Evidence

The protocol inside zTreatment has been studied in a randomized, sham-controlled clinical trial and described in the clinic's own published experience. Both are summarized here with their own numbers and their own limits.

A randomized, sham-controlled trial

The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: a randomized, sham-controlled clinical trial. Argenta PA, Ballman KV, Geller MA, and others. Gynecologic Oncology, January 2017, volume 144, pages 159 to 166. Read it at the journal. Registered as NCT02000908.

Seventy patients with neuropathy caused by chemotherapy, recruited at the University of Minnesota's gynecologic oncology clinic, were randomized to laser treatment or a sham that produced the same sense of warmth. Patients, their oncologists and the assessors were blinded. Treatment was thirty minutes, three times a week for six weeks. All treatments took place at Realief Neuropathy Centers in St. Louis Park, Minnesota, and were delivered by its certified laser technicians. The treatment zones and times were assigned by a deterministic algorithm driven by the patient's reported symptoms and the signs found on examination, the same inputs zTreatment records today.

What the trial found:

• Patients treated with the laser improved by a mean of 6.8 points on the modified total neuropathy score at eight weeks, a 52.6% reduction. Sham-treated patients did not improve.
• 89.7% of treated patients had a clinically meaningful improvement, defined in advance as a 30% reduction in score, against 3.3% of sham-treated patients. The number needed to treat was 1.2.
• The improvement was still present at sixteen weeks, ten weeks after treatment ended.
• Patients who crossed over from sham to treatment improved the same way.
• Adding physiotherapy did not improve results over the laser alone.
• No complications were observed in treated patients. The one adverse event in the trial, a burn, was in the sham group from the heat probe.

What it does not show: the trial studied chemotherapy-induced neuropathy in women at one center, so its numbers are not a claim about every cause of neuropathy or every clinic. Realief Neuropathy Centers funded the trial and supplied the lasers and technicians; the paper records that the clinic took no part in the design, data, analysis or decision to publish.

The clinic's experience with 100 patients

Realief Therapy for Peripheral Neuropathy: Experience with 100 Patients. Kelm T, Weigel R, Ruff NL. Realief Neuropathy Centers, 2011. Read the paper (PDF).

One hundred consecutive patients with neuropathy of any cause were treated at the clinic with individualized laser treatment plans, and their symptoms and sensation were recorded at every visit, on numeric scales and by zone up the limb with a pinwheel and a tuning fork. Eighty patients with symptoms in the legs and complete treatment plans were analyzed.

What it found:

• Mean reductions of 52% for pain, 55% for numbness and 44% for burning.
• 69% of patients had a reduction of 50% or more on at least one symptom.
• Areas insensitive to pinprick and vibration retreated in most patients from above the ankle, calf or thigh to a limited region on the bottom of the foot.

What it does not show: it is a description of one clinic's patients, without a control group, written by the clinic. Its measurement of sensation by zone is the measurement zTreatment makes at every visit.

How RevMed Systems relates to the clinic

Realief Neuropathy Centers of Minnesota is Dr. Timothy Kelm's practice, where he treats patients. zTreatment was built there and runs every visit there. RevMed Systems, of which Dr. Kelm is a co-founder, is the company that provides it to other practices. Neither paper is a study of zTreatment the software; both are studies of the protocol and the measurements it carries.