Cost-effectiveness of acupuncture versus standard care for pelvic and low back pain in pregnancy: A randomized controlled trial

Objective To assess the cost-effectiveness of acupuncture for pelvic girdle and low back pain (PGLBP) during pregnancy. Design Pragmatic-open-label randomised controlled trial. Setting Five maternity hospitals Population Pregnant women with PGLBP Method 1:1 randomization to standard care or standard care plus acupuncture (5 sessions by an acupuncturist midwife). Main outcome measure Efficacy: proportion of days with self-assessed pain by numerical rating scale (NRS) ≤ 4/10. Cost effectiveness (societal viewpoint, time horizon: pregnancy): incremental cost per days with NRS ≤ 4/10. Indirect non-healthcare costs included daily compensations for sick leave and productivity loss caused by absenteeism or presenteeism. Results 96 women were allocated to acupuncture and 103 to standard care (total 199). The proportion of days with NRS ≤ 4/10 was greater in the acupuncture group than in the standard care group (61% vs 48%, p = 0.007). The mean Oswestry disability score was lower in the acupuncture group than with standard care alone (33 versus 38, Δ = 5, 95% CI: 0.8 to 9, p = 0.02). Average total costs were higher in the control group (€2947) than in the acupuncture group (€2635, Δ = —€312, 95% CI: -966 to +325), resulting from the higher indirect costs of absenteeism and presenteeism. Acupuncture was a dominant strategy when both healthcare and non-healthcare costs were included. Costs for the health system (employer and out-of-pocket costs excluded) were slightly higher for acupuncture (€1512 versus €1452, Δ = €60, 95% CI: -272 to +470). Conclusion Acupuncture was a dominant strategy when accounting for employer costs. A 100% probability of cost-effectiveness was obtained for a willingness to pay of €100 per days with pain NRS ≤ 4.

[1]  Sylvie Chevret,et al.  A multiple imputation approach for MNAR mechanisms compatible with Heckman's model , 2016, Statistics in medicine.

[2]  N. Foster,et al.  Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial. , 2016, Health technology assessment.

[3]  S. Clark,et al.  Validation, Replication, and Sensitivity Testing of Heckman-Type Selection Models to Adjust Estimates of HIV Prevalence , 2014, PloS one.

[4]  C. Hughes,et al.  A systematic review investigating the effectiveness of Complementary and Alternative Medicine (CAM) for the management of low back and/or pelvic pain (LBPP) in pregnancy. , 2014, Journal of advanced nursing.

[5]  S. Liddle,et al.  Interventions for preventing and treating pelvic and back pain in pregnancy. , 2013, The Cochrane database of systematic reviews.

[6]  B. Bjorvatn,et al.  Sick leave during pregnancy: a longitudinal study of rates and risk factors in a Norwegian population , 2013, BJOG : an international journal of obstetrics and gynaecology.

[7]  David Moher,et al.  Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. , 2013, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[8]  M. Lundberg,et al.  Impact of postpartum lumbopelvic pain on disability, pain intensity, health-related quality of life, activity level, kinesiophobia, and depressive symptoms , 2011, European Spine Journal.

[9]  Caroline Gatrell.  'I'm a bad mum': pregnant presenteeism and poor health at work. , 2011, Social science & medicine.

[10]  N. Vøllestad,et al.  Pelvic girdle pain - associations between risk factors in early pregnancy and disability or pain intensity in late pregnancy: a prospective cohort study , 2010, BMC musculoskeletal disorders.

[11]  Andrew H. Slattengren.  Acupuncture for pelvic and low back pain during pregnancy , 2010 .

[12]  A. Khalilian,et al.  Low back pain in 1,100 Iranian pregnant women: prevalence and risk factors. , 2009, The spine journal : official journal of the North American Spine Society.

[13]  Haiqun Lin,et al.  Auricular acupuncture as a treatment for pregnant women who have low back and posterior pelvic pain: a pilot study. , 2009, American journal of obstetrics and gynecology.

[14]  C. Smith,et al.  Does acupuncture have a place as an adjunct treatment during pregnancy? A review of randomized controlled trials and systematic reviews. , 2009, Birth.

[15]  H. Hagberg,et al.  Acupuncture as an adjunct to standard treatment for pelvic girdle pain in pregnant women: randomised double‐blinded controlled trial comparing acupuncture with non‐penetrating sham acupuncture , 2008, BJOG : an international journal of obstetrics and gynaecology.

[16]  J. Cabri,et al.  Validation transculturelle de l’Oswestry disability index en français , 2008 .

[17]  B. Stuge,et al.  European guidelines for the diagnosis and treatment of pelvic girdle pain , 2008, European Spine Journal.

[18]  Peter Croft,et al.  Interpreting Change Scores for Pain and Functional Status in Low Back Pain: Towards International Consensus Regarding Minimal Important Change , 2008, Spine.

[19]  J. Brazier,et al.  A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis , 2006, BMJ : British Medical Journal.

[20]  S. Willich,et al.  Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. , 2006, American journal of epidemiology.

[21]  A. Gutke,et al.  Pelvic Girdle Pain and Lumbar Pain in Pregnancy: A Cohort Study of the Consequences in Terms of Health and Functioning , 2006, Spine.

[22]  A. Eskild,et al.  Pelvic girdle pain in pregnancy: The impact on function , 2006, Acta obstetricia et gynecologica Scandinavica.

[23]  E. Svensson,et al.  Decrease of pregnant women's pelvic pain after acupuncture: a randomized controlled single‐blind study , 2006, Acta obstetricia et gynecologica Scandinavica.

[24]  F. Perrotin,et al.  Physiologie de l'appareil locomoteur au cours de la grossesse Le syndrome douloureux pelvien de la grossesse , 2005 .

[25]  H. Hagberg,et al.  Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial , 2005, BMJ : British Medical Journal.

[26]  Acupuncture Relieves Pelvic and Low Back Pain in Late Pregnancy (N=72) , 2004 .

[27]  O. G. Meijer,et al.  Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence , 2004, European Spine Journal.

[28]  Z. Kain,et al.  Low Back Pain During Pregnancy: Prevalence, Risk Factors, and Outcomes , 2004, Obstetrics and gynecology.

[29]  M. U. Nakamura,et al.  Acupuncture for Low Back Pain in Pregnancy – a Prospective, Quasi- Randomised, Controlled Study , 2004, Acupuncture in medicine : journal of the British Medical Acupuncture Society.

[30]  M. Timsit.  Grossesse et douleurs rhumatologiques lombaires basses et de la ceinture pelvienne , 2004 .

[31]  L. Nilsson-Wikmar,et al.  Health‐related quality of life and physical ability among pregnant women with and without back pain in late pregnancy , 2004, Acta obstetricia et gynecologica Scandinavica.

[32]  P. Loubert,et al.  Diagnostic and management strategies for pregnant women with back pain. , 2003, JAAPA : official journal of the American Academy of Physician Assistants.

[33]  Gun Johansson,et al.  Lumbar back and posterior pelvic pain during pregnancy: a 3-year follow-up , 2002, European Spine Journal.

[34]  B. O'brien,et al.  The death of cost-minimization analysis? , 2001, Health economics.

[35]  KAJ WEDENBERG,et al.  A prospective randomized study comparing acupuncture with physiotherapy for low‐back and pelvic pain in pregnancy , 2000, Acta obstetricia et gynecologica Scandinavica.

[36]  H. Albert,et al.  Evaluation of clinical tests used in classification procedures in pregnancy-related pelvic joint pain , 2000, European Spine Journal.

[37]  Patrick A. Puhani,et al.  The Heckman Correction for Sample Selection and Its Critique - A Short Survey , 2000 .

[38]  M. Davidsen,et al.  Symptom‐giving pelvic girdle relaxation in pregnancy, II: Symptoms and clinical signs , 1999, Acta obstetricia et gynecologica Scandinavica.

[39]  B. Wijma,et al.  Increase in Sick Leave Rates Caused by Back Pain Among Pregnant Swedish Women After Amelioration of Social Benefits: A Paradox , 1998, Spine.

[40]  L. ñor,et al.  Reduction of Sick Leave for Lumbar Back and Posterior Pelvic Pain in Pregnancy , 1997, Spine.

[41]  Gunilla Zetherström,et al.  Regression of Back and Posterior Pelvic Pain After Pregnancy , 1996, Spine.

[42]  H. Östgaard.  ASSESSMENT AND TREATMENT OF LOW BACK PAIN IN WORKING PREGNANT WOMEN , 1996 .

[43]  R Robinson,et al.  Economic evaluation and health care. What does it mean? , 1993, BMJ.

[44]  G B Andersson,et al.  Prevalence of Back Pain in Pregnancy , 1991, Spine.

[45]  S. Wilson.  Methods for the economic evaluation of health care programmes , 1987 .

[46]  Franziska Wulf,et al.  Methods For The Economic Evaluation Of Health Care Programmes , 2016 .

[47]  A. Starkweather,et al.  Low back pain. , 2015, Nursing.

[48]  J G Hardman,et al.  Responsiveness of the EQ-5D health-related quality-of-life instrument in assessing low back pain. , 2013, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[49]  A. Weeks,et al.  Pelvic Girdle Pain and Low Back Pain in Pregnancy: A Review , 2010, Pain practice : the official journal of World Institute of Pain.

[50]  H. Östgaard,et al.  The posterior pelvic pain provocation test in pregnant women , 2005, European Spine Journal.

[51]  Y. Malinas.  Les algies pelviennes au cours de la grossesse , 1993 .

[52]  J. Heckman.  Sample selection bias as a specification error , 1979 .

[53]  P. Vara,et al.  Low back pain during pregnancy. , 1952, Annales chirurgiae et gynaecologiae Fenniae.