Dynamic spinal orthoses self-reported effects in patients with back pain due to vertebral fragility fractures: A multi-center prospective cohort study

Abstract

BACKGROUND:

Vertebral fragility fractures (VFFs) commonly result from low bone mass and microarchitecture deterioration of bone tissue. spinal orthoses are common non-pharmacological options for managing vertebral fracture pain. However, the effects of spinal orthoses on pain, physical functioning, and quality of life (QoL) are still debated.

OBJECTIVE:

This survey aimed to investigate the patients-reported outcomes of a dynamic spinal orthosis prescribed in the routine clinical practice of VFFs management.

METHODS:

This multi-center national-wide prospective cohort study assessed older patients (aged $>$ 60 years) diagnosed with acute VFFs and prescribed with a dynamic spinal orthosis (Spinfast^®). A survey questionnaire was realized and included sections on patient characterization, osteoporosis characterization, spinal orthosis, clinical outcomes, pain medications, and osteoporosis medications. The questionnaire was administered at baseline and after three months. A total of 68 patients completed the questionnaire at three months. Most patients had one or two VFFs and were treated with pain medications and osteoporosis medications. Compliance and tolerability of the spinal orthosis were assessed, and clinical outcomes such as pain intensity, physical functioning, and QoL were measured.

RESULTS:

The results showed no significant differences in outcomes between age subgroups. Italian physical medicine and rehabilitation physicians were commonly involved in the management of VFFs patients. Sixty-six patients completed the questionnaire. The results showed that pain intensity, physical functioning and QoL improved after three months of spinal orthosis wearing ( $p<$ 0.0001).

CONCLUSION:

The correct management of VFFs is mandatory to improve pain and reduce disability, and our findings suggested a positive role of dynamic spinal orthosis to improve the comprehensive management of VFFs patients. However, high-quality research trials are warranted to provide clear recommendations for the correct clinical management of VFF.

Keywords

Osteoporosis rehabilitation spinal orthoses spine vertebral fractures

1. Introduction

During the past century, life expectancy has largely enhanced worldwide, mostly due to advancements in public health, resulting in an increasing number of elderly adults in most developed and developing countries [1, 2]. In this context, osteoporosis is an age-related disorder characterized by low bone mass and microarchitecture deterioration of bone tissue, with a consequential increase in bone fragility and vulnerability to fracture [3]. Vertebral fragility fractures (VFFs) are the most common osteoporotic fracture that might be recognized from imaging from spine examination (e.g. spinal radiographs, DXA vertebral fracture assessment), or incidentally from images performed for other clinical indications (e.g. CT, MRI, abdominal radiograph) [4, 5, 6]. Moreover, despite being a common incidental finding on diagnostic imaging, most fractures are asymptomatic [7]. The core clinical manifestation might be represented by back pain, with subsequent weakening of physical function and independence in activities of daily living (ADL) [8, 9].

Despite the pertinence of these epidemiological data, along with the Health Systems burden, underdiagnosis, and eventual undertreatment remain two central problems in the domain of osteoporosis management, specifically in secondary prevention care [10].

Figure 1.

Different brace models commonly prescribed in clinical practice (rigid spinal orthosis, semi-rigid spinal orthosis, and dynamic spinal orthosis).

To date, pharmacological treatment is assumed to be a key intervention for fragility fractures, consisting of anti-absorptive and anabolic drug molecules [11, 12], combined with oral supplementation with calcium and vitamin D [13, 14]. On the other hand, physical and rehabilitative medicine (PRM) physicians generally prescribe a patient-tailored rehabilitation strategy (i.e., early mobilization exercises, strengthening, and proprioceptive training) to stimulate bone tropism, improve physical functioning, and reduce the risk of falling [15, 16, 17]. In this context, it has been proposed that rehabilitation combined with nutritional approach might provide additional benefits in older adults with VFFs [18, 19]. Moreover, spinal orthosis might be frequently prescribed to restrict the range of motion and facilitate neutral vertebral alignment as the fracture heals, minimizing secondary traumatic injury, improving posture, and alleviating pain [8, 20]. However, it has been argued that orthosis employs results in the decline of paraspinal musculature bulk with subsequently increased fragility [21]. However, the use of bracing in the medical community has generated concerns and uncertainty due to a lack of comprehensive literature. Some rehabilitative practitioners hesitate to consider bracing as a viable option for managing this complex condition, citing concepts such as the potential weakening of postural musculature and decreased proprioception, which could contribute to reduced overall well-being of elderly patients [16, 22]. In this scenario, orthoses are employed especially in acute or subacute phases, to lower excessive trunk flexion, to acquire a proper posture, to enhance pulmonary function, and to decrease back pain [20]. In recent years, evidence has demonstrated the efficacy of spinal orthoses as a valuable intervention for pain relief in the management of acute vertebral fragility fractures (VFFs), and different models are currently available (rigid, semi-rigid, or dynamic) [8]. Figure 1 shows different brace models currently available. More in detail, dynamic brace is a specialized orthotic device designed to provide support, alignment, and controlled movement to the vertebral column [23, 24]. It is used to address different spinal conditions, such as fractures, instability, deformities, and other disorders that affect the spinal column’s structure and function. In contrast with traditional rigid braces that limit movement, a dynamic spinal brace is engineered to allow controlled and adjustable motion while maintaining stability [24].

Interestingly, Sinaki et al. [23] recently introduced a dynamic brace that focuses on enhancing the strength of the spinal extensors through the utilization of a weighted kypho-orthosis, as well as proprioceptive and postural physical therapy. This approach is grounded on the hypothesis that sustained mechanical weight-bearing can induce a microstructural osteogenesis phenomenon in frail patients [25]. Moreover, the dynamic brace incorporates an extender base that stabilizes and alleviates the vertebral column, potentially leading to a reduction in kyphosis by exerting extension forces on the spine [26].

Despite these considerations, there is still little evidence about the real effectiveness of dynamic brace in the complex management of VFFs in terms of functioning improvement and pain reduction [26, 27]. Furthermore, the overall low quality of the studies and the controversial hinder to draw any strong conclusion about the real impact of spinal orthoses in VFF patients [28]. Lastly, there is high heterogeneity in the clinical suggestions of a spinal orthosis, with an outsized uncertainty of treatment conventions and outcome measures assessed [29, 30].

Taken together, these findings highlighted a large gap of knowledge in this field, and further studies are necessary to elucidate the role of dynamic brace in pain relief, functional recovery, and improving QoL. Therefore, this multi-center national-wide prospective cohort study aimed to assess the prospective role of dynamic spinal orthosis in the management of VFFs, underlining the potential correlation between spinal orthosis tolerability, pain intensity, physical function, and quality of life in the routine clinical practice of people with VFFs. Moreover, the study’s secondary purpose was to analyze age-related variations in clinical outcome measures in order to highlight the effects of age on patient’s tolerability and compliance with spinal orthosis devices.

2. Methods

2.1 Study design

This multi-center national-wide prospective cohort study was conducted according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement [31]. The study protocol was performed in accordance with the Declaration of Helsinki [32] and was approved by the Ethics Committee of the Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy (ASO.MTrasl.21.02; protocol number: 0022441: accepted on 26 October 2021).

All participants read and signed a written informed consent before being enrolled in the study. A physician specialized in PRM provided a detailed description of the study project and of the purpose of the study questionnaire before study initiation. The participants agreed to share the personal data before data collection, and researchers granted their privacy protection. All study participants were allowed to revoke their consent to participate in the study without limitation.

2.2 Participants

In this multicenter national-wide prospective cohort study, the study questionnaire was administered in person by different physical and rehabilitation specialists across the country. The patient was referred to the Outpatient Rehabilitation Service of the Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, and the Outpatient Rehabilitation Service of the University Hospital “Mater Domini” of Catanzaro, Italy, between November 2021 and November 2022. The patients included in the study were sourced from different centers. The study involved individuals from various medical facilities, who were subsequently referred to the two services and screened for eligibility.

The patients were considered eligible when met the following criteria: i) older people (aged more than 60 years), according to the definition by World Health Organization [33]; ii) symptomatic VFFs diagnosed within 1 month; iii) VFFs radiographic diagnosis according to the Genant criteria [34]; iv) back pain assessed with Visual Analogue Scale (VAS) score [35] over 4 points; v) dynamic spinal orthosis prescription (Spinfast^®); vi) able to read and understand the Italian language; vii) read and signed the informed consent.

The exclusion criteria were: i) premorbid bed-bound; ii) previous spinal pain or spinal surgery; iii) vertebral fracture related to underlying oncological pathology (multiple myeloma or metastasis); iv) dementia or cognitive impairment assessed by a Mini-mental State Examination (MMSE) $<$ 24 [36]; v) neurological deficits related to VFF; vi) severe morphological changes of spine related to osteoarthritis or scoliosis.

The eligibility was assessed by an expert physician specialized in PRM with years of expertise in osteoporosis and VFFs management.

2.3 Questionnaire development

The survey questionnaire realized according to the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) guidelines [37], and basing on the evidence of previous randomized clinical trials and reviews about spinal orthosis and VFFs [38, 39, 40]. The questionnaire was initially developed and critically evaluated by 6 independent physicians specialized in PRM with years of expertise in osteoporosis and VFFs management. Survey questions were realized independently, and all experts revised and agreed on the final edited questionnaire, providing feedback on content accuracy, wording, question order, and survey structure.

As a result, the preliminary version of the survey was piloted on 10 patients with VFFs wearing dynamic spinal orthosis (Spinfast^®), aiming at increasing the content validity. A PRM specialist administered the study questionnaires to the patients and registered their answers. Moreover, patients were asked to provide any concerns or questions related to the questionnaire, including confusing words or misleading sentences requiring further explanations. On the other hand, no further edit has been required based on their comments. The average time needed to complete the survey was approximately 10 minutes, that were advantageous for physicians in clinical practice without taking too much time.

The final version of the survey was composed of 6 different domains:

Patient characterization (4 questions): investigating gender, age, weight, and height of the study population.

Osteoporosis characterization (3 questions): investigating the number and anatomical site of VFFs, and thoracic hyperkiphosis, defined as a kyphosis angle over 50^∘ measured from X-ray in a standing position. Cobb’s method was utilized to evaluate the angle of thoracic kyphosis measured between the 5^th thoracic and 12^th thoracic vertebra, in accordance with previous studies [29, 41].

Spinal orthosis (4 questions), investigating spinal orthosis prescription, time of orthosis prescription, and (after the treatment) spinal orthosis compliance rate and tolerability. More in detail, compliance rate was calculated by dividing the number of days the patient wore the prescribed spinal orthosis by the total number of days it was recommended by the physician. The number of days the patient wore the prescribed spinal orthosis was assessed by a self-reported method in accordance with previous studies [42, 43].

Clinical outcomes (3 questions), investigating pain intensity assessed by the VAS [35], physical functioning assessed by the Short Physical Performance Battery (SPPB) [44], and health-related QoL assessed with the EuroQol visual analogue scale (EQ-VAS) [45].

Pain medications (5 questions), characterized by analgesics, non-steroidal anti-inflammatory drugs(NSAIDs), corticosteroids, nutraceuticals, or no medication.

Osteoporosis medications (6 questions), characterized by vitamin D, calcium, clodronate, other bisphosphonates (alendronate/risedronate/zoledronate), denosumab, and parathyroid hormone (1-34).

The study questionnaire was administered at baseline (T0) and three months after the study baseline (T1). The average time of 3 months was chosen in accordance with the mean time of spinal orthosis prescription in a previous survey [8]. All VFFs patients were treated as routinely clinical practice, and the study questionnaire was administered during personal visits scheduled for follow-up. A physician specialized in PRM with a wide expertise in VFFs and osteoporosis management administered the study questionnaire. The translation of the study questionnaire was reported in Supplementary Table 1. Any adverse effects or causes of poor compliance with the spinal orthosis treatment were recorded.

2.4 Statistical analysis

Sample size calculation was estimated in accordance with the Organizational Research Criteria [46]. More in detail, we based the sample size calculation on the response rate of a previous studies addressing spinal orthosis prescription [8]. Considering an a priori response rate of approximately 50%, we estimated to send the invitations to 130 patients to achieve a minimum number of 65 participants at the end of the study. A data completeness criterion was used for handling missing data, and assessors were encouraged to not miss data during the study.

All data were recorded, categorized, and subsequently entered GraphPad Prism 9.5.1 (GraphPad Software, Inc., San Diego, CA, USA). All analyses were performed for the whole sample, while a subgroup analysis was performed for patients aged between 60 and 74 and patients over 75 years old. Categorical variables have been described as numbers and percentages, while continuous variables were presented as means $\pm$ standard deviations. The non-Gaussian distribution of variables was assessed by the Shapiro–Wilk test. The Mann-Whitney U test was used to compare between-group differences for continuous variables. Fisher exact test was performed to compare categorical variables. Pearson correlation coefficient (r) with 95% confidence intervals (CI) was used to assess the correlation between different clinical variables. The correlation was considered as poor ( $r<$ 0.5), moderate (r ranging between 0.5 to $<$ 0.75), good (r ranging between 0.75 to 0.9), or excellent ( $r>$ 0.90). A subgroup analysis was performed in accordance with the age of study participants.

Figure 2.

Study flow chart.

A $p$ -value lower than 0.05 was considered statistically significant. Descriptive statistics have been used to summarize data, and the distribution of numerical variables was summarized in the tables.

3. Results

Among 128 patients with VFFs assessed at baseline, only 79 satisfied our eligibility criteria (12 patients were less than 60 years old, 1 patient was not able to read and understand the Italian language, 2 patients had premorbid bed-bound, 23 patients had previous low back pain or spinal surgery; 6 patients had an underlying cancer pathology; 1 patient had neurological deficits; 3 patients had scoliosis, 1 patient declined to participate without providing reasons, and 2 patients had an incomplete response rate). As a result, 66 patients completed the questionnaire after 3 months with a response rate of 100% and no missing data. Figure 2 shows the flowchart of the study selection process.

Table 1
Study population characteristics

	Whole sample		Age groups (years)				Between-group analysis
	( $n=$ 66)		60–74 ( $n=$ 15)		Over 75 ( $n=$ 51)		( $p$ -value)
Sex
Female	54	(81.8)	11	(73.3)	43	(84.3)	0.446
Male	12	(18.2)	4	(26.7)	8	(15.7)
Weight
$>$ 60 kg	9	(13.6)	1	(6.7)	8	(15.7)	0.503
61–70 kg	36	(54.5)	10	(66.7)	26	(51.0)
$<$ 71 kg	21	(31.8)	4	(26.7)	17	(33.3)
Height
$>$ 150 cm	15	(22.7)	2	(13.3)	13	(25.5)	0.201
151–165 cm	42	(63.6)	9	(60.0)	33	(64.7)
$<$ 166 cm	9	(13.6)	4	(26.7)	5	(9.8)
Vertebral Fragility Fracture
1	27	(40.9)	3	(20.0)	24	(47.1)	0.096
2	24	(36.4)	6	(40.0)	18	(35.3)
3 or more	15	(22.7)	6	(40.0)	9	(17.6)
Hyperkyphosis
Yes	36	(54.5)	5	(33.3)	31	(60.8)	0.080
No	30	(45.5)	10	(66.7)	20	(39.2)
Fragility Fracture Location
T7	1	(1.3)	0	(0.0)	1	(2.2)	0.648
T9	2	(2.5)	1	(3.0)	1	(2.2)
T10	2	(2.5)	1	(3.0)	1	(2.2)
T11	4	(5.1)	1	(3.0)	3	(6.5)
T12	15	(19.0)	6	(18.2)	9	(19.6)
L1	21	(26.6)	9	(27.3)	12	(26.1)
L2	18	(22.8)	8	(24.2)	10	(21.7)
L3	11	(13.9)	4	(12.1)	7	(15.2)
L4	3	(3.8)	2	(6.1)	1	(2.2)
L5	2	(2.5)	1	(3.0)	1	(2.2)
Pain Medications
NSAIDs	18	(27.3)	3	(20.0)	15	(29.4)	0.759
Analgesic drugs	39	(59.1)	6	(40.0)	33	(64.7)
Corticosteroids	3	(4.5)	1	(6.7)	2	(3.9)
Nutraceuticals	3	(4.5)	1	(6.7)	2	(3.9)
Osteoporosis Medications
Vitamin D	60	(90.9)	12	(80.0)	48	(94.1)	0.122
Calcium	36	(54.5)	9	(60.0)	27	(52.9)
Clodronate	6	(9.1)	0	(0.0)	6	(11.8)
Alendronate/Risedronate/ Zoledronate	15	(22.7)	0	(0.0)	15	(29.4)
Denosumab	3	(4.5)	0	(0.0)	3	(5.9)
Parathyroid hormone (1-34)	18	(27.3)	6	(40.0)	12	(23.5)

Note: variables are expressed as counts (percentages). Abbreviations: NSAIDs: Non-steroidal anti-inflammatory drugs.

The sample population was composed of 54 females and 12 males. Fifteen patients were aged between 60 and 75 years old, while 51 patients were over 75 years old. Most of the patients included ( $n$ : 27; 40.9%) had one VFF, 24 patients (36.4%) had two VFFs, and 15 patients (22.7%) had 3 or more VFFs. Most of VFF were at T11 ( $n$ : 15; 19.0%), T12 ( $n$ 21; 26.6%), L1 ( $n$ : 18; 22.8%), and L2 ( $n$ : 11; 13.9%) level. Further details are shown in Table 1. Pain medications quite vary among the study participants, including analgesic drugs ( $n$ : 39; 59.1%), non-steroidal anti-inflammatory drugs NSAIDs ( $n$ : 18; 27.3%), corticosteroids ( $n$ : 3; 4.5%), and nutraceuticals ( $n$ : 3; 4.5%). Most patients included were treated with a vitamin D supplementation ( $n$ : 60; 90.9%) and calcium supplementation (n: 36; 54.5%). Moreover, clodronate was administered in 6 patients (9.1%), bisphosphonates in 15 patients (22.7%), denosumab in 3 patients (4.5%), and parathyroid hormone (1–34) in 18 patients (27.3%).

Table 2

Clinical outcome measures of the whole sample ( $n=$ 66) assessed at the baseline and after 3 months

	Whole sample ( $n=$ 66)
	$T0$	$T1$	Delta T1-T0
VAS	7.727 $\pm$ 1.296	4.182 $\pm$ 2.844	3.545 $\pm$ 3.183
SPPB	8.184 $\pm$ 2.358	10.339 $\pm$ 2.937	2.155 $\pm$ 2.683
EQ-VAS	35.832 $\pm$ 14.127	53.124 $\pm$ 21.352	27.292 $\pm$ 25.601

Continuous variables are expressed as means $\pm$ standard deviations. $P$ values are considered significant when $P$ is less than 0.05. Abbreviations: T0: Baseline; T1: After 3 months; VAS: Visual analogue scale; SPPB: Short Physical Performance Battery; EQ-VAS: EuroQol visual analogue scale.

A subgroup analysis based on the age of the study participants was performed. The study subsample did not show statistical differences in terms of gender, body composition, VFFs, hyperkyphosis, pain medication, and osteoporosis pharmacological treatment. The demographic and clinical characteristics of the study population have been summarized in Table 2.

Patients with VFF wearing dynamic spinal orthosis reported improvements in terms of pain intensity (T0: 7.727 $\pm$ 1.296 vs T1: 4.182 $\pm$ 2.844), physical functioning (T0: 8.184 $\pm$ 2.358 vs T1: 10.339 $\pm$ 2.937), and QoL (T0: 25.832 $\pm$ 14.127 vs T1: 43.124 $\pm$ 21.352). Further details about the clinical outcome measures assessed in the whole sample are summarized in Table 2.

Table 3

Correlation between spinal orthosis variables and clinical outcome measures of the whole sample ( $n=$ 66)

	Whole sample ( $n=$ 66)
$r$ (CI)	Hours a day of spinal orthosis prescription	$P$ -value	Compliance with spinal orthosis	$P$ -value	Tolerability of spinal orthosis	$P$ -value
VAS improvements	0.8724 (0.7990–0.9201)	$<$ 0.0001	0.5005 (0.2942–0.6623)	$<$ 0.0001	0.4182 (0.1960–0.5996)	0.0005
Physical Functioning improvements	$-$ 0.7667 (0.6442–0.8508)	$<$ 0.0001	$-$ 0.5466 (0.3510 to 0.6965)	$<$ 0.0001	$-$ 0.5261 (0.3255–0.6814)	$<$ 0.0001
Quality of life improvements	0.4360 (0.2168–0.6133)	0.0003	0.7105 (0.5658 to 0.8128)	$<$ 0.0001	0.6792 (0.5232–0.7912)	$<$ 0.0001

Table 4

Subgroup analysis of the clinical outcome measures assessed at the baseline and after 3 months

	Group A (60–74 years old; $n=$ 15)				Group B (over 75 years old; $n=$ 51)				Between-group analysis
	$T0$	$T1$	Delta $T1$ - $T0$	P-value	$T0$	$T1$	Delta $T1$ - $T0$	P-value	$T0$ $p$ -value	$T1$ $p$ -value	Delta $p$ -value
VAS	7.800 $\pm$ 0.414	5.000 $\pm$ 2.699	2.800 $\pm$ 2.883	0.0039	7.706 $\pm$ 1.460	3.941 $\pm$ 2.866	3.765 $\pm$ 3.259	$<$ 0.0001	0.8488	0.3058	0.4048
SPPB	8.400 $\pm$ 2.213	10.500 $\pm$ 2.284	2.100 $\pm$ 3.183	0.0312	8.120 $\pm$ 2.213	10.292 $\pm$ 3.134	2.172 $\pm$ 3.837	$<$ 0.0001	0.2446	0.3731	0.0476
EQ-VAS	38.700 $\pm$ 13.563	55.600 $\pm$ 16.537	16.900 $\pm$ 21.411	0.0005	34.988 $\pm$ 14.336	52.395 $\pm$ 23.285	17.407 $\pm$ 27.48	$<$ 0.0001	0.1271	0.7856	0.0057

Interestingly, the Pearson correlation analysis revealed that hours a day of spinal orthosis prescription were significantly correlated with the improvements in clinical outcomes, showing an $r$ : 0.8724 CI: 0.7990–0.9201; $p<$ 0.0001 for VAS improvements, showing an $r$ : $-$ 0.7667; CI 0.6442–0.8508; $p<$ 0.0001 for physical functioning improvements and an $r$ : 0.4360; CI 0.2168–0.6133; $p$ : 0.0003 for QoL improvements. A moderate correlation was also reported between compliance with spinal orthosis and VAS improvements ( $r$ : 0.5005; CI 0.2942–0.6623; $p<$ 0.0001). On the other hand, a poor correlation was reported between spinal orthosis tolerability and VAS improvements ( $r$ : 0.4182; CI 0.1960–0.5996; $p$ : 0.0005). Further details about the correlation analysis are shown in Table 4.

The age group sub-analysis showed that dynamic spinal orthosis has a significant improvement in pain intensity, physical functioning, and QoL after 3 months. Moreover, no significant between-group differences were reported in terms of VAS improvement, while significant differences were reported in terms of physical functioning improvements and QoL improvements.

Five patients under 75 years old had hyperkyphosis before wearing dynamic spinal orthosis, and no differences were reported after the treatment. In contrast, 31 patients over 75 years old were hyperkyphotic, while after wearing dynamic spinal orthosis for 3 months, the number of patients with hyperkyphosis reduced to 18.

Lastly, no adverse events were reported wearing dynamic spinal orthosis, while the most common causes of poor compliance were pain improvement ( $n$ : 7), difficulty in wearing the spinal orthosis ( $n$ : 1), and non-comfortability ( $n$ : 1).

4. Discussion

The use of semi-rigid and dynamic spinal orthoses for the conservative treatment of VFFs is controversial. The present prospective cohort study aimed to assess patients-reported outcomes of spinal orthosis (Spinfast^®) prescribed in routine clinical practice in VFFs patients in terms of tolerability and compliance rate. These results could have relevant implications on clinical outcomes and point out the key role of PRM physicians in the challenging decision process of spinal orthosis prescription.

Our findings showed that female subjects had a higher prevalence of VFFs (81.8%), as supported by the current literature [47, 48]. It is widely accepted in the common clinical practice that one of the primary goals in the complex management of patients with acute back pain is pain relief and return to daily life activity, followed by postural control achieved by inhibiting the anterior spinal flexion. Several studies have investigated the effect of spinal orthoses, with controversial results [38, 39]. The RCT conducted by Hettchen et al. demonstrated a favorable effect of active spinal orthoses on chronic back pain, related disability, and hyperkyphosis in older women with vertebral fractures and chronic back pain [38]. On the other hand, in their systematic review, Pieroh et al. [39] reported that a clear recommendation for the application of spinal orthosis cannot be given. Indeed, this recommendation is predominately based on non-high-quality studies but is based on the grading of the different available studies and caused by the results of a meticulous quality assessment. These controversial data might also be due to the poor tolerance of spinal orthosis as reported by older people, given the cumbersome intrinsic nature of orthosis [49, 50]. However, our prospective cohort study showed a clinically important improvement of over three points [51] in terms of pain intensity at 3 months when dynamic spinal orthosis (Spinfast^®) was prescribed.

Interestingly, our results showed that the wearing time of spinal orthosis might be correlated with improvements in clinical outcomes and VAS improvement. Concerning spinal alignment in patients with VFFs, hyperkyphosis was more prevalent in older patients (60.8% vs 33.3%). In this context, the most common complications of a prolonged spinal orthosis wearing might be spinal extensor activity reduction [52] and muscle atrophy [53]. Nevertheless, Furrer et al. [54] reported that spinal orthosis had no significant influence on hyperkyphosis, neither on the radiologic change nor the PROMs, concluding that this is more of a theoretical consideration and should certainly be confirmed with further and significantly more extensive studies. In this context, previous studies demonstrated the potential positive influences of dynamic braces on the muscle strength of the trunk extensors, as well as more suitable compliance concerning rigid and semi-rigid orthoses [20, 55, 56]. Therefore, the dynamic semi-rigid brace was designed to potentially provide not only stability during rest but also promote proprioceptive tactile feedback to the patient [57]. This feature facilitates muscle stimulation and aids in reducing a kyphotic posture through a biomechanical feedback loop [27].

Interested to notice that wearing a dynamic spinal orthosis shows a significant improvement in terms of pain intensity, physical functioning, and QoL after 3 months independently from age, in line with a recent study conducted by Kweh et al. [55]. In fact, this recent systematic review has demonstrated moderate-quality evidence to support the use of spinal orthosis in the management of acute osteoporotic vertebral compression fractures in elderly patients aged 60 years and older who are neurologically intact. In light of the study by Kweh et al. [18], our results show a significant improvement in over 75 adults in terms of physical functioning and QoL.

Taken together, the reported data underline controversial findings reported in the current literature [24, 29]. Nevertheless, our findings might improve knowledge in the clinical practice not only of PRM specialists, paving the way for future research on this topic.

According to the literature, rigid and semi-rigid orthosis are the main prescriptions in acute and sub-acute VFFs among orthopedic surgeons. Nevertheless, several studies have demonstrated no difference between rigid and dynamic orthoses in terms of pain relief and QoL improvement in VFF patients [58]. Moreover, the rigidity of the orthoses makes it difficult to wear over extended periods with a negative impact on ADLs and can cause skin breakdown, pressure sores, and patient discomfort leading to a significant decrease in compliance and even worsening of spinal deformities [59]. Moreover, after prolonged bracing periods, a worsening in deconditioning and immobilization related issues could be frequently observed, leading to increased risk of future falls and further injuries and/or fractures, especially in older subjects [58].

The results of this study support the inclusion of dynamic spinal orthosis as an integral component of a comprehensive management approach for VFFs, including pharmacological interventions, physical therapy, and lifestyle modifications. In this context, NSAIDs, analgesics (including narcotics and tramadol), transdermal lidocaine, and agents used to relieve neuropathic pain (e.g., tricyclic antidepressants) are commonly used in clinical practice [60, 61]. Moreover, our data underlined a high prescription of bisphosphonates (31.9%) and parathyroid hormone (27.3%) that represented the first-line approach for patients with VFFs. Moreover, it should be noted how calcium, vitamin D, and probiotics should be considered in a multidisciplinary integrated intervention combined with lifestyle education to prevent or counteract the development of osteosarcopenia [62, 63, 64]. A recent Cochrane systematic review performed by Gibbs et al. supported exercise therapy as an effective intervention in functional outcomes in patients suffering from osteoporotic vertebral fractures [65]. In light of these findings, several countries need PRM physicians to refer their patients with VFFs to physiotherapists for adequate rehabilitative treatment.

To our knowledge, this is the first study designed to assess the prospective role of spinal orthosis in a multitarget rehabilitation approach including pain management, and anti-osteoporotic drugs. Therefore, further studies are necessary to understand the potential role of dynamic spinal orthosis in patients suffering from VFFs in terms of functional outcomes and QoL.

We are aware that this study is not free from limitations. First, the study participants who did not respond after the 3-month period might have not been satisfied with their treatment with potential implications for selection bias However, it should be noted that the present study showed for the first time in literature the heterogeneity in the clinical efficacy of spinal orthosis in VFFs patients, suggesting a lack of evidence and the need for further studies on larger samples and with robust methodological impact. Second, potential confounders (i.e., physical activity levels, premorbility physical functioning, nutritional status) were not screened and may affect the study results and in particular the results of subgroup analysis. In particular, several authors underlined that subgroup analysis might lead to different biases, including selection biases, confounding variables, limited generalizability, increased risk of false-positive findings, reduced statistical power, and the potential for overinterpretation of results [66, 67, 68, 69]. In accordance with previous considerations, it should be always cautious about using results of any subgroup analysis, including the results of the present study. In order to control confounding variables, we provided strict eligibility criteria and improved the sample characterization to limit the implications of missing confounders. In addition, the lack of a control group might be considered a main limitation. However, there were practical and ethical challenges in implementing a control group in patients with VFFs. Lastly, the Pearson correlation coefficient might provide data about the correlation between clinical variables, but no information is currently available about causality estimation that requires adjustment for confounding. Thus, further studies are needed to assess the effects and the causalities of tolerability and compliance rates to the spinal orthosis prescription in the rehabilitation management of people with VFFs.

5. Conclusions

Taken together, our findings suggested potential insight about the integration of dynamic spinal orthosis into the comprehensive rehabilitation management of people with VFFs. In particular, a dynamic spinal orthosis (Spinfast^®) might have a role in improving pain intensity, physical functioning and QoL in patients suffering from VFFs with a significant correlation between clinical outcomes, tolerability, and compliance to spinal orthosis. On the other hand, the large heterogeneity of clinical presentations of patients with VFFs represents important barriers to adequately managing these patients. This was mainly due to the lack of specific indications, emphasizing the need for randomized controlled trials investigating the role of dynamic spinal orthosis in VFFs patients to provide clear recommendations for the correct clinical management of this detrimental condition.

Author contributions

Conceptualization, A.d.S., L.L., and M.I.; Methodology, A.d.S., L.L., and M.I.; Investigation A.d.S., L.L., and M.I; Formal Analysis: A.d.S. and L.L.; Writing-Original Draft Preparation, L.L. and D.C.; Writing-Review and Editing, A.d.S., A.A., and M.I.; Visualization, D.C., N.M., K.M., R.C., and C.C. Supervision, A.d.S. and M.I. All authors read and agreed to the published version of the manuscript.

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethic Committee of the Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy (ASO.MTrasl.21.02; protocol number: 0022441; accepted on 26 October 2021).

Funding

The authors report no funding.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Footnotes

Acknowledgments

We would like to thank Aldo Barbarino, Giampiero Capasso, Stefano Cerruti, Domenico D’Aloisio, Giuseppina De Pace, Matteo Galgani, Lucia Maria Marcantonio, Alberto Marchetti, Giulio Marolda, Raffaele Partescano, Claudio Testi, Roberto Tiberi, Arturo Tricarico, and Alessio Turco for their support to this work. We also extend our gratitude to Stefano Moalli for his contributions to figure development.

Conflict of interest

The authors declare that they have no conflict of interest.

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Dynamic spinal orthoses self-reported effects in patients with back pain due to vertebral fragility fractures: A multi-center prospective cohort study

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

Keywords

1. Introduction

2.1 Study design

2.2 Participants

2.3 Questionnaire development

2.4 Statistical analysis

Table 1 Study population characteristics

5. Conclusions

Author contributions

Ethics approval

Funding

Informed consent

Footnotes

Acknowledgments

Conflict of interest

References

Table 1
Study population characteristics