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Prolotherapy as a treatment for chronic MSK pain

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					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

►To review the preliminary results of an
 NIH/UW clinical trial assessing
 prolotherapy for knee OA pain
 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
        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
     Prolotherapy Clinical Reports
               Number of Prolotherapy Research Papers over Time

16
14   16
     14
12                                                                Randomized
     12
                                                                  Controlled Trials
10   10
      8
                                                                  Non-Randomized
 8                                                                Controlled Trials
      6
                                                                  Case Reports
 6    4
      2
 4
      0
 2        1930s 1940s 1950s 1960s 1970s 1980s 1990s 2000s

 0
     1930s 1940s 1950s 1960s 1970s 1980s 1990s 2000s
                            Decade
                             Decade
 OA Knee Pain Trial: Hypotheses
             Rabago 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
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

                                   Follow up Questionnaires at weeks
Randomized Controlled Trial                  5, 9, 12, 24, 52
       Patient Eligibility Criteria
► Adults 35-75 y.o.        ► BMI  >42
► Osteoarthritic pain      ► Chronic pain greater
  > 3 months                 than knee pain
                           ► Chronic pain
► Crepitus
                             requiring narcotic
► Radiographic criteria    ► Prolo patient
► Quality-of-life impact   ► Surgical
  score
► Prolotherapist
  approval
           Intervention
►“Standard”   knee protocol
  Intra-articular: 25% Dex.
  Extra-articular: 15% Dex.
►3 prolo injection series monthly
►2 optional prolo sessions monthly
         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
  Baseline Subject Demographics
          ► Female,n (%) 21 (58.3%)
          ► Age, mean (SD) 60.5 ± 8.7
          ► BMI, mean (SD) 30.7 ± 6.9

► WOMAC                   ► KPS (Left)
  Pain      57.9 ± 2.9      Pain Freq 35.1 ± 4.9
  Stiffness 51.7 ± 3.8      Pain Sev 59.2 ± 3.9
  Function 57.3 ± 2.8
                          ► KPS (Right)
                             Pain Freq 33.6 ± 3.3
                             Pain Sev 57.8 ± 2.9
      Change in WOMAC Scores over
       Months (p<0.05) (93% of data)
   12 Change in WOMAC Score over Time
Score
  90
Score
  85
9080                                                                        Relative
  75                                                                       Effect Size
  70
8065                                                                      Pain    28.3%
  60
  55                                                                      Stiffness 28.9%
  50
70                                                                        Function 35.6%
             e



                     5



                             9


                                     12



                                              24



                                                       52
          in



                  k



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         l


                 W



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      se




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     Ba




60                               Time
                                  Pain        Stiffness        Function
50
       Baseline       Wk 5       Wk 9     Wk 12        Wk 24      Wk 52

                                     Time
  Change in KPS Score on Injected Left Knee
           (93% of data) (p<0.05)
  Score
  80


  70                                                            Relative



                           )
     1)


                          2)
                                                               Effect Size

                         15
  =3


                       =3


  60                   =                                      Pain Frequency
(n


                     (n


                    (n
                                                                  84.6%
          24


                 52


  50                                                           Pain Severity
    k


               k



                                                                  27.9%
   W


              W




  40
  Time                     Pain Frequency     Pain Severity
  30
         Baseline   Wk 5   Wk 9     Wk 12   Wk 24    Wk 52

                                  Time
    Change in KPS Score on Injected Right Knee
             (93% of data) (p<0.05)
    Score
    80


    70                                                           Relative
                                                                Effect Size


                             )
     1)


                            2)


                           15
  =3


                         =3

    60                                                         Pain Frequency
                         =
(n


                       (n


                      (n
                                                                   96.4%
2

            24


                   52


    50                                                          Pain Severity
          k




                                                                   29.9%
                 k
         W


                W




    40
     Time                   Pain Frequency     Pain Severity
    30
         Baseline   Wk 5   Wk 9     Wk 12    Wk 24    Wk 52
                                  Time
                 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
                  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
              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
                                  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.
                     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
     ►PatientSatisfaction
     ►Knee x-ray severity correlations
     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
 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?!
Thanks!
Strength of Evidence: 2,500 treatments
                 BMJ 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?
Knee OA trial: Subject Recruitment
  ICD-9 Billing code screen/Media/Direct
                   Clinic

    Phone Screen (Secondary                 Case Series
        incl/excl criteria)

      Meeting (Info, Consent,          Meeting (Info, Consent,
     Randomization, Q’naires)                Q’naires)

  Dextrose      Saline      Exercise           Dextrose
   N=37         N=37         M=37               N=37

      MRI: T0, 6 m & 12 m       MRI: T0 & 12 m


   Follow up questionnaires at wks 5, 9, 12,
                 24 and 52
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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