Non-specific low back pain (LBP) is one of the leading causes of global disability. Multidisciplinary pain treatment (MPT) programs comprising educational, physical, and psychological interventions ...have shown positive treatment effects on LBP. Nonetheless, such programs are costly and treatment opportunities are often limited to specialized medical centers. mHealth and other digital interventions may be a promising method to successfully support patient self-management in LBP. To address these issues, we investigated the clinical effects of a multidisciplinary mHealth back pain App (Kaia App) in a randomized controlled trial (registered at German Clinical Trials Register under DRKS00016329). One-hundred one adult patients with non-specific LBP from 6 weeks to 1 year were randomly assigned to an intervention group or a control group. In the intervention group, the Kaia App was provided for 3 months. Control treatment consisted of six individual physiotherapy sessions over 6 weeks and high-quality online education. The primary outcome, pain intensity, was assessed at 12-week follow-up on an 11-point numeric rating scale (NRS). Our per-protocol analysis showed no significant differences between the groups at baseline (Kaia App group:
= 5.10 (SD = 1.07) vs. control group:
= 5.41 (SD = 1.15). At 12-week follow-up the Kaia App group reported significantly lower pain intensity (
= 2.70 (SD = 1.51)) compared to the control group (
= 3.40 (SD = 1.63)). Our results indicate that the Kaia App as a multidisciplinary back pain app is an effective treatment in LBP patients and is superior to physiotherapy in combination with online education.
•Hypothalamo-limbic connectivity reflects the cyclic nature of migraine.•Hypothalamo-limbic connectivity is largest just before the attack.•Hypothalamo-limbic connectivity is collapsing during the ...attack.•Limbic perfusion is increasing and has a maximum during the attack.•The disrupted connectivity allows high limbic perfusion, resulting in migraine attack.
Migraine is a complex neurological disorder affecting approximately 12% of the population. The pathophysiology is not yet fully understood, however the clinical features of the disease, such as the cyclic behaviour of attacks and vegetative symptoms, suggest a prominent role of the hypothalamus. Previous research has observed neuronal alterations at different time points during the migraine interval, specifically just before the headache is initiated. We therefore aimed to assess the trajectory of migraineurs’ brain activity over an entire migraine cycle.
Using functional magnetic resonance imaging (fMRI) with pseudo-continuous arterial spin labelling (ASL), we designed a longitudinal intra-individual study to detect the rhythmicity of (1) the cerebral perfusion and (2) the hypothalamic connectivity over an entire migraine cycle. Twelve episodic migraine patients were examined in 82 sessions during spontaneous headache attacks with follow-up recordings towards the next attack.
We detected cyclic changes of brain perfusion in the limbic circuit (insula and nucleus accumbens), with the highest perfusion during the headache attack. In addition, we found an increase of hypothalamic connectivity to the limbic system over the interictal interval towards the attack, then collapsing during the headache phase.
The present data provide strong evidence for the predominant role of the hypothalamus in generating migraine attacks. Due to a genetically-determined cortical hyperexcitability, migraineurs are most likely characterised by an increased susceptibility of limbic neurons to the known migraine trigger. The hypothalamus as a metronome of internal processes is suggested to control these limbic circuits: migraine attacks may occur as a result of the hypothalamus losing control over the limbic system. Repetitive psychosocial stress, one of the leading trigger factors reported by patients, might make the limbic system even more vulnerable and lead to a premature triggering of a migraine attack. Potential therapeutic interventions are therefore suggested to strengthen limbic circuits with dedicated medication or psychological approaches.
Mobile health solutions are finding their way into health systems. The Kaia app has been shown to be able to reduce back pain in two studies. Since pain often comes along with disturbed sleep and ...both symptoms are strongly related we investigated whether the Kaia app training is associated with improved sleep quality.
User data of individuals with back pain were collected in two app versions (cohort 1:
= 180; cohort 2:
= 159). We analyzed the ratings of sleep quality and pain intensity on a 11-point numeric ratings scale (NRS; 0-10) both at the beginning of usage (baseline: BL) and on the individual last day of usage (follow-up: LU) within a 3-month training program.
In both cohorts, we found a significant reduction in pain intensity from BL to LU (cohort 1:
= 4.80;
= 1.59 to
= 3.75;
= 1.76, Δ
= -1.04;
= 2.12;
(158) = 6.207;
<.001/cohort 2:
= 4.20;
= 1.98 to
= 3.65;
= 1.78; Δ
= -0.50;
= 2.04;
(147) = 3.001;
= 0.003) and a significant improvement of sleep quality (cohort 1:
= 5.76;
= 2.12 to
= 6.56;
= 1.72; Δ
=
(158) = 4.310;
< 0.001/cohort 2:
= 6.08;
= 2.08 to
= 6.76;
= 1.55; Δ
= 0.67;
= 2.13; sleep:
(147) = 3.825;
< 0.001). Interestingly, improvement of sleep quality was not fully mediated by pain reduction.
Our analysis underlines the relationship between pain and sleep in the clinical context. Improvement of sleep quality came along with pain reduction and vice versa. Further study should explain the exact mechanisms of action which are associated with the improvement of both symptom parameters.
Non-specific low back pain (NLBP) exerts a profound impact on global health and economics. In the era of Web 3.0, digital therapeutics offer the potential to improve NLBP management. The Rise-uP ...trial introduces a digitally anchored, general practitioner (GP)-focused back pain management approach with the Kaia back pain app as the key intervention. Here, we present the 12-months evaluation of the Rise-uP trial including clinical and economic outcomes, patient satisfaction and behavioral tracking analysis.PurposeNon-specific low back pain (NLBP) exerts a profound impact on global health and economics. In the era of Web 3.0, digital therapeutics offer the potential to improve NLBP management. The Rise-uP trial introduces a digitally anchored, general practitioner (GP)-focused back pain management approach with the Kaia back pain app as the key intervention. Here, we present the 12-months evaluation of the Rise-uP trial including clinical and economic outcomes, patient satisfaction and behavioral tracking analysis.The cluster-randomized controlled study (registration number: DRKS00015048) enrolled 1237 patients, with 930 receiving treatment according to the Rise-uP approach and 307 subjected to standard of care treatment. Assessments of pain, psychological state, functional capacity, and well-being (patient-reported outcome measures; PROMs) were collected at baseline, and at 3-, 6-, and 12-months follow-up intervals. Health insurance partners AOK, DAK, and BARMER provided individual healthcare cost data. An artificial intelligence (AI)-driven behavioral tracking analysis identified distinct app usage clusters that presented all with about the same clinical outcome. Patient satisfaction (patient-reported experience measures; PREMs) was captured at the end of the trial.MethodsThe cluster-randomized controlled study (registration number: DRKS00015048) enrolled 1237 patients, with 930 receiving treatment according to the Rise-uP approach and 307 subjected to standard of care treatment. Assessments of pain, psychological state, functional capacity, and well-being (patient-reported outcome measures; PROMs) were collected at baseline, and at 3-, 6-, and 12-months follow-up intervals. Health insurance partners AOK, DAK, and BARMER provided individual healthcare cost data. An artificial intelligence (AI)-driven behavioral tracking analysis identified distinct app usage clusters that presented all with about the same clinical outcome. Patient satisfaction (patient-reported experience measures; PREMs) was captured at the end of the trial.Intention-to-treat (ITT) analysis demonstrated that the Rise-uP group experienced significantly greater pain reduction at 12 months compared to the control group (IG: -46% vs CG: -24%; p < 0.001) with only the Rise-uP group achieving a pain reduction that was clinically meaningful. Improvements in all other PROMs were notably superior in patients of the Rise-uP group. The AI analysis of app usage discerned four usage clusters. Short- to long-term usage, all produced about the same level of pain reduction. Cost-effectiveness analysis indicated a substantial economic benefit for Rise-uP.ResultsIntention-to-treat (ITT) analysis demonstrated that the Rise-uP group experienced significantly greater pain reduction at 12 months compared to the control group (IG: -46% vs CG: -24%; p < 0.001) with only the Rise-uP group achieving a pain reduction that was clinically meaningful. Improvements in all other PROMs were notably superior in patients of the Rise-uP group. The AI analysis of app usage discerned four usage clusters. Short- to long-term usage, all produced about the same level of pain reduction. Cost-effectiveness analysis indicated a substantial economic benefit for Rise-uP.The Rise-uP approach with a medical multimodal back pain app as the central element of digital treatment demonstrates both, clinical and economic superiority compared to standard of care in the management of NLBP.ConclusionThe Rise-uP approach with a medical multimodal back pain app as the central element of digital treatment demonstrates both, clinical and economic superiority compared to standard of care in the management of NLBP.
There are few published data on the treatment patterns and burden of neuropathic pain. We have investigated this in a large, observational, cross-sectional survey.
We surveyed 602 patients with ...neuropathic pain recruited from general practitioners in six European countries. Physicians recorded demographic and treatment information, including prescription medications. Patients completed Brief Pain Inventory (BPI) severity and interference questions, the EuroQol (EQ-5D), and questions about their productivity, non-prescription treatments, and frequency of physician visits. The BPI Pain Severity score (range: 0–10) is the mean of worst, least, average, and current pain ratings, with scores of 4–6 and 7–10 considered moderate and severe, respectively. We evaluated the impact of pain severity on functioning using analysis of variance models and
χ
2 tests.
Mean (SD) age was 62.9 (14.4) years (50% female). Most patients reported moderate (54%) or severe (25%) pain. Nearly all patients (93%) were prescribed medications for their neuropathic pain: analgesics (71%); anti-epileptics (51%); antidepressants (29%); sedatives/hypnotics (15%). Seventy-six percent visited their physician at least once in the past month. Employment status was affected in 43% of patients; those employed missed a mean (SD) of 5.5 (9.8) workdays during the past month. Pain severity was associated significantly (
P
<
0.001) with poorer EQ-5D scores (mild
=
0.67, moderate
=
0.46, severe
=
0.16), greater disruption of employment status (mild
=
24%, moderate
=
48%, severe
=
54%), and more frequent physician visits (% with one or more visits: mild
=
66%, moderate
=
79%, severe
=
83%).
Patients with neuropathic pain visit their physician frequently and report substantial pain that interferes with daily functioning despite receiving treatment.
Digital medicine has increasing influence on the German healthcare system. In times of social distancing during the ongoing coronavirus disease 2019 (COVID-19) pandemic, digital tools enable health ...professionals to maintain medical care. Furthermore, digital elements have potential to provide effective guideline-oriented treatment to a broad range of patients independently from location and time. This survey was used to assess the attitudes of members of the German Pain Society (health professionals) and of associated self-help groups (patients) towards digital medicine. It was sent out as an online survey to health professionals in September 2020 and to patients in February 2021. The survey referred especially to present usage, attitude and potential concerns regarding particular digital elements. Furthermore, technical affinity was assessed. In total, 250 health professionals and 154 patients participated in the survey. The results show that-although digital elements are already known-a substantial proportion of health professionals still lack broad transfer to regular treatment. The potential of digital tools seems to be recognized by both groups; interestingly, patients consider digital medicine as more useful than health professionals. Nevertheless, concerns about for example data security or digital competence remain in both groups. Taken together, our results indicate that disruptive changes, as the implementation of digital medicine in the healthcare system, have to be guided by intense education and channeled by political policies in order to successfully integrate digital elements into medicine on a long-term basis. This would be in favor for all involved parties and is demanded especially by patients.
When mobile health (mHealth) applications (apps) are investigated, the question of the proper control condition arises. Normally, the randomized controlled trial (RCT) is seen as the gold standard ...when testing efficacy of clinical interventions. Yet, mHealth apps rarely comprise innovative treatments but rather provide established treatments digitally. The classical RCT utilizing a placebo or waiting group condition may not always be the suitable methodology, since non-treatment is not appropriate if a disease urges treatment and the development of chronic disease needs to be prevented. The present commentary discusses conceivable control conditions in mHealth trials and illustrates their limitations.
Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Frequently, treatments are not oriented to existing guidelines. In the ...future, digital elements may be promising tools to support guideline-oriented treatment in a broader range of patients. The cluster-randomized controlled "Rise-uP" trial aims to support a General Practitioner (GP)-centered back pain treatment (Registration No: DRKS00015048) and includes the following digital elements: 1) electronic case report form (eCRF), 2) a treatment algorithm for guideline-based clinical decision making of GPs, 3) teleconsultation between GPs and pain specialists for patients at risk for development of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App).
In the Rise-uP trial, 111 GPs throughout Bavaria (southern Germany) were randomized either to the Rise-uP intervention group (IG) or the control group (CG). Rise-uP patients were treated according to the guideline-oriented Rise-uP treatment algorithm. Standard of care was applied to the CG patients with consideration given to the "National guideline for the treatment of non-specific back pain". Pain rating on the numeric rating scale was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes. All values were assessed at the beginning of the treatment and at 3-month follow-ups.
In total, 1245 patients (IG: 933; CG: 312) with NLBP were included in the study. The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=-33.3% vs CG: M=-14.3%). The Rise-uP group was also superior in secondary outcomes. Furthermore, high-risk patients who received a teleconsultation showed a larger decrease in pain intensity (-43.5%) than CG patients (-14.3%). ANCOVA analysis showed that the impact of teleconsultation was mediated by an increased training activity in the Kaia App.
Our results show the superiority of the innovative digital treatment algorithm realized in Rise-uP, even though the CG also received relevant active treatment by their GPs. This provides clear evidence that digital treatment may be a promising tool to improve the quality of treatment of non-specific back pain. In 2021, analyses of routine data from statutory health insurances will enable us to investigate the cost-effectiveness of digital treatment.
Recent neuroimaging studies have revealed a persistent architecture of intrinsic connectivity networks (ICNs) in the signal of functional magnetic resonance imaging (fMRI) of humans and other ...species. ICNs are characterized by coherent ongoing activity between distributed brain regions during rest, in the absence of externally oriented behavior. While these networks strongly reflect anatomical connections, the relevance of ICN activity for human behavior remains unclear. Here, we investigated whether intrinsic brain activity adapts to repeated pain and encodes an individual's experience. Healthy subjects received a short episode of heat pain on 11 consecutive days. Across this period, subjects either habituated or sensitized to the painful stimulation. This adaptation was reflected in plasticity of a sensorimotor ICN (SMN) comprising pain related brain regions: coherent intrinsic activity of the somatosensory cortex retrospectively mirrored pain perception; on day 11, intrinsic activity of the prefrontal cortex was additionally synchronized with the SMN and predicted whether an individual would experience more or less pain during upcoming stimulation. Other ICNs of the intrinsic architecture remained unchanged. Due to the ubiquitous occurrence of ICNs in several species, we suggest intrinsic brain activity as an integrative mechanism reflecting accumulated experiences.
► Repeated pain changes coherent intrinsic brain activity of a sensorimotor network. ► Activity in somatosensory cortex retrospectively codes recent pain perception. ► Prefrontal cortex predicts upcoming pain intensity on the basis of previous pain.
Functional neuroimaging with magnetic resonance imaging (fMRI) or positron emission tomography (PET) provides the methodology to unravel some of the fascinating, but hitherto largely unresolved ...interactions between physical exercise and brain function. Phenomena such as raised mood, pain modulation, and sport addiction associated with physical exercise are highly interesting psychophysical models that require further in depth understanding at the neurotransmitter level. PET ligand displacement studies allow
in vivo monitoring of endogenous transmitter trafficking in the entire brain and, thereby, to identify the link between exercise-induced behavioral measures and the endogenous neurotransmitter release. This review focuses on the methodology of ligand displacement in the opioidergic system, which together with the dopaminergic system has been considered as a central neurotransmitter system underlying diverse sport-induced psychophysical effects. Understanding the basic principles of exercise-induced transmitter release in the brain will potentially aid clinical applications of endurance training, both as a preventative or therapeutic intervention.
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