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Manual Therapy 12 (2007) 86–97 Diagnosis and classiﬁcation of pelvic girdle pain disorders—Part 1: A mechanism based approach within a biopsychosocial framework Peter B. O'Sullivan, Darren J. Beales School of Physiotherapy, Curtin University of Technology, GPO Box U1987, Perth, WA 6845, Australia Received 20 February 2007; received in revised form 21 February 2007; accepted 21 February 2007 The diagnosis and classiﬁcation of pelvic girdle pain (PGP) disorders remains controversial despite a proliferation of research into this ﬁeld. The majority of PGP disorders have no identiﬁed pathoanatomical basis leaving a management vacuum. Diagnostic andtreatment paradigms for PGP disorders exist although many of these approaches have limited validity and are uni-dimensional (i.e.
biomechanical) in nature. Furthermore single approaches for the management of PGP fail to beneﬁt all. This highlights thepossibility that ‘non-speciﬁc' PGP disorders are represented by a number of sub-groups with different underlying pain mechanismsrather than a single entity.
This paper examines the current knowledge and challenges some of the common beliefs regarding the sacroiliac joints and pelvic function. A hypothetical ‘mechanism based' classiﬁcation system for PGP, based within a biopsychosocial framework is proposed.
This has developed from a synthesis of the current evidence combined with the clinical observations of the authors. It recognises thepresence of both speciﬁc and non-speciﬁc musculoskeletal PGP disorders. It acknowledges the complex and multifactorial nature ofchronic PGP disorders and the potential of both the peripheral and central nervous system to promote and modulate pain. It isproposed that there is a large group of predominantly peripherally mediated PGP disorders which are associated with either‘reduced' or ‘excessive' force closure of the pelvis, resulting in abnormal stresses on pain sensitive pelvic structures. It acknowledgesthat the interaction of psychosocial factors (such as passive coping strategies, faulty beliefs, anxiety and depression) in these paindisorders has the potential to promote pain and disability. It also acknowledges the complex interaction that hormonal factors mayplay in these pain disorders. This classiﬁcation model is ﬂexible and helps guide appropriate management of these disorders within abiopsychosocial framework. While the validity of this approach is emerging, further research is required.
r 2007 Elsevier Ltd. All rights reserved.
Keywords: Pelvic girdle pain; Sacroiliac joint; Classiﬁcation; Pain mechanisms; Motor control 1. Pelvic girdle pain disorders (Maksymowych et al., 2005). However, PGP disordersmore commonly present as ‘non-specific' (no identiﬁed Pelvic girdle pain (PGP) disorders represent a small but pathoanatomical basis), often arising during or shortly signiﬁcant group of musculoskeletal pain disorders. Pain after pregnancy (Berg et al., 1988; Ostgaard et al., 1991; associated with the sacroiliac joints (SIJs) and/or the Bastiaanssen et al., 2005) or following traumatic injury to surrounding musc Author's personal copy
uloskeletal and ligamentous structures the pelvis (O'Sullivan et al., 2002a; Chou et al., 2004).
represent a sub-group of these disorders. Specific Frequently these pain disorders are misdiagnosed and inﬂammatory pain disorders of the SIJs, such as managed as lumbar spine disorders, as pain originating sacroiliitis, are the most readily identiﬁed PGP disorders from the lumbar spine commonly refers to the SIJ region.
However, there is growing evidence that PGP disorders manifest as a separate sub-group with a unique clinical Corresponding author. Tel.: 61 8 9266 3629; fax: 61 8 9266 3699.
E-mail address: P.Osullivan@curtin.edu.au (P.B. O'Sullivan).
presentation and the need for speciﬁc management.
1356-689X/$ - see front matter r 2007 Elsevier Ltd. All rights reserved.
doi:10.1016/j.math.2007.02.001 P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 A number of PGP disorders do not resolve (Ostgaard while another group of subjects with SIJ pain (with a et al., 1996; Larsen et al., 1999; Albert et al., 2001; positive active straight leg raise test (ASLR)) demon- Noren et al., 2002; To and Wong, 2003), becoming strate impaired control of the pelvic ﬂoor (O'Sullivan chronic despite the absence of pathoanatomical ab- et al., 2002a; O'Sullivan and Beales, 2007). These normalities on radiological examination or signs of a ﬁndings highlight that; (i) there may be various under- systemic or inﬂammatory disorder from blood screening lying mechanisms that drive different PGP disorders, (Hansen et al., 2005). This leads to a broad diagnosis of and (ii) the need for a classiﬁcation based approach a ‘non-speciﬁc' PGP disorder and leaves a diagnostic which guides targeted interventions for sub-groups of and management vacuum. These PGP disorders are subjects with PGP, which is based upon the underlying commonly associated with signs and symptoms indicat- pain mechanism(s) that drives the disorder.
ing that the pain originates from the SIJs and/or theirsurrounding connective tissue and myo-fascial struc-tures (Berg et al., 1988; Kristiansson and Svardsudd, 2. Challenging the beliefs regarding the sacroiliac joints 1996; Mens et al., 1999; Albert et al., 2000; Damen et al., 2001; Vleeming et al., 2002; O'Sullivan et al., 2002a;Laslett et al., 2003). However, identiﬁcation of a painful The SIJ perhaps more than any other joint complex in structure does not provide insight into the underlying the body has been shrouded by an enormous amount of mechanism(s) that drives the pain (O'Sullivan, 2005a).
mystique within the ﬁeld of Manual Therapy—with A number of theoretical models have been proposed complex, poorly validated and often confusing theories with regard to potential underlying pain mechanisms in and treatment approaches associated with it. Beliefs of PGP. Chiropractic, Osteopathic and Manual Therapy the clinician (that the pelvis is ‘displaced' or ‘unstable') models commonly propose that the SIJs can become commonly become the beliefs of the patients. For many ‘ﬁxated' or ‘displaced' leading to positional faults. There patients these clinical labels can be detrimental with the are a series of complex clinical procedures proposed to potential to render the patient passively dependent on identify these so-called ‘positional faults' and treatment someone to ‘ﬁx them', elevating anxiety levels, reinfor- with manipulation, mobilisation and/or muscle energy cing avoidance behaviours and promoting disability.
techniques has been suggested to rectify them (Don- Increased passive dependence and fear/anxiety has the Tigny, 1990; Sandler, 1996; Kuchera, 1997; Oldreive, potential to further increase the central drive of pain, 1998; Cibulka, 2002). Although manual and manipula- contributing to disability and the chronic pain cycle. It is tive techniques can result in short term pain modulation therefore important to be clear on the ‘facts' regarding (Wright, 1995), there is little evidence for the long term the SIJs and put them into the context of current beneﬁts of SIJ manipulation or other passive treatments knowledge. The basic anatomy, biomechanics and used in isolation for the management of chronic PGP stability models proposed for the SIJ are documented disorders (Stuge et al., 2003). The selection of these elsewhere and as such will not be reviewed in full here techniques is often directed by treating the signs and (Pool-Goudzwaard et al., 1998; Lee and Vleeming, 2000; symptoms of the disorder rather than a valid and clear Vleeming et al., 2006).
diagnostic and classiﬁcation paradigm based on themechanisms that underlie the pain disorder.
2.1. The facts regarding the SIJs More recently emphasis has been placed on enhancing motor control deﬁcits in PGP disorders. This is based on The SIJs are inherently stable (Vleeming et al., the premise that deﬁcits in lumbo-pelvic motor control 1990a, b; Snijders et al., 1993a).
result in impaired load transference through the pelvis The joints are designed for load transfer (Kapandji, and thereby contribute to a peripheral nociceptive drive 1982; Gray and Williams, 1989) and can safely of symptoms (Mens et al., 1996; Vleeming et al., 1996, transfer enormous compressive loading forces under 1990b; O'Sullivan et al., 2002a; O'Sullivan and Beales, normal conditions (Snijders et al., 1993a).
2007). There is growing evidence based on outcome The SIJ has little movement in non-weight bearing studies that some PGP disorders do indeed respond well (average 2.5 degrees rotation) (Sturesson et al., 1989; Author's personal copy
targeted motor training interventions Brunner et al., 1991; Jacob and Kissling, 1995; (Stuge et al., 2004a, b; O'Sullivan and Beales, 2007).
Vleeming et al., 1992a, b), and even less in weight However, not all PGP disorders respond to these bearing (average 0.2 degrees rotation) (Sturesson et interventions (Stuge et al., 2006). Relevant to this inconsistency in outcome, is the existence of different Movement of the SIJ cannot be reliably assessed by patterns of motor control impairments in PGP subjects.
manual palpation, particularly in weight bearing For instance increased pelvic ﬂoor activation has been (Sturesson et al., 2000; van der Wurff et al., 2000a, b).
documented in subjects with peripartum PGP consistent Due to its anatomical makeup, intra-articular dis- with SIJ involvement (Pool-Goudzwaard et al., 2005), placements within the SIJs are unlikely to occur. No P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 study utilising a valid measurement instrument has 3. Classiﬁcation of pelvic girdle pain disorders identiﬁed positional faults of the SIJ—in fact theconverse is true (Tullberg et al., 1998).
Chronic pain disorders are complex, multifactorial Distortions of the pelvis observed clinically are likely and need to be considered within a biopsychosocial to occur secondary to changes in pelvic and trunk framework. A different cluster of potential physical, muscle activity, resulting in directional strain and pathoanatomical, psychosocial, hormonal and neuro- not positional changes within the SIJs themselves physiological factors is associated with each disorder (Tullberg et al., 1998).
(Fig. 1). Needless to say the interactions between these No study utilising a valid measurement tool has factors are very complex. This highlights the need for a demonstrated that pelvic manipulation alters the ﬂexible classiﬁcation and management approach for position of the pelvic joints (Tullberg et al., 1998)— each disorder.
pain relief from these procedures is likely to result Although the SIJs and the surrounding ligamentous from nociceptive inhibition based on neuro-inhibi- and myofascial structures are potentially nociceptive tory factors and/or altered patterns of motor activity structures (Fortin et al., 1994a, b; Vilensky et al., 2002), (Wright, 1995; Pickar, 2002).
from a neurophysiologic perspective it is well known Asymmetrical laxity of the SIJs, as measured with that ongoing pain can be mediated both peripherally Doppler imaging, has been shown to correlate with and centrally, and the forebrain can greatly modulate moderate to severe levels of symptoms in subjects this process (Zusman, 2002; Woolf, 2004). It is therefore with peripartum PGP (Damen et al., 2001). General- logical that PGP disorders can potentially be both ised SIJ laxity is not associated with peripartum peripherally or centrally induced/maintained, with a pelvic pain (Damen et al., 2001).
different balance or dominance of peripheral and central When clinical signs of reduced force closure have factors associated with each disorder (Elvey and been identiﬁed (positive ASLR), the increased move- O'Sullivan, 2005).
ment is identiﬁed at the symphysis pubis—not the Furthermore with PGP there is the potential con- SIJs (Mens et al., 1999). It is likely that the torsional tributing role of sex hormones. There are a number of forces occurring at the SIJs can cause strain across possible pathways by which hormones may inﬂuence pain sensitised tissue.
PGP (Fig. 2). There is some evidence that sex hormones Pain from the SIJ is located primarily over the joint are active in pain modulation (Aloisi and Bonifazi, (inferior sulcus) and may refer distally, but not to the 2006). Sex hormones are also known to inﬂuence the low back (Fortin et al., 1994a, b; Schwarzer et al., inﬂammatory process in inﬂammatory pain disorders 1995; Dreyfuss et al., 1996; Maigne et al., 1996; (Schmidt et al., 2006). Furthermore sex hormones may Slipman et al., 2000; Young et al., 2003; van der alter collagen synthesis (Kristiansson et al., 1999), Wurff et al., 2006).
thereby effecting the load capacity of the pelvis. There SIJ pain disorders can be diagnosed using clinical is some evidence to support the role of hormones in PGP examination (Laslett et al., 2003; Young et al., 2003; disorders, with higher serum levels of progesterone and Petersen et al., 2004; Laslett et al., 2005a, b). This relaxin in early pregnancy being found in subjects who includes the ﬁnding of pain primarily located to the develop peripartum PGP compared to those who do not inferior sulcus of the SIJs, positive pain provocation (Kristiansson et al., 1999). Via these processes sex tests for the SIJs and an absence of painful lumbar hormones have the potential to contribute to PGP in spine impairment.
different clinical presentations (Fig. 2). Further research The SIJ has many muscles that act to compress is required to clarify how the role of hormones may and control it (force closure), thereby enhancing differ in these various presentations of PGP.
pelvic stability (creating stiffness) allowing for The proposed classiﬁcation model for PGP disorders effective load transfer via the pelvis during a variety is based on the potential mechanisms that can drive the of functional tasks (Vleeming et al., 1990a, b, 1995; PGP. This classiﬁcation approach is not exhaustive but Snijders et al., 1993a, b; ; Snijders et al., 1998; Damen rather provides a framework to guide the clinician.
et al., 2002; Richardson et al., 2002; O'Sullivan Based on the mechanism(s) that underlie these disorders et al., 2002a; Author's personal copy
Pool-Goudzwaard et al., 2004; van and operating within a biopsychosocial framework, the Wingerden et al., 2004; Mens et al., 2006; Snijders classiﬁcation model aims to facilitate the diagnosis, et al., 2006).
classiﬁcation (Fig. 3), and targeted management of these PGP disorders may be associated with ‘excessive' 3.1. The clinical examination (O'Sullivan et al., 2002a; Hungerford et al., 2003;Pool-Goudzwaard et al., 2005; O'Sullivan and The clinical examination is critical to the clinical Beales, 2007).
reasoning process that underpins this diagnosis and P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 motor activation) peripheral pain g − acute, sub-acute, chronic − intermittent vs constant − local / generalised / referred Patho-anatomical factors
- identification of - mechanism of injury if present - disorder history (pregnancy related) - disorder stage - pain behaviour − provocative and relieving factors - mechanical vs non-mechanical provocation - +ve active straight leg raise - SIJ provocation tests - adaptive vs mal-adaptive movement behaviours - motor control impairments ( - disability levels - activity levels / conditioning / strength / muscle endurance - work / home environment / lifestyle - ergonomic factors - peripheral sensitisation - hormonal factors - central sensitisation - sympathetic nervous system activity - somatic complaints - glial cell activation Genetic factors
potentially influencing all other domains- Author's personal copy
− family, friends, work − passive vs active Social factors
- caring for children - medical advice and treatment - support structures - compensation (emotional, financial) - cultural factors - socio-economic factors Psychological factors
- personality type - beliefs & attitudes towards pain disorder - coping strategies - hyper-vigilance - fear avoidance behaviour - emotions- fear / anxiety / depression / anger / helplessness - illness behaviour P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 Collagen
Fig. 2. Possible actions of hormones in the development and maintenance of pelvic girdle pain. Factors affecting hormone levels are also presented.
CHRONIC PELVIC GIRDLE PAIN DISORDERS
Non-specific pelvic pain disorders
Specific pelvic pain disorders
- Specific inflammatory pain
Centrally mediated pelvic girdle
Peripherally mediated pelvic girdle
(+/- cognitive / psychosocial factors - Fractures
resulting in central pain amplification) Dominant
- Medical management
- Management advice
- Motor learning
- Motor learning
- Medical management
- Functional rehabilitation
Psychological (cognitive framework
behavioural therapy), medical, (reduce force closure Author's personal copy
functional rehabilitation - Functional
Fig. 3. Mechanism based classiﬁcation and management of chronic pelvic girdle pain disorders.
classiﬁcation framework. In the interview process all the pain pattern (intermittent versus constant, 24 hour following need to be considered: pain pattern, sleep disturbances), pain intensity, the pain area (localised versus generalised pain can pain behaviour (speciﬁc movements and postures that indicate peripheral from central pain drive), provoke and relieve pain), P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 levels of disability and impairment, areas or to assess for coexisting pathology/dysfunction speciﬁc pain history (speciﬁc and surrounding events in these regions.
that may have contributed to the development of viour, beliefs and levels of impairment with his/her family history of PGP, clinical presentation (observing for avoidance beha- the patient's pain coping strategies (active versus viours, catastrophising, etc.) is important to determine whether cognitive issues such as fear of movement are the patient's pain beliefs, present and dominant. On synthesis of this material presence of avoidant behaviours due to fear of a diagnosis and classiﬁcation of the PGP disorder can movement and other psychosocial factors including present and past history of anxiety and depression, pacing patterns and concurrent presence of disorders of continence and/ 4. Speciﬁc pelvic girdle pain disorders or sexual dysfunction.
Pelvic girdle pain disorders associated with specific Review of radiology if present and screening for pathological processes include inﬂammatory arthritis, speciﬁc causes of PGP may be indicated from this sacroiliitis, infections and fractures. These disorders are process. This allows for a determination as to the area amenable to speciﬁc diagnosis with appropriate blood and nature of the pain.
screening and radiological investigation. They can be A thorough physical examination is then required to associated with altered patterns of motor control determine the pain source and behaviour in relationship behaviour that are ‘adaptive' and/or protective of the to the patient's movement behaviour. Physical tests underlying disorder. Treating the signs and symptoms of these disorders by manual therapy and/or speciﬁcexercise interventions is generally not appropriate as itdoes not address the underlying pain mechanism of the Palpation of the inferior sulcus of the SIJ and disorder. Physiotherapy may be limited to management surrounding pelvic ligamentous and myo-fascial of the sequelae of the underlying disease/pathological processes especially in disorders such as ankylosing Provocative tests for the SIJ and surrounding ligamentous and myofascial structures (Laslett etal., 2003, 2005a, b; Young et al., 2003; Petersen et al.,2004).
5. Non-speciﬁc pelvic girdle pain disorders The ASLR test in supine and prone as a test of load transfer, with a positive test resulting in normal- 5.1. Non-specific inflammatory pelvic girdle pain isation of ASLR with the addition of pelvic compression (Mens et al., 1999; O'Sullivan andBeales, 2007).
There appears to be a group of PGP disorders that Careful analysis of the pain provoking and relieving present as being inﬂammatory in nature, rather than activities and postures (functional impairments) high- mechanical. They are characterised by constant, dis- lighted from the interview to identify the presence of abling and non-remitting pain, located in the SIJs, that impairments of movement and motor control as well is provoked with weight bearing, pelvic compression as avoidance behaviours and to determine their (such as a SIJ belt) and with SIJ pain provocation tests.
relationship to the pain disorder. Determining These disorders may show areas of increased uptake on whether altered motor patterns are adaptive/protec- bone scan but are not linked to a speciﬁc inﬂammatory tive (pain is aggravated when motor control patterns disorder diagnosis based on blood screening. They may are normalised) or mal-adaptive (pain is relieved be relieved with rest, anti-inﬂammatory medications and when motor control deﬁcits are normalised) is local steroid injections to the SIJ, but are resistant to Tests for speciﬁc Author's personal copy
muscle function for the pelvic ﬂoor, Although the exact underlying mechanism for these the abdominal wall, the back muscles, iliopsoas, PGP disorders is unknown it is possible that hormonal quadratus lumborum, the gluteal muscles and pir- factors play a role, particularly given their common onset in the ﬁrst trimester of pregnancy or painmodulation with hormonal cycles or changes. Although In addition the adjacent areas of the lumbar spine the role of sex hormones is purely speculative in this (including neural tissue) and hip joints should be group of patients, further research into their effect is thoroughly investigated to rule out involvement of these P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 5.2. Peripherally mediated (mechanically induced) pelvic ciated with spinal movement related pain and/or spinal girdle pain disorders movement impairment. A speciﬁc pain source at the SIJand its surrounding structures can usually be identiﬁed These disorders are characterised by localised pain by speciﬁc provocative manual tests (Laslett et al., 2003, that has a deﬁned anatomical location (SIJ and 2005a, b; Young et al., 2003; Petersen et al., 2004). These associated connective tissue and myofascial struc- disorders are usually associated with consistent local tures+/ symphysis pubis). The pain is intermittent in motor control changes (inhibition or excitation). These nature and is provoked and relieved by speciﬁc postures disorders usually have a clear mechanism or time of and activities related to vertical or directional loading in onset (either repeated strain or direct trauma to the weight bearing positions. They are not usually asso- pelvis or peripartum PGP). It is proposed that these Mal-adaptive chronic pelvic girdle pain disorders where motor control impairments
represent dominant underlying driving mechanism for pain
Tissue injury / localised pain Excessive force closure
- hyper-activity of pelvic muscles
Factors that may influence pain and motor with excessive joint compression pathoanatomical ligamentous laxity Non resolution
mal-adaptive patterns adopted - education − regarding pain mechanism poor coping strategies - identify factors that drive motor system neurophysiological prolonged neuromuscular response - cognitive behavioural approach excessive reduced force closure - relaxation of motor system - relaxation strategies coping strategies abnormal tissue loading - graded movement restoration - functional restoration - normalise movement behaviour compensation genetic Reduced force closure
Resolution of the disorder
- motor control deficit of pelvic
stabilising muscles with loss of force
Author's personal copy
- education − regarding pain mechanism - cognitive behavioural motor control intervention - pain control (avoid provocation)- specific motor activation - retrain faulty postures and movements - normalise movement behaviour - functional restoration Fig. 4. Sub-classiﬁcation of pelvic girdle pain disorders with a primary peripheral nociceptive drive. Peripheral drive is perpetuated by mal-adaptivemotor control dysfunctions.
P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 disorders may be classiﬁed into two clinical subgroups these in isolation tend not to beneﬁt the long term outcome of the disorder. There is evidence that longlever exercise regimes may aggravate these disorders 5.2.1. Reduced force closure (Mens et al., 2000). These disorders can be further sub- The ﬁrst group represents disorders where the grouped based on their pattern of motor control peripheral pain drive is associated with excessive strain dysfunction. Different combinations of motor control to the sensitised SIJs and/or surrounding connective deﬁcits may be found within the local lumbopelvic tissue and myofascial structures secondary to ligamen- muscles such as is observed in low back pain disorders tous laxity (Damen et al., 2001), coupled with motor that result in different directional (vertical, rotational) control deficits of muscles that control force closure of strain patterns within the pelvis (O'Sullivan, 2005b).
the SIJs (O'Sullivan et al., 2002a; Hungerford et al., Management of these disorders focuses on function- 2003; O'Sullivan and Beales, 2007). These motor control ally enhancing force closure across the pelvic structures deﬁcits may have originally developed secondary to the based on the speciﬁc motor control deﬁcits present. The pain disorder, but now their presence is mal-adaptive as aim of the intervention is to provide functional the resultant ‘reduced forced closure' leads to impaired activation of the motor system in order to control pain load transfer through the pelvis, acting as a mechanism and restore functional capacity (Fig. 4). There is good for ongoing strain and peripheral nociceptive drive for evidence to support the efﬁcacy of this type of approach the pain disorder. Hormonal inﬂuences on collagen in these disorders (Stuge et al., 2004a, b; O'Sullivan and synthesis may be an important factor in this group.
These disorders are commonly associated with post- partum PGP and present with a positive ASLR test 5.2.2. Excessive force closure (normalised with pelvic compression) (O'Sullivan et al., The second group is deﬁned by a group of PGP 2002a; Stuge et al., 2004a). The motor control deﬁcits disorders where the peripheral nociceptive drive is based that present in these disorders are variable and are on excessive, abnormal and sustained loading of linked to a loss of functional patterns of co-contraction sensitised pelvic structures (SIJs and surrounding con- of the local force closure muscles of the pelvis (such as nective tissue and/or myofascial structures) from the the pelvic ﬂoor, the transverse abdominal wall, the excessive activation of the motor system local to the pelvis lumbar multiﬁdus, iliopsoas and the gluteal muscles).
(excessive force closure). This patient group presents This is commonly associated with attempts to stabilise with localised pain to the SIJs and commonly also the the lumbopelvic region via co-activation of other trunk surrounding connective tissue and myo-fascial struc- muscles (quadratus lumborum, thoracic erector spinae, tures (such as the pelvic ﬂoor and piriformis muscles) as diaphragm, external oblique, rectus abdominis and well as positive pain provocation tests. However this vertical ﬁbres of internal oblique). Their primary group of patients has a negative ASLR (no feeling of functional impairments are associated with pain in heaviness). Compression (manual or using a SIJ belt), is weight bearing postures such as sitting, standing and often provocative, as is local muscle activation (pelvic walking, or loaded activities inducing rotational pelvic ﬂoor, transverse abdominal wall, back muscles, iliop- strain associated with coupled spine/hip loading activ- soas, gluteal muscles). They commonly hold habitual ities (i.e. cycling and rowing resulting in posterior erect lordotic lumbopelvic postures associated with high rotational strain on ilium). These patients commonly levels of co-contraction across various muscles such as assume postures that are associated with inhibition of the abdominal wall, pelvic ﬂoor, local spinal muscles the local pelvic muscles (pelvic ﬂoor, transverse abdom- (lumbar multiﬁdus, psoas major) and in some cases the inal wall, lumbar multiﬁdus and the gluteal muscles) gluteal and piriformis muscles which may become pain such as ‘sway' standing, ‘hanging off one leg', ‘slump' sensitised. These motor control responses often become sitting or ‘thoracic upright' sitting (O'Sullivan et al., habitual secondary to excessive cognitive muscle train- 2002b, 2006; Dankaerts et al., 2006; Sapsford et al., ing and/or muscle guarding of the lumbopelvic muscles, 2006) and present with a loss of lumbopelvic control and are themselves mal-adaptive (provocative). These (inability to disassociate pelvic from thoracic move- patients report pain relief from cardiovascular exercise, Author's personal copy
disorders may be relieved with a SIJ belt relaxation, assuming passive spinal postures (which they (Ostgaard et al., 1994; Mens et al., 2006), training seldom do), as well as short-term relief with stretching, optimal alignment of their spino-pelvic posture and soft tissue massage, manipulation, muscle energy functional enhancement of local co-contraction strate- techniques and cessation of stabilisation exercises. These gies across the pelvis with relaxation of the thoraco- disorders are commonly associated with the patient's pelvic musculature (O'Sullivan and Beales, 2007). These belief that their pelvis is ‘unstable' or ‘displaced' and disorders may gain short term relief from mobilisation, that more muscle contraction or ‘pelvic re-alignment' is muscle energy techniques, soft tissue massage and beneﬁcial. This is commonly reinforced by the treating manipulation of the SIJs (clinical observation) although therapist's beliefs. These disorders may be induced by P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 intensive ‘stabilisation exercises', Pilates, ball exercise, 5.3. Central nervous system driven pelvic girdle pain and cognitive muscle exercise training of the abdominal wall, lumbar multiﬁdus and pelvic ﬂoor. Patients withthese disorders are commonly anxious, under high levels The mechanisms of central nervous system sensitisa- of stress, highly active and seldom rest.
tion and/or glial cell activation and their involvement in Management of these disorders focuses on reducing the maintenance of chronic pain states are well known force closure across the pelvic structures (Fig. 4). This is (Woolf, 2004; Hansson, 2006), and may persist even carried out with a combination of approaches such as: once a peripheral nociceptive drive is removed or general as well as targeted relaxation strategies, breath- has resolved. In this way chronic PGP can be poten- ing control, muscle inhibitory techniques, enhancing tially mediated largely or entirely via the central passive/relaxed spinal postures, pacing strategies, hy- nervous system. In these disorders, the pain may have drotherapy, cessation of stabilisation exercise training, initially presented as a peripherally driven disorder, but and a focus on cardiovascular exercise. Anecdotally this once chronic, the pain does not have a presentation approach appears very effective although clinical studies consistent with a peripheral pain source. These pain are required to validate this.
disorders are commonly associated with widespread,severe, and constant pain that is non-mechanical in 5.2.3. Psychosocial influences on peripherally mediated nature. They lack a speciﬁc detectable peripheral pelvic girdle pain nociceptive drive or pathological basis and are com- It is known that chronic pain and PGP disorders are monly associated with widespread allodynia. These commonly associated with not only physical but also disorders are associated with high levels of physical psychosocial and cognitive impairments (Main and impairment and social impact, and may be associated Watson, 1999; Bastiaenen et al., 2004, 2006; Linton, with widespread and inconsistent motor control dis- 2000, 2005) (Fig. 1). Even in the presence of a dominant turbances and abnormal pain behaviours that are peripheral nociceptive drive to PGP (such as described secondary to the pain state and do not clearly drive above), cognitive and psychosocial factors are invariably the pain disorder. These disorders are often associated linked to these disorders inﬂuencing pain ampliﬁcation with dominant psychosocial factors (somatisation, and disability levels to varying degrees. This highlights catastrophising, pathological fear and/or elevated anxi- the need for a biopsychosocial (behavioural) approach ety, depression, as well as signiﬁcant social factors such to understanding and managing chronic PGP disorders as past history of sexual abuse etc).
even when they are peripherally mediated in nature.
Although these disorders appear to represent a small Psychosocial factors have the potential to both ‘up' sub-group of chronic PGP disorders, they are highly regulate or ‘down' regulate pain. For example, a disabling and resistant to physical interventions. Man- classiﬁcation of ‘reduced force closure' may be asso- agement of these disorders must be multidisciplinary ciated with cognitive impairments such as faulty beliefs, involving medical and psychological management as a elevated anxiety levels and passive coping strategies that primary approach. Functional rehabilitation should aim ampliﬁes pain via the central nervous system and to enhance normal general body function and address promotes high levels of disability associated with the abnormal pain behaviours without a focus on pain.
pain disorder. In this case the intervention must address Passive treatments and rehabilitation that focuses on the cognitive impairments associated with the disorder speciﬁc muscle control strategies may simply act to within the motor learning intervention such as by reinforce abnormal pain behaviours and hyper-vigilance promoting accurate beliefs, relaxation techniques and in these patients.
active coping strategies. On the other hand, if the same‘reduced force closure' classiﬁcation is associated with 5.4. Genetics and pelvic girdle pain positive beliefs, active coping strategies and limitedfunctional impairments, then the primary focus can be The role that genetics play with non-speciﬁc PGP placed more on the physical impairments of the disorder disorders is largely unknown although its potential to establish pain control.
must be recognised. Subjects with PGP are more Author's personal copy
classiﬁcation of ‘excessive force closure' likely to have a mother or sister who also has PGP may be associated with underlying stress and anxiety. In (Mogren and Pohjanen, 2005; Larsen et al., 1999) this case dealing with these cognitive factors with which may implicate a genetic link although social relaxation, breathing strategies, pacing and cardiovas- inﬂuences may also mediate this effect. A genetic cular exercise is a critical adjunct to the motor learning predisposition in PGP patients related to changes in management of these disorders. Where the psychosocial/ action of relaxin is proposed as one mechanism of cognitive components of the disorders are resistant to genetic inﬂuence on PGP (MacLennan and MacLennan, change, complementary psychological and/or medical 1997). Clearly further research into genetic inﬂuences intervention may be essential.
P.B. O'Sullivan, D.J. Beales / Manual Therapy 12 (2007) 86–97 asymmetric laxity of the sacroiliac joints. Acta Obstetricia etGynecologica Scandinavica 2001;80(11):1019–24.
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Draft guidance for industry drug interaction studies — study design, data analysis, and implications for dosing and labeling
Guidance for Industry Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Shiew-Mei Huang, 301-796-1541, or (CBER) Toni Stifano, 301-827-6190.
StePhanorum Aktion 2009 Ob Schwein, ob Huhn, ob Gnitze, alles kommt in Wahrheit aus derselben „Ritze" Und das ist und macht die immer wiederkehrende, pandemische Rumsfeld Grippe *Das sogenannte „Donald-Syndrom" aus dem Disneyland Schreiben und Texte von StePhan Bützberger ©, 26. April 2009 / 02.47h Schräggedrucktes übernommen ohne Haftung