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When the right dose goes wrong
It must gall to have performed a controlled clinical trial for a year only to find at the end that your physics department had adjusted the active laser such that it did not perform as planned.
The trial by Tumilty et al (TITLE: Clinical effectiveness of low-level laser therapy as an adjunct to eccentric exercise for the treatment of Achilles’ tendinopathy: a randomized controlled trial) set out to deliver twelve treatments of 100mW/cm2 of 810nm laser for 30 seconds to 6 points (3J per point) on the Achilles tendon over a 4 week period, but something went wrong and the treatment failed to have any significant effect over placebo.
What went wrong: The university physics dept had been asked to adjust the 810nm 100mW, 2.5W/cm2 power density to 100mW/cm2. They achieved the 100mW/cm2 by expanding the beam, but unfortunately they also decided to reduce the aperture to 0.07cm2. This had two unfortunate effects, the 100mW beam became reduced to 7mW and the beam did not adequately cover the pathology. So only 0.21J was delivered and only a tiny part of the pathology was treated.
WALT guidelines say 2-3 points should be treated with 8 Joules, the beam power density should not exceed 100mW/cm2 and irradiation should cover most of the pathological tissue. So this trial was a long way short of the recommended energy and it did not adequately cover the pathology.
Unfortunately these errors are hard to find in the paper. The “method’ reported states that the laser was 100mW, the power density was 100mW/cm2, treatment time was 30 seconds, giving a dose of 3J per point. It is only late in the “discussion” that the errors are presented.
Throughout the paper it is implied that the correct parameters were used and the WALT Guidelines were adhered to, but that is not true. It is not apparent in the paper that the tube had a cap at the end and that it had a 0.07cm2 hole drilled in it. Our initial presumption was that he tube was an empty tube, it was only after correspondence with the authors that we learned these extra facts.
What worries me is that this trial will be used in systematic reviews or as evidence against LLLT or the WALT guidelines
Don’t make these mistakes on your patients or in research, register for a THOR training course and learn about parameters, dose calculations and treatment methods, especially if you intend to run a clinical trial and maybe contact me to help get your trial parameters right,
leave a comment below
Not invented here
I had a meeting with the Chief Exec of the UK’s premier cancer research hospital, last year. He was genuinely interested by my pitch about LLLT. He said I should meet his pain team to present data on Oral Mucositis (OM). Eventually a meeting was set and I gave my best to the Head of Pain Services. Lets call him Dr Fred. Dr Fred listened patiently then, when I had finished, he gave me some feedback: 1) he did not like the company logo 2) he accepts the mechanism of action but 3) LLLT achieves too many things and 4) he had to go to another meeting. A surgeon friend of mine offered to go persuade Dr Fred and they had two hour meeting. Dr Fred said he would pitch it to his team, but after a few weeks chasing for an update, he said that nobody was interested.
How can that be when (according to the article in this months literature watch by Rene-Jean Bensadoun and Raj Nair) there is no consensus on a single agent or agents that can be used either prophylactically or therapeutically to reduce severity or duration of oral mucositis, and yet four associations/agencies* either suggest or recommend LLLT for OM.
Could it be the case that they did not discover LLLT for OM so they are not interested? The good news is that there are three cancer hospitals in three different countries coordinating to run a multi centred trial with THOR lasers so maybe then we can get some interest.
* European Society for Medical Oncology, Multinational Association of Supportive Care in Cancer, International Society of Oral Oncology, U.S. Dept of Health and Human Services Agency for Healthcare Research and quality.
Tell me about your experience, leave a comment below.
Posted in Rants
5 Comments
The truth will set you free, but you might need a political bulldozer
I love introducing LLLT to an audience of doctors oblivious and innocent of its effects on tissue regeneration, inflammation and pain. At first, the response is that no therapy can do all of this (heal diabetic wounds, improve recovery from sports injuries, neck pain, osteoarthritis and neuropathic pain etc), then I explain the mechanism by which LLLT increases ATP and reduces oxidative stress. By the time I have finished, the final question is not “what is LLLT?” or “how does it work?” or “is there clinical evidence?” but “why is this not used everywhere throughout medicine?”.
The truth is that evidence is not enough. I am involved in the early stages of putting together an international multicentre clinical trial for a pathology that already has 14 RCTs behind it. What difference will one more trial make? The difference may not be the trial itself, but the eminence of the doctors / scientists and their institutions doing it. I am also involved in the early stages of fund raising for another trial that has considerably less clinical data behind it and will be far less ambitious in its scale but, I suspect, will make greater progress. Why ? The focus on political influence. It is not enough to do good science, not enough to address a big unmet need, not enough to influence key opinion leaders, you have got to get the political bulldozers in.
Watch this space…..
Posted in Rants
3 Comments
The Bottom Line – Your phototherapy is not the same as mine
Lilach wrote to me this morning (if you are a regular at LLLT conferences you will know her) and in the dialogue she referred to the “phototherapy community”. I had just downloaded 121 LLLT and other phototherapy papers for this monthly literature watch blog. I had to wade through 99 papers that were not LLLT in order to arrive at 22 that were. Many of those were phototherapy and I thought I should bring them to your attention:
Phototherapy for Neonatal hyperbilirubinemia
Phototherapy for Psoriasis and vitiligo (and many other skin problems)
Phototherapy for Seasonal Effective Disorder or depression
Phototherapy for Vitamin D deficiency
Phototherapy for jet lag and sleep disorders
and to a greater or lesser degree these are already somewhat accepted in mainstream medicine.
Why is it that, and why is LLLT not yet accepted ?
send me a short comment back below.
One word answers are acceptable.
Posted in Rants
3 Comments
LLLT and TRPV1
TRPV1 is a nonselective cation channel involved in nociception. At a pain conference in London I attended last week a speaker reported that about $ billion has been spent by the pharmaceutical industry on developing a new class of analgesics to block this protein. However there is a sided effect on body temperature (hyperthermia) making it unusable which is a shame as the potential benefits are huge read here on Wikipedia.
TRPV1 is new to me and I wondered if perhaps anyone had looked at the effect of LLLT on it and they have. A group in Korea have shown that Er,Cr:YSGG laser has an analgesic effect via TRPV1 inhibition. Well hooray for the Koreans, if they really have discovered Inhibition of TRPV1 with laser (and without hyperthermia), it could become another medical holy grail assailed by LLLT.
Posted in Rants
5 Comments
LLLT / Low level laser therapy and the rise and fall of modern medicine
I have been reading The rise and fall of modern medicine by James Le Fanu, I’m just 30% in and am encouraged by how hard it is to introduce a radically new drug / medical procedure. Why encouraged? because LLLT has been a long time coming and occasionally I wonder if perhaps it will never gain universal clinical acceptance. Le Fanus book reminds us that penicillin, cortisone, open-heart surgery, kidney transplants and hip joint replacements (to name just a few) all took decades of refinement, practice and persuasion to achieve mainstream use just like LLLT
Posted in Books and Journals, Rants
9 Comments
Are “Superluminous Diodes” better or different than super bright LEDs ?
Peter Jenkins (PJ) and I are competitors in business but friends in search of the truth about LLLT devices, mechanisms, treatment method and dose. We have different strengths and one of Peters is his nose for BS and willingness to dig up the truth and write about it on public forums.
I was cruising the net as you do reading blogs and PR nonsense about LLLT when I read for the thousandth time a reference to “Superluminous Diodes”. So I dropped PJ a line to ask for his view on the use of these terms, and with his permission I am publishing his response:
On 1/26/11 1:58 PM, “James Carroll” wrote:
PJ
Just want to make sure we are on the same page on this …
Superluminous Diodes are a marketing hype term used exclusively by the LED therapy / LLLT industry and no better than LEDs right ?
On 26 Jan 2011, at 11:21, Peter A Jenkins wrote:
There are such devices – correctly called ‘superluminescent diodes’ – but they are rarely used in LLLT/LEDT due to their cost.
Superluminescent diodes are a crossover-type device that essentially operates like an edge-emitting laser diode at the lasing threshold, so it’s not lasing but is producing a beam that is of better quality and higher intensity/brightness than that of an LED.
They’re usually used in imaging operations where monochromaticy is desired but the coherence is not (due to the ‘noise’ of the speckle field).
Typically those devices used for LEDT are what the LED industry generally calls ‘super-bright’, although some Chinese LED producers occasionally – and incorrectly – use the terms ‘super luminous’ and ‘superluminescent’ to mean the same thing.
Googling “superluminous diode” shows up 2330 results, most of which are about LEDT/LLLT, which shows the limited application of the term.
OR, the short answer…
Pretty much.
Posted in Rants, Special Feature
on Are “Superluminous Diodes” better or different than super bright LEDs ?
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