scholarly journals Perspectives and experiences of people who were randomly assigned to wait-and-see approach in a gluteal tendinopathy trial: a qualitative follow-up study

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044934
Author(s):  
Melanie Louise Plinsinga ◽  
Rebecca Mellor ◽  
Jenny Setchell ◽  
Kelsie Ford ◽  
Leonard Lynch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Corticosteroid Injection ◽  
Imaging Diagnosis ◽  
Parallel Group ◽  
Data Collection And Analysis ◽  
Gluteal Tendinopathy ◽  
Semistructured Interviews ◽  
Registration Number ◽  
Wait And See

ObjectiveTo explore participants’ perspectives on, and experiences of, being assigned to a wait-and-see arm of a gluteal tendinopathy trial.DesignDescriptive qualitative.SettingGeneral community in Brisbane and Melbourne, Australia.ParticipantsFifteen participants who had been randomly allocated to the wait-and-see group in a recent parallel group superiority clinical trial. That trial compared the wait-and-see approach to a physiotherapist-led education plus exercise approach, and an ultrasound-guided corticosteroid injection. The wait-and-see approach involved one physiotherapy session in which participants received reassurance, general advice and encouragement to stay active for the management of gluteal tendinopathy.Data collection and analysisSemistructured interviews were conducted by four interviewers in person or over the internet, audio recorded and transcribed verbatim. Transcripts were coded and data analysed using an inductive thematic approach.ResultsFive themes were extracted from the interview transcripts: (1) Feeling disenfranchised by being assigned to a wait-and-see approach; (2) the importance of having a clinical and imaging diagnosis during screening for inclusion into the clinical trial; (3) feelings regarding the effectiveness of the approach; (4) the convenient and easy to follow nature of the wait-and-see approach and (5) the connotation of wait-and-see not always being perceived as an intervention.ConclusionsParticipants found the wait-and-see approach convenient and easy to follow, yet almost always felt disenfranchised that nothing was being done. Participants highlighted the importance of a definite clinical and imaging diagnosis.Trial registration numberACTRN12612001126808; Post-results.

Bei Schmerzen im Bereich des großen Trochanters erzielen Schulung plus Bewegungstherapie mehr allgemeine Verbesserung als Cortison-Injektionen

2018 ◽  
Vol 28 (04) ◽  
pp. 205-205
Author(s):  
K. Ammer
Keyword(s):  
Clinical Trial ◽  
Corticosteroid Injection ◽  
Randomised Clinical Trial ◽  
Gluteal Tendinopathy ◽  
Injection Use ◽  
Wait And See

Referat zur Arbeit von Mellor R, Bennell K, Grimaldi A, Nicolson P, Kasza J, Hodges P,Wajswelner H, Vicenzino B. Education plus exercise versus corticosteroid injection use versus a wait and see approach on global outcome and pain from gluteal tendinopathy: prospective, single blinded, randomised clinical trial. BMJ 2018; 360: k1662

Leucocyte-Rich Platelet-Rich Plasma Treatment of Gluteus Medius and Minimus Tendinopathy: A Double-Blind Randomized Controlled Trial With 2-Year Follow-up

2019 ◽  
Vol 47 (5) ◽  
pp. 1130-1137 ◽  
Author(s):  
Jane Fitzpatrick ◽  
Max K. Bulsara ◽  
John O’Donnell ◽  
Ming Hao Zheng
Keyword(s):  
Randomized Controlled Trial ◽  
Ultrasound Guidance ◽  
Platelet Rich Plasma ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Harris Hip Score ◽  
Randomized Controlled ◽  
Gluteal Tendinopathy ◽  
To Receive

Background: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). Purpose: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This trial included 80 patients randomized 1:1 to receive LR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. Results: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). Conclusion: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. Registration: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).

Compression sutures combined with intracameral air injection versus thermokeratoplasty for acute corneal hydrops: a prospective-randomised trial

2020 ◽  
pp. bjophthalmol-2020-316414
Author(s):  
Zelin Zhao ◽  
Siteng Wu ◽  
Weina Ren ◽  
Qinxiang Zheng ◽  
Cong Ye ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Trial ◽  
Randomised Clinical Trial ◽  
Air Injection ◽  
Clinical Trial Registration ◽  
Duration Of Symptoms ◽  
Prospective Randomised Trial ◽  
Registration Number ◽  
Corneal Hydrops

AimsTo compare the efficacy of compression sutures combined with intracameral air injection (CSAI) and thermokeratoplasty (TKP) for the management of acute corneal hydrops in keratoconus.MethodsIn this multi-centre randomised clinical trial, 20 patients with keratoconus (20 eyes) with acute corneal hydrops were enrolled and randomised to receive either CSAI or TKP and followed-up for a period of 6 months.ResultsThere were no significant differences in patient demographics, severity of corneal hydrops and preoperative duration of symptoms between the two groups. In both groups, corneal oedema resolved within 2 weeks. The maximum thickness of the corneal scars following CSAI and TKP was not significantly different. Best spectacle-corrected visual acuity was superior in the CSAI group at 6-month follow-up (CSAI vs TKP, 0.52 (0.37, 0.85) vs 0.96 (0.70, 1.34) LogMAR, p=0.042). CSAI resulted in greater corneal endothelial cell density (CSAI vs TKP, 2677.8±326.7 vs 1955.3±298.1 cells/mm2, p<0.001) and flatter corneal curvature (CSAI vs TKP: mean keratometry value, 52.13±4.92 vs 63.51±5.83D, p<0.001; maximum keratometry value, 65.21±7.42 vs 77.13±12.01D, p=0.016) at the 6-month follow-up.ConclusionAlthough both CSAI and TKP resulted in resolution of acute corneal hydrops in keratoconus, CSAI was associated with superior clinical outcomes in this study.Chinese Clinical trial registration numberChiCTR-IOR-17013764

Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial

2021 ◽  
pp. annrheumdis-2021-220512
Author(s):  
Siddharth Jain ◽  
Varun Dhir ◽  
Amita Aggarwal ◽  
Ranjan Gupta ◽  
Bidyalaxmi Leishangthem ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Controlled Trial ◽  
Group Differences ◽  
Drug Discontinuation ◽  
Open Label ◽  
Intention To Treat ◽  
Parallel Group ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesThere are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of ‘usual’ (5 mg every 4 weeks) versus ‘fast’ (5 mg every 2 weeks) escalation of oral MTX.MethodsThis multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat.Results178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group over initial 8 weeks (27%, 40%, p=0.048), but not over 16 weeks. There was no difference in cytopenias, transaminitis, or drug discontinuation/dose reduction between the groups. No serious AE were seen.ConclusionA faster MTX escalation strategy in RA was not more efficacious over 16-24 weeks, and did not significantly increase AE, except higher gastrointestinal AE initially.Trial registration numberCTRI/2018/12/016549

Data from a qualitative study of participants assigned to a wait and see approach in a clinical trial on gluteal tendinopathy.

UQ eSpace ◽  
2020 ◽  
Author(s):  
Melanie Plinsinga ◽  
Rebecca Mellor ◽  
Jenny Setchell ◽  
Kelsie Ford ◽  
Leonard Lynch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Qualitative Study ◽  
Gluteal Tendinopathy ◽  
Wait And See

scholarly journals Does foot mobility affect the outcome in the management of patellofemoral pain with foot orthoses versus hip exercises? A randomised clinical trial

2020 ◽  
Vol 54 (23) ◽  
pp. 1416-1422 ◽  
Author(s):  
Mark Matthews ◽  
Michael Skovdal Rathleff ◽  
Andrew Claus ◽  
Tom McPoil ◽  
Robert Nee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
A Priori ◽  
Randomised Clinical Trial ◽  
Patellofemoral Pain ◽  
Foot Orthoses ◽  
Success Rates ◽  
Insidious Onset ◽  
Registration Number ◽  
Foot Pronation

ObjectivesTo test (i) if greater foot pronation (measured as midfoot width mobility) is associated with better outcomes with foot orthoses treatment, compared with hip exercises and (ii) if hip exercises are superior to foot orthoses, irrespective of midfoot width mobility.MethodsA two-arm parallel, randomised superiority clinical trial was conducted in Australia and Denmark. Participants (18–40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running). Participants were stratified by midfoot width mobility (high ≥11 mm change in midfoot width) and site, randomised to foot orthoses or hip exercises and blinded to objectives and stratification. Success was defined a priori as much better or better on a patient-perceived 7-point scale at 12 weeks.ResultsOf 218 stratified and randomised participants, 192 completed 12-week follow-up. This study found no difference in success rates between foot orthoses versus hip exercises in those with high (6/21 vs 9/20; 29% vs 45%, respectively) or low (42/79 vs 37/72; 53% vs 51%) midfoot width mobility. There was no association between midfoot width mobility and treatment outcome (Interaction effect p=0.19). This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).ConclusionMidfoot width mobility should not be used to help clinicians decide which patient with patellofemoral pain might benefit most from foot orthoses. Clinicians and patients may consider either foot orthoses or hip exercises in managing patellofemoral pain.Trial registration numberACTRN12614000260628.

scholarly journals A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation

2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
Valerio Mezzasalma ◽  
Enrico Manfrini ◽  
Emanuele Ferri ◽  
Anna Sandionigi ◽  
Barbara La Ferla ◽  
...  
Keyword(s):  
Clinical Study ◽  
Controlled Trial ◽  
Double Blind ◽  
Parallel Group ◽  
Registration Number ◽  
The Times ◽  
Irritable Bowel ◽  
Species Specific ◽  
Microbiological Analyses

Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated.Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics.Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period.Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration numberISRCTN15032219.

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