An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: Recommendations for an international clinical research registry

Introduction: Complex Regional Pain Syndrome (CRPS) is a persistent pain condition with low prevalence. Multi-centre collaborative research is needed to attain sufficient sample sizes for meaningful studies. This international observational study: (1) tested the feasibility and acceptability of collecting outcome data using an agreed core measurement set (2) tested and refined an electronic data management system to collect and manage the data. Methods: Adults with CRPS, meeting the Budapest diagnostic clinical criteria, were recruited to the study from 7 international research centres. After informed consent, a questionnaire comprising the core set outcome measures was completed: on paper at baseline (T1), and at 3 or 6 months (T2) using a paper or e-version. Participants and clinicians provided feedback on the data collection process. Clinicians completed the CRPS severity score at T1 and optionally, at T2. Ethical approval was obtained at each international centre. Results: Ninety-eight adults were recruited (female n=66; mean age 46.6 years, range 19-89), of whom 32% chose to receive the T2 questionnaire in an electronic format. Fifty-five participants completed both T1 and T2. Eighteen participants and nine clinicians provided feedback on their data collection experience. Conclusion: This study confirmed the questionnaire core outcome data are feasible and practicable to collect in clinical practice. The electronic data management system provided a robust means of collecting and managing the data across an international population. The findings have informed the final data collection tools and processes which will comprise the first international, clinical research registry and data bank for CRPS

Does Passive Leg Activity Influence Oxygen Saturation and Activity in Sedentary Elderly Adults?

This study aimed to investigate whether any physiological changes might have a clinically significant effect on function in sedentary, institutionalized, older adults treated by a passive training program. A total of 18 subjects (mean age 60.7 ± 3.4) with intellectual disability (ID) participated. We measured SpO2 (arterial oxygen saturation) before, during, and after passive training, and used Barthel Index to measure daily living activities. The general trend indicated that inactive people with ID evidenced a continual increase in SpO2% levels and some functional gains during passive treatment, with superiority to manual passive treatment compared to mechanical active passive training. For current clinical practice, most sedentary patients who experience clinically significant deconditioning and desaturation can benefit from passive treatment

Effects of Dual-Channel Functional Electrical Stimulation on Gait Performance in Patients with Hemiparesis

The study objective was to assess the effect of functional electrical stimulation (FES) applied to the peroneal nerve and thigh muscles on gait performance in subjects with hemiparesis. Participants were 45 subjects (age 57.8 ± 14.8 years) with hemiparesis (5.37 ± 5.43 years since diagnosis) demonstrating a foot-drop and impaired knee control. Thigh stimulation was applied either to the quadriceps or hamstrings muscles, depending on the dysfunction most affecting gait. Gait was assessed during a two-minute walk test with/without stimulation and with peroneal stimulation alone. A second assessment was conducted after six weeks of daily use. The addition of thigh muscles stimulation to peroneal stimulation significantly enhanced gait velocity measures at the initial and second evaluation. Gait symmetry was enhanced by the dual-channel stimulation only at the initial evaluation, and single-limb stance percentage only at the second assessment. For example, after six weeks, the two-minute gait speed with peroneal stimulation and with the dual channel was 0.66 ± 0.30 m/sec and 0.70 ± 0.31 m/sec, respectively (). In conclusion, dual-channel FES may enhance gait performance in subjects with hemiparesis more than peroneal FES alone

The cientificWorldJOURNAL Clinical Study Effects of Dual-Channel Functional Electrical Stimulation on Gait Performance in Patients with Hemiparesis

The study objective was to assess the effect of functional electrical stimulation (FES) applied to the peroneal nerve and thigh muscles on gait performance in subjects with hemiparesis. Participants were 45 subjects (age 57.8 ± 14.8 years) with hemiparesis (5.37 ± 5.43 years since diagnosis) demonstrating a foot-drop and impaired knee control. Thigh stimulation was applied either to the quadriceps or hamstrings muscles, depending on the dysfunction most affecting gait. Gait was assessed during a two-minute walk test with/without stimulation and with peroneal stimulation alone. A second assessment was conducted after six weeks of daily use. The addition of thigh muscles stimulation to peroneal stimulation significantly enhanced gait velocity measures at the initial and second evaluation. Gait symmetry was enhanced by the dual-channel stimulation only at the initial evaluation, and single-limb stance percentage only at the second assessment. For example, after six weeks, the two-minute gait speed with peroneal stimulation and with the dual channel was 0.66 ± 0.30 m/sec and 0.70 ± 0.31 m/sec, respectively (P < 0.0001). In conclusion, dual-channel FES may enhance gait performance in subjects with hemiparesis more than peroneal FES alone

An EEG Tool for Monitoring Patient Engagement during Stroke Rehabilitation: A Feasibility Study

Objective. Patient engagement is of major significance in neural rehabilitation. We developed a real-time EEG marker for attention, the Brain Engagement Index (BEI). In this work we investigate the relation between the BEI and temporary functional change during a rehabilitation session. Methods. First part: 13 unimpaired controls underwent BEI monitoring during motor exercise of varying levels of difficulty. Second part: 18 subacute stroke patients underwent standard motor rehabilitation with and without use of real-time BEI feedback regarding their level of engagement. Single-session temporary functional changes were evaluated based on videos taken before and after training on a given task. Two assessors, blinded to feedback use, assessed the change following single-session treatments. Results. First part: a relation between difficulty of exercise and BEI was identified. Second part: temporary functional change was associated with BEI level regardless of the use of feedback. Conclusions. This study provides preliminary evidence that when BEI is higher, the temporary functional change induced by the treatment session is better. Further work is required to expand this preliminary study and to evaluate whether such temporary functional change can be harnessed to improve clinical outcome. Clinical Trial Registration. Registered with clinicaltrials.gov, unique identifier: NCT02603718 (retrospectively registered 10/14/2015)

Central Sensitization and Psychological State Distinguishing Complex Regional Pain Syndrome from Other Chronic Limb Pain Conditions: A Cluster Analysis Model

Complex regional pain syndrome (CRPS) taxonomy has been updated with reported subtypes and is defined as primary pain alongside other chronic limb pain (CLP) conditions. We aimed at identifying CRPS clinical phenotypes that distinguish CRPS from other CLP conditions. Cluster analysis was carried out to classify 61 chronic CRPS and 31 CLP patients based on evoked pain (intensity of hyperalgesia and dynamic allodynia, allodynia area, and after-sensation) and psychological (depression, kinesiophobia, mental distress, and depersonalization) measures. Pro-inflammatory cytokine IL-6 and TNF-α serum levels were measured. Three cluster groups were created: ‘CRPS’ (78.7% CRPS; 6.5% CLP); ‘CLP’ (64.5% CLP; 4.9% CRPS), and ‘Mixed’ (16.4% CRPS; 29% CLP). The groups differed in all measures, predominantly in allodynia and hyperalgesia (p 0.58). ‘CRPS’ demonstrated higher psychological and evoked pain measures vs. ‘CLP’. ‘Mixed’ exhibited similarities to ‘CRPS’ in psychological profile and to ‘CLP’ in evoked pain measures. The serum level of TNF-αwas higher in the ‘CRPS’ vs. ‘CLP’ (p < 0.001) groups. In conclusion, pain hypersensitivity reflecting nociplastic pain mechanisms and psychological state measures created different clinical phenotypes of CRPS and possible CRPS subtypes, which distinguishes them from other CLP conditions, with the pro-inflammatory TNF-α cytokine as an additional potential biomarker

A multi-centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol

OBJECTIVES This international, multicentre study will inform the final data collection tools and processes which will comprise the first international, clinical research registry for complex regional pain syndrome (CRPS). This study will: (a) test the feasibility and acceptability of collecting outcome measurement data using a patient reported, questionnaire core measurement set (COMPACT [Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies]); and (b) test and refine an electronic data management system to collect and manage the data. METHODS A maximum of 240 adults, meeting the Budapest diagnostic clinical criteria for CRPS type I or II, will be recruited across eight countries. The COMPACT questionnaire will be completed on two occasions: at baseline (T1) and 6 months later (T2). At T2, participants will choose to complete COMPACT using a paper or electronic version. Participants will be asked to feed back on their experience of completing COMPACT via a questionnaire. A separate questionnaire will ask clinicians to feed back their experience of data collection. ANALYSIS The study is not aiming to derive statistically significant data but to ascertain the practicalities of collecting data, using the COMPACT questionnaire set, across a range of different cultures and populations. At the end of the study, a single workshop will be convened to review the findings and agree the final documents and processes for the international registry

Sensory modulation dysfunction is associated with Complex Regional Pain Syndrome.

OBJECTIVE:Complex Regional Pain Syndrome (CRPS), a chronic pain condition, develops mainly after limb trauma and severely inhibits function. While early diagnosis is essential, factors for CRPS onset are elusive. Therefore, identifying those at risk is crucial. Sensory modulation dysfunction (SMD), affects the capacity to regulate responses to sensory input in a graded and adaptive manner and was found associated with hyperalgesia in otherwise healthy individuals, suggestive of altered pain processing. AIM:To test SMD as a potential risk factor for CRPS. METHODS:In this cross-sectional study, forty-four individuals with CRPS (29.9±11 years, 27 men) and 204 healthy controls (27.4±3.7 years, 105 men) completed the Sensory Responsiveness Questionnaire-Intensity Scale (SRQ-IS). A physician conducted the CRPS Severity Score (CSS), testing individuals with CRPS. RESULTS:Thirty-four percent of the individuals with CRPS and twelve percent of the healthy individuals were identified to have SMD (χ2 (1) = 11.95; p<0.001). Logistic regression modeling revealed that the risk of CRPS is 2.68 and 8.21 times higher in individuals with sensory over- and sensory under-responsiveness, respectively, compared to non-SMD individuals (p = 0.03 and p = 0.01, respectively). CONCLUSIONS:SMD, particularly sensory under-responsiveness, might serve as a potential risk factor for CRPS and therefore screening for SMD is recommended. This study provides the risk index probability clinical tool a simple evaluation to be applied by clinicians in order to identify those at risk for CRPS immediately after injury. Further research is needed

An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: recommendations for an international clinical research registry

INTRODUCTION Complex Regional Pain Syndrome (CRPS) is a persistent pain condition with low prevalence. Multi-centre collaborative research is needed to attain sufficient sample sizes for meaningful studies. This international observational study: (1) tested the feasibility and acceptability of collecting outcome data using an agreed core measurement set (2) tested and refined an electronic data management system to collect and manage the data. METHODS Adults with CRPS, meeting the Budapest diagnostic clinical criteria, were recruited to the study from 7 international research centres. After informed consent, a questionnaire comprising the core set outcome measures was completed: on paper at baseline (T1), and at 3 or 6 months (T2) using a paper or e-version. Participants and clinicians provided feedback on the data collection process. Clinicians completed the CRPS severity score at T1 and optionally, at T2. Ethical approval was obtained at each international centre. RESULTS Ninety-eight adults were recruited (female n=66; mean age 46.6 years, range 19-89), of whom 32% chose to receive the T2 questionnaire in an electronic format. Fifty-five participants completed both T1 and T2. Eighteen participants and nine clinicians provided feedback on their data collection experience. CONCLUSION This study confirmed the questionnaire core outcome data are feasible and practicable to collect in clinical practice. The electronic data management system provided a robust means of collecting and managing the data across an international population. The findings have informed the final data collection tools and processes which will comprise the first international, clinical research registry and data bank for CRPS

CRPS site and etiology (N = 44).

<p>CRPS site and etiology (N = 44).</p