Clinical Trial Results No Surprise to Specialists

That the results of a just-released new clinical study showed the Oska Pulse significantly reduced pain in patients came as no surprise to at least two experts – because they conducted the test.

I don’t think there was much surprise, just extremely pleased to have the positive results,” said Dr. Mark Wiederhold, a renowned pain management expert.  “To have this type of trial, it’s all pretty remarkable.

And Dr. Brenda K. Wiederhold, who partners with her husband, was just as thrilled.

I was a believer in the Oska Pulse,” she said.  “I think I knew it was going to work.

The Wiederholds, along with Dr. Shurman, another pain management expert, conducted a 30-person, randomised, double-blind placebo study at La Jolla’s famed Scripps Memorial Hospital.  Those patients taking part in the clinical study kept daily logs of their pain levels with the results checked after one week and then again after two weeks.

What really made the study so impressive, the Wiederholds said, is the use of the placebo, in this case a near-identical version of the Oska Pulse except that it was only a non-functioning model.  Neither the patients nor the doctors were aware who was using the real Oska Pulse and who was using the placebo until the end of the testing period.  This double-blind condition of the study was key, said Mark Wiederhold.

It really eliminated a lot of biases,” he said.  “That makes the results highly significant because it is very difficult to do trials without a good placebo.  We used a very, very excellent, high-quality placebo.

None of the patients, recruited from two San Diego-area pain clinics, received monetary compensation and all were in their 50s and 60s.  Participants in the study used a device, either the Oska Pulse or the look-alike placebo, two-to-four times a day for 30 minutes a session and recorded their pain, stress and daily usage in their logs.

The results of the study showed that a majority of those who used the Oska Pulse noticed a significant decrease in pain levels while not one patient using the real Oska Pulse recorded an increase in pain.  Additionally, the participants who used the placebo device actually experienced an increase in pain.

The Wiederholds were first introduced to the Oska Pulse in 2016, and while Mark Wiederhold knew much about the device’s PEMF (Pulsed Electromagnetic Field) technology, it was almost totally new for Brenda.

As a result, she started on the ground floor with the Oska Pulse. “I was sceptical,” she said.  

Said Mark Wiederhold:  “I wasn’t so much sceptical as I was intrigued to see a lightweight wearable device.   Since technology has become more mobile, it is just so interesting to have the Oska Pulse become such a rapidly growing company.

Now that their randomise double-blind clinical study is public and everyone can find out for himself how to benefit from using the Oska Pulse, Mark Wiederhold said the new information will show it to be a valuable device:  “People will be pleased they have another option - they can use the device with medicine, they can use it with exercise, it’s such a benefit.”

And Brenda Wiederhold, once a sceptic, has been convinced of the Oska Pulse’s benefit long before the new study confirmed it.  She is a believer in the Oska Pulse – and it looks good, too. “To have this cute, little sexy device was key for me,” she said.

 
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The Double Blind Clinical Trial

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