K. Dean Reeves, M.D.

Clinical Associate Professor            Physical Medicine and Rehabilitation

Emphasis on Research in Use of Prolotherapy (Also called  Regenerative Injection Therapy)

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 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.

  

 

 

 

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Last modified: December 29, 2008