scholarly journals Efficacy of periacetabular osteotomy followed by progressive resistance training compared to progressive resistance training as non-surgical treatment in patients with hip dysplasia (PreserveHip) – a protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032782
Author(s):  
Lisa Cecilie Urup Reimer ◽  
Stig Storgaard Jakobsen ◽  
Louise Mortensen ◽  
Ulrik Dalgas ◽  
Julie Sandell Jacobsen ◽  
...  

IntroductionPeriacetabular osteotomy (PAO) is an established treatment for adolescent and adult patients with hip dysplasia. However, the efficacy of PAO has not been tested against another surgical intervention or conservative treatment in a randomised controlled trial before. We suggest that progressive resistance training (PRT) could be an alternative to PAO. The primary aim of this trial is therefore to examine the efficacy of PAO followed by 4 months of usual care followed by 8 months of PRT compared to 12 months of solely PRT in patients with hip dysplasia eligible for PAO in terms of patient-reported pain measured by The Copenhagen Hip and Groin Outcome Score (HAGOS).Methods and analysisThis trial is a single-blinded multicentre randomised controlled clinical trial, where patients with hip dysplasia, who are eligible for PAO, will be randomised to either PAO followed by usual care and PRT or PRT only. Primary outcome is patient-reported pain, measured on the subscale pain on the HAGOS questionnaire 12 months after initiation of PAO or PRT. The key secondary outcomes are the other subscales of the HAGOS, adverse and serious adverse events, usage of painkillers (yes/no) and type of analgesics. Based on the sample size calculation, the trial needs to include 96 patients.Ethics and disseminationThe trial is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-234-18) and by the Danish Data Protection Agency (Journal No 1-16-02-120-19). The trial is also approved by The Regional Committee for Medical and Health Research Ethics, Region South-East Norway (Ref. 2018/1603). All results from this trial will be published in international peer-reviewed scientific journals regardless of whether the results are positive, negative or inconclusive.Trial registration numberNCT03941171

Pain ◽  
2011 ◽  
Vol 152 (2) ◽  
pp. 440-446 ◽  
Author(s):  
Lars L. Andersen ◽  
Charlotte A. Saervoll ◽  
Ole S. Mortensen ◽  
Otto M. Poulsen ◽  
Harald Hannerz ◽  
...  

Burns ◽  
2020 ◽  
Author(s):  
Paul M. Gittings ◽  
Benedict M. Wand ◽  
Dana A. Hince ◽  
Tiffany L. Grisbrook ◽  
Fiona M. Wood ◽  
...  

Thorax ◽  
2019 ◽  
Vol 74 (8) ◽  
pp. 787-796 ◽  
Author(s):  
Lara Edbrooke ◽  
Sanchia Aranda ◽  
Catherine L Granger ◽  
Christine F McDonald ◽  
Mei Krishnasamy ◽  
...  

BackgroundLung cancer is associated with poor health-related quality of life (HRQoL) and high symptom burden. This trial aimed to assess the efficacy of home-based rehabilitation versus usual care in inoperable lung cancer.MethodsA parallel-group, assessor-blinded, allocation-concealed, randomised controlled trial. Eligible participants were allocated (1:1) to usual care (UC) plus 8 weeks of aerobic and resistance exercise with behaviour change strategies and symptom support (intervention group (IG)) or UC alone. Assessments occurred at baseline, 9 weeks and 6 months. The primary outcome, change in between-group 6 min walk distance (6MWD), was analysed using intention-to-treat (ITT). Subsequent analyses involved modified ITT (mITT) and included participants with at least one follow-up outcome measure. Secondary outcomes included HRQoL and symptoms.ResultsNinety-two participants were recruited. Characteristics of participants (UC=47, IG=45): mean (SD) age 64 (12) years; men 55%; disease stage n (%) III=35 (38) and IV=48 (52); radical treatment 46%. There were no significant between-group differences for the 6MWD (n=92) at 9 weeks (p=0.308) or 6 months (p=0.979). The mITT analyses of 6MWD between-group differences were again non-significant (mean difference (95% CI): 9 weeks: −25.4 m (−64.0 to 13.3), p=0.198 and 6 months: 41.3 m (−26.7 to 109.4), p=0.232). Significant 6-month differences, favouring the IG, were found for HRQoL (Functional Assessment of Cancer Therapy–Lung: 13.0 (3.9 to 22.1), p=0.005) and symptom severity (MD Anderson Symptom Inventory–Lung Cancer: −2.2 (−3.6 to –0.9), p=0.001).ConclusionsHome-based rehabilitation did not improve functional exercise capacity but there were improvements in patient-reported exploratory secondary outcomes measures observed at 6 months.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12614001268639).


BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021631 ◽  
Author(s):  
Michael Reddington ◽  
Stephen J Walters ◽  
Judith Cohen ◽  
Susan K Baxter ◽  
Ashley Cole

ObjectiveTo investigate the feasibility of undertaking a definitive randomised controlled trial (RCT).SettingThis was a pilot, pragmatic superiority RCT with a qualitative element, recruiting from 14 general practitioner (GP) practices in England.ParticipantsPatients over 18 years of age presenting to their GP with unilateral lumbar radicular syndrome (LRS), defined as radicular pain and/or neurological symptoms originating from lumbar nerve roots, were eligible to participate in the study, those who did not have a clear understanding of the English language or had comorbidities preventing rehabilitation were ineligible.InterventionsParticipants were randomised into early intervention physiotherapy or usual care with the former receiving their treatment within 2 weeks after randomisation and the latter 6 weeks postrandomisation. Both groups received a patient-centred, goal-orientated physiotherapy programme specific to their needs. Participants received up to six treatment sessions over an 8-week period.Outcome measuresProcess outcomes to determine the feasibility of the study and an exploratory analysis of patient-reported outcomes, including self-rated disability, pain and general health, these were collected at baseline, 6, 12 and 26 weeks postrandomisation.Results80 participants were recruited in 10 GP practices over 34 weeks and randomised to (early intervention physiotherapy n=42, usual care n=38). Follow-up rates at 26 weeks were 32 (84%) in the usual care and 36 (86%) in the early intervention physiotherapy group. The mean area under the curve (larger values indicating more disability) for the Oswestry Disability Index over the 26 weeks was 16.6 (SD 11.4) in the usual care group and 16.0 (SD 14.0) in the intervention group. A difference of −0.6 (95% CI −0.68 to 5.6) in favour of the intervention group.ConclusionsThe results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with LRS.Trial registration numberNCT02618278,ISRCTN25018352.


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