C. Randomized Clinical Trials in Low Back Pain:
In
the treatment of low back pain there are four treatment comparison studies.
The control group in all back studies involved needle contact with attachments
of ligaments and tendons. By injecting ligaments and tendons, there is needle
contact with cell membranes of connective tissue cells. Disrupting cell
membranes releases lipids, which in turn cause signaling of fibroblasts.
In
addition, microbleeding from needle contact is expected, and Edwards and
colleagues have demonstrated the potential healing effect of whole blood
injection in patients with recalcitrant tennis elbow. Edwards
SG, Calandruccio JH: Autologous blood injections for refractory lateral
epicondylitis J Hand Surg [Am] 28(2):272, 2003.
PDG: Klein et al 1993 Near
significant (P = .056) evidence for superior effect of the inflammatory
proliferant solution anesthetic needling (Klein et al) in chronic low back pain.
Klein RG, Bjorn CE, DeLong B, et
al: A randomized double-blind trial of dextrose-glycerine-phenol injections for
chronic low back pain. J Spinal Disord 6:23, 1993.
PDG: Ongley et al 1987
Significant (P < .001)
evidence for superior effect of the inflammatory proliferant solution over
saline needling in chronic low back pain. Ongley
MJ, Klein RG, Dorman TA, et al: A new approach to the treatment of chronic low
back pain. Lancet 2:143, 1987.
Despite better-than-placebo improvement in the control group,
the first two blinded studies of chronic low back pain (using
phenol/dextrose/glycerin as active solution) demonstrated significant (P <
.001) Ongley MJ, Klein RG, Dorman TA, et al: A new
approach to the treatment of chronic low back pain. Lancet 2:143, 1987. and
near significant (P = .056) Klein
RG, Bjorn CE, DeLong B, et al: A randomized double-blind trial of dextrose-glycerine-phenol
injections for chronic low back pain. J Spinal Disord 6:23, 1993.
evidence for superior effect of the inflammatory proliferant solution over
saline needling (Ongley et al) and anesthetic needling (Klein et al). These two
studies were weakened somewhat by multiple simultaneous treatments, although the
injection solution was the only significant difference between the two groups.
PDG: (Phenol Dextrose Glycerine) Dechow et
al 1999 Incorrect injection sites
along with failure to examine lead to worse rather than better outcomes.
Dechow E, Davies RK, Carr AJ, et al: A randomized, double-blind,
placebo-controlled trial of sclerosing injections in patients with chronic low
back pain. Rheumatology 39:1255, 1999.
The third study was led by a chief investigator (rheumatologist)
who had a mandate to "prove or disprove prolotherapy", was armed with
a complete lack of knowledge of prolotherapy technique or referral patterns for
ligament or tendon, and brilliantly, but probably unwittingly, designed the
study to fail. Dechow E, Davies RK, Carr AJ, et al: A
randomized, double-blind, placebo-controlled trial of sclerosing injections in
patients with chronic low back pain. Rheumatolgy 39:1255, 1999. Failure
was insured by:
1. Accepting patients with axial (back) pain only and
excluding patients with leg pain referral.
2. Finding a physician who was conversant with prolotherapy
but preventing him from examining the patients for areas to inject. Rather the
physician was forced to inject only specified areas.
3. Allowing treatment only on ligaments that would cause leg
pain and not any ligaments that would treat axial (back) pain, and .
4. Injecting inflammatory (phenol-based) proliferant in
these incorrect areas. .
As a consequence of injecting inflammatory solution in
completely wrong areas, this study is recorded as a prolotherapy study in which
the active group did worse than the control. This study is worthy of inclusion
in a discussion of back pain studies because of what it says about study design
in musculoskeletal medicine. IE: It trumpets the importance of knowing
anatomy, and referral patterns in connective tissue, and of hands-on
examination.
DEX: Yelland et al 2004 Injection
alone, even without proliferant, is effective long term for chronic intractable
back pain. Yelland MJ, Glasziou PP, Bogduk
N, et al: Prolotherapy injections, saline injections, and exercises for chronic
low-back pain: A randomized trial. Spine 29(1):9, 2004.
A fourth study was reported in 2004 and designed by an
experienced physician in Brisbane.
Yelland MJ, Glasziou PP, Bogduk N, et
al: Prolotherapy injections, saline injections, and exercises for chronic
low-back pain: A randomized trial. Spine
29(1):9, 2004. This study, like the previous
studies, compared repetitive needle contact with bone, with and without
proliferant. A gentler proliferant (dextrose) was utilized. Substantial and
sustainable important improvements in pain and function were demonstrated by
both injection groups, despite incomplete injection which minimized areas that
several key areas. Highlighted by this study is the importance of the beneficial effect of needling alone and that
needling is not a placebo intervention.
The hope is that future studies on low back pain will include
a near-placebo arm that avoids connective tissue contact or blood effects and
that standard injection methods will be used. In the treatment of low back pain,
standard treatment methods are now taught in cadaver courses offered by the
American Academy of Orthopedic Medicine. An example of such a near-placebo would
be needle insertion through skin without contacting bone or ligament. Meanwhile
consecutive patient studies with complete technique continue to support a high
percentage of response to proliferant injection in chronic back pain patients. Hooper
RA, Ding M: Retrospective case series on patients with chronic spinal pain
treated with dextrose prolotherapy. J Altern Complement Med 10(4):670, 2004.