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A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises.

ABSTRACT: BACKGROUND:Chemotherapy-induced polyneuropathy (CIPN) is a common toxicity after chemotherapy, immunomodulatory drugs or proteasome inhibitors, which is difficult to treat and may also have impact on quality of life. The objective of the study was to evaluate whole-body vibration (WBV) on the background of an integrated program (IP) including massage, passive mobilization and physical exercises on CIPN. PATIENTS AND METHODS:In an exploratory phase-2 study patients with CIPN (NCI CTC grade 2/3) were randomized for WBV plus IP (experimental) to IP alone (standard). 15 training sessions within 15 weeks were intended. As primary endpoint we used chair-rising test (CRT) to assess physical fitness and coordination. In addition, locomotor and neurological tests and self-assessment tools were performed. RESULTS:A total 131 patients with CIPN were randomized (standard, n = 65; experimental, n = 66). The median age was 60 (range 24-71) years; 44 patients had haematological neoplasms and 87 solid tumors. At baseline, all patients presented with an abnormal CRT. Fifteen (standard) and 22 (experimental) patients left the program due to progression/relapse or concomitant disease. There was no significant difference in the proportion of patients with normal CRT (<10 s) at follow up between experimental (68%) and standard (56%) (p = 0.20). All patients experienced less symptoms and pain (p < 0.001) and had improved CRT (p < 0.001) over time. WBV was significantly associated with a higher reduction of time needed for CRT (p = 0.02) and significantly improved warm-detection-threshold comparing baseline to follow-up assessment (p = 0.02). CONCLUSION:Whole-body vibration on the background of an IP may improve physical fitness and coordination in patients suffering from CIPN. Trial registration Retrospectively registered at http://www.iscrtn.com (ISRCTN 51361937) and http://www.clinicaltrials.gov (NCT02846844).

SUBMITTER: Schonsteiner SS

PROVIDER: S-EPMC5297221 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises.

Schönsteiner Stefan S SS Bauder Mißbach Heidi H Benner Axel A Mack Silja S Hamel Thomas T Orth Michael M Landwehrmeyer Bernhard B Süßmuth Sigurd D SD Geitner Carolin C Mayer-Steinacker Regine R Riester Anneliese A Prokein Andrea A Erhardt Elfriede E Kunecki Jelena J Eisenschink Anna M AM Rawer Rainer R Döhner Hartmut H Kirchner Elisabeth E Schlenk Richard F RF

Experimental hematology & oncology 20170207

<h4>Background</h4>Chemotherapy-induced polyneuropathy (CIPN) is a common toxicity after chemotherapy, immunomodulatory drugs or proteasome inhibitors, which is difficult to treat and may also have impact on quality of life. The objective of the study was to evaluate whole-body vibration (WBV) on the background of an integrated program (IP) including massage, passive mobilization and physical exercises on CIPN.<h4>Patients and methods</h4>In an exploratory phase-2 study patients with CIPN (NCI C ...[more]

PMID: 28194306

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Project description:This pilot randomized controlled trial investigated massage therapy for symptomatic relief of chemotherapy-induced peripheral neuropathy (CIPN) to determine the ideal weekly frequency and number of weeks of providing massage. We evaluated the feasibility and initial efficacy of a Swedish massage protocol to treat lower extremity (LE) CIPN. Inclusion criteria: LE neuropathy attributed to oxaliplatin, paclitaxel, or docetaxel, with no other attributable causes; ≥ 6 months since last chemotherapy; self-reported neuropathy score ≥ 3, 0-10 scale; age ≥ 18. Participant randomization (2:2:1:1) to one of four groups: LE (2) or head/neck/shoulder (control; 1) massage 3 times (3X) a week for 4 weeks; LE (2) or control (1) massage 2X/week for 6 weeks. Completion rate and the Pain Quality Assessment Scale (PQAS) was measured at baseline and 10 weeks later. 71 patients participated: 77.5% women; 57.7% (breast cancer), and 42.3% (GI cancer); mean age 60.3 y/o (range: 40-77); average > 3 years since last chemotherapy. Massage was deemed feasible: mean completion rates (max = 12) were 8.9 (SD 4.2) for 3X/week and 9.8 (SD 4.0) for 2X/week with no statistically significant differences. There were no statistically significant treatment group interactions in PQAS scores at 10-weeks follow-up. There was a statistically significant treatment schedule main effect for PQAS subscales (p < 0.05) at 10 weeks, with lower CIPN symptoms for 3X/week groups versus 2X/week groups. Improvements considered clinically significant favored the LE 3X/week group. Completion rates met pre-defined feasibility criteria. We seemed to observe better outcomes (CIPN symptom reduction) with the more intensive (3X/week for 4 weeks) massage intervention with no differences in adherence, regardless of whether the massage was directly to the CIPN-affected area or not. However, there was some suggestion that the massage program targeting the CIPN-affected area directly provided 3X a week for 4 weeks resulted in the best outcomes.

Project description:Volar locking plates have permitted early mobilization, omitting the need for prolonged cast immobilization, after distal radial fractures (DRFs). However, the type of rehabilitation following plate fixation of DRFs remains an unresolved issue. The purpose of this study was to evaluate the effect of physiotherapy after volar plate fixation of DRFs. At a 2-year follow-up, we compared the results of immediate physiotherapy (early mobilization) with those of home exercises following 2 weeks in a dorsal plaster splint (late mobilization). Patients with an extra-articular DRF scheduled for open reduction and internal fixation (ORIF) with a volar locking plate were evaluated for eligibility for enrollment in the study. The patients were randomized into 2 groups: (1) early mobilization and physiotherapy and (1) late mobilization and home exercise. In the early mobilization group, the plaster splint was removed after 2 to 3 days. During the first 3 months, the patients met with the institution's physiotherapist every other week. The late mobilization group wore the dorsal splint for 2 weeks and only met with our physiotherapist once, when the splint was removed. This group was provided with a home physiotherapy program and instructed to perform home exercises on their own. One hundred and nineteen patients were included in the study. The 2 groups had similar demographics with respect to age, sex, and baseline values. Seven patients were lost to follow-up. No clinically relevant difference in scores on the shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire was found between the 2 groups at any of the follow-up evaluations. The largest difference in the QuickDASH score was found at 6 weeks, when the early mobilization group had a mean score of 30 compared with a mean of 37 in the late mobilization group (p = 0.05). Early mobilization and multiple physiotherapy visits did not improve wrist function compared with standard treatment of 2 weeks in a dorsal plaster splint, a single physiotherapy visit, and home exercises. Early mobilization following ORIF of an extra-articular DRF is safe. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:ObjectivesTo determine the long-term clinical effects of spinal manipulative therapy (SMT) or mobilization (MOB) as an adjunct to neurodynamic mobilization (NM) in the management of individuals with Lumbar Disc Herniation with Radiculopathy (DHR).DesignParallel group, single-blind randomized clinical trial.SettingThe study was conducted in a governmental tertiary hospital.ParticipantsForty (40) participants diagnosed as having a chronic DHR (≥3 months) were randomly allocated into two groups with 20 participants each in the SMT and MOB groups.InterventionsParticipants in the SMT group received high-velocity, low-amplitude manipulation, while those in the MOB group received Mulligans' spinal mobilization with leg movement. Each treatment group also received NM as a co-intervention, administered immediately after the SMT and MOB treatment sessions. Each group received treatment twice a week for 12 weeks.Outcome measuresThe following outcomes were measured at baseline, 6, 12, 26, and 52 weeks post-randomization; back pain, leg pain, activity limitation, sciatica bothersomeness, sciatica frequency, functional mobility, quality of life, and global effect. The primary outcomes were pain and activity limitation at 12 weeks post-randomization.ResultsThe results indicate that the MOB group improved significantly better than the SMT group in all outcomes (p < 0.05), and at all timelines (6, 12, 26, and 52 weeks post-randomization), except for sensory deficit at 52 weeks, and reflex and motor deficits at 12 and 52 weeks. These improvements were also clinically meaningful for neurodynamic testing and sensory deficits at 12 weeks, back pain intensity at 6 weeks, and for activity limitation, functional mobility, and quality of life outcomes at 6, 12, 26, and 52 weeks of follow-ups. The risk of being improved at 12 weeks post-randomization was 40% lower (RR = 0.6, CI = 0.4 to 0.9, p = 0.007) in the SMT group compared to the MOB group.ConclusionThis study found that individuals with DHR demonstrated better improvements when treated with MOB plus NM than when treated with SMT plus NM. These improvements were also clinically meaningful for activity limitation, functional mobility, and quality of life outcomes at long-term follow-up.Trial registrationPan-African Clinical Trial Registry: PACTR201812840142310.

Project description:New findingsWhat is the central question of this study? How does passive heat stress and subsequent heat acclimation affect the circulating concentration of extracellular vesicles? What is the main finding and its importance? Passive heat stress increased the circulating concentration of total and platelet extracellular vesicles. Seven days of hot water immersion did not modify the change in circulating concentrations of extracellular vesicles during passive heat stress.AbstractThis retrospective exploratory analysis aimed to improve our understanding of the effect of passive heat stress and subsequent heat acclimation on the circulating concentration of extracellular vesicles (EVs). Healthy young adults (four females and six males, 25 ± 4 years of age, 1.72 ± 0.08 m in height and weighing 71.6 ± 9.0 kg) were heated with a water-perfused suit before and after seven consecutive days of hot water immersion. Pre-acclimation, participants were heated until oesophageal temperature increased to ∼1.4°C above baseline values. Post-acclimation, participants were heated until oesophageal temperature reached the same absolute value as the pre-acclimation visit (∼38.2°C). Venous blood samples were obtained before and at the end of passive heating to quantify plasma concentrations of EVs from all cell types (CSFE+ ), all cell types except erythrocytes (CSFE+ MHCI+ ), platelets (CSFE+ MHCI+ CD41+ ), endothelial cells (CSFE+ MHCI+ CD62e+ ), red blood cells (CSFE+ CD235a+ ) and leucocytes (CSFE+ MHCI+ CD45+ ) via flow cytometry. Passive heat stress increased the concentration of CFSE+ EVs (46,150,000/ml [3,620,784, 88,679,216], P = 0.036), CFSE+ MHCI+ EVs (28,787,500/ml [9,851,127, 47,723,873], P = 0.021) and CSFE+ MHCI+ CD41+ EVs (28,343,500/ml [9,637,432, 47,049,568], P = 0.008). The concentration of CSFE+ MHCI+ CD62e+ EVs (94,230/ml [-55,099, 243,559], P = 0.187), CSFE+ CD235a+ EVs (-1,414/ml [-15,709, 12,882], P = 0.403) or CSFE+ MHCI+ CD45+ EVs (-192,915/ml [-690,166, 304,336], P = 0.828) did not differ during heat stress. The change in circulating EVs during passive heat stress did not differ after heat acclimation (thermal state × acclimation interactions, all P ≥ 0.180). These results demonstrate that passive heat stress increases the circulating concentration of total and platelet EVs and that passive heat acclimation does not alter this increase.

Dataset Information

A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises.

Publications

A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises.

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