A 4NP, United Kingdom

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek H Mehta

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: The ReActiv8 IPG, and the ReActiv8 leads (available in either 45 cm or 65 cm lengths), plus suture sleeves. The Lead is designed to be placed using a commercially available 7 Fr Introducer Kit (not included with ReActiv8) and the Mainstay Model TUN1 Tunneler (included with ReActiv8) or commercially available equivalent. The electrodes are located at the distal end of a Stimulation Lead that is connected to an implantable pulse generator (IPG) placed in a surgical pocket typically above the buttocks (in a place similar to that used in Spinal Cord Stimulation implants). Two leads are placed (one each left and right side) and connected to the IPG. The IPG is externally programmable with a Programmer. Stimulation is manually initiated by an external device (Activator) and can be stopped with the Activator or Magnet.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Mainstay ReActiv8 is an implantable electrical stimulation system that consists of an implantable pulse generator, implantable leads, programmer, activator and magnet.

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: August 19, 2021
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)