Prolotherapy Research

Prolotherapy Definition: Injection to stimulate healing of soft tissue. 

Types of Prolotherapy:  Enthesofascial, myofascial and neurofascial (See recent talk  for explanation)

Site Administrator: K. Dean Reeves, M.D., AAPM&R, Clinical Associate Professor, University of Kansas.   DeanReevesMD@gmail.com  (913) 362 1600

 

Dextrose/Polidocanol/Whole Blood/PRP:  Rabago et al 2008. Review article on the above injectants in tennis elbow.  There is strong pilot-level evidence supporting the use of dextrose, polidocanol, autologous whole blood and platelet-rich plasma injections in the treatment of LE.  Note the authors appear to use the term prolotherapy synonomously for dextrose injection.  This researcher's view is that prolotherapy is injection to create repair or regeneration of soft tissue and can use any solution.  Thus prolotherapy can use dextrose, polidocanol, autologous whole blood, platelet rich plasma, bone marrow aspirate, etc.   

Rabago D; Best T; Zgierska A; Zeisig E; Ryan M; Crane D A systematic review of four injection therapies for lateral epicondylosis: prolotherapy, polidocanol, whole blood and platelet rich plasma.  Br J Sports Med (England), Jul 2009, 43(7) p471-81 
 

ABSTRACT:  OBJECTIVE: To appraise existing evidence for prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injection therapies for lateral epicondylosis (LE). DESIGN: Systematic Review. DATA SOURCES: Medline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine. Search strategy: names and descriptors of the therapies and LE. Study Selection: All human studies assessing the four therapies for LE. MAIN RESULTS: Results of five prospective case series and four controlled trials (3 prolotherapy, 2 polidocanol, 3 autologous whole blood and 1 platelet-rich plasma) suggest each of the four therapies is effective for LE. In follow-up periods ranging from 9 to 108 weeks, studies reported sustained, statistically significant(p <0.05) improvement on visual analog scale primary outcome pain score measures and disease specific questionnaires; relative effect sizes ranged from 51% to 94%; Cohen's d ranged from 0.68 to 6.68. Secondary outcomes also improved, including biomechanical elbow function assessment (polidocanol and prolotherapy), presence of abnormalities and increased vascularity on ultrasound (autologous whole blood and polidocanol). Subjects reported satisfaction with therapies on single-item assessments. All studies were limited by small sample size. CONCLUSIONS: There is strong pilot-level evidence supporting the use of prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injections in the treatment of LE. Rigorous studies of sufficient sample size, assessing these injection therapies using validated clinical, radiological and biomechanical measures, and tissue injury/healing-responsive biomarkers, are needed to determine long-term effectiveness and safety, and whether these techniques can play a definitive role in the management of LE and other tendinopathies.

 

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Review article on low back treatment   Chou et al 2009   Authors who review prolotherapy as a treatment option in low back pain commonly commit a major error by assuming that injection with concomitant needling and bleeding is a placebo.   They thus ignore the resulting substantial and sustained improvements in pain and disability in both proliferant and non proliferant injection groups.   They also are typically unaware of the incompetent study design by a lead author in one of the randomized trials. (Dechow 1999)  Four randomized controlled trials have been performed. (Ongley 87, Klein 93, Dechow 99, Yelland 04). One was egregioiusly flawed (Dechow 99) due to complete lack of knowledge of prolotherapy method or ligament referral patterns. The lead author was assigned to "prove or disprove prolotherapy". The designer assigned patients based on incorrect referral pattern assumptions and required the injector to treat areas that had nothing to do with the pain the patient was having without allowing any examination to take place.  This was with a strong proliferant and naturally led to pain flare in the proliferant group with a worse outcome than the control group. The other three randomized and blinded trials demonstrated long term and substantial reductions in disability in both active and control groups, favoring the proliferant group but not with statistical significance because even the control groups were not placebo groups (Repetitive needling causes a proliferant effect through several mechanisms.) Note that other consecutive case series of low back pain patients have confirmed the substantial improvements in pain and function with injection of connective tissue with proliferant in patients with chronic low back pain. (Hooper 04, Wilkinson 05, Cusi 07). Every study other than the flawed study above thus far has confirmed that with needling with or without proliferant, substantial functional improvement has resulted at 6 months to 1 year followup. There is no other modality of treatment that has more evidence of long term benefit for low back pain. 

Here is the abstract, keeping in mind that the authors have made both major errors mentioned above. 

Chou R; Atlas SJ; Stanos SP; Rosenquist RW : Nonsurgical interventional therapies for low back pain: a review of the evidence for an american pain society clinical practice guideline [In Process Citation] Spine (United States), May 1 2009, 34(10) p1078-93

ABSTRACT: STUDY DESIGN: Systematic review. OBJECTIVE: To systematically assess benefits and harms of nonsurgical interventional therapies for low back and radicular pain. SUMMARY OF BACKGROUND DATA: Although use of certain interventional therapies is common or increasing, there is also uncertainty or controversy about their efficacy. METHODS: Electronic database searches on Ovid MEDLINE and the Cochrane databases were conducted through July 2008 to identify randomized controlled trials and systematic reviews of local injections, botulinum toxin injection, prolotherapy, epidural steroid injection, facet joint injection, therapeutic medial branch block, sacroiliac joint injection, intradiscal steroid injection, chemonucleolysis, radiofrequency denervation, intradiscal electrothermal therapy, percutaneous intradiscal radiofrequency thermocoagulation, Coblation nucleoplasty, and spinal cord stimulation. All relevant studies were methodologically assessed by 2 independent reviewers using criteria developed by the Cochrane Back Review Group (for trials) and by Oxman (for systematic reviews). A qualitative synthesis of results was performed using methods adapted from the US Preventive Services Task Force. RESULTS: For sciatica or prolapsed lumbar disc with radiculopathy, we found good evidence that chemonucleolysis is moderately superior to placebo injection but inferior to surgery, and fair evidence that epidural steroid injection is moderately effective for short-term (but not long-term) symptom relief. We found fair evidence that spinal cord stimulation is moderately effective for failed back surgery syndrome with persistent radiculopathy, though device-related complications are common. We found good or fair evidence that prolotherapy, facet joint injection, intradiscal steroid injection, and percutaneous intradiscal radiofrequency thermocoagulation are not effective. Insufficient evidence exists to reliably evaluate other interventional therapies. CONCLUSION: Few nonsurgical interventional therapies for low back pain have been shown to be effective in randomized, placebo-controlled trials.

 

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