Background Colorectal cancer is associated with secondary sarcopenia (muscle loss) and myosteatosis (fatty infiltration of muscle) and patients who exhibit these host characteristics have poorer outcomes following surgery. Furthermore, patients who undergo curative advanced rectal cancer surgery such as pelvic exenteration, are at risk of skeletal muscle loss due to immobility, malnutrition and a post-surgical catabolic state. Neuromuscular electrical stimulation (NMES) may be a feasible adjunctive treatment to help ameliorate these adverse side-effects. Hence, the purpose of this study is to investigate NMES as an adjunctive pre- and post-operative treatment for rectal cancer patients in the radical pelvic surgery setting and to provide early indicative evidence of efficacy in relation to key health outcomes. Method In a phase II, Double-blind, randomised controlled study, 58 patients will be recruited and randomised (1:1) to either a treatment (NMES plus standard care) or placebo (sham-NMES plus standard care) group. The intervention will begin two weeks pre-operatively and continue for eight weeks after exenterative surgery. The primary outcome will be change in mean skeletal muscle attenuation, a surrogate marker of myosteatosis. Sarcopenia, quality of life, inflammatory status and cancer specific outcomes will also be assessed. Discussion This pilot study will provide study important preliminary evidence of the potential for this adjunctive treatment. It will provide guidance on subsequent development of phase 3 studies on the clinical benefit of NMES for rectal cancer patients in the radical pelvic surgery setting. Trial Registration ClinicalTrials.gov Identifier: NCT04065984; Registered August 22, 2019; Recruiting.
Background Osteoarthritis (OA) is a major cause of chronic pain; however, the exact pathophysiology of OA pain remains poorly understood. Quantitative sensory testing (QST) is a tool used to assess pain perception. People with OA demonstrate reduced pain thresholds to blunt pressure over affected joints and also at remote body sites, suggesting a contribution of central sensitization to OA pain [1]. Thresholds for thermally induced pain have been less intensively investigated in OA, perhaps because OA pain is traditionally thought to be of mechanical origin. Recent studies have used QST in functional magnetic resonance imaging to further understand the mechanisms of OA pain. For technical reasons, such studies may report thermal rather than pressure pain thresholds; the generalisation of findings to mechanical stimulation is uncertain. Objectives We hypothesised that thermal and pressure pain thresholds both measure aspects of central sensitisation in people with knee OA, and that findings with one modality may predict thresholds to other stimuli. This study aimed to compare pressure with thermal pain thresholds in people with knee OA. Methods 22 participants satisfying American College of Rheumatology criteria for knee OA were recruited from a previous larger pain study. Pressure then thermal (heat and cold) pain thresholds were measured using a Sensebox (Somedic) both at affected (lateral and medial joint margins) and remote (ipsilateral anterior tibia, hand and sternum) sites. Participants were given a PainDETECT questionnaire to evaluate pain phenotype. Results Seven participants scored over the threshold for likely neuropathic pain with PainDETECT. Cold pain thresholds were below -2 °C at joint margins and anterior tibia in >25% of participants. Significant heterogeneity in pain thresholds was detected between sites. Pressure pain thresholds were lowest at the sternum and anterior tibia; heat pain thresholds were lowest in the hand (median 41 °C), and highest at the anterior tibia and lateral joint margin (medians 45 °C). However, within each modality, pain thresholds were significantly correlated between sites (r = 0.48 to 0.86, all p < 0.025). There was a significant positive correlation between pressure and heat pain thresholds at all sites (r = 0.46 to 0.58, p = 0.03 to 0.004), except the sternum. Pressure and cold pain thresholds were significantly associated at the hand (r = -0.64, p = 0.001) and medial knee (r = -0.46, p = 0.03). Conclusions We showed regional differences in pain thresholds, emphasising the need for standardised protocols in QST studies. Strong correlations within each modality between sites suggest that patient rather than local factors predominantly influence measured pain thresholds. Cold pain thresholds did not generate continuous data in the leg, as thresholds were often below -2 C. We show that heat pain thresholds predict pressure pain thresholds in people with OA, both at affected and unaffected sites, suggesting either may be a valid measure of central pain processing. Fu...
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