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Prolotherapy as a treatment for knee osteoarthritic pain

Prolotherapy as a treatment for knee osteoarthritic pain. David Rabago, MD Rosa DeLucia UW Department of Family Medicine NIH-NCCAM, DFM, Hackett-Hemwall Foundation Jeff Patterson, Jessica Grettie. Learning Objectives. To briefly review significance of knee osteoarthritis

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Prolotherapy as a treatment for knee osteoarthritic pain

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  1. Prolotherapy as a treatment for knee osteoarthritic pain David Rabago, MD Rosa DeLucia UW Department of Family Medicine NIH-NCCAM, DFM, Hackett-Hemwall Foundation Jeff Patterson, Jessica Grettie

  2. Learning Objectives • To briefly review significance of knee osteoarthritis • To review the preliminary results of an NIH/UW clinical trial assessing prolotherapy for knee OA pain

  3. The efficacy of prolotherapy for knee osteoarthritic pain • Knee OA: Bad • leading cause of disability/pain in the world • present and symptomatic in up to 6% of the population over 30 in the US • Multiple risk factors and presumed etiologies • incidence increases up to 10 fold from 30 to 65 years of age • no definitive non-surgical, pain-control and disease-modifying treatment

  4. What is Prolotherapy? Technique for treating chronic MSK pain • Multiple injections of bioactive solution • Proliferant injected and at tender ligament and tendon insertion points and within joints • Stimulates the body’s native healing • ?Inflammatory process • ?Growth factor recruitment • ?Sclerose neovascularity associated with chronic tendon disease • Growing in popularity nationwide

  5. Prolotherapy Clinical Reports Decade

  6. OA Knee Pain Trial: HypothesesRabago et al. In progress • 1. Prolotherapy can improve chronic pain, stiffness, function and… • 2. Subjects will adhere to therapy, be satisfied and use less pain medication

  7. Knee OA trial: Subject Recruitment ICD-9 Billing codes/Media/Direct Clinic Phone Screen (Secondary Inclusion/Exclusion criteria) Prospective Case Series Meeting (Info, Consent, Questionnaires) Dextrose (n=36) 3-5 monthly sessions Randomized Controlled Trial Follow up Questionnaires at weeks 5, 9, 12, 24, 52

  8. Adults 35-75 y.o. Osteoarthritic pain > 3 months Crepitus Radiographic criteria Quality-of-life impact score Prolotherapist approval BMI >42 Chronic pain greater than knee pain Chronic pain requiring narcotic Prolo patient Surgical Patient Eligibility Criteria

  9. Intervention • “Standard” knee protocol • Intra-articular: 25% Dex. • Extra-articular: 15% Dex. • 3 prolo injection series monthly • 2 optional prolo sessions monthly

  10. Outcome Measures • Western Ontario and McMaster University osteoarthritis index (WOMAC) • pain, stiffness, function • Knee Pain Scale (KPS) • pain severity, frequency per knee • Quality of life, side effects, patient satisfaction and medication use

  11. Baseline Subject Demographics • Female, n (%) 21 (58.3%) • Age, mean (SD) 60.5 ± 8.7 • BMI, mean (SD) 30.7 ± 6.9 • KPS (Left) • Pain Freq 35.1 ± 4.9 • Pain Sev 59.2 ± 3.9 • KPS (Right) • Pain Freq 33.6 ± 3.3 • Pain Sev 57.8 ± 2.9 • WOMAC • Pain 57.9 ± 2.9 • Stiffness 51.7 ± 3.8 • Function 57.3 ± 2.8

  12. Change in WOMAC Scores over 12 Months (p<0.05) (93% of data) Score Relative Effect Size 90 80 70 60 50 Pain 28.3% Stiffness 28.9% Function 35.6% Baseline Wk 5 Wk 9 Wk 12 Wk 24 Wk 52 Time

  13. Change in KPS Score on Injected Left Knee (93% of data) (p<0.05) Score 80 70 60 50 40 30 Relative Effect Size Pain Frequency 84.6% Pain Severity 27.9% Baseline Wk 5 Wk 9 Wk 12 Wk 24 Wk 52 Time

  14. Change in KPS Score on Injected Right Knee (93% of data) (p<0.05) Score 80 70 60 50 40 30 Relative Effect Size Pain Frequency 96.4% Pain Severity 29.9% Baseline Wk 5 Wk 9 Wk 12 Wk 24 Wk 52 Time

  15. Correlations • Do any of the following demographic criteria predict outcomes? • No • Tobacco • BMI • Hx Arthroscopic Surgery • Diabetes • Duration of Knee Pain • Weight • History of ACL surgery • X-ray severity grade

  16. Correlations • Do any other demographic criteria predict better outcomes? • Yes • Gender (F) • Pain 36% (p=0.03) • Stiffness 59.7% (p=0.003) • Function 39.9% (p=0.02) • Maybe • Age (56-65) • Pain 52% (p=0.08) • Stiffness 36% NS • Function 39% NS

  17. Further Analyses • Demographic Data Correlations • Duration of Knee Pain • Weight • History of ACL surgery • X-ray severity grade • Patient Satisfaction, Qualitative Interview • Patient Adherence • Medication Use

  18. Safety • Routine injection side effects • Injection pain • Mild bleeding, bruising • One case of superficial neuropathy, slowly resolving • No significant adverse effects • Prolotherapy appears to be no more dangerous than other injection therapies • Dagenais S, Ogunseitan O, Haldeman S, Wooley JR, Newcomb RL. Side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain: a survey of practitioners. Arch Phys Med Rehabil 2006;87:909-913.

  19. Context • Percentage improvement meets or exceeds minimal clinical important difference for WOMAC (12% improvement from baseline) and chronic pain (15-20%) • Comparison to standard of care therapies in progress • Further analyses in progress • More to come! • Study complete in early 2009 • Data Analysis in Progress • Patient Satisfaction • Knee x-ray severity correlations

  20. Strengths and Limitations • Strengths • Pragmatic: generalizable patients • Tests a usual prolotherapy protocol for a common condition • 1 year follow-up • Standard, validated patient-oriented outcome measure • Substantial, consistent results • Weaknesses • Non-randomized design • Small sample size

  21. Conclusions/Future Directions • Consistent moderate-large effect sizes in this pragmatic sample • Prolotherapy may be of clinical use for knee OA; further studies are warranted • Larger, randomized studies • Other injectants • Platelet-Rich Plasma • Sodium Morrhuate/Dextrose solution • Autologous Stem Cells?!

  22. Thanks!

  23. Strength of Evidence: 2,500 treatmentsBMJ Clinical Evidence; How much do we know?; http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp; 2007 • Where does prolotherapy fit? • What is required to change practice?

  24. Knee OA trial: Subject Recruitment ICD-9 Billing code screen/Media/Direct Clinic Phone Screen (Secondary incl/excl criteria) Case Series Meeting (Info, Consent, Randomization, Q’naires) Meeting (Info, Consent, Q’naires) Dextrose N=37 Dextrose N=37 Saline N=37 Exercise M=37 MRI: T0, 6 m & 12 m MRI: T0 & 12 m Follow up questionnaires at wks 5, 9, 12, 24 and 52

  25. What really happened? • Screened: 1198 • Interviewed: 193 • Total Injected: 134 • Knees Injected: 201 • 4.5 sessions/pt • 20 skin punctures/knee • 4 skin slides/puncture • 72,360 solution “deliveries”

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