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Postoperative braces for...

Authors: Machado A.N.; Ayala, A.P.; Rubinstein, S.M.; Dib, R.E.; Rodrigues L; Gotfryd, A.; Tamaoki, Marcel Jun Sugawara; Belloti J.C.

FI 7.755

Cochrane Database of Systematic Reviews, v. 6, p. CD012550, 2017. 

DOI: http://dx.doi.org/10.1002/14651858.CD012550

aluno Mestrado

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

The primary objective is to evaluate the effectiveness of orthosis following lumbar spinal surgery for people with degenerative disease on pain reduction and improvement of functional status. Secondary objectives are to examine the effect of the intervention on overall health or health‐related quality of life and treatment success (from the patient's perspective). We will compare the effect of the intervention to no immobilization.

 

Background

Description of the condition

Low back pain (LBP) is defined as pain below the last rib and above the inferior gluteal folds either with or without leg pain (Woolf 2003). It is considered chronic when symptoms are present for over three months (Phillips 2013). A source of LBP is only identified in 15% of patients with LBP (Deyo 2001; Wong 2012; Maher 2016). A variety of spinal structures can be identified as sources of pain, including ligaments, facet joints, the vertebral periosteum, the paravertebral musculature and fascia, blood vessels, the anulus fibrosus, and spinal nerve roots. The musculoligamentous injuries and age‐related degenerative processes in the intervertebral disks and facet joints are the most common sources (Deyo 2001; de Schepper 2010).

LBP is the most common reason for missing work in the USA and costs the economy over US$100,000 million per year (Phillips 2013). It is the most burdensome non‐fatal disease and responsible for increasing healthcare costs and productivity loss(Theo Vos 2012). It is the second most common cause for visiting a physician (Deyo 2001) with 2.3% of all doctor visits (Wong 2012). Studies estimate that 77% of people will have LBP and 35% will have sciatica at some point during their life (Heliövaara 1987; Deyo 2001). It is the leading cause of incapacity in adults under 45 years of age and is one of the most frequent cause of early retirement in industrialized countries (Gibson 2007).

Many therapies exist for the treatment of LBP. People are first treated non‐operatively, with either medication, physical therapy, or activity modification, amongst other interventions. If the pain persists or progressive neurological involvement is present, surgery is considered. There is a large number of surgical options available from epidural injections, decompression surgery (instrumented or non‐instrumented), and new technologies, such as disc arthroplasty, interspinous spacer, and intradiscal electrotherapy (Gibson 2005). Fusion is classically indicated in the presence of instability to eliminate painful motion between the two or more vertebrae (Roy‐Camille 1986; Phillips 2013).

Lumbar degenerative disease is the most frequent reason for spinal surgery for which fusion is an option (Deyo 2005; de Schepper 2010). The rate of lumbar fusion is increasing 10 times faster than other orthopaedic procedures, such as total hip or knee replacement (Deyo 2005). Lumbar arthrodesis can be accomplished in a number of ways, for example, through a posterolateral fusion, bone grafting between transverse processes, an interbody technique bone grafting between vertebral bodies, or a combined approach (Fritzel 2002).

Description of the intervention

There is evidence of lumbosacral orthosis being used since biblical times for aesthetic purposes and only since 1530 AD for external lumbar support (Fidler 1983). Its use, nowadays, varies from management of LBP (Ahlgren 1978; Sato 2012) to restricting the movement of an operated spine (Lorenz 1991; Johnsson 1992; Fritzel 2002; Bible 2009).

Many types of orthosis have been created for medical purposes. The most commonly used are rigid, flexible, corset and jacket, lumbar, thoracolumbar, and lumbosacral, and all with the intention to provide more stability to the spine (Ahlgren 1978; Fidler 1983; Lorenz 1991; Johnsson 1992; Fritzel 2002; Bible 2009; Sato 2012).

The first description of orthosis following spinal surgery was reported by Hibbs 1924. The technique used was posterolateral fusion without instrumentation followed by a full‐time external immobilization with rigid braces for approximately six months to one year.

With the advent of spinal implants, such as hooks and pedicle screws, surgeons have been able to provide rigid internal stabilization of spine. The improvement in fusion rates with the new generation of spinal implants has been demonstrated in a prospective study of a one‐level fusion with and without instrumentation for disabling back pain (Lorenz 1991). The author reported superior results to instrumented fusions. In addition, there were no reports of pseudarthrosis among the instrumented group. However, even with this evidence, external immobilization is still being used as a complement to the surgery (Johnsson 1992; Fritzel 2002; Bible 2009).

The controversial question is whether braces reduce movement in the operated spine causing higher rates of consolidation (Johnsson 1992). Some authors believe that pain following a surgery is less severe when an external brace is applied, which may be due to increased stability from the brace, and it also gives the patients a psychological sense of security following the procedure (Connolly 1998; Bible 2009).

Potential complications associated with postoperative spinal orthosis include skin discolouration, pressure sores, injury to the lateral femoral cutaneous nerve, allergic reaction to bracing material, and heat retention causing skin maceration. In addition, the cost of a custom‐moulded orthosis can be high (Connolly 1998; Bible 2009).

How the intervention might work

External postoperative orthoses may improve patient outcomes by allowing less movement to the segment operated and creating more stability to the spine, causing less pain, allowing better healing, and increasing the fusion rates (Fidler 1983; Connolly 1998; Bible 2009).

Why it is important to do this review

Postoperative orthoses are widely prescribed for postoperative purposes. However, there is a lack of consensus regarding the most appropriate type, duration, and indications for use (Johnsson 1992). There is no consistent scientific evidence that suggests use of a thoracolumbosacral orthosis may significantly reduce lumbar intervertebral mobility, particularly in the lower lumbar spine, and improve the patient's outcome (Fidler 1983; Connolly 1998; Bible 2009).

 

Objectives

The primary objective is to evaluate the effectiveness of orthosis following lumbar spinal surgery for people with degenerative disease on pain reduction and improvement of functional status. Secondary objectives are to examine the effect of the intervention on overall health or health‐related quality of life and treatment success (from the patient's perspective). We will compare the effect of the intervention to no immobilization.

 

Methods

Criteria for considering studies for this review

Types of studies

We will include randomized controlled trials (RCTs) and quasi‐RCTs, as defined by those studies that use a method of treatment allocation that is not strictly random e.g. date of birth, hospital record number, or alternation. Studies will be eligible regardless of the language or date of publication. We will only consider trials published as full‐text articles or available as a full trial report for inclusion.

Types of participants

We will include adults (greater than 18 years of age) with degenerative lumbar disease and degenerative instability who have undergone lumbar surgery. We will include patients with one or more of the following diagnoses: degenerative disc disease, lumbar disc herniation, lumbar stenosis, degenerative scoliosis, spondylolysis, or spondylolisthesis.

We will not place any restrictions on the type of graft (autograft or allograft) or spinal implants used to achieve fusion. We will exclude studies with patients with documented osteoporoses, infection, fixed imbalance correction surgery, or fusion extended to iliac bone.

Types of interventions

We will include studies that examine postoperative lumbar orthoses, and we will not place any restriction on the type, i.e. whether it is rigid or flexible, lumbar, thoracolumbar, or lumbosacral. We will include studies that employ co‐interventions in addition to orthoses provided we can determine the effect of the intervention, i.e. as long as potential co‐interventions are equivalent in both the intervention and comparison group.

Types of outcome measures

Primary outcomes

1. Back‐specific functional status (Oswestry Disability Index (ODI) (Fairbank 2000; Roland 2000)), Roland‐Morris Questionnaire (RMQ) (Roland 1983; Roland 2000)).
2. Back pain (as measured by Visual Analogue Scale (VAS)).

Secondary outcomes

1. Quality of life (general health questionnaire, Short‐Form 36 (SF‐36) (Garratt 1993)).
2. Use of analgesic medications.
3. Failure and complications in postoperative period (neurological, vascular, infection, hardware failure).
4. Return‐to‐work.

We will extract outcome measures that assess the benefits of treatment at the following time points: short‐term (less than three months after randomization), medium‐term (three to six months after randomization), and long‐term (greater than six months after randomization).

Search methods for identification of studies

One co‐author of this review is an experienced librarian (AY) and she will assist the team with the development of the electronic search strategies.

Electronic searches

We will search the following databases from inception to the current period for relevant trials.

• The Cochrane Back and Neck Trials Register (CENTRAL or the Cochrane Register of Studies (CRS), or both).
• The Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library, latest issue).
• MEDLINE (Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE Daily and Ovid MEDLINE) (OvidSP, 1946 to present).
• Embase (OvidSP, 1980 to present).
• Web of Science (Thomson Reuters, 1900 to present).
• Latin American and Caribbean Health Sciences Literature (LILACS) (1982 to present).
• ClinicalTrials.gov.
• The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP)

The search strategy will be composed of terms for the intervention (orthosis) and the condition (degenerative disorders) in order to maximize sensitivity. As we will search both subject headings and free text words, we expect that we will identify all relevant studies.

A draft MEDLINE search strategy is in Appendix 1. We will adapt the search strategy as closely as possible to the other databases listed above.

Searching other resources

We will also screen the reference lists of the included studies and all related (systematic) reviews; perform citation tracking; and contact specialists in the field and authors of the included trials for information on unpublished data.

Data collection and analysis

For study selection and data extraction, we will follow a standard protocol as recommended by Cochrane Back and Neck's (CBN) method guideline (Furlan 2015). Two review authors (AOG and ANM) will independently conduct all steps that are potentially prone to bias. This includes the selection of studies, 'Risk of bias' assessments, and data extraction. We will use a standardized data extraction form. We will resolve any discrepancies first by discussion and, when necessary, a third review author (SMR) will act as arbiter. Review authors will not be involved in data extraction and the analyses for studies of which they are a co‐author.

In all cases where the studies provide insufficient data and there is uncertainty, we will attempt to contact the corresponding study author(s) for clarification.

Selection of studies

Two review authors (AOG and ANM) will independently screen the titles and abstracts of all reports identified by the literature searches and will include those studies based upon the study design, types of participants, and type of intervention as defined in the inclusion criteria. We will obtain and assess the full‐text articles of all studies that appear to be potentially relevant. We will list all studies excluded after full‐text assessment and their reasons for exclusion in a 'Characteristics of excluded studies' table. Also we will construct a PRISMA flow diagram to illustrate the study selection process.

Data extraction and management

We will extract the following data from the included studies.

• Study characteristics (e.g. country where the study was conducted, patient population source or setting, methods of recruitment and randomization, sources of funding, inclusion criteria.
• Population characteristics (e.g. number of patients, age, gender, duration of LBP, co‐morbidity).
• Intervention characteristics (e.g. description of the modality: rigid or flexible orthosis, duration of time that the orthosis must be worn, co‐interventions).
• Outcome measures (e.g. pain, functional status, overall health, adverse events).

We will enter all extracted data into Review Manager 5 (RevMan 5).

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