Moving tele-monitoring and tele-treatment from promise to practice : a business model approach for a chronic lower back pain application

The availability of new information and communication technologies creates opportunities for new, mobile tele-health services. While many promising tele-health projects deliver working R&D prototypes, they often do not result in actual deployment. We aim to identify critical issues than can increase our understanding and enhance the viability of the mobile tele-health services beyond the R&D phase by developing a business model. The present study describes the systematic development and evaluation of a service-oriented business model for tele-monitoring and -treatment of chronic lower back pain patients based on a mobile technology prototype. We address challenges of multi-sector collaboration and disruptive innovation.

From prototype to exploitation : mobile services for patients with chronic lower back pain

Many research and development projects that are carried out by firms and research institutes are technology-oriented. There is a large gap between research results, for instance in the form of prototypes, and the actual service offerings to customers. This becomes problematic when an organization wants to bring the results from such a project to the market, which will be particularly troublesome when the research results do not readily fit traditional offerings, roles and capabilities in the industry, nor the financial arrangements. In this chapter, we discuss the design of a business model for a mobile health service, starting with a research prototype that was developed for patients with chronic lower back pain, using the STOF model and method. In a number of design sessions, an initial business model was developed that identifies critical design issues that play a role in moving from prototype toward market deployment. The business model serves as a starting-point to identify and commit relevant stakeholders, and to draw up a business plan and case. This chapter is structured as follows. We begin by discussing the need for mobile health business models. Next, the research and development project on mobile health and the prototype for chronic lower back pain patients are introduced, after which the approach used to develop the business model is described, followed by a discussion of the developed mobile health business model for each of the STOF domains. We conclude with a discussion regarding the lessons that were learned with respect to the development of a business model on the basis of a prototype.

Prevalence and correlates of low back pain among occupational therapy students in Northern Queensland

Background: Although low back pain (LBP) is an important issue for the health profession, few studies have examined LBP among occupational therapy students. Purpose. To investigate the prevalence and distribution of LBP, its adverse sequelae; and to identify potential risk factors.----------- Methods: In 2005, a self-reported questionnaire was administered to occupational therapy students in Northern Queensland.----------- Findings: The 12-month period-prevalence of LBP was 64.6%. Nearly half (46.9%) had experienced pain for over 2 days, 38.8% suffered LBP that affected their daily lives, and 24.5% had sought medical treatment. The prevalence of LBP ranged from 45.5 to 77.1% (p=0.004), while the prevalence of LBP symptoms persisting longer than two days was 34.1 to 62.5% (p=0.020). Logistic regression analysis indicated that year of study and weekly computer usage were statistically-significant LBP risk factors.----------- Implications: The occupational therapy profession will need to further investigate the high prevalence of student LBP identified in this study.

Physiological effects of mechanical pain stimulation at the lower back measured by functional near-infrared spectroscopy and capnography

The aim was to investigate the effect of mechanical pain stimulation at the lower back on hemodynamic and oxygenation changes in the prefrontal cortex (PFC) assessed by functional near-infrared spectroscopy (fNIRS) and on the partial pressure of end-tidal carbon dioxide ( PetCO 2) measured by capnography. 13 healthy subjects underwent three measurements (M) during pain stimulation using pressure pain threshold (PPT) at three locations, i.e., the processus spinosus at the level of L4 (M1) and the lumbar paravertebral muscles at the level of L1 on the left (M2) and the right (M3) side. Results showed that only in the M2 condition the pain stimulation elicited characteristic patterns consisting of (1) a fNIRS-derived decrease in oxy- and total hemoglobin concentration and tissue oxygen saturation, an increase in deoxy-hemoglobin concentration, (2) a decrease in the PetCO 2 response and (3) a decrease in coherence between fNIRS parameters and PetCO 2 responses in the respiratory frequency band (0.2-0.5 Hz). We discuss the comparison between M2 vs. M1 and M3, suggesting that the non-significant findings in the two latter measurements were most likely subject to effects of the different stimulated tissues, the stimulated locations and the stimulation order. We highlight that PetCO 2 is a crucial parameter for proper interpretation of fNIRS data in experimental protocols involving pain stimulation. Together, our data suggest that the combined fNIRS-capnography approach has potential for further development as pain monitoring method, such as for evaluating clinical pain treatment.

Biomechanics of the trunk and lower limbs during gait in individuals with and without chronic low back pain

Combining information on kinetics and kinematics of the trunk during gait is important for both clinical and research purposes, since it can help in better understanding the mechanisms behind changes in movement patterns in chronic low back pain patients. Although three-dimensional gait analysis has been used to evaluate chronic low back pain and healthy individuals, the reliability and measurement error of this procedure have not been fully established. The main purpose of this thesis is to gain a better understanding about the differences in the biomechanics of the trunk and lower limbs during gait, in patients and healthy individuals. To achieve these aims, three studies were developed. The first two, adopted a prospective design and focused on the reliability and measurement error of gait analysis. In these test-retest studies, chronic low back pain and healthy individuals were submitted to a gait assessment protocol, with two distinct evaluation moments, separated by one week. Gait data was collected using a 13-camera opto-electronic system and three force platforms. Data analysis included the computation of time-distance parameters, as well as the peak values for lower limb and trunk joint angles/moments. The third study followed a cross sectional design, where gait in chronic low back pain individuals was compared with matched controls. Step-to-step variability of the thoracic, lumbar and hips was calculated, and step-to-step deviations of these segments from their average pattern (residual rotations) were correlated to each other. The reliability studies in this thesis show that three-dimensional gait analysis is a reliable and consistent procedure for both chronic low back pain and healthy individuals. The results suggest varied reliability indices for multi-segment trunk joint angles, joint moments and time-distance parameters during gait, together with an acceptable level of error (particularly regarding sagittal plane). Our findings also show altered stride-to-stride variability of lumbar and thoracic segments and lower trunk joint moments in patients. These kinematic and kinetic results lend support to the notion that chronic low back pain individuals exhibit a protective movement strategy.

The effectiveness of low-level laser therapy for nonspecific chronic low back pain: a systematic review and meta-analysis.

BACKGROUND: In recent decades, low-level laser therapy (LLLT) has been widely used to relieve pain caused by different musculoskeletal disorders. Though widely used, its reported therapeutic outcomes are varied and conflicting. Results similarly conflict regarding its usage in patients with nonspecific chronic low back pain (NSCLBP). This study investigated the efficacy of low-level laser therapy (LLLT) for the treatment of NSCLBP by a systematic literature search with meta-analyses on selected studies. METHOD: MEDLINE, EMBASE, ISI Web of Science and Cochrane Library were systematically searched from January 2000 to November 2014. Included studies were randomized controlled trials (RCTs) written in English that compared LLLT with placebo treatment in NSCLBP patients. The efficacy effect size was estimated by the weighted mean difference (WMD). Standard random-effects meta-analysis was used, and inconsistency was evaluated by the I-squared index (I(2)). RESULTS: Of 221 studies, seven RCTs (one triple-blind, four double-blind, one single-blind, one not mentioning blinding, totaling 394 patients) met the criteria for inclusion. Based on five studies, the WMD in visual analog scale (VAS) pain outcome score after treatment was significantly lower in the LLLT group compared with placebo (WMD = -13.57 [95 % CI = -17.42, -9.72], I(2) = 0 %). No significant treatment effect was identified for disability scores or spinal range of motion outcomes. CONCLUSIONS: Our findings indicate that LLLT is an effective method for relieving pain in NSCLBP patients. However, there is still a lack of evidence supporting its effect on function.

Exercise and Auricular Acupuncture for Chronic Low Back Pain: A Feasibility Randomised Controlled Trial

Objectives: To evaluate the feasibility of a randomized-controlled trial (RCT) investigating the effects of adding auricular acupuncture (AA) to exercise for participants with chronic low-back pain (CLBP). Methods: Participants with CLBP were recruited from primary care and a university population and were randomly allocated (n=51) to 1 of 2 groups: (1) "Exercise Alone (E)"-12-week program consisting of 6 weeks of supervised exercise followed by 6 weeks unsupervised exercise (n=27); or (2) "Exercise and AA (EAA)"-12-week exercise program and AA (n=24). Outcome measures were recorded at baseline, week 8, week 13, and 6 months. The primary outcome measure was the Oswestry Disability Questionnaire. Results: Participants in the EAA group demonstrated a greater mean improvement of 10.7% points (95% confidence interval, -15.3,-5.7) (effect size=1.20) in the Oswestry Disability Questionnaire at 6 months compared with 6.7% points (95% confidence interval, -11.4,-1.9) in the E group (effect size=0.58). There was also a trend towards a greater mean improvement in quality of life, LBP intensity and bothersomeness, and fear-avoidance beliefs in the EAA group. The dropout rate for this trial was lower than anticipated (15% at 6 mo), adherence with exercise was similar (72% E; 65% EAA). Adverse effects for AA ranged from 1% to 14% of participants. Discussion: Findings of this study showed that a main RCT is feasible and that 56 participants per group would need to be recruited, using multiple recruitment approaches. AA was safe and demonstrated additional benefits when combined with exercise for people with CLBP, which requires confirmation in a fully powered RCT.

Pedometer-driven walking for chronic low back pain:A feasibility randomized controlled trial

OBJECTIVES: To evaluate the feasibility of an RCT of a pedometer-driven walking program and education/advice to remain active compared with education/advice only for treatment of chronic low back pain (CLBP). METHODS: Fifty-seven participants with CLBP recruited from primary care were randomly allocated to either: (1) education/advice (E, n=17) or (2) education/advice plus an 8-week pedometer-driven walking program (EWP, n=40). Step targets, actual daily step counts, and adverse events were recorded in a walking diary over the 8 weeks of intervention for the EWP group only. All other outcomes (eg, functional disability using the Oswestry Disability Questionnaire (ODQ), pain scores, physical activity (PA) measurement etc.) were recorded at baseline, week 9 (immediately post-intervention), and 6 months in both groups. RESULTS: The recruitment rate was 22% and the dropout rate was lower than anticipated (13% to 18% at 6 mo). Adherence with the EWP was high, 93% (n=37/40) walked for =6 weeks, and increased their steps/day [mean absolute increase in steps/d, 2776, 95% confidence interval (CI), 1996-3557] by 59% (95% CI, 40.73%-76.25%) from baseline. Mean percentage adherence with weekly step targets was 70% (95% CI, 62%-77%). Eight (20%) minor-related adverse events were observed in 13% (5/40) of the participants. The EWP group participants demonstrated an 8.2% point improvement [95% CI, -13 to -3.4] on the ODQ at 6 months compared with 1.6% points [95% CI, -9.3 to 6.1) for the E group (between group d=0.44). There was also a larger mean improvement in pain (d=0.4) and a larger increase in PA (d=0.59) at 6 months in EWP. DISCUSSION: This preliminary study demonstrated that a main RCT is feasible. EWP was safe and produced a real increase in walking; CLBP function and pain improved, and participants perceived a greater improvement in their PA levels. These improvements require confirmation in a fully powered RCT.

Individuals with chronic low back pain have greater difficulty in engaging in positive lifestyle behaviours than those without back pain : an assessment of health literacy

Background: Despite the large volume of research dedicated to understanding chronic low back pain (CLBP), patient outcomes remain modest while healthcare costs continue to rise, creating a major public health burden. Health literacy - the ability to seek, understand and utilise health information - has been identified as an important factor in the course of other chronic conditions and may be important in the aetiology of CLBP. Many of the currently available health literacy measurement tools are limited since they measure narrow aspects of health literacy. The Health Literacy Measurement Scale (HeLMS) was developed recently to measure broader elements of health literacy. The aim of this study was to measure broad elements of health literacy among individuals with CLBP and without LBP using the HeLMS.
Methods: Thirty-six community-dwelling adults with CLBP and 44 with no history of LBP responded to the HeLMS. Individuals were recruited as part of a larger community-based spinal health study in Western Australia. Scores for the eight domains of the HeLMS as well as individual item responses were compared between the groups.
Results: HeLMS scores were similar between individuals with and without CLBP for seven of the eight health literacy domains (p > 0.05). However, compared to individuals with no history of LBP, those with CLBP had a significantly lower score in the domain ‘Patient attitudes towards their health’ (mean difference [95% CI]: 0.46 [0.11- 0.82]) and significantly lower scores for each of the individual items within this domain (p < 0.05). Moderate effect sizes ranged from d = 0.47-0.65.
Conclusions: Although no differences were identified in HeLMS scores between the groups for seven of the health literacy domains, adults with CLBP reported greater difficulty in engaging in general positive health behaviours. This aspect of health literacy suggests that self-management support initiatives may benefit individuals with CLBP.

Low back pain in microgravity and bed rest studies

BACKGROUND: The prevalence of low back pain (LBP) for astronauts in space (68%) is higher than the 1-mo prevalence for the general population on Earth (39%). It is unclear whether differences occur between healthy subjects and astronauts with a history of LBP. Knowledge of this issue is important to assess whether a history of LBP could have an operational impact. METHODS: We evaluated LBP prospectively during short duration spaceflight (15 d; N=20) and compared this with similar data collected during two bed rest studies (N=40). Astronauts completed a questionnaire 5-10 d preflight, during each flight day, and 5-10 d postflight. RESULTS: All astronauts with a history of LBP also developed LBP in flight. These astronauts reported a significantly longer duration of LBP and a different pain location. LBP was most often experienced in the central area of the lower back during spaceflight with an incidence of 70% and a mean pain level of 3 (on a scale of 0-10). Pain resolved within 10 d of flight. No neurological signs were present. The most frequently reported countermeasure was assuming a "knees to chest (fetal tuck) position" combined with stretching. Greater LBP intensity was reported in spaceflight than bed rest with a trend indicating a greater number of days of pain during spaceflight. DISCUSSION: The current study represents a prospective study of LBP in spaceflight. The results indicate that LBP is self-limiting in spaceflight and should not pose an operational risk. Prior LBP on Earth appears to be a risk factor for LBP in spaceflight.

Coordination of spinal motion in the transverse and frontal planes during walking in people with and without recurrent low back pain

STUDY DESIGN. Observational cohort study. OBJECTIVE. To investigate spinal coordination during preferred and fast speed walking in pain-free subjects with and without a history of recurrent low back pain (LBP). SUMMARY OF BACKGROUND DATA. Dynamic motion of the spine during walking is compromised in the presence of back pain (LBP), but its analysis often presents some challenges. The coexistence of significant symptoms may change gait because of pain or adaptation of the musculoskeletal structures or both. A history of LBP without the overlay of a current symptomatic episode allows a better model in which to explore the impact on spinal coordination during walking. METHODS. Spinal and lower limb segmental motions were tracked using electromagnetic sensors. Analyses were conducted to explore the synchrony and spatial coordination of the segments and to compare the control and subjects with LBP. RESULTS. We found no apparent differences between the groups for either overall amplitude of motion or most indicators of coordination in the lumbar region; however, there were significant postural differences in the mid-stance phase and other indicators of less phase locking in controls compared with subjects with LBP. The lower thoracic spinal segment was more affected by the history of back pain than the lumbar segment. CONCLUSION. Although small, there were indicators that alterations in spinal movement and coordination in subjects with recurrent LBP were due to adaptive changes rather than the presence of pain. © 2013, Lippincott Williams & Wilkins.

Do people with recurrent back pain constrain spinal motion during seated horizontal and downward reaching?

Background: Although the effect of symptomatic back pain on functional movement has been investigated, changes to spinal movement patterns in essentially pain-free people with a history of recurrent back pain are largely unreported. Reaching activities, important for everyday and occupational function, often present problems to such people, but have not been considered in this population. The purpose of this study was to compare the amplitude and timing of spinal and hip motions during two, seated reaching activities in people with and without a history of recurrent low back pain (RLBP).Methods: Spinal and hip motions during reaching downward and across the body, in both directions, were tracked using electromagnetic sensors. Analyses were conducted to explore the amplitudes, velocities and timings of 3D segmental movements and to compare controls with subjects with recurrent, but asymptomatic lumbar or lumbosacral pain.Findings: We detected significant differences in the amplitude and timing of movement in the lower thoracic region, with the RLBP group restricting movement and demonstrating compensatory increased motion at the hip. The lumbar region displayed no significant between-group differences. The order in which the spinal segments achieved peak velocity in cross-reaching was reversed in RLBP compared to controls, with lumbar motion leading in controls and lagging in RLBP.Interpretation: Subjects with a history of RLBP show a number of altered kinematic features during reaching activities which are not related to the presence or intensity of pain, but which suggest adaptive changes to movement control. (C) 2013 Elsevier Ltd. All rights reserved.

Prevalence of low back pain and associated factors in adults from a middle-size Brazilian city

Objective: To determine the prevalence of low back pain and some related variables among adults of both genders. Methods: Was conduct a cross-sectional study of population-based in the urban area of Presidente Prudente, São Paulo. The sample consisted of 743 adult residents for over two years in this city. Low back pain, quality of sleep and physical activity were collected through face to face interview at the residence of respondents. Was used the chi-square test to analyze the association between variables, later was created tree multivariate models with hierarchical inclusion of confounding factors. Results: The prevalence of low back pain reported last year was 50.2% (95% CI: 46.6, 53.8), and the last week 32.3% (95% CI: 28.9, 35.6). Was association among low back pain and females (p-value = 0.031), older age, lower education, altered sleep and overweight, the adjusted model found that people over the age of 45 years (45 to 59.9 years, OR = 13.1 [1.72-98.5] and ≥ 60 years, OR = 9.10 [1.15-71.7]), with some alteration of sleep (OR = 3.21 [1.84-5.61]) and obese (OR = 2.33 [1:26 to 4:33]) seems to be a risk group for low back pain. Conclusion: The prevalence of low back pain is high and obese people aged over 45 years, with any sleep disturbance are a group at higher risk for low back pain.

The relationship between obesity, low back pain, and lumbar disc degeneration when genetics and the environment are considered: a systematic review of twin studies

BACKGROUND CONTEXT: The relationships between obesity and low back pain (LBP) and lumbar disc degeneration (LDD) remain unclear. It is possible that familial factors, including genetics and early environment, affect these relationships.PURPOSE: To investigate the relationship between obesity-related measures (eg, weight, body mass index [BMI]) and LBP and LDD using twin studies, where the effect of genetics and early environment can be controlled.STUDY DESIGN: A systematic review with meta-analysis.METHODS: MEDLINE, CINAHL, Scopus, Web of Science, and EMBASE databases were searched from the earliest records to August 2014. All cross-sectional and longitudinal observational twin studies identified by the search strategy were considered for inclusion. Two investigators independently assessed the eligibility, conducted the quality assessment, and extracted the data. Metaanalyses (fixed or random effects, as appropriate) were used to pool studies'estimates of association.RESULTS: In total, 11 articles met the inclusion criteria. Five studies were included in the LBP analysis and seven in the LDD analysis. For the LBP analysis, pooling of the five studies showed that the risk of having LBP for individuals with the highest levels of BMI or weight was almost twice that of people with a lower BMI (odds ratio [OR] 1.8; 95% confidence interval [CI] 1.6-2.0; I-2 = 0%). A dose-response relationship was also identified. When genetics and the effects of a shared early environment were adjusted for using a within-pair twin case-control analysis, pooling of three studies showed a reduced but statistically positive association between obesity and prevalence of LBP (OR 1.5; 95% CI 1.1-2.1; I-2 = 0%). However, the association was further diminished and not significant (OR 1.4; 95% CI 0.8-2.3; I-2 = 0%) when pooling included two studies on monozygotic twin pairs only. Seven studies met the inclusion criteria for LDD. When familial factors were not controlled for, body weight was positively associated with LDD in all five cross-sectional studies. Only two cross-sectional studies investigated the relationship between obesity-related measures and LDD accounting for familial factors, and the results were conflicting. One longitudinal study in LBP and three longitudinal studies in LDD found no increase in risk in obese individuals, whether or not familial factors were controlled for.CONCLUSIONS: Findings from this review suggest that genetics and early environment are possible mechanisms underlying the relationship between obesity and LBP; however, a direct causal link between these conditions appears to be weak. Further longitudinal studies using the twin design are needed to better understand the complex mechanisms underlying the associations between obesity, LBP, and LDD.

A randomised controlled trial of spinal manipulative therapy in acute low back pain

OBJECTIVE: To determine whether treatment with spinal manipulative therapy (SMT) administered in addition to standard care is associated with clinically relevant early reductions in pain and analgesic consumption. METHODS: 104 patients with acute low back pain were randomly assigned to SMT in addition to standard care (n = 52) or standard care alone (n = 52). Standard care consisted of general advice and paracetamol, diclofenac or dihydrocodeine as required. Other analgesic drugs or non-pharmacological treatments were not allowed. Primary outcomes were pain intensity assessed on the 11-point box scale (BS-11) and analgesic use based on diclofenac equivalence doses during days 1-14. An extended follow-up was performed at 6 months. RESULTS: Pain reductions were similar in experimental and control groups, with the lower limit of the 95% CI excluding a relevant benefit of SMT (difference 0.5 on the BS-11, 95% CI -0.2 to 1.2, p = 0.13). Analgesic consumptions were also similar (difference -18 mg diclofenac equivalents, 95% CI -43 mg to 7 mg, p = 0.17), with small initial differences diminishing over time. There were no differences between groups in any of the secondary outcomes and stratified analyses provided no evidence for potential benefits of SMT in specific patient groups. The extended follow-up showed similar patterns. CONCLUSIONS: SMT is unlikely to result in relevant early pain reduction in patients with acute low back pain.