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…
ID
Source
Brief title
Condition
- Muscle disorders
Health condition
calcifying tendinitis shoulder
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
Between group difference in recovery of functional outcome score of the CMS between baseline and 12 months follow-up
Secondary outcome
Between group differences in change in pain scores, quality of life, adverse events and use of medications. Also cost-effectiveness will be analyzed to be able to analyze this parts of the iPCQ and ProDisq must be completed. Furthermore, the ‘Diagnose & Behandel Combinatie (DBC)’ will be examined two find a difference in the procedural costs of the two treatment modalities
Background summary
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.
Study objective
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.
Study design
T0 = start of study
T1 = 8 weeks post-intervention
T2 = 6 months post-intervention
T3 = 12 months post-intervention
Intervention
focused extracorporeal shockwave therapy
M van der Steen
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
The Netherlands
telephone: 0031-40-8885257
ortho_research@mmc.nl
M van der Steen
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
The Netherlands
telephone: 0031-40-8885257
ortho_research@mmc.nl
Age
Inclusion criteria
- age: >18 years
- chronic shoulder complaints (> 6 months)
- calcifications on conventional x-rays O type I en II calcifications according to the Gärtner classification O minimal diameter of calcification of 10 mm on AP view
- able and willing to comply to study protocol
Exclusion criteria
- clinical signs of a frozen shoulder or adhesive capsulitis
- operations of the affected shoulder in history
- ESWT or NACD treatment during the last 6 months
- clinical and radiological signs of acute subacromial bursitis
- full-thickness lesion of the rotator cuff tendon(s) on sonography
- clinical and radiological signs of acromioclavicular osteoarthritis
- Rheumatic Arthritis or fibromyalgia
- other intra articular pathology: cartilage lesions, biceps pathology
- any contra-indication for the specific treatments (e.g. coagulopathies, malignancies in treated area)..
Design
Recruitment
IPD sharing statement
Postbus 7777
5500 MB Veldhoven
040 888 9528
metc@mmc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5527 |
| NTR-old | NTR7093 |
| CCMO | NL60762.015.17 |
| OMON | NL-OMON49558 |