in article 1144334435.016205.57290@g10g2000cwb.googlegroups.c om,
Susan.Simon@Dartmouth.EDU at Susan.Simon@Dartmouth.EDU wrote on 4/6/06 9:40
AM:
I read through the FDA web page
http://www.fda.gov/cdrh/mda/docs/p040001.html, and I was not impressed.
First of all "lumbar spinal stenosis" is rather vague. Stenosis of the
spinal canal, the nerve root canal(s) or of the foramen(s)--the openings
through which nerves pass? Reading the FDA Summary of Safety and
Effectiveness, p. 9, they include all kinds. Except that they excluded
"Severe symptomatic lumbar spinal stenosis at > 2 levels". I believe this
means more than 2 joint levels--eg, S1-L5, L5-L4, L4-L3.
I looked through the FDA Summary of Safety and Effectiveness and I noted a
number of adverse outcomes. The number related to the device and surgery
might be small -- 3% -- but note there were 21 adverse musculoskeletal
events (judged "not related to the device") in 16 patients related to the
lower back alone, out of 100 patients that started the study in the
experimental group. To me, that means 16% who did not have their lower back
problem solved, in a 2 year study.
I'll confess to a prejudice. I think reconstructive ligament therapy should
be the treatment of choice for almost all chronic back pain problems. It
should certainly be tried before surgery. The main reason that I have this
prejudice, is that it worked for me. I consider that Dr. Milne Ongley's
protocol for treating chronic low back pain to be scientifically proven for
safety and effectiveness even though it is not FDA approved. It is certainly
less invasive, less risky, and less expensive than any back surgery--except
that you have to pay for it yourself, with no insurance.
The scientific proof was published in "The Lancet" July 18, 1987, pp. 143 -
146, authors Milne J. Ongley, Robert G. Klein, Thomas A. Dorman, Bjorn C.
Eek, and Lawrence J. Hubert. The text of this article can be found online at
http://ongleyonline.com/lancetstudy.html.
Some highlights: 81 patients were studied. 40 received Ongley's treatment,
consisting of:
1. 1 manipulation of the lower back, facilitated by intravenous diazepam
(Valium).
2. Weekly injections of Ongley's proliferant solution (phenol, dextrose,
glycerin, water, and Xylocaine) into various ligaments of the sacro-illiac
joints and lumber facet joints, and some other ligaments of the lower back.
3. Daily flexion exercices, including 50 "toe touches" done three times a
day (actually, the paper says "forwad flexion"--some patients may not be
able to touch their toes, and this is not a goal of the treatment).
41 patients received a placebo treatment, consisting of a fake manipulation,
injections of fake proliferant solution (20 ml of physiological saline
solution), and real exercises.
In the experimental group, 35 patients (88%) reported reductions in
disability scores of 50% or more, six months after treatment ended. 15 were
free from disability. In the control group, 16 reported disabiltiy at 50%
or less, and 4 were free from disability.
"At the onset of the study 12 patients in the experimental group and 12 in
the placebo group had pain radiating into the distal part of one or both
legs. At six months this had resolved completely in 10 and 2, respectively
(p<0·01)"
Side-effects and Laboratory Data
"Patients in both groups complained of pain and stiffness for 12-24 h after
each injection; this was never severe enough to necessitate bed rest or
absence from work. 2 patients in the experimental group and 1 in the control
group had an increase in menstrual flow and 2 in the experimental group had
postmenopausal spotting four weeks after starting treatment. 1 patient in
the placebo group withdrew after the day-two injections because of severe
headache and cough; these had resolved at follow-up a week later. There were
no significant differences in laboratory data from the two groups."
Physicians Klein, Dorman, and Eek participated as skeptical
observer/participants. All three left their previous specialties to
specialize in Ongley's mode of treatment for chronic back pain and other
orthopedic problems.
The only questions I have, are "Why hasn't the FDA approved this mode of
treatment?" and "Why hasn't the NIH funded a lot more research on this mode
of treatment?"
For more information, see http://ongleyonline.com
David Wagner
A patient of Milne Ongley
