Treatment with and without stabilizing lumbar spinal orthosis after one- or two-level spondylodesis: A randomized controlled trial

2020 ◽  
Vol 28 (5) ◽  
pp. 541-549
Author(s):  
Yorck Rommelspacher ◽  
Hannah Bode ◽  
Jana Ziob ◽  
Charlotte Struwe ◽  
Adnan Kasapovic ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Patient Reported ◽  
Subjective Pain ◽  
Postoperative Mobility ◽  
Lumbar Spinal ◽  
Spinal Orthosis

BACKGROUND AND OBJECTIVE: Musculature affected during spondylodesis surgery may benefit and recover faster if supported by spine orthosis postoperatively. METHODS: This prospective study included 50 consecutive patients undergoing one- or two-level spondylodesis. The intervention group received a lumbar spine orthosis (n= 23), while the control group remained without orthosis (n= 27). Patients were assessed for pain (Visual Analogue Scale, VAS), Oswestry Disability index (ODI) as well as the use of analgesics. RESULTS: Patients wearing an orthosis postoperatively reported a higher degree of subjective stability. However, both intervention as well as control group did not show any significant differences for each of the follow-up points regarding VAS, ODI or the use of analgesics. CONCLUSION: Wearing an orthosis has neither impact on subjective pain, the need for analgesics nor for postoperative functionality. However, patients reported that they profited from wearing the orthosis by feeling more stable, thereby nicely improving their postoperative mobility. Thus, novel patient reported outcome measures have to be developed to assess these features in future studies.

Robot-assisted training after proximal humeral fracture: A randomised controlled multicentre intervention trial

2020 ◽  
pp. 026921552096165
Author(s):  
Inga Kröger ◽  
Corinna Nerz ◽  
Lars Schwickert ◽  
Sabine Schölch ◽  
Janina Anna Müßig ◽  
...  
Keyword(s):  
Prospective Trial ◽  
Intervention Group ◽  
Humeral Fracture ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Robot Assisted ◽  
Patient Reported ◽  
Usual Therapy ◽  
Randomised Controlled

Objective: To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF). Design: Multicentre, assessor-blinded, randomised controlled prospective trial. Setting: Three different rehabilitation hospitals in Germany. Subjects: In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group n = 23; control group n = 25). Intervention: The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO®-Spring. Main measures: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery. Results: The mean age of participants was 55 ± 10 years and was similar in both groups ( p > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was −15 (CI = 8–22), at follow-up six month −7 (CI = −2 to 16) at follow up 13 month −9 (CI = 1–16); in control group −14 (CI = 11–18), at follow-up six month −13 (CI = 7–19) at follow up 13 month −6 (CI = −3 to 14). No difference in the change was found between groups ( p > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy. Conclusion: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.

scholarly journals The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 100 (4) ◽  
pp. 662-676 ◽  
Author(s):  
Jenna C Gibbs ◽  
Caitlin McArthur ◽  
John D Wark ◽  
Lehana Thabane ◽  
Samuel C Scherer ◽  
...  
Keyword(s):  
Vertebral Fractures ◽  
Functional Performance ◽  
Physical Therapist ◽  
Controlled Trial ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Feasibility Trial ◽  
Home Exercise ◽  
Intention To Treat ◽  
Patient Reported

Abstract Background Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures. Objective This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures. Design This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups. Setting This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers. Participants This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures. Intervention A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise ≥3 times weekly. Controls received equal attention. Measurements Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses. Results There was a small effect of exercise on 5 times sit-to-stand test versus control (MD = −1.58 [95% CI = −3.09 to −0.07], intention-to-treat; MD = −1.49 [95% CI = −3.12 to 0.16], per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time. Limitations Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses. Conclusions Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.

Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial

2016 ◽  
Vol 57 (1) ◽  
pp. 47-56 ◽  
Author(s):  
Femke M.A.P. Claessen ◽  
Jos J. Mellema ◽  
Nicky Stoop ◽  
Bart Lubberts ◽  
David Ring ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Randomized Controlled ◽  
Patient Reported

scholarly journals Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials (Preprint)

2018 ◽  
Author(s):  
Jennifer Huberty ◽  
Ryan Eckert ◽  
Linda Larkey ◽  
Jonathan Kurka ◽  
Sue A Rodríguez De Jesús ◽  
...  
Keyword(s):  
Physical Health ◽  
Sleep Disturbance ◽  
Controlled Trial ◽  
Myeloproliferative Neoplasm ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Pharmacologic Therapy ◽  
Control Group ◽  
Limited Efficacy ◽  
Patient Reported

BACKGROUND Myeloproliferative neoplasm (MPN) patients often report high symptom burden that persists despite the best available pharmacologic therapy. Meditation has gained popularity in recent decades as a way to manage cancer patient symptoms. OBJECTIVE The aim of this study was to examine the feasibility of 2 different consumer-based meditation smartphone apps in MPN patients and to examine the limited efficacy of smartphone-based meditation on symptoms compared with an educational control group. METHODS Patients (n=128) were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into 1 of 4 groups, 2 of which received varying orders of 2 consumer-based apps (10% Happier and Calm) and 2 that received one of the apps alone for the second 4 weeks of the 8-week intervention after an educational control condition. Participants were asked to perform 10 min of meditation per day irrespective of the app and the order in which they received the apps. Feasibility outcomes were measured at weeks 5 and 9 with a Web-based survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. RESULTS A total of 128 patients were enrolled across all 4 groups, with 73.4% (94/128) patients completing the intervention. Of the participants who completed the 10% Happier app, 61% (46/76) enjoyed it, 66% (50/76) were satisfied with the content, and 77% (59/76) would recommend to others. Of those who completed the Calm app, 83% (56/68) enjoyed it, 84% (57/68) were satisfied with the content, and 97% (66/68) would recommend to others. Of those who completed the educational control, 91% (56/61) read it, 87% (53/61) enjoyed it, and 71% (43/61) learned something. Participants who completed the 10% Happier app averaged 31 (SD 33) min/week; patients completing the Calm app averaged 71 (SD 74) min/week. 10% Happier app participants saw small effects on anxiety (P<.001 d=−0.43), depression (P=.02; d=−0.38), sleep disturbance (P=.01; d=−0.40), total symptom burden (P=.13; d=−0.27), and fatigue (P=.06; d=−0.30), and moderate effects on physical health (P<.001; d=0.52). Calm app participants saw small effects on anxiety (P=.29; d=−0.22), depression (P=.09; d=−0.29), sleep disturbance (P=.002; d=−0.47), physical health (P=.005; d=0.44), total symptom burden (P=.13; d=−0.27), and fatigue (P=.13; d=−0.27). Educational control participants (n=61) did not have effects on any patient-reported outcome except for a moderate effect on physical health (P<.001; d=0.77). CONCLUSIONS Delivering meditation via the Calm app is feasible and scored higher in terms of feasibility when compared with the 10% Happier app. The Calm app will be used to implement a randomized controlled trial, testing the effects of meditation on symptom burden in MPNs. CLINICALTRIAL ClinicalTrials.gov NCT03726944; https://clinicaltrials.gov/ct2/show/NCT03726944 (Archived by WebCite at http://www.webcitation.org/77MVdFJwM)

scholarly journals Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial

2022 ◽  
Author(s):  
Wei Dai ◽  
Wenhong Feng ◽  
Yuanqiang Zhang ◽  
Xin Shelley Wang ◽  
Yangjun Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Usual Care ◽  
Symptom Management ◽  
Intervention Group ◽  
Lung Cancer Surgery ◽  
Patient Reported Outcome ◽  
Cancer Surgery ◽  
Interquartile Range ◽  
Control Group ◽  
Patient Reported

PURPOSE We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery. METHODS Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted. RESULTS Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert. CONCLUSION PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

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