Reporting of Rehabilitation Intervention for Low Back Pain in Randomized Controlled Trials

Gianola, Silvia; Castellini, Greta; Agostini, Michela; Bolotta, Rosa; Corbetta, Davide; Frigerio, Pamela; Gasparini, Monica; Gozzer, Paolo; Guariento, Erica; Li, Linda; Pecoraro, Valentina; Sirtori, Valeria; Turolla, Andrea; Andreano, Anita; Moja, Lorenzo

doi:10.1097/brs.0000000000001290

Cited by 12 publications

(14 citation statements)

References 19 publications

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“…While neither intervention was adequately reported, the control group was more likely to be underreported as compared to the intervention group, despite both containing exercise components. These findings are fairly consistent with recent literature which suggests less than one fifth of studies adequately report exercise interventions in other musculoskeletal conditions, [ 132 ] educational interventions, [ 133 ] as well as in the intensive care unit [ 134 ]. Additionally, previous studies have shown that reporting of interventions has improved with time in other health conditions [ 132 ]; however, the results of this study show no differences in reporting of interventions over time.…”

Section: Discussionsupporting

confidence: 90%

“…These findings are fairly consistent with recent literature which suggests less than one fifth of studies adequately report exercise interventions in other musculoskeletal conditions, [ 132 ] educational interventions, [ 133 ] as well as in the intensive care unit [ 134 ]. Additionally, previous studies have shown that reporting of interventions has improved with time in other health conditions [ 132 ]; however, the results of this study show no differences in reporting of interventions over time. This suggests a significant proportion of researchers assessing post-operative TKA interventions have not adapted the newer recommendations for reporting of interventions.…”

Section: Discussionsupporting

confidence: 90%

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Reporting of post-operative rehabilitation interventions for Total knee arthroplasty: a scoping review

Bakaa

Chen

Carlesso

et al. 2021

BMC Musculoskelet Disord

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Objective The aim of this study was to evaluate the completeness of reporting of exercise adherence and exercise interventions delivered as part of clinical trials of post-operative total knee replacement (TKA) rehabilitation. Design: Scoping review Literature search A literature search was conducted in PubMed, EMBASE, AMED, CINAHL, SPORTDiscus and Cochrane Library. Study selection criteria All randomized controlled trials (RCT) that examined post-operative exercise-based interventions for total knee arthroplasty were eligible for inclusion. Studies that were multifactorial or contained exercise interventions for both hip and knee arthroplasty were also included. Data synthesis The definition, type of measurement used and outcome for exercise adherence were collected and analyzed descreptively. Quality of reporting of exercise interventions were assessed using the Consensus for Exercise Reporting Tool (CERT) and the Cochrane Risk of Bias Tool. Results There were a total of 112 RCTs included in this review. The majority of RCTs (63%, n = 71) did not report exercise adherence. Only 23% (n = 15) of studies provided a definition of adherence. RCTs were of poor quality, with 85% (n = 95) of studies having high or unclear risk of bias. Reporting of exercise interventions was poor, with only 4 items (of 19) (21%) of the CERT adequately reported (88–99%), with other items not fulfilled on at least 60% of the RCTs. There were no RCTs that had fulfilled all the criteria for the CERT. Conclusion The RCTs included in this study poorly reported exercise adherence, as well as description of the post-operative TKA rehabilitation intervention. Future RCTs should use valid and reliable measures of adherence and a proper tool for reporting of exercise interventions (e.g., CERT, TiDER). Pre-registration OSF:https://osf.io/9ku8a/

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 90%

Reporting of post-operative rehabilitation interventions for Total knee arthroplasty: a scoping review

Bakaa

Chen

Carlesso

et al. 2021

BMC Musculoskelet Disord

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“…In the literature, disability and pain are the most frequently investigated outcomes in lowback pain rehabilitation: several authors have recommended including these measurements in the back-specific core outcome sets because they are most relevant to patients, health care practitioners, regulators, industry representatives, and policy-makers 28 . They were also the elective outcome measures most often used in RCTs according to our and a recent review which found a low frequency of reporting outcome and intervention descriptions, reflecting a multidimensional lack of quality in rehabilitation RCTs 29 .…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Improving Power and Sample Size Calculation in Rehabilitation Trial Reports: A Methodological Assessment

Castellini

Gianola

Bonovas

et al. 2016

Archives of Physical Medicine and Rehabilitation

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To systematically assess the reporting of sample size calculation in RCTs on rehabilitation interventions for mechanical low-back pain (mLBP). Study selection We conducted an electronic database search for RCTs published from 1968 through February 2015 and included in Cochrane Systematic Reviews (SRs). Data extraction Two investigators independently applied an ad hoc six-item checklist derived from the CONSORT 2010 statement recommendations to extract data on sample size calculation. Primary outcome was the proportion of RCTs that reported sample size calculation; secondary outcome was the completeness of sample size analysis reporting. We also evaluated reporting' improvement over time. Data synthesis Sample size calculation was reported in 80 (36.0%) of the 222 eligible RCTs included in 14 Cochrane SRs. Only 13 (16.3%) of these RCT reports gave a complete description and about half reported four or more of the six elements of sample size calculation (median=4, IQR 3-5). Completeness of reporting sample size calculation improved from 1968 to 2013; beginning in 2005, the number of RCT reports containing this information increased over those not reporting it. Conclusions Despite improvement, reporting of sample size calculation and power analysis remains inadequate, limiting the reader's ability to assess the quality and accuracy of rehabilitation studies.

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“…This is a common problem of complex non-pharmacological interventions [55, 56]. Potential issues of the proposed review include high clinical heterogeneity, poor quality of reporting of the included trials, and difficulty in interpreting measures of effect when the pooled estimates come from trials that measured the outcome using different measurement tools [35, 57]. Another plausible limitation, solely concerning the network meta-analysis, might be the lack of available treatment comparisons to build robust nodes.…”

Section: Discussionmentioning

confidence: 99%

“…We will include them since they could be clinically relevant for LBP stakeholders and there is sparse evidence of their efficacy for acute LBP in the literature [22, 29–31]. We will extract sufficient and important intervention details as suggested by the TIDieR checklist [32] in order to create consistent nodes [33–35]. Thus, we will set the following classification of interventions for potential nodes:Biopsychosocial rehabilitation (including cognitive behavioral treatment and back school)Exercise (e.g., resistance or aerobic training)Manual therapy (e.g., spinal manipulation, mobilization, trigger point/myofascial therapy)Dry needling and acupunctureEducation (e.g., booklet)Any physical therapy (e.g., low-laser therapy, diathermy, transcutaneous electrical nerve stimulation, ultrasound therapy, heat wrap)Taping (e.g., kinesiotaping)Usual care defined as treatment suggested by general medicine (minimal intervention: advice to stay active or to take drugs as needed)ParacetamolNon-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitorsMuscle relaxant drugsOpioid drugsSteroidsAntidepressant drugsInert treatment (e.g., placebo drug, sham therapy)No treatment (no treatment, waiting list control)…”

Section: Methodsmentioning

confidence: 99%

Effectiveness of treatments for acute and sub-acute mechanical non-specific low back pain: protocol for a systematic review and network meta-analysis

et al. 2019

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Background Non-specific low back pain (LBP) is the leading cause of disability worldwide. Acute LBP usually has a good prognosis, with rapid improvement within the first 6 weeks. However, the majority of patients develop chronic LBP and suffer from recurrences. For clinical management, a plethora of treatments is currently available but evidence of the most effective options is lacking. The objective of this study will be to identify the most effective interventions to relieve pain and reduce disability in acute and sub-acute non-specific LBP. Methods/design We will search electronic databases (MEDLINE, Embase, CENTRAL) from inception onwards. The eligible population will be individuals with non-specific LBP older than 18 years, both males and females, who experience pain less than 6 weeks (acute) or between 6 and 12 weeks (subacute). Eligible interventions and comparators will include all conservative rehabilitation or pharmacological treatments provided by any health professional; the only eligible study design will be a randomized controlled trial. The primary outcomes will be pain intensity and back-specific functional status. Secondary outcomes will be any adverse events. Studies published in languages other than English will also potentially be included. Two reviewers will independently screen the titles and abstracts retrieved from a literature search, as well as potentially relevant full-text articles. General characteristics, potential effect modifiers, and outcome data will be extracted from the included studies, and the risk of bias will be appraised. Conflicts at all levels of screening and abstraction will be resolved through team discussions. After describing the results of the review, if appropriate, a random effects meta-analysis and network meta-analysis will be conducted in a frequentist setting, assuming equal heterogeneity across all treatment comparisons and accounting for correlations induced by multi-arm studies using a multivariate normal model. Discussion Our systematic review will address the uncertainties in the use of pharmacological or non-pharmacological treatments, and their relative efficacy, for acute and subacute LBP. These findings will be useful for patients, healthcare providers, and policymakers. Systematic review registration PROSPERO CRD42018102527 Electronic supplementary material The online version of this article (10.1186/s13643-019-1116-3) contains supplementary material, which is available to authorized users.

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Reporting of Rehabilitation Intervention for Low Back Pain in Randomized Controlled Trials

Abstract: 1.

Cited by 12 publications

References 19 publications

Reporting of post-operative rehabilitation interventions for Total knee arthroplasty: a scoping review

Reporting of post-operative rehabilitation interventions for Total knee arthroplasty: a scoping review

Improving Power and Sample Size Calculation in Rehabilitation Trial Reports: A Methodological Assessment

Effectiveness of treatments for acute and sub-acute mechanical non-specific low back pain: protocol for a systematic review and network meta-analysis

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