Orthotics and taping in the management of vertebral fractures in people with osteoporosis: a systematic review

Objective To establish the current evidence base for the use of orthotics and taping for people with osteoporotic vertebral fracture (OVF). Design Systematic review of quantitative and qualitative studies. Data sources Medline, Medline-In Process, EMBASE, AMED, CINAHL, PEDro, TRIP, EThOS, ProQuest Dissertations and Theses and Cochrane (CDSR, DARE, CMR, HTA, EED) plus Cochrane Central, UK Clinical Research Network portfolio, Controlled Clinical Trials register and the Australian and New Zealand Clinical Trials register. Eligibility criteria for selecting studies All study designs were considered if they reported in English and evaluated the impact of using an external support, such as a spinal brace, orthosis or postural tape, with adults with OVF. All outcomes were considered. Results Nine studies were included comprising two parallel-group randomised controlled trials, four randomised cross-over trials, two before-after (single arm) studies and a parallel group observational study. No qualitative studies were identified. A wide range of outcomes assessing impairments, activities and participation were assessed but the findings were mixed. The quality of studies was limited. Conclusions The current evidence for using orthotic devices or taping for people with OVF is inconsistent and of limited quality and therefore careful consideration should be taken by clinicians before prescribing them in practice. Systematic review registration number CRD42015020893.


INTRODUCTION
Symptomatic osteoporotic vertebral fractures (OVF) affect 1 in 6 women and 1 in 12 men during their lifetime. 1 In Europe the annual incidence of OVF is 10.7 and 5.7 per thousand in women and men, respectively. 2 In the USA, 700 000 people are reported to have an OVF each year, 3 however, these figures may underestimate the actual size of the problem as most OVF go unreported and, therefore, undiagnosed. 4 With the prevalence of osteoporosis predicted to increase by 2021, a rise in associated fractures is also likely. 5 OVF have personal, societal and economic costs. 6 Patients experience severe pain in the acute phase but also up to 2 years postfracture. 1 7 Increased disability and depression, and a reduced quality of life are also reported. 8 Up to a fifth will suffer a subsequent vertebral fracture within a year 9 and there is an increased risk of mortality. 10 The use of primary care services has been found to be 14 times that of the general population, 11 with 8% of people with OVF requiring hospitalisation. 12 In the USA, the management OVF has an annual estimated cost of $13.8 billion. 1 Guidelines for the non-medical and nonsurgical management of OVF are conflicting. The American Academy of Orthopaedic Surgeons (AAOS) 13 report inconclusive evidence in relation to rehabilitative interventions whereas the Scottish Intercollegiate Guidelines Network (SIGN) 14 recommend electrical field therapy and supervised exercise programmes. There are a variety of external support devices available including rigid thoracolumbar spinal orthoses (TLSO) or hyperextension braces that are often used in the management of OVF, however, they are not recommended in current guidelines. 13 Bracing is reported to assist healing when worn for up to 3 months but when worn for an extended period can result in muscle atrophy, postural muscle weakness 15 and skin problems. 16 This said, these devices are used by the people with OVF and clinicians continue to prescribe them, although practice varies. In view of recently published studies, this review aimed to identify and update the current evidence base for the use of orthotics and taping for people with OVF.

METHODS
We used the preferred reporting items for systematic reviews and meta-analyses (PRISMA) as a guideline for reporting this study. A predefined protocol was registered with PROSPERO (CRD 42015020893).

Identification and selection of studies
We included primary studies that used quantitative or qualitative methods evaluating the impact of using an external support, such as a spinal brace, orthosis or postural tape, with adults with OVF. We were interested in outcomes relating to the WHO International Classification of Functioning, Disability and Health (ICF) domains of body structure and function, activities and participation. We were also interested in the experiences and perceptions of users of the external support.
We excluded studies that involved traumatic vertebral fractures, non-vertebral fractures and those involving children, reviews and opinion papers, studies published only as an abstract and those where full text was not available in English. We also excluded controlled studies where the intervention also included surgical, pharmacological and rehabilitation interventions, except where these were provided to intervention and comparator participants. For non-controlled studies, only those where the evaluation related to the orthotic device/tape were included.
The search strategy (see online supplementary file) was applied from 1980 to April 2015 to Medline, Medline-In Process, EMBASE, AMED, CINAHL, PEDro, TRIP, EThOS, ProQuest Dissertations and Theses and Cochrane (CDSR, DARE, CMR, HTA, EED). In addition we searched clinical trials databases, including Cochrane Central, UK Clinical Research Network portfolio, Controlled Clinical Trials register and the Australian and New Zealand Clinical Trials register. We also undertook forward and backward citation checking.
The search and screening process was managed using Endnote. Two reviewers independently screened titles and abstracts. Full-text papers were then screened against the eligibility criteria independently by two reviewers. Discrepancies were discussed and agreed.

Assessment of study characteristics
Data were extracted using a prepiloted form by one reviewer and checked by a second. The data included study characteristics (study design, selection criteria, setting and sample size), funding sources, ethical approval, population (age, gender, time since OVF), intervention and comparator characteristics (nature of intervention, duration of wear, concomitant interventions and adherence), outcomes, time points of follow-up and findings.
Study quality was assessed using the Cochrane Risk of Bias tool 17 and was extracted by one reviewer and checked by a second. The data included random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other sources of bias. Each item was rated as low risk, high risk or unclear risk of bias and reported for individual studies and across the studies.

Data synthesis
A narrative approach was used to synthesise the study findings due to methodological (study design, outcomes) and clinical ( participant and intervention characteristics) heterogeneity. This approach enabled exploration of relationships within the data. 18 Risk of bias was summarised for individual studies and across studies.

RESULTS
Our initial search resulted in 667 citations (figure 1) of which 84 were assessed against the selection criteria; the remainder did not meet the inclusion criteria. Nine studies were included in this review

Characteristics of studies
The studies included 468 participants of which 404 (86%) were women. Where reported, participants had a mean (SD) age of 72.1 (7.9) years and had sustained an OVF between 3 days and 2 years previously. Six studies did not report time since fracture. The number of participants in each study varied from 13 to 108 (Mean=52). Studies took place in Europe, [19][20][21][22] Asia 23-26 and Australia. 27 The majority of participants were ambulatory and community-dwelling. One study was undertaken with inpatients. 25 Most studies took place in an outpatient setting with the setting being unclear in one study. 26 Eight studies evaluated six different orthotic devices including rigid supports (TLSO, 3 point orthosis, plaster corset); semi-rigid supports (Spinomed and Spinomed Active); and flexible supports (soft brace) and one examined the effect of postural taping. Four studies evaluated two different types of orthotics. Controls included no brace, an alternative orthotic device (soft brace) or placebo (hypoallergenic tape). The devices were worn for between 15 min and 24 h a day (table 1). Adherence to wearing the orthotics was assessed by self-report in three studies 21 22 26 although adherence was not defined. Additional data regarding individual study characteristics are reported in table 1.
Two parallel-group randomised controlled trials, 25 26 four randomised cross-over trials, 21 22 24 27 two before-after (single arm) studies 19 23 and a parallel group observational study 20 were included. Three studies had three study arms. 21 26 27 No qualitative studies were identified. Of the four studies using crossover design, two did not report the findings from the first treatment period. 24 27 The two studies undertaken by Pfeifer et al 21 22 reported that almost all participants that received the intervention during the first period refused to stop using the device for the crossover. Therefore, to maintain clarity when comparing the different intervention groups in these two studies, only the findings from the first period were considered in this review.

Study quality
The results of the risk of bias assessment of study quality are presented in figure 2 and table 2. The reporting of studies was poor with no studies using ConSORT guidelines. 28 Only one study reported the randomisation allocation processes. None had previously registered their studies or published a protocol. Four studies did not report ethical approvals 20 22-24 and three did not report funding sources. 20 23 27 One study was termed a 'pilot' although the aims were stated to determine efficacy. 25 Four studies undertook sample size calculations. 21 22 26 27 For the four studies using a cross-over design, additional quality assessments were made in relation to appropriate design, randomised treatment order, carry-over effect and unbiased data 29 and these are recorded in table 2 under 'Other'.

Effect of the intervention
The effectiveness of orthotics and taping are reported in terms of impairments, activities and participation.
Postural stability: A range of different methods were used to assess postural stability such as a force plate, 27 computerised dynamic posturography 24 and a sway metre. 21 22 Each assessment method reported multiple complex components of postural stability but there were no consistent findings within or across the studies. One cross-over study 24 examined the immediate effect of the brace or no brace on balance performance but did not appear to consider potential carry-over effects nor report the findings from the first time period so it remains unclear as to the actual effect on postural stability of the orthosis.
Back strength: Three studies assessed the use of Spinomed on isometric back strength. 19 21 22 Pfeifer et al 21 22 reported a mean increase (SD) of 180 (152) Newtons when wearing the device and with an absolute difference of 182 (95% CI 125.1 to 238.9) Newtons compared with wearing no brace.
Angle of kyphosis: Five studies reported angle of kyphosis using a range of techniques, including an inclinometer, 27 radiographs 23 25 and three-dimensional photomorphometry. 21 22 Postural taping was found to have immediate improvements in thoracic kyphosis when compared with placebo or no tape (Mean angle in degrees (SD) 55.3 (13.5); 57.2 (13.8); and, 58.2 (12.3) respectively; p=0.024). 27 Li et al 25 only assessed this outcome on 10/51 participants and it was unclear as to how they were selected. Two studies were unclear as to whether the findings represented an improvement or deterioration in kyphosis. 23 25 Fracture union: Murata et al 23 reported at 2 months 54.7% of participants had fracture 'settling'; with 88.7% settled at 6 months, however, the study did not have a control group and was, therefore, not possible to establish what benefit wearing the TLSO gave over 'normal' healing. The reporting of adverse events was poor with only one study explicitly identifying them as an outcome of interest. 20 Talic et al 20 found that plaster corsets resulted in an increased risk with four patients (16%) developing pressure sores, with no adverse events related to using a three-point orthosis.

Activities
The impact of orthotics on activities was evaluated using the Oswestry Disability Index (ODI), 26 the Functional Independence measure, Elderly Mobility Scale and Modified Functional Ambulation Category, 25 limitations in everyday life 21 22 and walking ability component of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire ( JOABPEQ). 23 Pfeifer et al 21 22 reported reduced disability associated with using Spinomed when compared with no brace (absolute difference −2.3 (95% CI −1.7 to −2.9), 21 although it is unclear whether this is superior to a soft brace. 25 Kim et al 26 found no between group differences in ODI for those with an acute OVF when comparing TLSO (mean difference −1.88; 95% CI −7.02 to 9.38) or soft bracing (mean difference 2.41; −7.86 to 9.27) with no brace.

Participation
Participation, in relation to quality of life and well-being, was evaluated in four studies. 19 21 22 26 The SF36 domains were not improved by using a TLSO or soft brace when compared with no brace (Mean Physical component score (PCS) 32, 35 and 30 respectively; p=0.716) 26 or Spinomed (median within-group difference in Physical component score=6.5, range −9.2 to 13.3; p=0.07) 19 whereas the Hobi well-being scale did improve after wearing Spinomed (absolute differ-ence=12.7; 95% CI 9.7 to 15.7). 21 There was no indication that either outcome was moderated by population characteristics.

DISCUSSION
This review aimed to establish the effectiveness of orthotics or taping in the management of OVF. We found that the nine included studies were of limited quality and reported varied populations, interventions and outcomes. For example, no studies reported whether outcome assessors were blinded to allocation, thus the potential for detection bias is unknown. A previous review of the non-surgical management of OVF included three RCTs evaluating bracing 30 reported medium term pain relief and reduced disability; however, studies were considered to be of low/very low quality. We found little consideration of any potential adverse events associated with bracing or taping with this population. It has been suggested that adherence to wearing orthotics is poor 31 but despite several included studies stating adherence data was collected it was never defined and rarely reported. In addition, there is a complete absence of qualitative research involving this population and their experiences of wearing these devices which would be an essential component of any future development and evaluation. This said, in two cross-over studies, 21 22 the fact that the participants refused to stop wearing the orthotics at the point of crossover would suggest positive experiences. We found no evidence to counter the recommendations of the American Academy of Orthopaedic Surgeons 13 that indicated there was inconclusive evidence to support the using of bracing in the management of OVF, and that the quality of studies in this clinical area remains limited. Our findings also concur with a recent systematic review of taping that reported it was no better than placebo or no taping in terms of pain or disability for people with back pain. 32 In terms of strengths, our study used contemporary methods for undertaking a systematic review and registered the protocol prospectively on PROSPERO. We searched an extensive range of databases, including grey literature. One limitation was the exclusion of non-English full-text papers, however, we are confident from our extensive search (that was not restricted to English) and screening process that any potential papers would have failed to meet other selection criteria and therefore would not have been included in the review. It could also be suggested that including non-randomised and non-controlled studies is a limitation. However, the purpose of our review was to establish the current evidence base, and not establish effectiveness, and therefore we considered it important to include all study designs. In addition, the use of the risk of bias tool enabled a judgement on the overall quality of the  included studies, and we found that even the included randomised controlled trials were not without limitations.

CONCLUSIONS
There is inconclusive evidence that TLSO or soft braces reduce pain or disability. Although the use of the Spinomed appears to have some benefit in terms of increasing back strength and reducing disability, it does not necessarily offer better outcomes when compared with other devices, such as soft braces. The quality of studies examining the effectiveness of orthotics or taping for the management of OVF is generally limited and therefore we would err on the side of caution when considering their use in clinical practice. Overall, there is limited evidence for the use of orthotics or taping either in the acute or long-term management of those with OVF. Further studies using high-quality methods and reporting are required to determine whether taping or orthotics are effective and cost-effectiveness.
Contributions VAG, AJH and AB developed the study protocol. AH and AB performed the searches. VG and AH undertook all screening and all authors were involved in data extraction. VG undertook the synthesis. All authors contributed to the final manuscript.
Funding This review was supported by a research grant from AGILE (Chartered Physiotherapists working with Older People) and also by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
Open Access This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http:// creativecommons.org/licenses/by/4.0/