N of 1, two contemporary arm, randomised controlled clinical trial for bilateral epicondylitis: a new study design

Abstract

Objective To investigate the use of a novel study design in analysis of bilateral elbow pain.Design N of 1, two contemporary arm, open label, randomised controlled clinical trial.Setting A clinical epidemiologist at a university hospital in Pavia, Italy. Participants Two elbows with epicondylitis.Interventions Autologous platelet lysate versus "wait and see" strategy.Main outcome measures Visual analogue scale for pain on elbow extension and resisted wrist extension.Results Over six months' follow-up, the patient experienced bilateral improvement in pain, but higher in the treated arm, with a drop in visual analogue scale for pain from 28 to 4 for right (control) arm (drop of 24 points) and from 67 to 10.5 for left (treated) arm (drop of 56.5 points).Conclusions Platelet lysate might (or might not) work. Competing interests and lack of blinding might be relevant issues in the interpretation of trial results. However, the new study design can be applied to a number of conditions such as bilateral sport or trauma injuries, bilateral otitis, or any condition affecting chiral organs or limbs.

Platelet-Rich Plasma Promotes Axon Regeneration, Wound Healing, and Pain Reduction: Fact or Fiction

“…PRP is being increasingly injected into joints to promote healing and reduce the pain associated with osteoarthritis [177, 185,186]) and by sports medicine clinicians to promote tendon, ligament, connective tissue, and other soft tissue healing, to reduce neuropathic pain [171, 174, 177, [186][187][188][189][190][191][192][193] and to promote axon regeneration [194]. PRP has also been applied to reduce neuropathic pain in case where neuropathic pain is caused by arthroplasty and transgluteal decompression of the pudendal nerve [195] and to the surgical site following tonsillectomy [196].…”

Neck Muscle Strength and Endurance in Patients with Lateral Epicondylitis

“…LE hastalarında unilateral omuz kuşağı kaslarında ve sağlam taraf ön kol ekstansör kaslarında kuvvet eksiklikleri ölçümlemiştir[41]. Scudeller tarafından yapılan çalışmada bilateral tutulumu olan bireylerin etkilenen taraf dirsek çevresine trombosit içerikli enjeksiyon yapılmış ve 6 ay sonunda enjeksiyon tarafında daha fazla olmak üzere bilateral iyileşme gözlemlemişlerdir[42]. Bu alanda yapılan ve yukarıda sonuçları verilen çalışmalar LE'nin sadece etkilenen alanda problem oluşturmadığını destekler niteliktedir Bu çalışmada ise değerlendirilen LE'i olan bireylerin %36.6'sının bilateral tutulumu bulunmaktaydı.…”