Autologous Blood Injection for Treatment of Achilles Tendinopathy? A Randomised Controlled Trial

In patients with achilles tendinopathy what is the short-term efficacy of adding autologous blood injection to conservative treatment compared with that of conservative treatment alone?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001020077

Enrollment

Registered

2010-11-22

Start date

2008-03-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Abstract: Aim: To determine whether autologous blood injections added to standard management was effective in alleviating symptoms of achilles tendinopathy. Methods: Thirty three patients (18 female, 15 male) aged 50 years (SD 9) with 40 cases of achilles tendinopathy of 11 months (SD 7) duration were enrolled in the study. Participants were randomised to autologous blood injection added to standard treatment (eccentric-loading exercises) or standard treatment alone for 12 weeks. Victorian Institute of Sport Assessment for Achilles (VISA-A) score and ratings of discomfort during and following the injection were measured at baseline, six and 12 weeks. Analytically-derived effect-size thresholds of 5 (small) and moderate (15) were utilised as the reference values for clinical inference. Results: Improvements in VISA-A of 7.7 units (95%CL: +/-6.7) and 8.7 units (+/-8.8) were observed in the treatment and control groups respectively at six weeks relative to baseline with no clear effect of blood injection. At 12 weeks VISA-A score improved to 18.9 units (+/-7.4) in the treatment group revealing a clinically small blood injection effect of 9.6 units (+/-11.5), relative to a comparatively unchanged condition in control (9.4 units; +/-9.0). Predictors of response to treatment were unremarkable, and a 10% rate of post-injection flare was the only noteworthy side-effect. Most patients described the discomfort experienced during the baseline injection as mild, and while there was greater variability in the change in discomfort over the 48 hours following the injection this was on average mild to moderate discomfort. Conclusions: There is some evidence for small symptomatic improvements in the short-term with the addition of autologous blood injection to standard treatment for achilles tendinopathy, although confirmatory research is required to eliminate a possible placebo effect.

Interventions

Autologous blood injection - injection of 2ml of patients own blood around their injured Achilles tendon - added to standard conservative treatment program. All patients in the treatment group received an initial injection following enrolment in the study. Depending on the response to the initial injection, a second injection following the 6 week follow-up was performed in almost half of these patients.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of mid achilles tendinopathy (activity-related pain of gradual or semi-acute onset, post-inactivity stiffness, and tenderness, swelling and nodularity localised to the mid-tendon) with duration of symptoms of at least three months.

Exclusion criteria

Diagnostic uncertainty or concurrent presence of insertional pathology, Anticoagulant therapy, Systemic disease that may contribute to pathology, Elite level sportsperson, or Having received any injection therapy for the tendon within the last three months.

Outcome results