Investigational study for "Scrambler Therapy" - MC5-A Calmare - Patient Experience and Report

[rtswen]

Hi everyone,

I hope this is posted in the proper forum, I'm still new here. I introduced myself a little over a month ago, my wife has had a failed back surgery and chronic pain for 3 years. We were looking for information on a new technology that I have seen in some literature - the Calmare MC5-A device. The information from the company seemed sketchy, and as I mentioned in my introduction my quack meter was going off the chart.

Since that introduction I have found a number of different study reports and more scientific information. It was enough to convince us to consider travelling to a clinic a few hundred miles away and pay out-of-pocket to try it. I took the studies to her pain/spine doctor for a second opinion, and in a surprising twist of luck they were looking at the device and planning their own clinical study. We jumped at the chance and she was put on the study list.

The clinical study began yesterday, and honestly I was afraid to go. The technology looked promising, and as long as it was in the future there was hope. But if she didn't respond? I'm afraid that would have been devastating.

Her first session took about an hour to find the proper placement of the gel patches and find a response, but they did find a response. After an initial 25 minute treatment, her pain level had reduced from a 7 to a 5, and she was able to lie flat without significant discomfort for the first time in years.

We left yesterday excited and hopeful. Her pain relief lasted for a little over 3 hours before it started to return, but that is expected. The course of treatment is 10 days, and the studies show that those who do respond effectively step down in pain throughout the treatment, something like 7 to 5, returns to 7, then 7-5, returns to 6, 6-4, returns to 6, 6-3, returns to 5... etc. (about 8% are complete non-responders)

After the 10 day treatment cycle, most patients seem to settle into a pain level of 1 or 2, but about 25% have a complete disappearance of pain (I'm summarizing from memory all of the studies I have read, so some report more promising results, others less). Some patients require a "booster" single treatment every few months, while others have gone years without it. I know that there are clinics in the Eastern US that are using it, along with a clinic in St. George, Utah. I also know that Walter Reed Hospital and the Mayo Clinic are investigating it. It's unlikely to be covered by any insurance, it is still investigational here, and citing those clinics that are looking at it simply means that - they are looking at it, studying it.

I'll update this post throughout our experience. If it works, you may want to consider it. If it is unsuccessful, I'll report that too. I have no connection to the company, I'm just a tired husband looking for relief for his wife, and in all of my searching it has been incredibly difficult to find actual information on this technology. Perhaps by posting this it will help others searching for real information, and hopefully help you in your efforts to find relief.

Here are the links to some of the studies I have found (I have a PDF of the ASCO publication that really got me interested in investigating this, but can't find a direct link to it anymore):

Minerva Anestesiologica 2005 July-August;71(7-8):479-82
Scrambler therapy - Minerva Anestesiologica 2005 July-August;71(7-8):479-82 - Minerva Medica - Journals

Virginia Commonwealth University Study (This is a PDF file)
http://www.calmarett.com/media/pdf/A...er_Jun2010.pdf

Journal of Pancreas article:
Marineo G. Untreatable Pain Resulting from Abdominal Cancer: New Hope from Biophysics? . JOP. J Pancreas (Online) 2003; 4(1):1-10. [Full text]

Again, this is all tentative, but hopeful. Fingers crossed.

[trkdoc714]

It looks like you and your wife have done your homework. Technology is bringing a lot of exciting devices to the field. I hope this reduces the pain for your wife! Please keep us in the loop as the trial progresses.

Best of luck to you both!

Bob

[rtswen]

An update after 5 of the 10 treatment sessions.

Each treatment appears to be 45 minutes, but that time seems to be flexible. This trial is really an evaluative study for the medical clinic to determine whether they want to purchase these machines, so much of the time is spent in training the technicians on pad placement and treatment methods. Things are getting a bit better, and we are trying to make sure she gets the full treatment each session, but it varies.

Treatment 1 – Beginning pain 7/10, ending pain 5/10. Pain relief sustained for about 3 hours.

Treatment 2 – Bg 7/10, end 5/10. Pain relief sustained for 7 hours.

Treatment 3 – Bg 7/10, end 4/10. Pain relief sustained for 7 hours. (Note, we were incredibly excited at this point, because 4 is the lowest she has scored on the pain scale since before her injury)

Treatment 4 – Bg 7/10, end 5/10. Relief only lasted about 3 hours, and this treatment was a Friday. Saturday she flared back up to an 8, Sunday a 7, and Monday morning an 8. This was incredibly discouraging and worrisome, because we seemed to be making progress and this jump back to a high level wasn't expected.

Treatment 5 – Bg 8/10, end 6/10. Relief lasted until bed, and this morning it maintained at a 6-6.5. This is as encouraging as the flare-up was worrisome. Maintaining the pain relief throughout the night seems to be a significant step. Today she’ll be starting from a lower number, so I’m hoping she reports a drop to 4 again.

A few observations midway through:

1 – Something seems to be happening and it is encouraging. In terms of actual pain, this has worked as well or better than any other treatment she has received – the only thing that works faster is the lidocaine injections during a procedure, which eliminates the pain for a few hours. But that is temporary, obviously. She has had no relief from steroidal injections, RF neurotomy, physical therapy, etc., and in fact these have at times exacerbated the problem. So far, there are no side effects and the pain seems to be affected. We’re just hoping to see bigger gains this week.

2 – This is frustrating, but I feel more qualified to administer this treatment to my wife than the young medical assistants they have doing it. Granted, I've been researching this for months, but even so they ought to be familiarizing themselves with the studies and concepts behind it. Further, there seems to be a hit and miss on pad placement. My wife and I have taken more active roles, prodding them for action and suggesting steps, “There is a tingling here, but no pain relief. Let’s reposition the pads and try again.” The doctor is one I trust and he has been cautious about this technology, but after reading up on it and seeing this investigation unfold, he’s becoming an advocate. I wish he were in the room, though, throughout the procedure. He has a busy practice and cannot be there all the time. This is a good example of the need for patients to take an active and assertive role in their treatment.

3 – The results among all patients are varied, but none seem discouraged. The best result thus far is a man with neuropathic leg and foot pain. They started with only one side in order to evaluate and compare, and after 2 treatments he was pain-free for 18 hours. They are treating him bilaterally now.

4 – While the pain has been up and down, there are some very encouraging changes going on in my wife’s activity levels and pain locations. Looking at just the numbers it gets discouraging – we want pain-free now! But her pain location prior to this was across L4 and down into the back of her thighs. Horizontally it stretched from side-to-side on the pelvis. Now? She is pain-free on the sides, and it only begins to hurt about 2-2.5 inches in from the pelvis. In other words, horizontally the diameter of the pain has shrunk or retreated about 4-5 inches. Vertically she has reduced the pain near the L4 and sees typical pain beginning now around L5-S1.

As far as activity goes, she is seeing functional changes. She is able to lie flat, she finds herself doing more at home with the kids, and overall she is more active. Further, she completely forgot to change out her pain patch (fentanyl) on Friday. Between the increased activity and the lapsed pain medication, that very well may account for the flare-up over the weekend. We hope so.

She has 4 more treatments this week, and then one on Monday. I’ll update again next week, unless we see something more dramatic.

[KBear]

That sounds very promising and like she is seeing benefit. It's great when you start getting bits of your life back. Hoping she gets 100% relief from the pain.

[Cindylou]

rtswen, thank-you for such a detailed account of how this new technique is playing out for your wife. It seems very intriguing and actually hopeful. I will be anxiously watching for further posts from you with her continued treatments. You remind me of my husband, playing such an active role in the care and well-being of your spouse. You also seem like a real gem. Spine sufferer's need more caring folks like you in their lives. Thanks for being one of the good guys. Cindylou

[rtswen]

Thanks, everyone, for the encouraging words. It really is my intent to put something down for others to reference. We would love to know of similar experiences, to compare and to know what to expect. But I haven't found anything like this out there.

Yesterday's treatment (#6) resulted in a <4 pain level, and when she called me she was very emotional - big relief. Unfortunately that didn't last, and it flared up to an 8 in the evening, so the emotions turned to fear and frustration. She is back to a 6 this morning, which is actually (and we have to keep reminding ourselves of this) lower than when she started.

We're not sure what to make of the wild fluctuations, but there is definitely something going on with the nerves. Hoping for a better day today, and when I put on my positive hat I think that the last major fluctuation seemed to indicate a 'breakthrough' of sorts, where she was able to maintain the lower pain level. If that's true, and I hope to God it is, then maybe today or tomorrow she can maintain that 4.

[rtswen]

Ok - my last update to this thread, unless someone has specific questions.

We finished the course and actually added two treatments to finish with 12 sessions. The other participants in the study had various levels of success, with apparently both neuropathic leg and foot pain finishing and maintaining a pain-free status.

My wife, however, did not go below a 4, and even then the dips to that level didn't maintain more than a few hours.

The good: The radiating pain that stretched across her back and vertically from L3-L4 to the mid-thighs was reduced - retreated, if you will - to a focused area around her L5-S2. In this respect, she improved by eliminating the pain and trigger points that seem to have grown out of the original problem.

The bad: The original problem is still there. Her pain hovers around that focused area an is still a 6-7 most of the time. She's officially been labeled a failed back surgery. Next steps: Evaluate possible nerve-root adhesions and/or an implantable spinal stimulator.

[Justin]

rtswen, thank you for documenting your experience with the MC5-A Calmare. I wish you and your wife the best in the steps ahead.

[KBear]

rtwsen- I'm sorry that she didn't have as much success as you both wanted; but glad it helped a little. Please keep us updated on her next course of action. Kathy

[Cindylou]

rtswen, I'm also sorry your wife didn't get the long term desired results she and you were both hoping for. It's a bummer, but don't give up, ever. I look forward to your next plan of action. Good luck! Cindylou