Abstract
BACKGROUND AND OBJECTIVE:
Sleep disorders should be routinely evaluated and treated in low back pain (LBP) patients because they represent an important contributor to pain. However, no study thus far has investigated the potential benefit to LBP management of a device improving the sleep quality. Therefore, aim of this study was to assess the effectiveness of an innovative mattress overlay as add-on treatment to LBP rehabilitation.
METHODS:
Thirty eight LBP patients were randomized to standard rehabilitation plus mattress overlay use (cases) or standard rehabilitation only (controls). The intervention duration was 2 months and the following assessments were performed before and after: pain intensity; level of perceived back disability and sleep health; spine mobility; thickness and echo intensity of the lumbar multifidus.
RESULTS:
Significant pre-post-intervention improvements were observed in cases for resting and movement pain, perceived back disability, sleep, fingertip-to-floor distance, multifidus thickness (
CONCLUSIONS:
A combination of rehabilitation and mattress overlay use seems an effective approach for improvement of pain, perceived back disability, sleep, spine mobility, and lumbar multifidus size and structure of LBP patients.
Introduction
A complex and variable interplay among biological, psychological, and social factors underlies the development and progression of low back pain (LBP). Several previous studies have addressed the association of fatigability and weakness of paraspinal muscles with LBP [1, 2, 3, 4, 5]. In addition, recent evidences showed that decrements in sleep health (including insufficient sleep duration, irregular timing of sleep, poor sleep quality, and sleep-wake circadian cycle disorders), that are widespread in modern society, can be associated with an array of disease risks and outcomes, including those contributing to health disparities [6]. Consistently, clinical [7, 8, 9] and epidemiological [10, 11] studies found that sleep disorders should be routinely evaluated and treated in LBP patients because they represent an important contributor to pain and disability.
Although the management of LBP is always multifactorial and may include the use of foot orthotics to normalize lower limb, pelvis and trunk mechanics as the well the use of other devices (e.g., lumbar corset, belts and supports) to provide support to or reduce the load on the lower back and/or pelvic joints [12], no study thus far has investigated the potential benefit to LBP management of a device improving the sleep quality. Mattress overlays are commonly used to prevent pressure ulcers in patients at high risk such as elderly and immobilized patients [13]. Price et al. [14] have previously showed that 4 weeks of mattress overlay use in rheumatology patients with chronic pain and sleep disorders produced improvements of both sleep and pain. Consistently, it may be hypothesized that mattress overlay use could also improve the sleep quantity and/or quality in LBP patients, thereby contributing to improve the effectiveness of a rehabilitation protocol through a modulation of the vicious cycle between sleep impairment, fatigue, and pain. Therefore, the aim of this study was to assess the effectiveness of an innovative mattress overlay as add-on treatment to rehabilitation of LBP patients.
Methods
Study design and patients
Thirty eight LBP patients of both genders [16 males, 22 females; median (interquartile range) age: 58 (18.5) years; body mass index: 23.9 (3.9) kg/m
Chronic LBP was diagnosed as LBP (without radiation) for at least 6 months without a known pathological basis (neurological, trauma-induced, etc.) as the underlying cause. The established exclusion criteria were: major trauma documented from the medical history, pregnancy, widespread pain, inflammatory, hormonal, and neurological disorders, severe psychiatric illness, or if the patient was unable to speak or write Italian to complete the questionnaires. In addition, participants were excluded if they were under anti-inflammatory, analgesic, anticoagulant, muscle relaxant, or antidepressant medication use 1 week before the start of the study, had fibromyalgia syndrome, or had any contraindication to rehabilitation (infection, fever, hypothyroidism, cancer or other systemic disease).
Patients were randomized to one of the following two experimental groups: mattress overlay use plus standard rehabilitation for 2 months (cases:
The patients received a detailed explanation of the study and gave written informed consent prior to participation. The study conformed with the guidelines in the Declaration of Helsinki and was approved by the local ethics committee.
Interventions
The Aiartex device (Herniamesh srl, Chivasso, Italy) used in the study was a 0.9 cm-thick volumetric mattress overlay manufactured with polyester, with suspensory monofilaments that support the weight of a person lying in bed. It has also a moderate stiffness that allows natural movements during sleep. Patients were instructed to use the mattress overlay every night for a period of 2 months.
A multi-domain rehabilitation intervention consisting of supervised rehabilitation therapy to improve back strength, balance, and mobility utilizing reproducible targeted exercises was administered to each patient. Patients participated in the rehabilitation program for 1 hour daily, 3 days per week for 2 months.
Pre-post-intervention assessments
The following assessments were performed before and after the 2-month intervention: (1) pain intensity; (2) fingertip-to-floor test [15]; (3) Oswestry Disability Index; (4) Roland Disability Questionnaire; (5) Pittsburgh Sleep Quality Index; (6) thickness and echo intensity measurements of the lumbar multifidus muscle by ultrasonography.
Assessment of resting and movement pain intensity
Participants were asked to rate the pain using a 100-mm visual analogue scale (VAS) on a vertical, consisting of a 100-mm horizontal line with pain descriptors marked “no pain” on the left side and “the worst imaginable pain” on the right side.
Resting pain intensity was measured prior to any study procedures. Movement pain was measured during active trunk flexion and extension.
Self-report instruments
The level of perceived back disability was measured with well-known self-report instruments for the assessment of the condition specific functional status of LBP patients. The Italian versions of the Oswestry Disability Index [16] and of the Roland Disability Questionnaire [17], that were previously cross-culturally adapted and validated, were adopted.
The Italian Version of the Pittsburgh Sleep Quality Index (PSQI) [18] was adopted for the sleep health assessment. It is a 19-item self-report questionnaire that measures sleep quality over the previous month. Seven clinically derived domains of sleep difficulties (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) are assessed by the questionnaire. Taken together, these sleep domains are scored as a single factor of global sleep quality (i.e., PSQI global score). A global score higher than 5 is considered as an indicator of relevant sleep disturbances.
Finally, all cases were also requested to express their general preference for one of the following two conditions: mattress overlay use during sleep or conventional sleep without mattress overlay.
Lumbar multifidus ultrasound assessments
Ultrasound B-mode images of the lumbar multifidus muscle of both sides were acquired while the patients were prone with a pillow placed under the abdomen to minimise the lumbar lordosis. The same experienced examiner performed all of the assessments and acquired all images.
Six consecutive transversal scans (three for each side) were acquired from the L5 vertebral segment while the patient was relaxed, while twelve longitudinal scans (six for each side) were acquired from the L4–L5 facet joint according to the following protocol [19, 20, 21]: (a) the examiner first identified the L4 spinous process, (b) the examiner then placed the transducer parasagittally along the patient’s spine, with the midpoint over the L4 spinous process, sliding it laterally and tilting it medially until the images of the L4–L5 facet joint, of multifidus muscle, and of the thoracolumbar fascia could be identified, (c) the examiner acquired three consecutive longitudinal scans while the patient was relaxed, (d) the patient performed three times the prone hip extension test and the examiner acquired three scans when the multifidus muscle reached its maximal thickness. The prone hip extension test was selected to assess the multifidus muscle activation (see Section 3) because it has been previously documented that the hip extension is more effective for selective activation of lumbar multifidus muscle than trunk extension or the arm lift [22].
A suitable amount of ultrasound coupling gel was used to ensure optimal image quality and to minimize the transducer pressure on the skin. All measurements were taken using a RS80 ultrasound device (Samsung Electronics Italia, Milano, Italy) equipped by a convex transducer with variable frequency band (2–8 MHz). Gain was set at 50% of the range, dynamic image compression was turned off, and time gain compensation was maintained in the same (neutral) position for all depths. All system-setting parameters were kept constant throughout the study and for each subject. Pictures were stored as DICOM files and transferred to a computer for processing.
Muscle thickness was measured on the longitudinal images acquired for each side. As previously described [23, 24, 25, 26] and shown in Fig. 1 (upper panels), muscle thickness was measured in one point as the distance between the thoracolumbar fascia and the posterior-most portion of the L4–L5 facet joint. The mean of three measurements (one measurement per image) was considered to measure the lumbar multifidus thickness in each of the two experimental conditions (resting and active contraction conditions).
Examples of ultrasound scans of the lumbar multifidus muscle acquired from a representative patient. Upper panels show the longitudinal scans used to measure muscle thickness (white continuous line) for the resting (panel A: 2.5 cm) and active contraction (panel B: 3.1 cm) conditions. Lower panels show the transverse scan used to calculate the echo intensity of the region of interest (panel C: white continuous line). Luminance histogram generated for the region of interest (and used to calculate the mean echo intensity) is reported in panel D.
Muscle echo intensity was measured on the transversal images acquired for each side. As previously described [21, 23] and shown in Fig. 1 (lower panels), a region of interest was chosen to include as much of the muscle as possible without any bone (i.e., the spinous and transverse processes) or surrounding fascia. The mean echo intensity (8-bit resolution, resulting in a number between 0 and 255, where black
Measurements of muscle thickness and echo intensity were performed by using Image J (National Institutes of Health, Bethesda, MD, USA).
Since the Shapiro-Wilk test for the normal distribution of the data failed, non-parametric tests were used. The Mann-Whitney U test was adopted for comparisons between the two groups (cases vs controls), while the Wilcoxon signed-rank test was adopted for comparisons between sides (right vs left), experimental conditions (resting condition vs active contraction), and experimental phases (pre- vs post-intervention). The Fisher’s exact test was adopted for comparisons between proportions.
Data are expressed as median (and interquartile range) and are represented as box-and-whisker plots. Threshold for statistical significance was set at
Results
The two groups of LBP patients were comparable (
All patients who received the mattress overlay were compliant with its use for the 2-month intervention period: the percentage of cases who preferred the mattress overlay use during sleep (71.5%) was significantly (
Significant reductions were observed in cases for the post-intervention pain intensity for both resting (
Upper panel: pre- and post-intervention values of resting and movement pain intensity obtained in cases (leftmost part of the panel) and controls (rightmost part of the panel). 
Pre- and post-intervention values of Oswestry Disability Index (upper panel) and Roland Disability Index (lower panel) obtained in cases (leftmost part of the panels) and controls (rightmost part of the panels). 
Significant reductions were observed in cases for the post-intervention scores of both the Oswestry Disability Index (
The PSQI global score remained constant between the two experimental phases in both cases [pre- intervention: 5.0 (4.0) vs post-intervention: 5.0 (4.0),
Lumbar multifidus thickness was comparable between the two sides (
Pre- and post-intervention values of lumbar multifidus thickness obtained for the two sides (left and right) and for the two experimental conditions (resting and active contraction) in cases (upper panel) and controls (lower panel). 
Significant increases were observed in controls for the pre-intervention multifidus thickness of both sides measured after active contraction compared to the resting condition (left side:
Pre- and post-intervention values of lumbar multifidus echo intensity obtained for the two sides (left and right) in cases (upper panel) and controls (lower panel). 
Significant reductions were observed in cases for the post-intervention multifidus echo-intensity (of both sides) compared to the pre-intervention values (left side:
The main findings of this study were that the mattress overlay use in combination with rehabilitation was associated with better and clinically meaningful results for resting and movement pain, level of perceived back disability, sleep, fingertip-to-floor test performance of LBP patients (cases) when compared with rehabilitation only (controls). These results obtained in cases were also paralleled by pre-post-intervention improvements in muscle size (i.e., multifidus thickness increase) and structure (i.e., multifidus echo intensity reduction) that were not observed in controls.
We found high percentages of LBP patients presenting sleep disturbances in the pre-intervention phase (
The pre-post-intervention increase of the lumbar multifidus thickness observed in cases resembles the physiological adaptations of muscle size in response to training [34, 35, 36] and could be the result of the muscle anabolic response. To our knowledge, this is the first study investigating the lumbar multifidus echo intensity and its pre-post-intervention changes in LBP patients. Muscle echo intensity is related to the fibrous and adipose tissue content of muscles (i.e., myosteatosis) [27, 37, 38]. Although no muscle biopsy was performed in this study, the post-intervention reduction of the muscle echo intensity observed in cases can be related to a reduction of myosteatosis that could, in turn, be underlain by post-intervention improvements of insulin sensitivity [39] and/or changes in muscle fiber type composition [39, 40]. The pre-post-intervention improvements of muscle size and structure observed in cases were paralleled by improvements in the fingertip-to-floor test performance, but not in multifidus muscle activation. It may be hypothesized that the selected duration and/or paradigm of the rehabilitation intervention were not enough to elicit muscle activation improvements. Alternatively, it may be suggested that the responsiveness to change [33] of the ultrasound-based muscle activation assessment was poor and that other techniques (e.g., EMG analysis, muscle strength assessment) may be required to unravel the multifidus muscle function adaptations elicited by rehabilitation.
From a clinical perspective, the present results have three relevant implications for the management of LBP patients. First, given the high percentages of LBP patients presenting sleep disturbances, it may be suggested that LBP evaluation in clinical practice should systematically include the sleep health assessment. Second, given the observed compliance (and preference) of cases who received the mattress overlay and given the differences in the pre-post-intervention changes observed between cases and controls, it may be concluded that a device improving the sleep quality was also useful to improve rehabilitation effectiveness, ultimately resulting in improvement of pain and other clinical outcomes. These findings support the device incorporation in clinical protocols for rehabilitation of LBP patients. However, further studies are required to confirm these preliminary findings and to assess the effects on sleep and pain of different types of mattress overlays (e.g., inflatable mattress overlay, viscoelastic foam overlay, gel foam overlay) commonly used for prevention of pressure ulcers [13]. Third, the ultrasound assessment of multifidus thickness and echo intensity was useful to track the progression of muscle size and structure over time and to monitor their responses to interventions. These findings support the incorporation of quantitative muscle ultrasonography in clinical research studies performed in LBP patients to assess longitudinally their responses to rehabilitation protocols.
In conclusion, we showed that a combination of rehabilitation and mattress overlay use seems an effective approach for improvement of pain, perceived back disability, sleep, spine mobility, and lumbar multifidus size and structure of LBP patients.
Footnotes
Acknowledgments
Authors thank Herniamesh srl (Chivasso, Italy) for proving the mattress overlays used in this study.
Conflict of interest
None to report.
