Is Platelet-Rich Plasma (PRP) superior to dry needling prolotherapy for promoting recovery in rugby players with ankle syndesmosis injury?

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As a low risk, readily available treatment, PRP injections are becoming an increasingly popular therapeutic adjunct offered by musculoskeletal clinicians. However, there is a clear need to scientifically assess the merits of this treatment option for athletes with ankle syndesmosis injury in order to establish recommendations for evidence-based practice. We published a pilot study entitled- "Effectiveness of a single platelet-rich plasma injection to promote recovery in rugby players with ankle syndesmosis injury". Available at http://bmjopensem.bmj.com/content/1/1/e000033.full.pdf+html We found a reduction in return to play by 20.7 days for the intervention (PRP) group, when compared to an historical control treated with the same rehabilitation protocol. The study supports the viability of an RCT to fully evaluate this treatment. We have calculated that a minumum of 30 participants would be required to detect a significant difference between groups in return to play, but would define a clinically significant difference as a minimum of one week. We will conduct a prospective randomised controlled trial comparing single US-guided PRP injection to an active placebo prolotherapy. Assessors, investigators and participants will be blinded to their allocation and only the treating radiologist who will only interact with particpants to perform injections, will know allocations. Prospective participants from Rugby union clubs within the Sydney Rugby Union Championship will be invited to enrol. On clinical assessment, only those with a low probability for ASI will not be referred for MRI. After MRI, those meeting enrolment criteria and consenting to participate will be randomly allocated to PRP or active placebo groups, and given usual injury management in accordance with our previously published milestone based rehabilitation protocol (Samra et al 2015). A single injection by co-author JL will be provided within 14 days of injury. A central randomisation register will provide the allocation to JL only. The injection protocol will be identical between groups, except for lack of injection of the PRP in the active placebo group. 1-2mL of 2% lignocaine will be infiltrated to the skin and superficial tissues. Blood will be drawn and centrifuged at 3000RPM for 8 minutes. The PRP will be manually aspirated. 0.5-1mL of PRP will be injected with a 25 guage needle into the defect of the AITFL seen on ultrasound in the intervention group. The active placebo group will undergo the same process with the omission of injection of the PRP. Instead, a peppering technique of 5 passes into the AITFL will be performed. Participants will be given oral analgesia and post-injection care information and followup. No other injections of the ankle will be permitted during the rehabilitation of these athletes or within 1 week of return to play. Return to play will be recorded in days from injury onset to first competitive match (of any duration) played since injury

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