
Randomized Clinical Trials: Other:
Dextrose and Sodium morrhuate: Scarpone et
al 2008
Injection
of combination of sodium morrhuate (.72%) and dextrose (10.7%) on 3
occasions in patients with tennis elbow (lateral epicondylosis) resulted in
marked improvement in pain, wrist extension and grip strenth in comparision to
injection of saline.
Scarpone M, Rabago DP, Zgierska A, Arbogast G, Snell E. The efficacy of
prolotherapy for lateral epicondylosis: a pilot study [In Process Citation] Clin
J Sport Med (United States), May 2008, 18(3) p248-54
Dr Scarpone et al reported this year in a randomized and controlled
study that 12 adults with lateral epicondylosis injected at 0, 1 and 3 months
with 0.72% sodium morrhuate, 10.7% dextrose, .29% lidocaine and .04% sensorcaine
improved far more in pain levels (91% versus 33%; P < .001) and extension
strength (P < .01) and grip strength (P < .05) than 12 subjects given
saline injection with the same number of needle punctures and volume. Note this
is despite the fact that saline injection is not a placebo, suggesting that
saline injection is indeed not equivalent to injection of a combination of
sodium morrhuate and dextrose. Although a small study, these results and this
design are excellent. Here is that abstract. From the Department of
Family Medicine, University of Wisconsin-Madison, Madison, Wisconsin.
ABSTRACT: OBJECTIVES:: To assess whether prolotherapy, an injection-based
therapy, improves elbow pain, grip strength, and extension strength in patients
with lateral epicondylosis. SETTING:: Outpatient Sport Medicine clinic. STUDY
DESIGN:: Double-blind randomized controlled trial. PARTICIPANTS:: Twenty-four
adults with at least 6 months of refractory lateral epicondylosis.
INTERVENTION:: Prolotherapy participants received injections of a solution made
from 1 part 5% sodium morrhuate, 1.5 parts 50% dextrose, 0.5 parts 4% lidocaine,
0.5 parts 0.5% sensorcaine and 3.5 parts normal saline. Controls received
injections of 0.9% saline. Three 0.5-ml injections were made at the
supracondylar ridge, lateral epicondyle, and annular ligament at baseline and at
4 and 8 weeks. OUTCOME MEASURES:: The primary outcome was resting elbow pain (0
to 10 Likert scale). Secondary outcomes were extension and grip strength. Each
was performed at baseline and at 8 and 16 weeks. One-year follow-up included
pain assessment and effect of pain on activities of daily living. RESULTS:: The
groups were similar at baseline. Compared to Controls, Prolotherapy subjects
reported improved pain scores (4.5 +/- 1.7, 3.6 +/- 1.2, and 3.5 +/- 1.5 versus
5.1 +/- 0.8, 3.3 +/- 0.9, and 0.5 +/- 0.4 at baseline and at 8 and 16 weeks,
respectively). At 16 weeks, these differences were significant compared to
baseline scores within and among groups (P < 0.001). Prolotherapy subjects
also reported improved extension strength compared to Controls (P < 0.01) and
improved grip strength compared to baseline (P < 0.05). Clinical improvement
in Prolotherapy group subjects was maintained at 52 weeks. There were no adverse
events. CONCLUSIONS:: Prolotherapy with dextrose and sodium morrhuate was well
tolerated, effectively decreased elbow pain, and improved strength testing in
subjects with refractory lateral epicondylosis compared to Control group
injections.
Polidocanol: Alfredson et al 2005
Injection of small amount of polidocanol
were targeted using, ultrasound and color doppler guidance, to areas of abnormal
small blood vessels found just outside the tendon on the anterior (deeper) side.
The control group received anesthetic injection to the same areas. 5/10 patients
in the polidocanol group responded to treatment within 2 treatments and the
additional 5 responded to additional treatment. 0/10 of the anethetic patients
responded to 2 treatments, but this group then received polidocanol injection
and 9/10 responded. Alfredson
H; Ohberg L Sclerosing injections to areas of neo-vascularisation reduce pain in
chronic Achilles tendinopathy: a double-blind randomised controlled trial.
Knee Surg Sports Traumatol Arthrosc May 2005, 13(4) p338-44.
ABSTRACT: Local injections of the sclerosing substance
Polidocanol has been demonstrated to give good clinical results in a pilot study
on patients with chronic Achilles tendinopathy. In this study, 20 consecutive
patients (9 men and 11 women, mean age 50 years) with chronic painful
mid-portion Achilles tendinopathy were randomised to injection treatment with
either Polidocanol (5 mg/ml) (group A) or Lidocaine hydro-chloride (5 mg/ml) +
Adrenaline (5 microg/ml) (group B). Both substances have a local anaesthetic
effect, but Polidocanol also has a sclerosing effect. The patients and the
treating physician were blinded to the substance injected. The short-term
effects were evaluated after a maximum of two treatments, 3-6 weeks apart.
Before treatment, all patients had structural tendon changes and neo-vascularisation
demonstrated with US and color doppler. Under US and color doppler-guidance,
the injections targeted the area of neo-vascularisation just outside the ventral
part of the tendon. For evaluation, the patients recorded the severity of
Achilles tendon pain during tendon loading activity, before and after treatment,
on a VAS. Patient's satisfaction with treatment was also assessed. At follow-up
(mean 3 months) after a maximum of two treatments, 5/10 patients in group A were
satisfied with the treatment and had a significantly reduced level of tendon
pain (p < 0.005). In group B, no patient was satisfied with treatment. In the
pain-free tendons, but not in the painful tendons, neo-vascularisation was
absent after treatment. After completion of the study, treatment with
Polidocanol injections (Cross-over in group B and additional treatments in group
A) resulted in 10/10 and 9/10 satisfied patients in group A and B, respectively.
In summary, injections with the sclerosing substance Polidocanol have the
potential to reduce tendon pain during activity in patients with chronic painful
mid-portion Achilles tendinopathy.
For further explanation note this 2 year followup
report by Dr. Alfredson showing
sonographic remodeling with a thinner tendon and more normal structure.
By using ultrasound (US) + colour Doppler (CD),
immunohistochemical analyses of tendon biopsies, and diagnostic injections of
local anaesthesia, sensory nerves (Substance-P-SP and Calcitonin Gene Related
Peptide-CGRP) were found inside and outside the vascular wall. In following
clinical studies we have demonstrated good short-and mid-term clinical results
using treatment with US+CD-guided sclerosing polidocanol injections, targeting
the area with neovessels outside the tendon. Two-year follow ups have showed
remaining good clinical results, and sonographically signs of remodelling with a
significantly thinner tendon with a more normal structure. Whether the effects
of polidocanol are mediated through destruction of neovessels, activity on
nerves or a combination, is under evaluation. Alfredson
H; Lorentzon R: Sclerosing polidocanol injections of small vessels to treat the
chronic painful tendon.: Cardiovasc Hematol Agents Med Chem (Netherlands), Apr
2007, 5(2) p97-100
POLIDOCANOL: Alfredson et al
2005 15 elite or
recreational athletes with patellar tendinosis/jumpers knee were injected with
Polidocanol, targeting areas of neovascularization. At 6 month followup there
was a good clinical result in 12/15 tendons. With previous sport level reached
in 12/15 and pain decrease (VAS) from 81 to 10 on a 100 point scale. Alfredson
H; Ohberg L Neovascularisation in chronic painful patellar tendinosis--promising
results after sclerosing neovessels outside the tendon challenge the need for
surgery. Knee Surg Sports Traumatol Arthrosc (Germany), Mar 2005, 13(2) p74-80
ABSTRACT: Sclerosing injections targeting
neovascularisation have been demonstrated to give promising clinical results in
patients with chronic painful Achilles tendinosis. In this study, fifteen elite
or recreational athletes (12 men and three women) with the diagnosis patellar
tendinosis/Jumper's knee in 15 patellar tendons were included. All the patients
had a long duration of pain symptoms (mean = 23 months) from the patellar
tendon, and ultra-sonography + colour doppler examination showed structural
tendon changes with hypo-echoic areas and a neovascularisation, corresponding to
the painful area. The patients were treated with ultrasound and colour doppler-guided
injections of the sclerosing substance Polidocanol, targeting the area with
neovascularisation. At follow-up (mean = 6 months) after a mean amount of three
treatments, there was a good clinical result in 12/15 tendons. The patients were
back to their previous (before injury) sport activity level, and the amount of
pain recorded on a VAS-scale had decreased significantly (VAS from 81 to 10).
Our findings indicate that treatment with sclerosing injections, targeting the
area with neovessels in patellar tendinosis, has the potential to cure the pain
in the tendons and also allow the patients to go back to full patellar-tendon
loading activity.