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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.

ABSTRACT: OBJECTIVE:To compare the effects of a programme of load management education plus exercise, corticosteroid injection use, and no treatment on pain and global improvement in individuals with gluteal tendinopathy. DESIGN:Prospective, three arm, single blinded, randomised clinical trial. SETTING:Brisbane and Melbourne, Australia. PARTICIPANTS:Individuals aged 35-70 years, with lateral hip pain for more than three months, at least 4/10 on the pain numerical rating scale, and gluteal tendinopathy confirmed by clinical diagnosis and magnetic resonance imaging; and with no corticosteroid injection use in previous 12 months, current physiotherapy, total hip replacement, or neurological conditions. INTERVENTIONS:A physiotherapy led education and exercise programme of 14 sessions over eight weeks (EDX; n=69), one corticosteroid injection (CSI; n=66), and a wait and see approach (WS; n=69). MAIN OUTCOMES:Primary outcomes were patient reported global rating of change in hip condition (on an 11 point scale, dichotomised to success and non-success) and pain intensity in the past week (0=no pain, 10=worst pain) at eight weeks, with longer term follow-up at 52 weeks. RESULTS:Of 204 randomised participants (including 167 women; mean age 54.8 years (standard deviation 8.8)), 189 (92.6%) completed 52 week follow-up. Success on the global rating of change was reported at eight weeks by 51/66 EDX, 38/65 CSI, and 20/68 WS participants. EDX and CSI had better global improvement scores than WS (risk difference 49.1% (95% confidence interval 34.6% to 63.5%), number needed to treat 2.0 (95% confidence interval 1.6 to 2.9); 29.2% (13.2% to 45.2%), 3.4 (2.2 to 7.6); respectively). EDX had better global improvement scores than CSI (19.9% (4.7% to 35.0%); 5.0 (2.9 to 21.1)). At eight weeks, reported pain on the numerical rating scale was mean score 1.5 (standard deviation 1.5) for EDX, 2.7 (2.4) for CSI, and 3.8 (2.0) for WS. EDX and CSI participants reported less pain than WS (mean difference -2.2 (95% confidence interval -2.89 to -1.54); -1.2 (-1.85 to -0.50); respectively), and EDX participants reported less pain than CSI (-1.04 (-1.72 to -0.37)). Success on the global rating of change was reported at 52 weeks by 51/65 EDX, 36/63 CSI, and 31/60 WS participants; EDX was better than CSI (20.4% (4.9% to 35.9%); 4.9 (2.8 to 20.6)) and WS (26.8% (11.3% to 42.3%); 3.7 (2.4 to 8.8)). Reported pain at 52 weeks was 2.1 (2.2) for EDX, 2.3 (1.9) for CSI, and 3.2 (2.6) for WS; EDX did not differ from CSI (-0.26 (-1.06 to 0.55)), but both treatments did better than WS (1.13 (-1.93 to -0.33); 0.87 (-1.68 to -0.07); respectively). CONCLUSIONS:For gluteal tendinopathy, education plus exercise and corticosteroid injection use resulted in higher rates of patient reported global improvement and lower pain intensity than no treatment at eight weeks. Education plus exercise performed better than corticosteroid injection use. At 52 week follow-up, education plus exercise led to better global improvement than corticosteroid injection use, but no difference in pain intensity. These results support EDX as an effective management approach for gluteal tendinopathy. TRIAL REGISTRATION:Prospectively registered at the Australian New Zealand Clinical Trials Registry (ACTRN12612001126808).

SUBMITTER: Mellor R

PROVIDER: S-EPMC5930290 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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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.

Mellor Rebecca R Bennell Kim K Grimaldi Alison A Nicolson Philippa P Kasza Jessica J Hodges Paul P Wajswelner Henry H Vicenzino Bill B

BMJ (Clinical research ed.) 20180502

<h4>Objective</h4>To compare the effects of a programme of load management education plus exercise, corticosteroid injection use, and no treatment on pain and global improvement in individuals with gluteal tendinopathy.<h4>Design</h4>Prospective, three arm, single blinded, randomised clinical trial.<h4>Setting</h4>Brisbane and Melbourne, Australia.<h4>Participants</h4>Individuals aged 35-70 years, with lateral hip pain for more than three months, at least 4/10 on the pain numerical rating scale, ...[more]

PMID: 29720374

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Project description:BackgroundPlantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP.MethodsTwenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance.DiscussionTo reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT.Trial registrationThe trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ACTRN12619000987167) on 11th July 2019.

Project description:ImportanceCorticosteroid injections and exercise therapy are commonly used to treat chronic midportion Achilles tendinopathy, but the evidence for this combination is limited.ObjectiveTo investigate the effect of corticosteroid injection and exercise therapy compared with placebo injection and exercise therapy for patients with Achilles tendinopathy.Design, setting, and participantsThis was a participant-blinded, physician-blinded, and assessor-blinded randomized clinical trial of patients with Achilles tendinopathy verified by ultrasonography. Assessment of pain and function were conducted at baseline and at 1, 2, 3, 6, 12, and 24 months. Patients were recruited from a university medical clinic and a private rheumatology clinic in Denmark between April 2016 and September 2018. Data analysis was performed from June to September 2021.InterventionsCorticosteroid injection and placebo injection were performed with ultrasonography guidance. Exercise therapy was based on previous trials and consisted of 3 exercises done every second day.Main outcomes and measuresThe primary outcome was the Victorian Institute of Sports Assessment-Achilles (VISA-A) score (range, 1-100, with 100 representing no symptoms) at 6 months. Secondary outcomes included pain measured using a 100-mm Visual Analog Scale for morning pain and pain during exercise (with higher scores indicating worse pain), global assessment (Likert scale), and tendon thickness.ResultsA total of 100 patients were included, with 52 randomized to placebo (mean age, 46 years [95% CI, 44-48 years]; 32 men [62%]) and 48 randomized to corticosteroid injection (mean age, 47 years [95% CI, 45-49 years]; 28 men [58%]). Patients in the 2 groups had similar height (mean [SD], 177 [8] cm), weight (mean [SD], 79 [12] kg), and VISA-A score (mean [SD], 46 [18]) at baseline. The group receiving exercise therapy combined with corticosteroid injections had a 17.7-point (95% CI, 8.4-27.0 points; P < .001) larger improvement in VISA-A score compared with patients receiving exercise therapy combined with placebo injections at 6 months. No severe adverse events were observed in either group, and there was no deterioration in the long term (2-year follow-up).Conclusions and relevanceCorticosteroid injections combined with exercise therapy were associated with better outcomes in the treatment of Achilles tendinopathy compared with placebo injections and exercise therapy. A combination of exercise therapy and corticosteroid injection should be considered in the management of long-standing Achilles tendinopathy.Trial registrationClinicalTrials.gov Identifier: NCT02580630.

Project description:BackgroundGluteal tendinopathy is the most common lower limb tendinopathy. It presents with varying severity but may cause debilitating lateral hip pain.PurposeTo review the therapeutic options for different stages of gluteal tendinopathy, to highlight gaps within the existing evidence, and to provide guidelines for a stage-adjusted therapy for gluteal tendinopathy.Study designSystematic review; Level of evidence, 4.MethodsWe screened Scopus, Embase, Web of Science, PubMed, PubMed Central, Ovid MEDLINE, CINAHL, UpToDate, and Google Scholar databases and databases for grey literature. Patient selection, diagnostic criteria, type and effect of a therapeutic intervention, details regarding aftercare, outcome assessments, complications of the treatment, follow-up, and conclusion of the authors were recorded. An assessment of study methodological quality (type of study, level of evidence) was also performed. Statistical analysis was descriptive. Data from multiple studies were combined if they were obtained from a single patient population. Weighted mean and range calculations were performed.ResultsA total of 27 studies (6 randomized controlled trials) with 1103 patients (1106 hips) were included. The mean age was 53.7 years (range, 17-88 years), and the mean body mass index was 28.3. The ratio of female to male patients was 7:1. Radiological confirmation of the diagnosis was most commonly obtained using magnetic resonance imaging. Reported treatment methods were physical therapy/exercise; injections (corticosteroids, platelet-rich plasma, autologous tenocytes) with or without needle tenotomy/tendon fenestration; shockwave therapy; therapeutic ultrasound; and surgical procedures such as bursectomy, iliotibial band release, and endoscopic or open tendon repair (with or without tendon augmentation).ConclusionThere was good evidence for using platelet-rich plasma in grades 1 and 2 tendinopathy. Shockwave therapy, exercise, and corticosteroids showed good outcomes, but the effect of corticosteroids was short term. Bursectomy with or without iliotibial band release was a valuable treatment option in grades 1 and 2 tendinopathy. Insufficient evidence was available to provide guidelines for the treatment of partial-thickness tears. There was low-level evidence to support surgical repair for grades 3 (partial-thickness tears) and 4 (full-thickness tears) tendinopathy. Fatty degeneration, atrophy, and retraction can impair surgical repair, while their effect on patient outcomes remains controversial.

Project description:ObjectiveTo evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy.DesignRandomised controlled trial.SettingNeurology outpatient clinics in three Dutch hospitals.Participants205 patients with symptoms and signs of cervical radiculopathy of less than one month's durationInterventionsTreatment with a semi-hard collar and taking rest for three to six weeks; 12 twice weekly sessions of physiotherapy and home exercises for six weeks; or continuation of daily activities as much as possible without specific treatment (control group).Main outcome measuresTime course of changes in pain scores for arm and neck pain on a 100 mm visual analogue scale and in the neck disability index during the first six weeks.ResultsIn the wait and see group, arm pain diminished by 3 mm/week on the visual analogue scale (beta=-3.1 mm, 95% confidence interval -4.0 to -2.2 mm) and by 19 mm in total over six weeks. Patients who were treated with cervical collar or physiotherapy achieved additional pain reduction (collar: beta=-1.9 mm, -3.3 to -0.5 mm; physiotherapy: beta=-1.9, -3.3 to -0.8), resulting in an extra pain reduction compared with the control group of 12 mm after six weeks. In the wait and see group, neck pain did not decrease significantly in the first six weeks (beta=-0.9 mm, -2.0 to 0.3). Treatment with the collar resulted in a weekly reduction on the visual analogue scale of 2.8 mm (-4.2 to -1.3), amounting to 17 mm in six weeks, whereas physiotherapy gave a weekly reduction of 2.4 mm (-3.9 to -0.8) resulting in a decrease of 14 mm after six weeks. Compared with a wait and see policy, the neck disability index showed a significant change with the use of the collar and rest (beta=-0.9 mm, -1.6 to -0.1) and a non-significant effect with physiotherapy and home exercises.ConclusionA semi-hard cervical collar and rest for three to six weeks or physiotherapy accompanied by home exercises for six weeks reduced neck and arm pain substantially compared with a wait and see policy in the early phase of cervical radiculopathy. Trial registration Clinical trials NCT00129714.

Dataset Information

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.

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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.

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