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Study protocol: a double blind randomised control trial of high volume image guided injections in Achilles and patellar tendinopathy in a young active population.

ABSTRACT: Chronic tendinopathy is a significant problem particularly in active populations limiting sporting and occupational performance. The prevalence of patellar tendinopathy in some sports is near 50% and the incidence of lower limb tendinopathy is 1.4% p.a. in the UK Military. Management includes isometric, eccentric, heavy slow resistance exercises and extracorporeal shockwave therapy (ESWT). Often these treatments are inadequate yet there is no good evidence for injection therapies and success rates from surgery can be as low as 50%. High Volume Image Guided Injection (HVIGI) proposes to strip away the neovascularity and disrupt the nerve ingrowth seen in chronic cases and has shown promising results in case series. This study aims to investigate the efficacy of HVIGI in a randomised controlled trial (RCT).RCT comparing 40ml HVIGI, with or without corticosteroid, with a 3ml local anaesthetic sham-control injection. Ninety-six participants will be recruited.male, 18-55 years old, chronic Achilles or patellar tendinopathy of at least 6 months, failed conservative management including ESWT, and Ultrasound (US) evidence of neovascularisation, tendon thickening and echogenic changes. Outcome measures will be recorded at baseline, 6 weeks, 3, 6 and 12 months. Primary outcome measures include The Victoria Institute of Sport Assessments for Achilles and patellar tendinopathy (VISA-A and VISA-P) and VAS pain. Secondary outcome measures include Modified Ohberg score, maximum tendon diameter and assessment of hypoechoic appearance on US, and Functional Activity Assessment.Despite previous interventional trials and reviews there is still insufficient evidence to guide injectable therapy for chronic tendinopathy that has failed conservative treatment. The scant evidence available suggests HVIGI has the greatest potential however there is no level one RCT evidence to support this. Investigating the efficacy of HVIGI against control in a RCT and separating the effect of HVIGI and corticosteroid will add high level evidence to the management of chronic tendinopathy resistant to conservative treatment.EudraCT: 2015-003587-36 3 Dec 2015.

SUBMITTER: Barker-Davies RM

PROVIDER: S-EPMC5441076 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Study protocol: a double blind randomised control trial of high volume image guided injections in Achilles and patellar tendinopathy in a young active population.

Barker-Davies Robert M RM Nicol Alastair A McCurdie I I Watson James J Baker Polly P Wheeler Patrick P Fong Daniel D Lewis Mark M Bennett Alexander N AN

BMC musculoskeletal disorders 20170522 1

<h4>Background</h4>Chronic tendinopathy is a significant problem particularly in active populations limiting sporting and occupational performance. The prevalence of patellar tendinopathy in some sports is near 50% and the incidence of lower limb tendinopathy is 1.4% p.a. in the UK Military. Management includes isometric, eccentric, heavy slow resistance exercises and extracorporeal shockwave therapy (ESWT). Often these treatments are inadequate yet there is no good evidence for injection therap ...[more]

PMID: 28532478

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Project description:BackgroundChronic Achilles and patellar tendinopathy are a significant burden in physically active populations. High-volume image-guided injection (HVIGI) proposes to strip away associated neovascularity, disrupt painful nerve ingrowth, and facilitate rehabilitation.PurposeTo investigate the efficacy of HVIGI with and without steroid relative to placebo.Study designRandomized controlled trial; Level of evidence, 1.MethodsA total of 62 participants were recruited between May 25, 2016, and March 5, 2020. Participants were men aged 18 to 55 years with Achilles or patellar tendinopathy of at least 6-month chronicity that had not improved with nonoperative management (including physical therapy and shockwave therapy), with ultrasound evidence of neovascularization, tendon thickening, and echogenic changes. They were assigned to the following groups: control (3 mL of subcutaneous 0.5% bupivacaine), HVIGI (10 mL of 0.5% bupivacaine and 30 mL of normal saline, ultrasound-guided between tendon and underlying fat pad), or HVIGI with steroid (HVIGIwSteroid; 0.25 mL of 100 mg/mL hydrocortisone). Clinicians and assessors were blinded. All participants were supervised through a pain-guided progressive loading program for 6 months postinjection. The main outcome measures were the Victoria Institute of Sport Assessments (VISA) for Achilles and patellar tendinopathy and the visual analog scale (VAS) for pain at 6 months postinjection.ResultsThe VISA score improved by a mean of 22.8 points (95% CI, 10.4-35.3 points; effect size [ES], 1.51) in the control group (n = 21), 18.6 points (95% CI, 9.1-28.0 points; ES, 1.31) in the HVIGI group (n = 21), and 18.5 points (95% CI, 3.4-33.6 points; ES, 0.88) in the HVIGIwSteroid group (n = 20). VAS pain improved by a mean of 15 points (interquartile range [IQR], -38.75, 8 points; ES, 0.39) in controls, 13 points (IQR,-34.0, 3.75 points; ES, 0.47) in the HVIGI group, and 27 points (IQR,-38.0, -1.0 points; ES, 0.54) in the HVIGIwSteroid group. The main effects were significant for time (P < .001) but not group (P ≥ .48), with no group × time interaction (P = .71). One participant was lost to follow-up from each group, multiple imputation was used for missing data points. No adverse events occurred.ConclusionStudy findings did not demonstrate superiority of HVIGI over control injection.RegistrationEU Clinical Trials Register (EudraCT: 2015-003587-36).

Project description:BackgroundCorticosteroid injections can be performed blind (landmark-guided) or with image guidance, and this may account for variable clinical outcomes. The objective of this study was to assess the effectiveness and safety of image-guided versus blind corticosteroid injections in improving pain and function among adults with shoulder pain.MethodsMEDLINE, the Cochrane Controlled Trials Register and EMBASE were searched to May 2010. Additional studies were identified by searching bibliographies of shortlisted articles. Search items included blind, landmark, anatomical, clinical exam, image-guided, ultrasound, fluoroscopy, steroid injection, frozen shoulder, random allocation, randomized controlled trial (RCT) and clinical trial.Randomized controlled studies comparing image-guided versus blind (landmark-guided) corticosteroid shoulder injections that examined pain, function and/or adverse events were included. Independent extraction was done by two authors using a form with pre-specified data fields, including risk of bias appraisal. Conflicts were resolved by discussion. The decision to pool data was based on assessment of clinical design homogeneity. When warranted, studies were pooled under a random-effects model.ResultsTwo RCTs for pain, function and adverse events (n = 101) met eligibility criteria. No serious threats to validity were found. Both trials compared ultrasound-guided versus landmark-guided injections and were judged similar in clinical design. Low to moderate heterogeneity was observed: shoulder pain I2 = 60%, function I2 = 22%. A meta-analysis demonstrated greater improvement with ultrasound-guided injections at 6 weeks after injection in both pain (mean difference = 2.23 [95% CI: 1.27, 3.18]), as assessed with a 0 to 10 visual analogue scale, and shoulder function (standardised mean difference = 1.09 [95% CI: 0.61, 1.57]) as assessed with shoulder function scores. Although more adverse events (all mild) were reported with landmark-guided injections, the difference was not statistically significant (risk ratio = 0.20 [95% CI: 0.04, 1.13]).This review was only based on two moderate-sized trials. Blinding of patients was not performed in both trials, causing some risk of bias in outcome assessment since primary endpoints were wholly or partially patient-reported.ConclusionThere is a paucity of RCTs on image-guided versus landmark-guided corticosteroid shoulder injections examining pain, function and adverse events. In this review, patients who underwent image-guided (ultrasound) injections had statistically significant greater improvement in shoulder pain and function at 6 weeks after injection. Image-guided (ultrasound) corticosteroid injections potentially offer a significantly greater clinical improvement over blind (landmark-guided) injections in adults with shoulder pain. However, this apparent benefit requires confirmation from further studies (adequately-powered and well-executed RCTs).

Project description:BackgroundInsertional Achilles tendinopathy (IAT) is a common cause of chronic posterior heel pain. Surgical intervention reproducibly improves patients' pain and functional status. We hypothesized that patients older than 60 years would have similar improvements in pain and function and low rates of complications after surgery for IAT when compared to a younger cohort.MethodsRetrospective review of adult case series in patients undergoing surgical management of IAT. Patients were stratified into those 60 years and younger and those older than 60 years. Patients with prior or concomitant surgical procedures and revisions were excluded. Visual analog scale (VAS), Short Form-36 Physical Component Summary and Mental Component Summary (SF-36 PCS/MCS) scores, wound infection, and recurrence, defined as a redevelopment of heel pain in the operative extremity within 6 months, were assessed with a minimum follow-up of 12 months. Statistical analysis was performed using linear regression mixed models and χ2 analysis. Thirty-seven patients were enrolled, with 38 operative heels. The younger cohort had an average age of 49.1 (range, 26-60) years. The older group had an average age of 66.8 (range, 61-76) years.ResultsVAS and SF-36 PCS scores for the entire cohort significantly improved at 6 and 12 months postoperatively (P < .001). Postoperative SF-36 MCS scores for the cohort significantly improved only at 12 months (P < .001). No significant differences between the young and elderly were seen with regard to improvements in VAS and SF-36 PCS/MCS at 6 or 12 months postoperatively. Multiple linear regression models showed no significant difference between age groups and VAS score, SF-36 PCS/MCS, or change in pain scores after controlling for comorbidities. No significant difference in overall complication rates was seen between the 2 groups (4.9% vs 29.4%, P = .104). There was 1 recurrence of heel pain in the younger group and 4 recurrences of pain in the older group (23.5%) at 6 months, of which 2 resolved at 1 year. There was 1 case of a superficial wound infection requiring antibiotics in the older cohort (5.9%). No patients required surgical revision.ConclusionSurgical management of IAT in an older population produced similar improvements in clinical results when compared to a younger cohort, with no significant increase in postoperative complications.Level of evidenceLevel III, retrospective comparative series.

Project description:ObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine department of a large district general hospital, the Netherlands.Participants80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and neovascularisation on ultrasonography. 39 were randomised to a high volume injection without corticosteroids and 41 to placebo.InterventionsParticipants were instructed to perform an exercise programme for 24 weeks (usual care) combined with one 50 mL high volume injection of saline and lidocaine (intervention group) or one 2 mL placebo injection of saline and lidocaine (placebo group) at baseline.Main outcome measuresPrimary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks (analysed using a generalised estimation equations model). Secondary outcomes were patient satisfaction, return to sport, degree of ultrasonographic Doppler flow, visual analogue scale on 10 hop test, power and flexibility of the gastrocnemius and soleus muscles, pain detect questionnaire for neuropathic pain, and pain coping inventory. Participants were evaluated at baseline and at 2, 6, 12, and 24 weeks.ResultsOnly one participant (1%) was lost to follow-up. The estimated mean VISA-A score improved significantly, from 40.4 (95% confidence interval 32.0 to 48.7) at baseline to 59.1 (50.4 to 67.8) at 24 weeks in the high volume injection group and from 36.9 (27.1 to 46.8) to 58.5 (47.9 to 69.1) in the placebo group. The VISA-A score over time did not differ between the groups (adjusted between group difference at 24 weeks 0.5 points, 95% confidence interval -17.8 to 18.8). No significant between group differences were found for patient satisfaction (21/37 (57%) v 19/39 (49%) patients, P=0.50) and return to desired sport (15/29 (52%) v 19/31 (61%) patients active in sports, P=0.65) at 24 weeks. None of the other secondary outcomes differed between the two groups.ConclusionsA high volume injection without corticosteroids in addition to usual care is not effective for symptom reduction in patients with chronic midportion Achilles tendinopathy. On the basis of our findings, we cannot recommend the use of a high volume injection in this patient group.Trial registrationClinicalTrials.gov NCT02996409.

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Study protocol: a double blind randomised control trial of high volume image guided injections in Achilles and patellar tendinopathy in a young active population.

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Study protocol: a double blind randomised control trial of high volume image guided injections in Achilles and patellar tendinopathy in a young active population.

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