NECST studie

Calcifying tendinitis (CT) of the shoulder is a common disease in which calcium particles are deposited in one or more tendons of the rotator cuff. This can result in a typical pattern of pain, impairments in daily living and decreased range of motion. In a patient with shoulder complaints the incidence of CT is reported as high as 54%. This disease mainly affects individuals between 30 and 60 years of age. Males and females are thought to be equally affected.(1-5,8) There is very limited evidence available about the cost-effectiveness of any intervention of CT of shoulder. Only Haake et al(18) published results concerning the cost-effectiveness. They found that ESWT costs EUR 1.750 to EUR 3.500 as a results of being unfit to work. The etiology of CT of the rotator cuff is still a matter of dispute. It has been suggested that it is related to a locally decreased oxygen tension or hypoxia.(2)

The treatment consists at first conservative measures such as anti-inflammatory drugs, ice-therapy, physical therapy and/or corticosteroid injections.(2,10,11, 17) When this fails next step treatment must be considered. New treatment modalities have emerged. Needle aspiration of the calcific deposits (NACD) and focused extracorporeal shockwave therapy (ESWT) are proven to be effective therapeutic options. NACD has shown promising results, mainly in non-comparing studies.(2) However, ESWT also shows promising results and focused ESWT has been proven to be the more effective then radial ESWT.(19) Although in the existing orthopedic literature both treatment methods seem to be viable, comparative studies are not available yet. Therefore, the exact place in the treatment algorithm of CT is not clear yet.(17) The aim of the current study is to compare the functional and clinical outcome of the aforementioned treatment options on the short and midterm in a randomized trial. A secondary aim is to compare the cost-effectiveness.

Our primary objective is to compare the effectiveness of NACD and ESWT for patients with calcifying tendinitis of the shoulder. Our hypothesis is superiority of NACD or ESWT above the other treatment in functional recovery over a period of 12 months will be found. (superiority design) Secondary objective is to compare the cost-effectiveness of both treatment options.

T0 = start of study

T1 = 8 weeks post-intervention

T2 = 6 months post-intervention

T3 = 12 months post-intervention

Patients will be randomized to receive NACD or ESWT treatment. NACD treatment: a sonographically guided removal of the calcific deposits will be performed. ESWT treatment: patients will receive a focused ESWT. Both will be conducted according to a standardized protocol