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Accelerometer Study

Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)

This study is enrolling participants by invitation only.


Holy Cross Hospital, Florida

Information provided by (Responsible Party):

Holy Cross Hospital, Florida Identifier: NCT02948049


This study is a single site, prospective, observational trial utilizing a wrist-worn accelerometer to evaluate clinical outcomes of SCS and PNS in the treatment of chronic pain.


Chronic Pain
Back Pain
Neck Pain


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)


Further study details as provided by Holy Cross Hospital, Florida:

Primary Outcome Measures:

  • Assess whether there is an increase in objective measurements of physical function in subjects after treatment with an FDA-approved spinal cord stimulation device (SCS) or FDA-approved peripheral nerve stimulation (PNS) device compared with pre-implant. [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]

A subject is considered to have met the primary objective if there is a statistically significant (p value < .05) increase in physical function.


Secondary Outcome Measures:

  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Numeric Rating Scale (NRS). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Short Form-36 Health Survey (SF-36). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Oswestry Disability Index (ODI). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Neck Disability Index (NDI). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]


Other Outcome Measures:

  • Evaluate the relationship between physical function and/or pain in subjects stratified into subgroups based on descriptive variables. [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]


Estimated Enrollment: 150
Study Start Date: October 2016
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Detailed Description:

Up to 150 evaluable subjects will be recruited at this site on an ongoing basis. Evaluable subjects are defined as subjects that complete the End of Study visit. Each subject will be assigned an accelerometer and have data recorded for a seven-day period pre-implant trial to collect baseline data. The accelerometer will also be worn during the trial for a period of up to seven (7) days. If the trial is successful and the subject is implanted, the subject will wear the accelerometer for a seven-day period at least six (6) weeks post-permanent implant. The following assessments will be administered to subjects at the baseline (pre-implant trial) visit, the end of implant trial visit and the end of study visit (8 weeks post-permanent implant): the Numerical Rating Scale (NRS) 11-point scale for pain; the SF-36 Health Survey; the Oswestry Disability Index (ODI). Subjects treated for neck pain will also complete the Neck Disability Index (NDI). Additionally, the subjects will be asked to complete a subject diary to record average daily NRS scores for days the accelerometer is worn.


Ages Eligible for Study: 18 Years and older   (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample


Study Population

The subjects recruited for this study will be representative of the population of subjects with chronic pain and a candidate for SCS or PNS trial. Subjects recruited for this study must be 18 years of age or older. It is anticipated that approximately equal numbers of males and females will be recruited. No subjects will be excluded based upon his/her race or ethnicity.


Inclusion Criteria:

Subjects enrolled in this study must meet the following criteria:

  1. Subject is 18 years of age or older
  2. Subject is a candidate for on label use of a SCS or PNS device
  3. Subject is ambulatory
  4. Subject is able to understand and willing to comply with study procedures and requirements
  5. Subject is able to provide informed consent to participate in the study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they meet any one of the following criteria:

  1. Subject has comorbidities that, in the judgment of the investigator, may confound the reliability of the information acquired in this study
  2. In the judgment of the investigator, the subject is not seeking an improvement in physical function as a treatment goal of SCS or PNS

Accelerometer Studytriangle  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02948049

Sponsors and Collaborators
Holy Cross Hospital, Florida
Principal Investigator: William P McRoberts, MD Holy Cross Hospital, FL
Accelerometer Studytriangle  More Information
Additional Information:
  1. Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. Review.
  2. Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967 Jul-Aug;46(4):489-91.
  3. Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O’Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008 Oct;63(4):762-70; discussion 770. doi: 10.1227/01.NEU.0000325731.46702.D9.
  4. Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Review.
  5. Perruchoud C, Buchser E, Johanek LM, Aminian K, Paraschiv-Ionescu A, Taylor RS. Assessment of physical activity of patients with chronic pain. Neuromodulation. 2014 Jun;17 Suppl 1:42-7. doi: 10.1111/ner.12036. Review.
  6. Paraschiv-Ionescu A, Perruchoud C, Buchser E, Aminian K. Barcoding human physical activity to assess chronic pain conditions. PLoS One. 2012;7(2):e32239. doi: 10.1371/journal.pone.0032239.
  7. Huang KT, Martin J, Marky A, Chagoya G, Hatef J, Hazzard MA, Thomas SM, Lokhnygina Y, Lad SP. A national survey of spinal cord stimulation trial-to-permanent conversion rates. Neuromodulation. 2015 Feb;18(2):133-9; discussion 139-40. doi: 10.1111/ner.12199.
  8. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT.. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. Review.
  9. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
  10. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review.
  11. Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum in: J Manipulative Physiol Ther 1992 Jan;15(1):followi.
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Mainstay – ReActiv8 Study

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The ReActiv8® Clinical Study Study Overview

What is ReActiv8®?

ReActiv8 is a surgically-implanted device that uses mild electrical stimulation to activate the key stabilizing muscles of the lower back. Similar to exercise programs used to restore muscle control, ReActiv8 stimulation is delivered twice a day for about 30 minutes. You control when to start and stop each stimulation session via a handheld wireless remote control. Over time, ReActiv8 is designed to help your body regain control over the muscles that provide lower back stability, which may help relieve chronic low back pain.

ReActiv8 is placed through a minimally invasive, reversible surgical procedure. Your doctor will make a small incision to place thin wires, called leads, on either side of your spine. The leads connect to a small pulse generator (about the size of a matchbox). The pulse generator is implanted just below the skin, normally in the upper buttock.

About the ReActiv8® Clinical Study

Right now, doctors at select centers throughout the U.S. are accepting participants for a new clinical study to evaluate ReActiv8 for the treatment of chronic low back pain. If you qualify and choose to participate in the study, you will receive the ReActiv8 system and all study-related care at no cost.

Step 1:

Screening/Baseline To see if you might be eligible for the ReActiv8 Study, the first step is the Screening/Baseline evaluation. During this evaluation, your study doctor will perform a routine physical exam and will ask you about past medications and treatments for your back pain. You will also complete several questionnaires to measure the severity of your pain and its impact on your quality of life. If you pass the Screening/Baseline evaluation and wish to continue with the study, you will be scheduled to have the ReActiv8 system implanted.

Step 2:

ReActiv8 Implant Procedure & Activation ReActiv8 is placed through a minimally-invasive, reversible surgical procedure (performed under local or general anesthesia). On average, the procedure takes about 1 – 2 hours, and you may remain in the hospital overnight and go home the day after.

Approximately 7 to 14 days after the ReActiv8 system is implanted, you will return to your study doctor’s office to have the system turned on (activated). As part of the ReActiv8 study, you will be randomly assigned (like a coin flip) to either the Treatment Group or the Control Group. If you are assigned to the Treatment Group (50% chance), your ReActiv8 device will be set to deliver stimulation at an appropriate level for your circumstances. If you are assigned to the Control Group (50% chance), your device will be set to deliver only minimal stimulation. You will not be told to which group you were assigned until approximately 4 months after activation. However, if you were originally assigned to the Control Group, you will be given the option at this stage to “crossover” to the Treatment Group.

Step 3:

Follow-Up Visits Following activation of your ReActiv8 device, you will be asked to return to your study doctor’s office about 8 times over a 1-year period, and then once a year thereafter (up to a maximum of 6 years). These visits are an important part of the study, as they allow your study doctor to closely monitor your individual results and experiences. During these visits, the settings of your ReActiv8 device will be reviewed, and may be adjusted as needed.

The ReActiv8® Clinical Study Frequently Asked Questions

1. What is the purpose of a clinical study?

Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of possible new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

2. How is ReActiv8® designed to work?

ReActiv8 is a surgically-implanted device that uses mild electrical stimulation to activate the key stabilizing muscles of the lower back. Similar to exercise programs used to restore muscle control, ReActiv8 stimulation is delivered twice a day for about 30 minutes. You control when to start and stop each stimulation session via a handheld wireless remote control. Over time, ReActiv8 is designed to help your body regain control over the muscles that provide lower back stability, which may help relieve chronic low back pain.

3. How do I conduct my ReActiv8 stimulation sessions?

You will be asked to apply stimulation to your back two times a day, each time for about 30 minutes. You will be asked to do this while you lie down on your side or your stomach. It is recommended you conduct your sessions about same time every day, with one time in the morning and one time in the evening.

4. Are there any costs involved in the ReActiv8® Study?

If you choose to join the ReActiv8 Study, you will receive all study-related care at no cost. This includes the ReActiv8 system and procedure, as well as any study visits to your study doctor’s office. You may also be compensated for travel expenses to attend study visits.

5. Why is there a Control Group?

To test a new treatment it’s important for researchers to be as certain as possible that any changes are because of the new treatment. The best way to do this is to have two groups that have the same characteristics and undergo the same care, except for the new treatment being studied.

6. Who is sponsoring the study?

The study is being sponsored by MML US, Inc. (, a global medical device company with offices in the US, Australia, and Ireland.

7. How do I know if I am eligible for the ReActiv8 Clinical Study?

If you struggle with chronic low back pain and have not received lasting relief through medications and physical therapy, you may qualify the ReActiv8 Clinical Study. If you are interested in possibly participating in the study, your study doctor and team will help see if you meet the study criteria.

Thank you for your interest in the ReActiv8 Clinical Study. Please contact us if you have any questions.

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CAUTION – Investigational device. Limited by Federal (or United States ) law to investigational use. © 2016 Mainstay Medical Limited. All rights reserved. ReActiv8®

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Nfl Jerseys Authorities Demand Salary Increase

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Dorsal Root Ganglion (DRG) Stimulation

Dorsal Root Ganglion (DRG) Stimulation


What Is DRG stimulation?

What is the mechanism of DRG stimulation?

What is a DRG stimulation system made up of?

Risks Associated with DRG stimulation

How is a DRG stimulator inserted?

How DRG stimulation work?

Indications for getting a DRG stimulator

Reviews of our Patients got DRG stimulator implanted


What Is DRG stimulation?

DRG or dorsal root ganglion is also known as posterior root ganglion is a bundle of sensory nerve cell bodies within the epidural space. The dorsal root ganglion carries sensory neural signals from the peripheral nervous system to the central nervous system, which includes the spinal cord  It is an easily accessible structure in the spine that plays a key role in the development and management of chronic neuropathic pain

Injury or irritation of the dorsal root ganglion can lead to intractable symptoms of neuropathic pain that may or may not respond to typical treatments. This can lead to additional complications in the form of impairment in functioning for the individual spinal cord stimulation.

Applying stimulation to the DRG allows treating specific areas of the body with pain hence targeting specific focal area. Easy accessibility of DRG  makes it a perfect target for treating chronic neuropathic pain that is not treated with traditional spinal cord stimulation, such as the hand, chest, abdomen, foot, knee or groin pains.

What is the mechanism of DRG stimulation?

Dorsal root ganglion stimulation works by blocking the transmission of pain. As every sensation passes through dorsal root ganglion, the signal of pain to the spinal cord and brain is interrupted. Stimulating the nerve bundles with low-intensity electrical impulses is also believed to reduce pain by replacing the sensation with a pleasant tingling sensation, known as paresthesia.

What is a DRG stimulation system made up of?

The system consists of three components:

Electrodes: These are a straight insulated wire with a curve on the tip to fit around the DRG. There are four electrical contacts near the tip to deliver the electrical pulses. The wire is passed into the spine through a large hollow needle. Up to four wires can be connected to one IPG so up to four DRGs can be stimulated, each with its own wire.

An implantable pulse generator (IPG): It is a small box that contains a battery and circuitry to produce the stimulus current:. If the electrode is being put in the lower back (e.g. for leg pain) the IPG is usually implanted under the skin of the abdomen (tummy). If the electrode is being put in the spine in the neck (e.g. for arm pain) the IPG may be implanted under the skin below the collar bone.

Programmer: It is a handheld  device that is given to the patient to adjust the stimulator to control pain.

Risks associated with DRG stimulation

As with every surgical procedure, there are risks involved with dorsal root ganglion neuromodulation. Though very little is known about the consequences of injecting pain relieving medication within the dorsal root ganglion or the spinal cord, neuromodulation of the neural tissue within this area is believed to be safe and completely reversible. The procedure itself for implanting the device is regarded as safe and conducted in such a way as to avoid inflammation or additional pain to the individual. In fact, many may return to normal activities of daily function within several days.

Risks associated with the condition are considered to be mild in nature and generally include minor bleeding at the site of the injections, infection, neural injury, and local anesthetic systemic toxicity. Individuals may also have a reaction to the medication used during the procedure.

How is a DRG stimulator inserted?

The procedure is carried under local anesthesia. When the skin has been numbed, a needle is passed into the space near the DRG and the electrical lead is fed through it and guided into place using Xrays.

Since the patient is awake, the effect of stimulation can be tested via the lead straight away. If the patient feels the tingling sensation, the procedure is completed by making a small incision around 3 cm nearby to allow placement of an implantable pulse generator under the skin and connecting the lead to it. If the test stimulation doesn’t give a definitive effect on the patient’s pain, a temporary extension wire is attached to the lead which is then brought out through the skin so that it can be tested for a few days using an external stimulator, before deciding whether the system is working well enough to complete.

How DRG stimulation Works?

DRG Stimulation is a more advanced and refined version of traditional spinal cord stimulation. Instead of positioning the leads over the posterior aspect of the spinal cord, smaller and more precise leads are placed over the dorsal root ganglion itself. Specifically, it is placed on the ganglia residing in the lumbar and sacral regions of the spine. This allows for greater and more targeted control of pain in the lower limbs.

-Largest study to date concerning lower limb pain associated with CRPS (ACCURATE Study), patients reported that the DRG Stimulator gave them significantly greater pain relief than SCS

-No changes in paresthesia intensity (pins and needles sensation) when changing body position as compared to SCS
-A more precise and targeted area of administration i.e. no feeling of electrical stimulation outside their area of pain

Indications for getting a DRG stimulator:

Dorsal root ganglion is now being preferred over spinal cord stimulation. Patients trialed with DRG stimulation have a greatly improved chance of success with much better pain relief.

In addition to CRPS, DRG stimulation can also treat:

  •  Discogenic pain due to degenerative disc disease
  •  Post-herpetic neuralgia
  •  Phantom limb pain
  •  Groin pain after a hernia repair (post-herniorrhaphy neuralgia)
  •  Lumbar radiculopathy
  •  Foot pain
  •  Neuropathic pain due to peripheral neuropathy
  •  Neuropathic chest wall pain
  •  Lumbar stenosis
  •  Chronic postsurgical pain


Reviews from our patient that got DRG stimulator


Dorsal root ganglion stimulation is a procedure for providing relief from symptoms of chronic pain resulting from a neural injury. This interventional approach is regarded as a relatively safe and effective procedure, with a low risk for side effects. The dorsal root ganglion is considered an ideal target for delivering pain relief because of a more targeted approach. Also dorsal root ganglion requires less neuronal stimulation to alter pain hence the devices for this treatment can work for a long time.

Another benefit of dorsal root ganglion stimulation is that the dorsal root ganglion lacks the protective capsular membrane that is found on other peripheral nerve fascicles. It has a permeable connective tissue, making it an ideal target for the application of neuromodulation.

The Food & Drug Administration (FDA) just granted approval to DRG Stimulation for use within the U.S. as of February 2016 for the treatment of CRPS.  Currently, the only device capable of DRG Stimulation is called the Axium which is available. Our site in Fort Lauderdale is the first site in Florida to implant the DRG stimulator.


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Superion® Interspinous Spacer (ISS)

What is Superion® Interspinous Spacer (ISS)?

How does it work?

When is it used? 

What will it accomplish?

When should it not be used?

Benefits of Superion device


What is Superion® Interspinous Spacer (ISS)?

The Superion® InterSpinous Spacer (Superion Spacer) is a small H-shaped spinal implant system for the treatment of moderate lumbar spinal stenosis implant. The device fits between two adjacent bones (spinous processes) in the lower back. This limits movement (extension) at the level where the device is placed. The Superion Spacer is made of titanium alloy.

Features of the Superion System:

  • One piece, expandable implant
  • Minimally invasive midline approach
  • Motion preserving
  • Tissue sparing and fully reversible

FIRST IN FLORIDA: Vertiflex Superion Interspinous Spacer Tx for Lumbar Spinal Stenosis

If standing or walking causes pain,weakness or fatigue in the legs, you’re probably suffering from lumber spinal stenosis or LSS. As you stand or walk, the lumbar curvature becomes more pronounced, the spinal nerve more crowded, and the back and legs more painful.
The aim of the Superion spacer is simply to hold the spine in the same open and neutral position as when sitting.
You are a candidate for this simple outpatient procedure if the following are true:
1) you suffer from neurogenic claudication from spinal stenosis: increased pain and tiredness in the buttocks or legs with walking that is relieved with sitting.
2) you have 2 or fewer levels of severe stenosis in the spine
3) the main level is not at the L5-S1 level
4) you want to avoid back surgery

How does it work?

The Superion® ISS system is designed to deliver the implant through a single small incision in the patient’s back. The procedure can be performed under local anesthesia on an outpatient basis and closed with a single suture. Spinal stenosis is a narrowing of the passageways in the spine. When the spinal cord and nerve roots get pinched or compressed during extension of the spine due to the narrowed passageways, this can cause pain, numbness, tingling ,weakness in the leg(s) or legs and back. The device is designed to limit extension of the spinal level to relieve these symptoms.

When is it used? 

The Superion Spacer treats patients who suffer from pain, numbness, cramping in their buttock, groin, or legs with or without back pain. The Superion Spacer is used in patients who have difficulty with daily physical activities and who experience relief in flexion from their symptoms.

Spinal stenosis symptoms are often characterized as:

  • Developing slowly over time, or slow onset
  • Coming and going, as opposed to continuous pain
  • Occurring during certain activities (such as walking)
  • Feeling relieved by rest (sitting or lying down).

The symptoms of lumbar stenosis generally develop slowly over time and symptoms may come and go. Lumbar stenosis symptoms may include:

  • Leg pain
  • Leg pain with walking (claudication)
  • Tingling, weakness or numbness that radiates from the lower back into the buttocks and legs.

Many people have evidence of spinal stenosis on X-rays, but may not have signs or symptoms. When symptoms do occur, they often start gradually and worsen over time. Symptoms vary, depending on the location of the stenosis:

  • In the neck (cervical spine).Cervical stenosis can cause numbness, weakness or tingling in a leg, foot, arm or hand. Tingling in the hand is the most common symptom. Nerves to the bladder or bowel may be affected, leading to incontinence.
  • In the lower back (lumbar spine).Compressed nerves in your lumbar spine can cause pain or cramping in your legs when you stand for long periods of time or when you walk. The discomfort usually eases when you bend forward or sit down.

What will it accomplish?

The device should help relieve the symptoms of moderate lumbar spinal stenosis by blocking extension of the affected spinal level.

When should it not be used?

Patients should avoid having surgery with the Superion Spacer if they are experiencing any of the following conditions:


Benefits of Superion device:

  • This surgery helps relieve pressure on your spinal nerves.
  • The Superion implant is designed to keep your spine still so when you stand upright the nerves in your back will not be pinched or cause pain.
  • The Superion implant is intended to allow you to continue to move your back more than with a fusion surgery. With the Superion implant in place, you should not need to bend forward to relieve your pain.

Video Testimonial for Superion® Interspinous Spacer (ISS)


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