A core outcome set for research and clinical practice in women with pelvic girdle pain: PGP-COS.

BACKGROUND: Inconsistent reporting of outcomes in clinical trials of women with Pelvic Girdle Pain (PGP) hinders comparison of findings and the reliability of evidence synthesis. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials on the condition. The aim of this study was to develop a consensus-based COS for evaluating the effectiveness of interventions in PGP during pregnancy and postpartum for use in research and clinical practice. METHODS: A systematic review of previous studies on PGP and semi-structured interviews with women were undertaken to identify all outcomes that were reported in prior studies and that are relevant to those experiencing the condition. Key stakeholders (clinicians, researchers, service providers/policy makers and individuals with PGP) then rated the importance of these outcomes for including in a preliminary PGP-COS using a 3-round Delphi study. The final COS was agreed at a face-to-face consensus meeting. RESULTS: Consensus was achieved on five outcomes for inclusion in the final PGP-COS. All outcomes are grouped under the "life impact" domain and include: pain frequency, pain intensity/severity, function/disability/activity limitation, health-related quality of life and fear avoidance. CONCLUSION: This study identified a COS for evaluating the effectiveness of interventions in pregnancy-related and postpartum-related PGP in research and clinical settings. It is advocated that all trials, other non-randomised studies and clinicians in this area use this COS by reporting these outcomes as a minimum. This will ensure the reporting of meaningful outcomes and will enable the findings of future studies to be compared and combined. Future work will determine how to measure the outcomes of the PGP-COS. CORE OUTCOME SET REGISTRATION: This PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 (http://www.comet-initiative.org/studies/details/958).

Does progestin-only contraceptive use after pregnancy affect recovery from pelvic girdle pain? A prospective population study.

OBJECTIVE: To estimate associations of progestin-only contraceptives with persistent pelvic girdle pain 18 months after delivery. METHODS: Prospective population based cohort study during the years 2003-2011. We included 20,493 women enrolled in the Norwegian Mother and Child Cohort Study who reported pelvic girdle pain in pregnancy week 30. Data were obtained by 3 self-administered questionnaires and the exposure was obtained by linkage to the Prescription Database of Norway. The outcome was pelvic girdle pain 18 months after delivery. RESULTS: Pelvic girdle pain 18 months after delivery was reported by 9.7% (957/9830) of women with dispense of a progestin-only contraceptive and by 10.5% (1114/10,663) of women without dispense (adjusted odds ratio 0.93; 95% CI 0.84-1.02). In sub-analyses, long duration of exposure to a progestin intrauterine device or progestin-only oral contraceptives was associated with reduced odds of persistent pelvic girdle pain (Ptrend = 0.021 and Ptrend = 0.005). Conversely, long duration of exposure to progestin injections and/or a progestin implant was associated with modest increased odds of persistent pelvic girdle pain (Ptrend = 0.046). Early timing of progestin-only contraceptive dispense following delivery (≤3 months) was not significantly associated with persistent pelvic girdle pain. CONCLUSIONS: Our findings suggest a small beneficial effect of progestin intrauterine devices and progestin-only oral contraceptives on recovery from pelvic girdle pain. We cannot completely rule out an opposing adverse effect of exposure to progestin injections and/or progestin implants. However, the modest increased odds of persistent pelvic girdle pain among these users could be a result of unmeasured confounding.

Comparación de resultados obtenidos en el tratamiento del dolor miofascial de la cintura pélvica con toxina botulínica sola y asociada con lidocaína / Comparison of results obtained in the treatment of the myofascial pain of the pelvic girdle with botulinum toxin alone and associated with lidocaine

Objetivos: entre el 70 y el 85 % de la población adulta sufre de dolor de espalda alguna vez en su vida. El síndrome de dolor miofascial (SDM) ha sido descrito recientemente definiéndose como dolor musculoesquelético no inflamatorio, localizado, desarrollado sin causa aparente, refractario a tratamientos farmacológicos y físicos, y se acompaña de la presencia de puntos gatillos y de bandas tensas palpables en el músculo. Su prevalencia se estima que varía entre un 30 y un 85 %. Los músculos psoas, cuadrado lumbar y piramidal son los más frecuentemente implicados en el SDM de cintura pélvica. Una de las principales alternativas para tratar el SDM es la toxina botulínica tipo A (TB), que actúa en la membrana sináptica en la placa neuromuscular, inhibiendo la liberación de acetilcolina, produciendo relajación muscular y alivio del dolor, aunque, en muchas ocasiones, su efecto no se hace evidente hasta transcurridos varios días. La lidocaína es un anestésico local (AL) tipo amida con duración de acción intermedia que actúa impidiendo la propagación del impulso nervioso disminuyendo la permeabilidad de los canales de sodio. El objetivo de este estudio era comprobar si al añadir AL a ladosis de TB, conseguíamos un acortamiento en el tiempo dela reducción de la EVA y mejoría de la calidad de vida. Material y métodos: el diseño del estudio fue prospectivo, controlado, longitudinal y aleatorizado en el que se ha valorado la evolución de 20 pacientes divididos en dos grupos. Al primer grupo se les administró TB tipo A (grupo T). Al segundo grupo se les trató con TB tipo A y dosis adicional de lidocaína al 2% (grupo TL). Previamente, ambos grupos, habían respondido de forma positiva a un test con infiltración del músculo afecto con lidocaína al 2 %. El seguimiento de los pacientes se hizo secuencialmente a los 3, 7, 15 y 90 días de iniciado el tratamiento. Para el análisis estadístico se utilizó un análisis de la varianza, ANOVA, complementada por la prueba de Mauchly para comprobación de la esfericidad y la prueba de Greenhouse-Geisser, con un intervalo de confianza del 95 %, considerando una p<0,05 para establecer diferencias estadísticas. Resultados: hubo diferencia estadísticamente significativa entre la EVA del grupo TL Y TB en la valoración a los tres días, del mismo modo en la evaluación del índice de Lattinen. No hubo diferencias significativas en el resto de valoraciones. En ambos grupos hubo diferencia significativa en la reducción del EVA y mejoría del índice de Lattinen, al principio y final del estudio. Conclusiones: la TXB-A presenta una alternativa al tratamiento de este cuadro cuando la terapia conservadora ha fracasado. Los anestésicos locales producen una relajación previsible, breve y reversible de la musculatura provocada por el bloqueo de la conducción nerviosa en las terminaciones nerviosas, mientras que la TXB actúa en las terminaciones neuronales de la placa motora, impidiendo la liberación de la acetil colina. Su acción la ejercen en lugares distintos y con características diferentes. La acción de los anestésicos locales es casi instantánea y breve, la de la TXB es diferida y duradera en el tiempo, por lo que pueden ser complementarias y agonistas en su efecto final

Objectives: between 70 and 85 % of the adult population suffers from back pain sometime in their life. Myofascial pain syndrome (MPS) has been described recently and defined as a localized non-inflammatory musculoskeletal pain, developed without apparent cause, being refractory to pharmacological and physical treatments, and is accompanied by the presence of trigger points and palpable taut bands in the muscle. Its prevalence is estimated to vary between 30 and 85 %. The psoas, quadratus lumborum and pyramidal muscles are the most frequently involved in the pelvic girdle MPS. One of the main alternatives to treat MPS is botulinum toxin type A (BT), which acts in the synaptic membrane at the neuromuscular junction, inhibiting the release of acetylcholine, producing muscle relaxation and pain relief, although in many cases its effect is not evident until several days have passed. Lidocaine is an amide type local anesthetic with an intermediate duration of action, which act by preventing the propagation of nerve impulses by decreasing the permeability of sodium channels. The objective of this study was to test whether adding LA to the BT dose, we got a shortening in the time of the reduction of EVA and improvement in quality of life. Material and methods: the study design was prospective, controlled, longitudinal and randomized in which we have evaluated the evolution of 20 patients randomly divided into two groups. The first group were given BT A type (group T). The second group was treated with BT A type and an additional dose of 2 % lidocaine (group TL). Previously, both groups had responded positively to a test with lidocaine 2 % infiltration of the affected muscle. Monitoring patients was sequentially to 3, 7, 15 and 90 days of treatment performed. For statistical analysis we used an analysis of variance, ANOVA, complemented by Mauchly test for sphericity check and by Greenhouse-Geisser test, with a confidence interval of 95 %, considering p < 0.05 to establish statistical differences. Results: there was statistically significant difference between group EVA TL and TB in the assessment on the third day, just as in the evaluation of Lattinen Index. No significant differences in the other reviews. In both groups there was significant difference in EVA reduction and Lattinen Index improvement at the beginning and end of the study. Conclusions: BT-A presents an alternative to the management of this condition when conservative therapy has failed. Local anesthetics cause a predictable, short and reversible muscle relaxation caused by blocking nerve conduction in nerve endings, while BT acts on the neuronal endings of the motor plate, preventing the release of acetylcholine. Its action is exercised in different places and with different characteristics. The action of local anesthetics is almost instantaneous and short, the TXB action is delayed and long lasting, so both can be complementary and agonists in their final effect