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WHY ISN'T THERE MORE PROLOTHERAPY
RESEARCH?
Ross A. 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.
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.
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