Are there indications (other than scoliosis) for rigid orthopaedic brace treatment in chronic, mechanical low back pain?




Abstract


Objectives


Mechanical low back pain (LBP) is a major public health problem. Today’s standard care strategy involves a combination of drug-based and non-drug therapies. The use of conservative orthopaedic brace treatment is subject to debate. The lack of data and consensus in the literature on the value of this treatment in chronic LBP prompted to us to seek to estimate the modalities and indications for brace use in France.


Materials and method


We performed a questionnaire-based survey of physician members of the French Society of Physical Medicine and Rehabilitation (SOFMER).


Results


We received 55 completed questionnaires. Although the indications for this treatment were very heterogeneous (in both clinical and paraclinical terms), the prescribing behaviour was rather uniform. The brace is worn during the day for less than 3 months (with a progressive reduction in use over 1 to 2 months), together with physiotherapy before and after immobilization. The patient keeps the brace at the end of the treatment period. Orthopaedic treatment appears to be prescribed in many chronic LBP situations. Analysis of spinal posture and magnetic resonance imaging results (and Modic changes in particular) influence the therapeutic decisions.


Conclusion


Clinical and paraclinical indications of this treatment must be precisely defined and evaluated in prospective, multicenter studies with homogeneous cohorts.


Résumé


Objectifs


La lombalgie commune représente un problème majeur de santé publique. La stratégie de prise en charge d’un lombalgique impose d’allier thérapeutiques médicamenteuses et thérapeutiques non médicamenteuses. Le traitement orthopédique conservateur par une immobilisation externe rigide est une alternative thérapeutique qui reste discutée. Le manque de données et de consensus dans la littérature sur ce traitement dans la lombalgie chronique nous a amenés à en évaluer ses modalités et ses indications en France.


Matériels et méthodes


Nous avons réalisé une enquête par questionnaire adressé aux médecins inscrits à la Société française de médecine physique et réadaptation (Sofmer).


Résultats


Nous avons reçu 55 questionnaires. Les indications de ce traitement sont très hétérogènes tant sur le plan clinique que paraclinique. Les modalités de prescription sont néanmoins assez homogènes. Ce traitement est porté la journée pendant moins de trois mois avec un sevrage progressif de un à deux mois associé à de la kinésithérapie pendant et après l’immobilisation. Le corset est laissé au patient en fin de traitement. Le traitement orthopédique semble être proposé dans de nombreuses situations cliniques de lombalgie chronique. L’analyse de la statique rachidienne ainsi que l’IRM et notamment le signe de Modic influencent le choix thérapeutique.


Conclusion


Les indications cliniques et paracliniques de ce traitement doivent être définies précisément et évaluées par des études prospectives, multicentriques avec des cohortes de patients homogènes.



English version



Introduction


Low back pain (LBP) constitutes a major public health problem by virtue of its direct socioeconomic impact. In France, the annual incidence is between 5 to 10%. Seventy percent of adults of working age have already experienced an episode of back pain and sick leave was required in a third of the cases. Overall, 90% of cases of LBP are cured within 3 months; however, the 10% become chronic and represent as much as 80% of the direct cost of LBP . The care strategy for chronic LBP often consists of a combination of drug-based and non-drug treatments. France’s hospital and medical standards organisation (ANAES) only recommends physical exercises, multidisciplinary programs and behavioural therapies .


However, “orthopaedic treatment” is prescribed by some physicians for some types of LBP. This consists of immobilization – initially in plaster, in most cases, and then via use of a lumbar support. By immobilizing the spine, the goal is to decrease local pain and inflammation . The use of immobilization stems from its use in the treatments of spinal deformities but the value of this therapy in chronic LBP remains controversial. Indeed, there are few reliable data on the indications and prescribing behaviour for lumbar braces in chronic LBP . Practice appears to differ (in terms of the frequency of prescription and duration of brace use) from one care team to another.


In the literature, the main indications essentially derive from work performed by Biot’s group in Lyons and are based on the following main indications: post-discectomy chronic LBP, pain with lumbar or thoracolumbar scoliosis , chronic LBP with nerve root symptoms and resistant LBP for over 6 months (regardless of the presence or absence of nerve root symptoms) . According to these authors, the treatment duration is six months.


Other literature data on the lumbar brace essentially concern the acute stage, with shorter periods of use. Indeed, the lumbar brace can be used to treat:




  • cases of acute LBP (in the presence or absence of nerve root symptoms) for between 6 to 8 weeks;



  • residual postoperative pain for 3 to 4 weeks.



Some clinicians also use it as a 15-day test of immobilization before fusion. Others prescribe it in cases of spondylolisthesis or vertebral instability but do not specify a precise duration . Lastly, in cases of acute and recurrent LBP pain in workers performing heavy labour, back belts can be of assistance during effort .


Hence, chronic LBP does not appear to be a common indication for brace prescription. The ANAES’ guidelines mention an orthosis but do not specify whether the latter should be rigid or somewhat flexible. Its effects have not been assessed . Furthermore, the harmful effects of wearing a brace are often highlighted: muscle atrophy, stiffness, neuromuscular mismatch and movement phobia – all of which we seek to avoid during immobilization after trauma or surgery. However, few studies on the side effects of immobilization for chronic LBP have been performed.


Given, firstly, the low number of studies and the lack of consensus on the indications and modalities for the orthopaedic treatment and, secondly, contradictory strategies of immobilization and intensive rehabilitation in chronic LBP, we decided to investigate prescribing practice for this treatment in the physical medicine and rehabilitation units throughout France.



Materials and method


This investigation was based on a written questionnaire featuring 71 questions grouped into 11 sections. The questionnaire was e-mailed to physician members of the French Society of Physical Medicine and Rehabilitation (SOFMER) in April 2007. A reminder was sent out in June 2007.


The first question enabled us to analyze the practitioners according to their frequency with which they prescribed orthopaedic treatment. The questionnaire consisted of two main parts ( Appendix A ):




  • the first part concerned the clinical and/or paraclinical context for orthopaedic treatment;



  • the second part concerned the treatment procedures: the therapeutic plan, the type of brace, the duration of use per day and the overall treatment duration, the follow-up procedures, the criteria for treatment withdrawal and type of physiotherapy used in association.



The questionnaire featured multiple-choice questions but also gave physicians the opportunity of giving additional comments.



Statistical analysis


The study was essentially descriptive. A Student’s t test was used to compare the various variables as a function of the groups of practitioners. The significance threshold was set to P = 0.05.



Results


We received responses from 55 physicians who treat chronic LBP. Ten never prescribe orthopaedic treatment. We divided the remaining 45 into two groups: group I (frequent brace prescribers) and group II (infrequent brace prescribers) and analyzed the following aspects:




  • indications for conservative orthopaedic treatment ( Table 1 ): the two groups differed significantly in terms of the clinical indication for brace treatment:




    • 70% of group I suggested that a brace was potentially indicated in all cases of LBP (isolated chronic LBP, nerve root symptoms, postural LBP and resistant LBP), whereas this proportion was only 40% in group II ( P = 0.046),



    • 15% in group I reserved orthopaedic treatment for resistant LBP only, versus 44% in group II ( P = 0.037);




  • paraclinical indications ( Table 1 ): 78% of the practitioners prescribed an X-ray before taking a decision on conservative orthopaedic treatment. In more than 50% of the cases, this corresponded to a thoracic and lumbar spine X-ray with a De Sèze false profile view. Forty-four percent of group I and 21% of group II prescribed a full spine X-ray examination, in order to analyze spinal posture before initiation of conservative orthopaedic treatment. This difference was not statistically significant. Overall, magnetic resonance imaging (MRI) results (and Modic signal changes in particular) influenced 40% of the practitioners in their prescription of conservative orthopaedic treatment. This was especially true for group I;



  • treatment parameters: physicians in group I usually prescribed a plaster or a resin brace, followed by use of a corset; the next most frequent practices involve use of a plaster/resin brace as a test of efficacy, use of a plaster brace only or immediate use of a corset. In group II, a corset was prescribed immediately in 52% of the cases and the other options comprised the remaining 48%. The two groups did not differ in terms of the exact types of plaster-resin brace or corset. In most cases, a neutral position was chosen as the analgesic position.



Table 1

Indication of orthopaedic treatment.





















































































































Total ( n = 45) Group I ( n = 20) Group II ( n = 25)
n % n % n %
Clinical indication
Resistant LBP 15 33 3 15 11 44
Isolated chronic LBP 3 7 1 5 2 8
Nerve root symptoms 4 9 0 4 16
Postural LBP 2 4 0 2 8
All cases 23 51 14 70 10 40
Paraclinical indication
X-ray 35 78 16 80 19 76
Full spine X-ray 11 31 7 44 4 21
Thoracic and lumbar spine X-ray 19 54 8 50 11 58
The two types of X-ray 5 14 1 6 4 21
Dynamic X-ray 8 18 1 5 7 28
MRI 18 40 9 45 9 36
Modic signal change 20 44 12 60 8 32

LBP: low back pain; MRI: magnetic resonance imaging.


The most frequent wearing regimens were as follows: day-only use for less than 3 months for plaster or resin, with physiotherapy during immobilization ( Table 2 ) and day-only use of less than 3 months for the corset, associated with physiotherapy during immobilization and followed by standard rehabilitation or a spine function rehabilitation programme. The patient generally kept the corset at the end of the treatment period ( Table 3 ).



Table 2

Therapeutic plan (plaster).



















































































Total ( n = 28) Group I ( n = 16) Group II ( n = 12)
n % n % n %
Duration of use per day
24/24 h 8 29 4 25 4 33
Standing/sitting 17 61 11 69 6 50
Treatment duration
Plaster < 1 month 12 43 7 44 5 42
1–3 months 12 43 8 50 4 33
3–6 months 0
6 months 0
Physiotherapy
During plaster 16 57 9 56 7 58


Table 3

Therapeutic plan (corset).























































































































































Total ( n = 45) Group I ( n = 20) Group II ( n = 25)
n % n % n %
Duration of use per day
24h/24 1 2 0 1 4
Standing/sitting 32 71 14 70 18 72
Standing/sleeping 5 11
Treatment duration
Corset < 1 month 0 0 0
1–3 months 22 49 10 50 12 48
3–6 months 6 13 2 10 4 16
6 months 9 20 5 25 4 16
End of treatment
Patient kept the corset 43 98 19 100 24 96
In case of pain 37 84 17 89 20 80
In case of effort 20 45 11 58 9 36
After sport 5 11 5 26 0
Physiotherapy
During brace 27 60 12 60 15 60
Standard rehabilitation 32 71 13 65 19 76
Functionnal restoration (FR) 27 60 13 65 14 56
Systematic FR 10 37 5 38 5 36



Discussion


Our questionnaire-based results have some limitations, due to the study methodology: the small number of responses relative to the high frequency of chronic LBP and the number of annual consultations in physical medicine departments for this condition. Although we received 55 questionnaires from physical medicine practitioners, LBP is also cared for by many other physicians: general practitioners, rheumatologists, neurosurgeons and pain specialists. Furthermore, the multiple-choice questions and yes/no answers in the questionnaire do not fully reflect the reality of practice in everyday life. Some physicians added comments to support their answers but the latter were difficult to analyse (relative to multiple-choice questions).


However, this study shows that the orthopaedic brace treatment does not appear to be a common indication for mechanical chronic LBP because only 20 of the 55 responding physicians prescribe it on a regular basis. Furthermore, our results show that there are no precise prescription criteria (in terms of either clinical or paraclinical data) for conservative orthopaedic treatment and that there is no consensus on the indications. This therapy appears to be suggested in many different clinical situations with chronic LBP; neither nerve root symptoms nor spinal posture influence its use. The analgesic effect of the brace is considered to be more important than its postural effect. The pain’s source and characteristics did not appear to matter and no specific type of pain was identified as justifying use of this treatment. The indications for this treatment appeared to be more related to the practitioner’s experience, since group I used a broader range of indications than group II. We believe that several issues should be examined in more detail.


Group I tended to prescribe a full spine X-ray in order to examine spinal posture. However, we were unable to find any literature data on the relationship between spinal posture analysis and the type of brace, the duration of use and the related physiotherapy for chronic LBP. Is it necessary to correct the spinal posture using brace? According to Biot and al., modifications in frontal and/or sagittal spinal posture increase the likelihood of anatomically related LBP. Hence, the aim of physiotherapy and brace use should be to normalize posture and decrease constraints (and thus inflammation and pain) . Roussouly has described a “back classification” (based on precise criteria observed on profile total spine X-rays) with four types of lumbar lordosis (depending on the sacral slope) in an asymptomatic population. Some researchers suggest that this classification enables the rehabilitation programme to be refined by identifying the patient’s ability to compensate and thus confirming the indication for brace use. Analyzing an LBP patient’s sagittal spinal balance when seeking to define the causes of postural pain causes seems to an important factor and constitutes an interesting “biomechanical” approach. However, is it possible to treat this imbalance by use of a brace for 6 months?


In terms of the discal inflammatory state, our results show that the MRI results (and Modic changes in particular) influence the therapeutic choice of 60% of the practitioners in group I. Modic et al. have described three types of signal changes on MRI: type I consists of fibrovascular tissue, type II is yellow fat and type III is sclerotic bone . Modic changes are common in patients with LBP (in 18 to 58% of samples) and are rare in asymptomatic persons . These signs (particularly type I) could objectivize pain in the LBP patient and prove the involvement of a mechanical, disc-related factor in the pain . Hence, by relieving local inflammation, brace treatment may have an effect on the Modic type I change. However, there are counterarguments to this hypothesis. First, the Modic change often involves discs L4-L5 and L5-S1, which are hardly or not at all immobilized by conventional lumbar brace use; a lumbar brace with a “Bermuda short” hip section is needed to immobilize these segments . Furthermore, the patient’s clinical outcome is not only due to a decrease in hydrostatic pressure on the discs. Questions remain concerning the duration of immobilization required for transformation into the less painful type II sign. In a longitudinal MRI follow-up study (over 1 to 3 years) of 16 chronic LBP patients (of whom six were initially scored as Modic I), Modic et al. reported a transformation into Modic II from the 14th month onwards for one of the subjects but did not give details of the therapy that had been implemented. In a study of 17 post-fusion Modic I chronic LBP patients, Vital et al. reported decreased pain in all patients 6 months after surgery, with four Modic 0 subjects and 14 Modic II subjects. However, these patients had been suffering from LBP for over a year and it thus seems difficult to relate the change in Modic type to the therapies used and to exactly define the point at which a Modic I changes into a Modic II. Hence, it is still necessary to clarify the correlation between the natural progression of Modic changes on one hand and pain on the other. Even though an anatomical cause (of which the Modic change is a good indicator, according to some authors) must be never underestimated in chronic LBP, we also know that chronic low back disability depends on psychosocial factors as well as physical disease (with ).


In contrast, the effects of rest (and thus the analgesic effect of immobilization) were widely acknowledged in the physicians’ daily practice. Even though studies concerning the analgesic effects of brace use are rare and poorly informative , many studies have sought to estimate the efficacy of flexible belts in acute or subacute LBP . However, the relationship with imaging data (and Modic change transitions in particular) has not been demonstrated.


In terms of the duration of treatment, our study results show that the majority of the practitioners recommend 3 months of use. A recent study of Scoliosis Study Group members (using a very similar methodology to ours) found that 60% of the practitioners prescribe 1 to 2 months of use – a period that is markedly lower than the 6 months recommended by Biot et al. . Indeed, if we summarize the data from Vital et al. and Modic et al. , longer treatment might enable a change in the Modic stage.


Conversely, many authors believe that prolonged immobilization is a risk factor for loss of muscle, ligament, joint and functional capacities. However, studies on the effect of brace use on muscles generally concern rather short periods (from 7 days to 2 months) and the use of flexible or moderately stiff belts . A 1990 study by Walsh et al. did not show any decrease in trunk flexor muscle strength after 6 months of belt use. However, to the best of our knowledge, there are no studies on the muscle-related effects of wearing a rigid brace for 6 months. Lastly, immobilization in the acute LBP phase is thought to induce progression to chronicity . The psychological and social impact of an orthopaedic treatment beyond 6 months (with potential problems following brace removal) and the associated sick leave remains a key issue. Biot et al. obtained their best results in a population with few risk factors – particularly in subjects who were not on sick leave work when treatment was initiated .



Conclusion


Our investigation revealed the heterogeneity and the lack of consensus on the indications and the procedures for orthopaedic brace treatment of LBP. It also highlights the existence of experience-based practice in each medical team and the lack of validated literature studies .


Brace use probably does have therapeutic value for chronic LBP but the exact indications have not yet been defined to this day. Only a precise definition of the indications will enable rigorous clinical evaluation of the efficacy of the orthopaedic brace treatment.





Version française



Introduction


La lombalgie commune représente un problème de santé publique par son coût direct en soins et par son retentissement socioéconomique. L’incidence annuelle est de 5 à 10 % en France. Soixante-dix pour cent des personnes en âge de travailler ont déjà présenté un tableau de lombalgie, nécessitant pour un tiers d’entre elles un arrêt de travail. Quatre-vingt dix pour cent des lombalgies communes guérissent en trois mois quels que soient les traitements entrepris ; 10 % deviennent chroniques et représentent à elles seules 80 % du coût direct de la lombalgie . La stratégie de prise en charge d’un patient lombalgique chronique consiste souvent en l’association de traitements médicamenteux et non médicamenteux. Selon l’Anaes, seuls les exercices physiques, les programmes multidisciplinaires et les thérapies comportementales sont recommandés .


Cependant, le « traitement orthopédique » est proposé par certaines équipes dans certaines formes de lombalgies. Il consiste en une immobilisation externe rigide, généralement initialement plâtrée, puis relayée par un corset en thermoformable. Il a pour but, en immobilisant le rachis, de diminuer les phénomènes douloureux et inflammatoires locaux . Il dérive des traitements des déviations rachidiennes, mais sa place dans la prise en charge des lombalgiques chroniques reste discutée. En effet, d’une part, il existe peu de données fiables sur les indications et les modalités de prescription d’une immobilisation externe rigide dans la lombalgie chronique et, d’autre part, les pratiques semblent variables selon les équipes (fréquence de prescription, durée de port). Les principales indications retrouvées dans la littérature émanent essentiellement de la même école lyonnaise. On retrouve comme principales indications pour ces auteurs : la lombalgie chronique postdiscectomie, la lombalgie sur scoliose lombaire ou dorsolombaire , les lomboradiculalgies chroniques et des lombalgies mécaniques résistantes au traitement médical, évoluant depuis plus de six mois avec ou sans radiculalgies . Pour ces auteurs, la durée de traitement est de six mois.


Les autres données de la littérature sur l’immobilisation externe rigide concernent essentiellement des tableaux plutôt aigus, avec des durées de port plus courtes. En effet, l’orthèse rigide peut être proposée dans les cas de lombalgie aiguë et lombosciatique avec une durée de port de six à huit semaines, de lombalgies résiduelles après discectomie, nucléotomie ou chimionucléolyse pendant trois à quatre semaines. Certains l’utilisent aussi comme test d’immobilisation de 15 jours avant arthrodèse. D’autres la prescrivent en cas de spondylolisthésis ou d’instabilité vertébrale mais sans durée précise . Enfin, en cas de lombalgie aiguë récidivante chez le travailleur de force, l’immobilisation externe peut être une aide lors des efforts mais, dans ce cas, ce sont plutôt des orthèses renforcées type ceinture d’immobilisation vertébrale (CIV) ou ceinture de maintien lombaire renforcée (CMLR) .


La lombalgie chronique commune n’apparaît donc pas comme une indication courante. Les recommandations de l’Anaes mentionnent la contention lombaire, sans préciser le caractère souple ou rigide, comme une thérapeutique dont les effets ne sont pas évalués . De plus, les effets délétères du port d’orthèse sont souvent mis en avant : atrophie musculaire, raideur, désadaptation neuromusculaire, phobie du mouvement… que l’on cherche à éviter lors des immobilisations en traumatologie ou postchirurgicales. Cependant, peu d’études sur les effets secondaires d’une immobilisation rigide chez le lombalgique chronique ont été réalisées.


Devant le faible nombre d’études et l’absence de consensus sur les indications et modalités du traitement orthopédique, ainsi que devant l’aspect contradictoire des stratégies d’immobilisation et de remobilisation dans la lombalgie chronique, nous avons décidé de réaliser une enquête destinée à analyser les pratiques de ce traitement dans les centres ou unités de médecine physique et de réadaptation (MPR) du territoire français.



Matériels et méthodes


Cette enquête a été réalisée à partir d’un questionnaire écrit, comprenant 71 questions groupées en 11 items. Le questionnaire a été adressé par courrier électronique aux médecins inscrits à la Société française de médecine physique et réadaptation (Sofmer) en avril 2007 avec une réponse souhaitée avant le 31 mai 2007. Un second envoi a eu lieu en juin 2007. La première question permettait de classer les prescripteurs selon leur fréquence de prescription du traitement orthopédique. Le questionnaire était composé de deux parties ( Annexe A ) :




  • la première partie concernait les indications du traitement orthopédique : orientation clinique et/ou paraclinique ;



  • la seconde partie concernait les modalités du traitement : schéma thérapeutique proposé, confection pratique de l’immobilisation, durée du port journalier et du traitement, modalités de surveillance, d’arrêt et prise en charge kinésithérapeutique associée.



Le questionnaire était établi avec des questions fermées, mais comportait aussi la possibilité de remarques complémentaires.



Analyse statistique


L’étude est essentiellement descriptive. Une comparaison des différentes variables selon les groupes de prescripteurs a été proposée par un test t de Student. Le seuil de significativité retenu est p ≤ 0,05.



Résultats


Nous avons reçu 55 réponses de médecins prenant en charge des lombalgiques chroniques, dont dix ne prescrivent jamais de traitement orthopédique.


Parmi les 45 prescripteurs, nous avons constitué deux groupes : le groupe I des prescripteurs habituels et le groupe II des prescripteurs non habituels.


Les réponses aux différentes questions font apparaître :




  • indications du traitement orthopédique conservateur ( Tableau 1 ) : l’indication clinique de ce traitement diffère statistiquement entre les deux groupes :




    • 70 % pour le groupe I posent l’indication d’une orthèse rigide dans tous les cas de lombalgie (lombalgie chronique isolée, lombosciatique chronique, lombalgie chronique sur trouble de la statique ou formes rebelles) contre 40 % dans le groupe II ( p = 0,046),



    • 15 % pour le groupe I réservent le traitement orthopédique aux formes rebelles contre 44 % dans le groupe II ( p = 0,037) ;




  • examens paracliniques ( Tableau 1 ) : les radiographies osseuses sont prescrites par 78 % des médecins pour poser l’indication d’un traitement orthopédique conservateur, avec dans plus de 50 % des cas des radiographies du rachis dorsolombaire avec cliché de De Sèze. Quarante-quatre pour cent du groupe I contre 21 % du groupe II prescrivent des radiographies du rachis total pour analyser la statique sagittale avant de prendre la décision de ce traitement. Cette différence n’est pas statistiquement significative. L’IRM, et plus particulièrement le signe de Modic, influencent 40 % des prescripteurs dans l’indication du traitement orthopédique conservateur surtout pour le groupe I ;



  • modalités de traitement : le groupe I réalise dans la majorité des cas un plâtre ou une résine suivi d’un corset ; dans l’autre majorité, les schémas thérapeutiques sont variables (soit un plâtre-résine comme test d’efficacité, soit uniquement un plâtre, soit un corset d’emblée) alors que pour le groupe II, un corset est prescrit d’emblée dans 52 % des cas, les autres schémas se partageant les 48 % restant. Les types de plâtre-résine ou de corset sur moulage sont les mêmes pour les deux groupes. La position neutre est la plus souvent choisie avec respect de la position antalgique.


Apr 23, 2017 | Posted by in PHYSICAL MEDICINE & REHABILITATION | Comments Off on Are there indications (other than scoliosis) for rigid orthopaedic brace treatment in chronic, mechanical low back pain?
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