Dataset Information

Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial.

ABSTRACT:

Objective

To study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.

Design

Patient and assessor blinded, placebo controlled randomised clinical trial.

Setting

Sports medicine department of a large district general hospital, the Netherlands.

Participants

80 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.

Interventions

Participants 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 measures

Primary 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.

Results

Only 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.

Conclusions

A 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 registration

ClinicalTrials.gov NCT02996409.

SUBMITTER: van der Vlist AC

PROVIDER: S-EPMC7479639 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial.

van der Vlist Arco C AC van Oosterom Robert F RF van Veldhoven Peter L J PLJ Bierma-Zeinstra Sita M A SMA Waarsing Jan H JH Verhaar Jan A N JAN de Vos Robert-Jan RJ

BMJ (Clinical research ed.) 20200909

<h4>Objective</h4>To study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.<h4>Design</h4>Patient and assessor blinded, placebo controlled randomised clinical trial.<h4>Setting</h4>Sports medicine department of a large district general hospital, the Netherlands.<h4>Participants</h4>80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and ...[more]

PMID: 33315586

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Project description:BackgroundAchilles tendinopathy (AT) is a common overuse injury in running-related sports where patients experience pain and impaired function which can persist. A graded rehabilitation program has been successful in reducing pain and improving function to enable a return to sport. The aim of this study is to compare the effectiveness of a criteria-based rehabilitation program including strength and reactive strength targets, with a previously successful rehabilitation program on changes in pain and function using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire. Secondary aims will be to assess changes in calf strength, reactive strength, and lower limb running and forward hop biomechanics over the course of a 12-week rehabilitation program, and long-term follow-up investigations.MethodsSixty eligible participants with chronic mid-portion AT who train in running-based sports will be included in this study. They will be randomly assigned to a group that will follow an evidence-based rehabilitation program of daily exercises with progression guided by symptoms or a group performing 3 high-intensity rehabilitation sessions per week with individualised load targets progressing to reactive strength exercises. Testing will take place at baseline, week 6 and 12. Plantar flexor peak torque will be measured using isokinetic dynamometry, reactive strength will be measured using a drop jump and lower limb biomechanical variables will be measured during a single leg forward hurdle hop test and treadmill running using 3D motion analysis. Follow-up interviews will take place at 6, 12 and 24 months after beginning the program which will assess patient participation in sport and possible re-injury.DiscussionThis is the first study to propose an individualised criteria-based graded rehabilitation program in patients in with chronic mid-portion Achilles tendinopathy where progression is guided by strength and reactive strength outcome measures. This study will provide a comprehensive assessment of plantar flexor strength, reactive strength and lower limb biomechanical variables in running and forward hopping with the VISA-A questionnaire as the primary outcome measure and long term post-intervention follow-up assessments performed.Trial registrationClinicalTrials.gov (ID: NCT04384874 ). Registered retrospectively on April 23rd 2020.

Project description:BackgroundThe insertion of filiform needles intramuscularly (a.k.a. intramuscular stimulation/dry needling) has been suggested as a possible treatment for various painful musculoskeletal conditions. Our aim was to answer the question, is intramuscular stimulation more effective than sham intramuscular stimulation/dry needling for the treatment of Achilles tendinopathy?Methods52 participants with persistent midportion Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control) (n = 8). The a priori primary outcome measure was change in VISA-A score at 12 weeks-VISA-A was also measured at 6 weeks, and at 6 and 12 months. Secondary outcome measures include the proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm).ResultsThe study retention was 94% at 12 weeks and 88% at 1 year. VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint. The percentage of patients who rated themselves as much or very much improved (i.e. treatment success) was not different after 12 weeks (G3 70%, G2 89%, G1 86% p = 0.94), or at 26 (p = 0.62) or 52 weeks (p = 0.71). No clinically significant effects of intervention group were observed in any of the secondary outcome measures.ConclusionThe addition of intramuscular stimulation to standard rehabilitation for Achilles tendinopathy did not result in any improvement over the expected clinical benefit achieved with exercise-based rehabilitation alone.

Project description:ImportancePlatelet-rich plasma injections are used as a treatment for chronic midportion Achilles tendinopathy, but evidence for this treatment is limited.ObjectiveIn adults with midportion Achilles tendinopathy, to assess the effects of a single platelet-rich plasma injection, compared with sham injection, on the outcome of the Victorian Institute of Sport Assessment-Achilles (VISA-A) score (a single composite measure of Achilles tendinopathy severity).Design, setting, and participantsA participant-blinded, multicenter randomized clinical trial that included 240 people from 24 sites assigned to either a platelet-rich plasma injection or a sham injection between April 2016 and February 2020. Final follow-up was July 2020. Participants were older than 18 years with midportion Achilles tendon pain for more than 3 months as confirmed by ultrasound, magnetic resonance imaging, or both.InterventionsA single intratendinous platelet-rich plasma injection (n = 121) or a single sham injection (insertion of a subcutaneous dry needle not entering the tendon) (n = 119).Main outcomes and measuresThe primary outcome was the VISA-A score, measured 6 months after treatment allocation. The VISA-A score contains 8 questions that cover 3 domains of pain, function, and activity, analyzed as a composite score (range, 0 [worst symptoms] to 100 [no symptoms]; minimal clinically important difference in score, 12 points). The primary analysis was adjusted for laterality, age, sex, and baseline VISA-A score.ResultsAmong 240 patients assigned to a platelet-rich plasma or sham injection (mean age, 52 years; 138 [58%] women), 221 (92%) completed the trial. At 6-month follow-up, mean VISA-A score values in the plasma-rich plasma group vs the sham injection group were 54.4 vs 53.4 (adjusted mean difference, -2.7 [95% CI, -8.8 to 3.3]). The most common adverse events compared between patients in the platelet-rich plasma group vs the sham group were injection site discomfort (97 vs 73 patients), swelling (56 vs 52 patients) and bruising (48 vs 49 patients).Conclusions and relevanceAmong patients with chronic midportion Achilles tendinopathy, treatment with a single injection of intratendinous platelet-rich plasma, compared with insertion of a subcutaneous dry needle, did not reduce Achilles tendon dysfunction at 6 months. These findings do not support the use of this treatment for chronic midportion Achilles tendinopathy.Trial registrationisrctn.org Identifier: ISRCTN13254422.

Project description:BackgroundAchilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. The exception to this is eccentric calf muscle exercises, which have become a standard non-surgical intervention for Achilles tendinopathy. Foot orthoses have also been advocated as a treatment for Achilles tendinopathy, but the long-term efficacy of foot orthoses for this condition is unknown. This manuscript describes the design of a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy.MethodsOne hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to either a control group (sham foot orthoses made from compressible ethylene vinyl acetate foam) or an experimental group (customised foot orthoses made from semi-rigid polypropylene). Both groups will be prescribed a calf muscle eccentric exercise program, however, the primary difference between the groups will be that the experimental group receive customised foot orthoses, while the control group receive sham foot orthoses. The participants will be instructed to perform eccentric exercises 2 times per day, 7 days per week, for 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. The secondary outcome measures will be participant perception of treatment effect, comfort of the foot orthoses, use of co-interventions, frequency and severity of adverse events, level of physical activity and health-related quality of life (assessed using the Short-Form-36 questionnaire - Version two). Data will be collected at baseline, then at 1, 3, 6 and 12 months. Data will be analysed using the intention to treat principle.DiscussionThis study is the first randomised trial to evaluate the long-term efficacy of customised foot orthoses for the treatment of Achilles tendinopathy. The study has been pragmatically designed to ensure that the study findings are generalisable to clinical practice.Trial registrationAustralian New Zealand Clinical Trials Registry Number: ACTRN12609000829213.

Project description:BackgroundMid-portion Achilles Tendinopathy (AT) is a common musculoskeletal condition with varying rehabilitation success rates. Despite the prevalence of this condition, a considerable proportion of individuals experience persisting pain and functional deficits. Current treatment approaches bias the biomedical model which emphasises physically treating and loading the tendon. Overall, there is a lack of consideration for the central nervous system that is commonly implicated in chronic injuries. The aim of this pilot study was to explore the feasibility of combining Action Observation Therapy (AOT), a treatment technique which targets central changes and influences motor learning, with eccentric exercises in the treatment of mid-portion AT. AOT involves the observation of movements and is commonly followed by the physical performance of these same movements.MethodologyThis was a double-blinded randomised controlled pilot feasibility study. All participants underwent the 12-week Alfredson eccentric training protocol. The intervention group watched videos of the exercises prior to performing these exercises, whilst the control group watched nature videos before performing the same exercises. Study feasibility was the primary outcome measure, with the Victorian Institute of Sports Assessment- Achilles (VISA-A) selected as the primary clinical outcome measure.ResultsThirty participants were recruited, reflecting a 75% eligibility rate and 100% of eligible participants enrolled in the study. The retention rate at week 12 was 80%. At week six the mean VISA-A score improved by 18.1 (95% CI 10.2-26.0) in the intervention group and 7.7 (95% CI 0.3-14.9) in the control group, and 75% and 33% of participants in the intervention and control group respectively exceeded the minimal clinically important difference (MCID). At week 12 the mean VISA-A score from baseline improved by 22.25 (95% CI 12.52-31.98) in the intervention group and 16.5-(95% CI 8.47-24.53) in the control group, equating to 75% and 58% in each group respectively exceeding the MCID.ConclusionThe positive feasibility outcomes and exploratory data from the clinical outcome measures suggest that a larger scaled RCT is warranted to further investigate the impact of AOT in the rehabilitation of mid-portion AT. Trial registration ISRCTN58161116, first registered on the 23/12/2020.

Dataset Information

Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial.

Objective

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Trial registration

Publications

Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial.

Similar Datasets

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