The Effectiveness of Manual Therapy on Chronic Pelvic Pain: An Evidence-Based Review Jessica Manley, DPTc PT 910 Evidence-Based Practice Spring 2012 Pelvic Floor Musculature The Roles of the Pelvic Floor Support for viscera Respiration Pelvic floor function Sexual function Spinal stability Bowel and bladder function Gentilcore-Saulnier et al. 2010, Fritsch et al. 2011 What is Chronic Pelvic Pain? Bowel and bladder dysfunction Pain in the pelvis or lower abdomen Sexual dysfunction CPP Pain with urination/defecation Pain with sex Anxiety and depression Anderson et al. 2011, FitzGerald et al. 2009, Heyman et al. 2006, Montenegro et al. 2010, Maigne et al. 2006, Oyama et al. 2004, Figuers et al. 2010 Significance of CPP Prevalence: 14.7% - 25% women and men 60-95% women and men with refractory CPP $881 million to $2 billion per year in the US Alappattu 2011, Stones et al. 2010, Montenegro 2007, Mathias et al. 1996, Tu et al. 2005 Causes of CPP Mechanical abnormalities Visceral pain Repetitive minor trauma Visceral disease Trauma Chronic holding patterns CPP Pain anxiety Alappattu 2011, Hoffman 2011, Anderson 2002, Gerwin 2002, Jarrell 2008, Wu et al. 2009 Current Treatment of CPP Surgery Pharmacology Psychotherapy Manual Therapy Laparoscopy Hormone therapy Psychotherapy Static magnetic therapy Laparotomy Tricyclic Antidepressants Writing in a diary PFM manual therapy? Coccygectomy SSRIs Local injection Botox injection Roth 2011, Stones et al. 2010, Butrick 2009, Patijn et al. 2010 The CPP Cycle Hypertonic PFM Sustained muscle activity Myofascial trigger points Pain anxiety Prevents normal resting tone PFM dysfunction Weiss 2001, Montenegro et al. 2008, Chaitow 2007 Relevance to PT Test and measure incontinence Myofascial trigger point release (MFR) Muscle length of PFM Toileting position PT Muscle performance of PFM Pauls and Shelly, 1999 PFM Manual Therapy • PFM Manual Therapy: Compression, contract/relax stretching and STM of myofascial trigger points • Abdominal wall, back, buttocks, thighs, and PFM transrectally or transvaginally • Thiele Massage: massage from origin to insertion along the direction of the PFM Butrick Weiss 2009 2001 Gap in Literature No current reviews on manual therapy for the treatment of men and women with CPP Little guidance to PTs on effective treatment for these symptoms Purposes Primary Purpose • Is manual therapy effective at reducing pain for men and women with CPP symptoms? • This is a foreground question. Secondary Purpose • Is manual therapy more effective than a control or comparison group at reducing pain for men and women with CPP symptoms? PICO P • Acyclic • Inflammatory or noninflammatory pelvic pain • Lower abdominal pain • Urogenital pain • > 1 month • Not associated with pregnancy I • PFM manual therapy • Thiele Massage C • Control • General, nonspecific massage • Counseling • Short-form wave therapy (magnetic) O • Visual Analog Scale (VAS) for pain Hypotheses First Null Hypothesis: • Manual therapy is not effective in reducing pain in patients with CPP First Alternative Hypothesis: • Manual therapy is an effective treatment for reducing pain for patients with CPP Second Null Hypothesis: • Manual therapy has no effect on pain reduction when compared to a control or comparison group Second Alternative Hypothesis: • Manual therapy has an effect on pain reduction when compared to a control or comparison group Expected Findings 10-20 articles on manual therapy for CPP Statistically significant reduction in pain with manual therapy interventions Statistically significant difference in pain with manual therapy interventions when compared to control or comparison groups Methods: Criteria Inclusion Criteria Exclusion Criteria • PFM Manual therapy • Outcome measurement of pain with the visual analog scale (VAS) • English • Human studies • Incorporation of other therapies (chiropractic manipulation, drug therapy, surgery, dry needling) • Perinatal subjects • Case reports Methods Databases searched • PubMed • Cochrane Library • CINAHL Search terms • Thiele massage, physiotherapy, manual therapy, physical therapy, trigger point, or myofascial and coccydynia, perineal, pudendal neuralgia, prostatitis, chronic pelvic pain, pelvic floor, pelvic pain, levator ani, interstitial cystitis, coccygodynia, or sexual dysfunction and pain. Methods: Statistics Analysis of reduction in pain via VAS: • • • • Single group effect size Two-group effect size Q statistic with inverse variance for weighting 95% confidence intervals Results: PRISMA Diagram A secondary reviewer confirmed that the studies met the inclusion criteria Results: Primary Articles Author, Year Type of Study Level of Evidence FitzGerald, 2009 Single-Blind RCT 2b Maigne, 2006 Randomized Case Control 3b Heyman, 2006 Randomized Case Control 3b Anderson, 2011 Case Series 4 Oyama, 2004 Case Series 4 Montenegro, 2010 Case Series 4 Figuers, 2010 Retrospective Case Series 4 Results: Population Study Patient Population Age N Diagnosis Duration FitzGerald, 2009 Females, Males 43 44 IC/PBS CP/CPPS <3 years Maigne, 2006 Females, Males 45 100 Coccygodynia 13 months Heyman, 2006 Females 34 44 CPP 29 months Anderson, 2011 Males 48 116 CP/Orchialgia 4.8 years Oyama, 2004 Females 42 13 IC 5-14 years Montenegro, 2010 Females 36 6 CPP >6 months Figuers, 2010 Females 52 5 CPP 13 years Results: Population Patient Characteristic Average Across Studies Males 45% Female 55% Age 42.9 years Symptom Duration Range 6 months to 14 years Results: Intervention Study Intervention Frequency/Duratio n Follow Up FitzGerald, 2009 Manual stretching PFM, MFR of PFM 10 visits, 30-60 mins 12 weeks Maigne, 2006 Manual stretching PFM 3 visits, 5 mins 12 weeks Heyman, 2006 Manual stretching PFM 2 visits, 5 mins 4 weeks Anderson, 2011 MFR to PFM 5 visits, 60 mins 4-6 weeks Oyama, 2004 Thiele massage 10 visits, 5 mins 6 months Montenegro, 2010 Thiele massage 4 visits, 5 mins 5-7 weeks Figuers, 2010 MFR to PFM 3-15 visits 4 weeks Single Group Effect Size for Pain VAS Q Statistic: 35.67 Random Effects Model Statistically Significant! -1.28 (-1.93, -0.63) Two Group Effect Size for Pain VAS Q Statistic: 14.28 Random Effects Model Not statistically significant -0.72 (-1.44, 0.004) Discussion Able to reject first null hypothesis! • Manual therapy is effective • Effect size is large • Clinically crucial effect Cohen 1988 Discussion Unable to reject second null hypothesis • Manual therapy is not statistically effective as an intervention when compared to control groups Clinical Significance Single group effect size • Change in VAS: Decreased by 2.56 points Two group effect size • Change in VAS: Difference between groups of 1.77 points MCID in endometriosis • 1 point change on 0-10 scale Gerlinger et al. 2010 Two Group Effect Size for Pain VAS Q Statistic: 14.28 Random Effects Model Not statistically significant -0.72 (-1.44, 0.004) Current Treatment of CPP Surgery Pharmacology Psychotherapy Manual Therapy Laparoscopy Hormone therapy Psychotherapy Static magnetic therapy Laparotomy Tricyclic Antidepressants Writing in a diary PFM manual therapy Coccygectomy SSRIs Local injection Botox injection Roth 2011, Stones et al. 2010, Butrick 2009, Patijn et al. 2010 Harm/Adverse Events 4 articles mentioned adverse events • Increase in pain from manual therapy Potential harm of other interventions vs. manual therapy • Surgical complications • Medication side effects Cost None of the articles specifically address cost No direct cost increase • Training for PTs in PFM manual therapy • Feasibility at a clinical site Improvement with brief duration of treatment • 4 of 8 studies used 5 min treatment sessions Implications for Clinical Practice Address this issue! • 70% of women diagnosed with endometriosis report that at least 1 physician has claimed their symptoms were due to psychological disturbance What specifically should YOU do? • Ask patients about pain in this area • Possible questionnaires: McGill Questionnaire • Refer as necessary! Roth 2011, Stones et al. 2010, Montenegro 2007 Limitations Articles in English available to author High Q statistic, heterogeneity in articles • Different manual therapy techniques • Different diagnoses Lack of functional outcomes Pathogenesis of CPP is poorly understood Future Work More studies on PFM manual therapy • CPP diagnosis • Functional outcomes • Intervention frequency/duration Conclusion PFM manual therapy is a low risk, effective intervention for pain associated with CPP Thank You! • Amy Selinger, PT, DPT, OCS • Jeannette Lee, PT, PhD • Diane Allen, PT, PhD • Brianna Pickering, DPTc • Justin Trumbull, DPTc • USCF/SFSU Faculty • UCSF/SFSU Class of 2012 References 1. Gentilcore-Saulnier E, McLean L, Goldfinger C, Pukall CF, Chamberlain S. Pelvic floor muscle assessment outcomes in women with and without provoked vestibulodynia and the impact of a physical therapy program. J Sex Med. 2010;7(2 Pt 2):1003-22. Available at: http://www.ncbi.nlm.nih.gov/pubmed/20059663. 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