Pelvic floor muscle pain: Outcome Measures, Tues 4th Sep 2012

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1 Pelvic floor muscle pain: Outcome Measures, Tues 4th Sep 2012 Helena Frawley, PhD, FACP Senior Lecturer, NH&MRC Research Fellow, The University of Melbourne Study / treatment end-points (Turk et al 2006) - Chronic pain: most measures of treatment response involve patient-reported outcomes (PROs), for which the patient is the most important judge of whether changes are important or meaningful - PROs: unmodified patient responses o Esp important for conditions which involve symptoms such as pain / fatigue, where objective measures of patient perception are not available. o Should include assessment of pain, physical functioning, emotional functioning, participant / patient rating of improvement, satisfaction with treatment - CROs (clinician-reported outcomes): o Include outcomes either observed by a provider or requiring interpretation o Also includes scales completed by a health care provider about the patient - Laboratory, behavioural and device measurements include objective and usually quantitative behavioural or physiological measures often performed by devices or raters PRO (1) Pain - Numerical rating scale (NRS): Visual Analogue Scale (VAS) Pain scaling: addresses sensory-discriminative intensity, but not motivational-affective nor cognitive-evaluative aspects. The symptom: pain in the PFM: On PFM palpation at rest, contraction, relaxation. How to measure PFM pain: Digital methods Digital pressure to elicit tenderness / pain: commonly reported: light ; moderate ; firm - Kavvadias et al (2012): o κ = 0.86 combined, for levator ani, obturator internus, piriformis muscle, measured on 0-10 VAS with cut-off at 3 o ICC= for levator ani - Montenegro et al (2010): pelvic muscle tenderness scale o Reliability: κ = 0.91 for tenderness (levator ani x) - Slieker-ten Hove et al (2009): pain scale o Intra-rater reliability: κw = 0.79; inter-rater reliability as κw = Tu et al (2008): muscle hyperalgesia scale o poor to fair reliability, κ values ranging from o formal reliability training was not conducted How to measure PFM pain: instrumented methods - finger-tip pressure algometer (Tu et al 2006, 2007, 2008) o applied to PFM sites and anterior and posterior vaginal raphe o high correlations between pressure applied and pain perceived (r=0.99) Page 1 of 5

2 o Short-term reliability of this test was good (ICC= ), however longerterm reliability was less so (r<0.40) o pressure-pain thresholds in women with and without chronic pelvic pain: found significant differences between groups (p<0.001) o PFM and vaginal site pain detection thresholds demonstrated moderate strong correlations with each other (r = ) chronic pelvic p associated with enhanced pelvic floor and vaginal pressure-pain sensitivity - vulvalgesiometer (Pukall et al 2009) PRO (2) Physical Functioning The Interference Scale of the Multidimensional Pain Inventory (MPI) (Kerns et al 1985) The MPI consists of 12 empirically derived scales that are grouped into 3 sections: 1. pain and its impact; 2. responses by significant others; 3.activities The Interference Scale is included in the section on pain and its impact and consists of 9 questions (eg, In general, how much does your pain interfere with your day-to-day activities? ; How much has your pain changed your ability to take part in recreational and other social activities? ), which are rated on 7-point scales ranging from 0 ( no interference/change ) to 6 ( extreme interference/change ) The Interference Scale of the Brief Pain Inventory (BPI) (Cleeland & Ryan 1994) 7-item self-report measure, designed to assess the extent to which pain interferes with various components of functioning, including physical and emotional functioning and sleep The items in this scale can be grouped into those that assess: - physical functioning (general activity; walking ability; normal work, including both work outside the home and housework) - those that assess emotional functioning (mood; relations with people; enjoyment of life) - and a single item that assess the extent to which pain interferes with sleep. PRO (3) Emotional functioning Beck Depression Inventory (BDI) (Beck et al 1961) excellent psychometric properties and its extensive use in pain clinical research and responsiveness to change in pain clinical trials. The BDI consists of 21 groups of 4 statements designed to assess severity of current symptoms of depressive disorders, with total scores on the measure ranging from 0 to 63. The Profile of Mood States (POMS) is a 65-item adjective checklist that provides a total mood disturbance score and 6 subscale scores: Tension, depression, anger, vigor, fatigue, and confusion (McNair et al 1992) Hospital Anxiety & Depression Scale (HADS) (Zigmond 1983, Bjelland 2002) PRO (4) Participant ratings of improvement and satisfaction with treatment The Patient Global Impression of Change scale (PGIC) (Guy 1976) 7-point scale PGI-I (improvement) (UI: Yalcin & Bump 2003; Sx for POP: Srikrishna et al 2010) Global Response Assessment (GRA) (Propert et al 2002, Fitzgerald et al 2012) Patient s Overall Rating of Symptom Index (PORIS scale) Page 2 of 5

3 patients globally assess their symptoms as either worse or improved by 0, 25, 50, 75 or 100% (Nickel et al 2005, Parsons et al 1993) Interpreting Changes in Chronic Pain Clinical Trial Outcome Measures (Dworkin et al 2008) Outcome Domain and Measure Type of Change improvement (1) Pain intensity: numerical rating scale Minimally important Moderately important Substantial 10 20% 30% 50% (2) Physical functioning: - Multidimensional Pain Inventory Interference Scale 0.6 point - Brief Pain Inventory Interference Scale Minimally important 1 point (3) Emotional functioning: - Beck Depression Inventory 5 point - Profile of Mood States: Total Mood Disturbance Specific subscales point 2 12 point Δ (4) Global rating of improvement: Patient Global Impression of Change Minimally important Moderately important Substantial Minimally improved Much improved Very much improved Clinician reported outcomes The sign: altered tension. Commonly measured on palpation at rest, contraction, relaxation. tone of the pelvic floor muscles is difficult to define and cannot be measured (Messelink et al 2005, p376). Is it Tone or Tension? - Muscle tone is the resting tension in the muscle and is clinically determined as resistance to passive movement or deformation (Mense & Simons 2001) - Muscle tightness: an equivalent meaning to tension? - high-tone / hypertonia and spasticity: have specific meanings in the neurophysiological sense related to upper motor neuron lesions - should be avoided when there is no indication of such a neurological condition How to measure PFM tone / tension: Digital methods - Several scales proposed, not tested for reliability (Carrico & Peters 2011, Devreese et al 2004, Lukban & Whitmore 2002) - Kavvadias et al (2012): ICC= (non-significant), scale? - Dietz & Shek (2008): o 6, 11 and 21-point resting tone scale analogous to the Modified Oxford Scale o validated against translabial ultrasound to detect levator hiatal dimensions and pelvic organ prolapse (POP) o tested for inter-rater reliability: moderate agreement (κ ) o resting tone can be measured digitally using the methodology reported o Limitations of this scale Page 3 of 5

4 - tone scale tested for reliability was undertaken in a cohort of patients with multiple sclerosis (de Ridder et al 1998) o Therefore this scale was a measure of true spasticity o may not be appropriately applied to a non-neurogenic PFM - Confounder: presence of myofascial trigger points How to measure PFM tone / tension: Instrumented methods - Pressure manometry: Rogalski et al (2010), Abbott et al (2006) - Dynamometry: Morin et al (2010) - Real-time ultrasound: Davis et al (2011) - Electromyographic activity: potentially a useful surrogate measure for muscle tension, as the degree of activation of the contractile apparatus of the muscle is a specific component of the definition of muscle tone. There areno widely accepted values for normal resting semg of the PFM o Tu et al (2008): 2µV o Voorham-van der Zalm et al (2007): 2µV for women and 2 3µV for men References Abbott, J. A., S. K. Jarvis, et al. (2006). "Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial." Obstetrics and Gynecology 108(4): Beck, A. (1991). Depression inventory. Philadelphia, Center for Cognitive Therapy. Bjelland, I., A. A. Dahl, et al. (2002). "The validity of the Hospital Anxiety and Depression Scale. An updated literature review." Journal of Psychosomatic Research 52(2): Cleeland CS, Ryan KM (1994): Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med 23: De Ridder, D., C. Vermeulen, et al. (1998). "Clinical assessment of pelvic floor dysfunction in multiple sclerosis: urodynamic and neurological correlates." Neurourology and Urodynamics 17(5): Dietz, H. P. and K. L. Shek (2008). "The quantification of levator muscle resting tone by digital assessment." INTERNATIONAL UROGYNECOLOGY JOURNAL 19(11): Dworkin, R. H. (2008). "Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations." Journal of Pain 9(2): Fitzgerald, M. P., C. K. Payne, et al. (2012). "Randomized Multicenter Clinical Trial of Myofascial Physical Therapy in Women With Interstitial Cystitis/Painful Bladder Syndrome and Pelvic Floor Tenderness." Journal of Urology. Guy W (1976): ECDEU assessment manual for psychopharmacology (DHEW Publication No. ADM ). Washington, DC, U.S. Government Printing Office Kavvadias, T., S. Pelikan, et al. (2012). "Pelvic floor muscle tenderness in asymptomatic, nulliparous women: topographical distribution and reliability of a visual analogue scale." International Urogynecology Journal. Kerns RD, Turk DC, Rudy TE (1985): The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 23: McNair DM, Lorr M, Droppleman LF (1992): Profile of Mood States (POMS) Manual. San Diego, CA, Educational and IndustrialTesting Service Page 4 of 5

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