scholarly journals Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression: study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study)

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038107
Author(s):  
Juan P Sanabria-Mazo ◽  
Carlos G Forero ◽  
Paula Cristobal-Narváez ◽  
Carlos Suso-Ribera ◽  
Azucena García-Palacios ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Cost Utility ◽  
Depression Symptoms ◽  
Low Back ◽  
Impact Study ◽  
Physiological Variables ◽  
Acceptance And Commitment ◽  
Randomised Controlled ◽  
Ecological Momentary ◽  
Momentary Assessment

IntroductionThe IMPACT study focuses on chronic low back pain (CLBP) and depression symptoms, a prevalent and complex problem that represents a challenge for health professionals. Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively. The objectives of this 12 month, multicentre, randomised, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding a group-based form of ACT or BATD to treatment-as-usual (TAU) for patients with CLBP and moderate to severe levels of depressive symptoms; (ii) identify pre–post differences in levels of some physiological variables and (iii) analyse the role of polymorphisms in the FKBP5 gene, psychological process measures and physiological variables as mediators or moderators of long-term clinical changes.Methods and analysisParticipants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain) and Hospital del Mar (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+ACT versus TAU+BATD. A comprehensive assessment to collect clinical variables and costs will be conducted pretreatment, post-treatment and at 12 months follow-up, being pain interference the primary outcome measure. The following physiological variables will be considered at pretreatment and post-treatment assessments in 50% of the sample: immune-inflammatory markers, hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin and vitamin D. Polymorphisms in the FKBP5 gene (rs3800373, rs9296158, rs1360780, rs9470080 and rs4713916) will be analysed at baseline assessment. Moreover, we will include mobile-technology-based ecological momentary assessment, through the Pain Monitor app, to track ongoing clinical status during ACT and BATD treatments. Linear mixed-effects models using restricted maximum likelihood, and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Ethics and disseminationThis study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu and Hospital del Mar. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities.Trial registration numberNCT04140838

scholarly journals Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation

2018 ◽  
Vol 52 (13) ◽  
pp. 859-868 ◽  
Author(s):  
Gisela Cristiane Miyamoto ◽  
Katherinne Ferro Moura Franco ◽  
Johanna M van Dongen ◽  
Yuri Rafael dos Santos Franco ◽  
Naiane Teixeira Bastos de Oliveira ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Economic Evaluation ◽  
Controlled Trial ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Low Back ◽  
Utility Analysis ◽  
Randomised Controlled ◽  
The Cost ◽  
Different Doses

ObjectivesTo evaluate the effectiveness and cost-utility of the addition of different doses of Pilates to an advice for non-specific chronic low back pain (NSCLBP) from a societal perspective.DesignRandomised controlled trial with economic evaluation.SettingPhysiotherapy clinic in São Paulo, Brazil.Participants296 patients with NSCLBP.InterventionsAll patients received advice and were randomly allocated to four groups (n=74 per group): booklet group (BG), Pilates once a week (Pilates group 1, PG1), Pilates twice a week (Pilates group 2, PG2) and Pilates three times a week (Pilates group 3, PG3).Main outcome measuresPrimary outcomes were pain and disability at 6-week follow-up.ResultsCompared with the BG, all Pilates groups showed significant improvements in pain (PG1, mean difference (MD)=−1.2, 95% CI −2.2 to −0.3; PG2, MD=−2.3, 95% CI −3.2 to −1.4; PG3, MD=−2.1, 95% CI −3.0 to −1.1) and disability (PG1, MD=−1.9, 95% CI −3.6 to −0.1; PG2, MD=−4.7, 95% CI −6.4 to −3.0; PG3, MD=−3.3, 95% CI −5.0 to −1.6). Among the different doses, PG2 showed significant improvements in comparison with PG1 for pain (MD=−1.1, 95% CI −2.0 to −0.1) and disability (MD=−2.8, 95% CI −4.5 to −1.1). The cost-utility analysis showed that PG3 had a 0.78 probability of being cost-effective at a willingness-to-pay of £20 000 per quality-adjusted life-year gained.ConclusionsAdding two sessions of Pilates exercises to advice provided better outcomes in pain and disability than advice alone for patients with NSCLBP; non-specific elements such as greater attention or expectation might be part of this effect. The cost-utility analysis showed that Pilates three times a week was the preferred option.Trial registration numberNCT02241538, Completed.

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