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 CAN ANY RESEARCH DEFINITELY PROVE
THAT PROLOTHERAPY WORKS?
Ross
Hauser, M.D.
Before double-blinded studies,
doctors would ask patients if they felt better. If patient after patient told
the physician they felt better, than it was presumed and accepted that the
therapy was effective. If it was a new therapy, then it was taught doctor to
doctor and eventually it was taught in medical schools. If this was still the
standard upon which medical therapies were judged, then clearly
Prolotherapy would be
taught in all the medical schools, but it is not. Why not?
Modern allopathathic medical research demands that therapies be proven by
double-blinded methods. This means that neither the patient nor the physician
knows which therapy is used. For medications this is easy because the pills can
be made to look alike and a sugar pill used as the placebo is presumed to have
no therapeutic value. Unfortunately for certain procedures, like
Prolotherapy
and most surgeries, there is no adequate placebo.
Prolotherapy
involves multiple
Prolotherapy injections
into the
ligament/bone interface and joints where a person is experiencing pain. Prolotherapy induces a mild inflammatory reaction that helps proliferate
fibroblasts which make the
collagen tissue which makes up
ligaments,
tendons, and most joint tissue.
Once enough collagen is made, that ligament, tendon, or joint structure will
improve its strength enough to eliminate the person's pain. Current researchers
typically use saline solution as a placebo in Prolotherapy studies instead of
one of the ‘normal’
Prolotherapy solutions.
In other words, the technique of the Prolotherapy injections versus the placebo
injections is exactly the same. The placebo injections involve piercing the skin
and injecting the saline solution into the bone/ligament interface or into the
respective joints. The problem with this method is that sticking needles into
areas of pain as the placebo, is not a placebo, it is called
acupuncture. It has
been shown that just dry needling an area of pain can help diminish or eliminate
the pain.1 Acupuncture is an accepted medical treatment. On top of that, to
diminish the pain of the Prolotherapy shots, researchers will often inject
lidocaine or anesthetics into the skin, but this again is an active treatment
for pain. Intradermal injection (injection into the skin) is another method
practitioners can use to eliminate pain. Another fact is that saline injections
into areas of pain is also an effective therapy to eliminate pain. For example,
in a controlled, double-blind comparison of mepivicaine injection versus saline
injection for
myofascial pain, the group receiving saline tended to have more
relief of pain, especially after the first injection. In this study, 28 patients
with acute, localized muscle pain received four local injections of mepivicaine
(anesthetic) and 25 patients with the same type of pain received local
injections of an equivalent volume of physiological saline. Considerable
improvement or freedom from symptoms was reported in 48% of patients treated
with physiological saline and 42% in the mepivicaine group.
The conclusion was that physiological saline is considered to be a more
appropriate fluid for injection therapy than local anaesthetics since it is less
likely to produce side-effects. The study, therefore, raises questions about the
mechanism by which local injections into muscles relieves pain, since there is
the possibility that a similar effect might also be achieved by merely inserting
a needle into the
trigger point.2 One wonders if the reason saline helps with
muscle pain is because it induces a mild inflammatory reaction. Such a reaction
deems the therapy then Prolotherapy. There have been other studies also to show
the pain-reducing effects of saline or just plain sterile water injections.3,4
Also, what worse
back pain can there be than labor pain? Subcutaneous injections
of sterile water into the area of back pain in women in labor can significantly
reduce their pain.5,6,7
In summary, sticking a needle through the skin eliminates pain (acupuncture),
sticking a needle through muscles eliminates pain (dry needling), sticking a
needle into the skin and injecting water into it eliminates pain, and saline
injections into muscles eliminates pain. So if one was to do a Prolotherapy
study it would be impossible to have a placebo group because the placebo group
even if they were injected with nothing would still be getting a treatment that
eliminates pain.
The reason I went through this whole explanation is that the latest study on
Prolotherapy used saline injections as the placebo group. The study was printed
in Spine and was entitled Prolotherapy Injections, Saline injections, and
Exercises for Chronic Low-Back Pain: A Randomized Trial.8 The null hypothesis
was that Prolotherapy injections and exercises would be no more effective than
the control treatment.
The authors did a good job to assure that their null hypothesis would be true
because the control treatment was a treatment. In other words, the control group
in this case involved the person getting the exact same shots as the person
getting ‘Prolotherapy’ except the solution was different. The Prolotherapy group
received injections of hypertonic
dextrose and the control group received
injections of saline. How much different of an inflammatory reaction do you
think would occur between the two. Not too much, but some. The results showed
that at 12 months, the proportions achieving more than 50% reduction in pain
from baseline by injection group were glucose-lidocaine: 0.46 versus saline:
0.36. The conclusion of the study was that in chronic nonspecific low-back pain,
significant and sustained reductions in pain and disability occur with ligament
injections, irrespective of the solution injected or the concurrent use of
exercises.
So in summary, ligament injections work to eliminate the pain. Since the
‘Prolotherapy’ solution did not significantly eliminate pain better than the
saline group in this study, some are reporting that this study shows that
Prolotherapy doesn’t work.
I wrote to the primary author Dr. Michael Yelland and he wrote me back and said,
“Our results may be interpreted as negative by those who focus solely on the
lack of significant differences between groups and choose not to notice the
sustained and significant reductions in pain and disability lasting two years.9
I let him know that the results of this study in regard to the dextrose
Prolotherapy group are far inferior to what
Hackett-Hemwall
Prolotherapists
achieve (50% pain reduction in this study, versus 75% cure rate with Hackett-Hemwall
Prolotherapy!). I encouraged him or his colleagues in Australia to contact me
about getting additional Prolotherapy training for him or his colleagues but
haven’t heard back.
In this study the amount of solution injected was far less than is used in a
typical Prolotherapy treatment by a Hackett-Hemwall Prolotherapist (30cc versus
80cc). In this study the deep
sacroiliac ligaments were not injected routinely
whereas in Hackett-Hemwall Prolotherapy they are typically included in a
comprehensive low back treatment. In this study, injections were performed
through an anesthetized wheal of skin over each site. Thus, an intradermal
injection of anesthetic was done over the area of pain in both the Prolotherapy
group and the control group. As I alluded to above, this is an active treatment
for pain. It has been shown in various studies to decrease pain, so the
‘placebo’ group in this study was an active treatment group. In this study if no
improvement was noted by the fifth session of injections, the deeper
interosseous sacroiliac ligaments on the affected sides or sides were also
treated. Again, this area is typically done at all visits with Hackett-Hemwall
Prolotherapy.
So what did this study show? At 12 months, the proportions of all participants
who rated their pain and disability as better than at enrollment were 76% in the
Dextrose-Prolotherapy group and 68% in the Saline-Prolotherapy group. I am
calling it Saline-Prolotherapy group because the technique of Prolotherapy was
used. In other words, a needle was used to inject solution into the
bone-ligament interface and such a ‘trauma’ would induce a mild inflammatory
reaction. At 12 months, the proportions of participants who achieved at least a
50% reduction of pain in each group were glucose-lidocaine Prolotherapy of 46%
and Saline- Prolotherapy 36%.
SUMMARY
The latest study on Prolotherapy once again showed that Prolotherapy works at
eliminating pain. The study looked at two different solutions: hypertonic
dextrose and saline. Hypertonic dextrose eliminated pain slightly better than
saline but it was not statistically significant.
In this study, and others regarding Prolotherapy, the difficulty lies in the
fact that there is not a placebo group that can satisfy the true requirements of
a placebo. A placebo is to have no biological effect. Studies have shown that
sticking a needle into an area of pain with or without injecting a substance
into the area has a biological effect and helps eliminate the pain. As such,
Prolotherapy studies can just compare one solution to another. As long as the
studies show that both solutions work, as the latest study has, instead of
allopathic physicians claiming Prolotherapy doesn’t work (because the
Prolotherapy solution group did not reduce pain significantly more than the
control injection group), they should accept the fact that simple solutions can
eliminate people’s pain as long as the technique of Prolotherapy is used.
Injecting sugar or saline-type solutions into the ligament/bone interface
eliminates chronic pain. This is consistent with the current thinking among
Prolotherapy physicians that the chronic pain that people suffer from is at the
ligament/bone interface called the fibro-osseous junction. Prolotherapy by
inducing a mild inflammatory reaction in the area helps it to repair. Once this
interface is strong the person's chronic pain is eliminated.
1. Garvey, T. A prospective, randomized, double-blind evaluation of trigger
point injection therapy for low back pain. Spine. 1989; 14: 962-964.
2. Frost, F. A control, double-blind comparison of mepivicaine injection versus
saline injection for myofascial pain. The Lancet. 1980; March 8, pp. 499-501.
3. Jenson, M. Improved patient compliance after trigger point injections using a
0.9% sodium chloride compared to bupivacaine 0.025% for patients with myofascial
pain syndrome. The Pain Practitioner. 2001; Fall, pp. 4-6.
4. Byrn, C. Subcutaneous sterile water injections for chronic neck and shoulder
pain following whiplash injuries. The Lancet. 1993; 341: 449-452.
5. Trolle, B. The effect of sterile water blocks on low back pain labor pain. Am
J Obstet Gynecol. 1991; 164: 1277-81.
6. Ader, L. Parturition pain treated by intracutaneous injections of sterile
water. Pain. 1990; 41: 133-8.
7. Byrn, C. Subcutaneous sterile water injections for chronic neck and shoulder
pain following whiplash injuries. The Lancet. 1993; 341: 449-452.
8. Yelland, Michael. Prolotherapy Injections, Saline Injections, and Exercises
for Chronic Low-Back Pain: A Randomized Trial. Spine; 2004: 9-16.
9. Personal email correspondence 3/22/04.
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Looking for a book about
Prolotherapy?
Prolo Your Pain
Away! details in common
lay language the conditions that can be cured with Prolotherapy
including arthritis, back pain,
migraines,
neck pain,
fibromyalgia, spastic torticollis, osteoporosis fracture pain,
whiplash, sports injuries, loose joints,
TMJ,
tendonitis, sciatica,
herniated discs,
and more!
In this new, third edition we included:
►
a new chapter all about the role
of nutrition in controlling chronic pain.
►
we updated the information on the
ingredients used in Prolotherapy solutions including the
up-and-coming platelet derived growth factors, and new research
in the area of Prolotherapy.
Ross Hauser, M.D., & Marion Hauser, M.S.,R.D.
Read more about this book at Amazon.com
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