Our primary objective is to compare the effectiveness of ESWT and NACD for patients with calcifying tendinitis of the shoulder. Our hypothesis is superiority of ESWT or NACD above the other treatment in functional recovery over a period of 12 months…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the between group differences in functional outcome
(measured with the Constant-Murley Score) between baseline and 12 months
follow-up.
Secondary outcome
1. to assess the cost-effectiveness of both interventions over a period of 12
months.
2. to assess between group differences in change in pain scores, quality of
life, adverse events and use of medications between baseline and 12 months
follow-up.
Background summary
Calcific tendinitis of the shoulder is a common disorder with a huge disease
burden. The initial treatment choice is non-operatively, including
anti-inflammatory drugs, ice-therapy, physiotherapy and/or corticosteroid
injection. If non-operative treatment is not successful to relieve the
symptoms, surgery is often the next step treatment. However, new treatment
modalities have emerged, namely focused extracorporeal shockwave therapy (ESWT)
and needle aspiration of the calcific deposits (NACD). Both modalities have
shown promising results. Till date, there are no studies available which
compare the effectiveness of both new treatment modalities. Consequently, it is
not clear what the most (cost-)effective treatment option is for patients with
calcifying tendinitis who do not respond to non-operative treatment.
Study objective
Our primary objective is to compare the effectiveness of ESWT and NACD for
patients with calcifying tendinitis of the shoulder. Our hypothesis is
superiority of ESWT or NACD 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
An open-labeled randomized, controlled trial.
Intervention
Patients will be randomized to receive ESWT or NACD treatment. ESWT treatment:
patients will receive a focused ESWT. NACD treatment: a sonographically guided
removal of the calcific deposits will be performed. Both will be conducted
according to a standardized protocol, as currently used in Máxima MC.
Study burden and risks
Both interventions are currently used as a part of usual care by orthopedic
surgeons of Máxima MC for the target population. Both interventions have
limited risk (less than 1%) on adverse events. Some patients report a
contemporary increase in pain a few weeks after treatment. This results from
the inflammatory response to reabsorb the calcific deposits. This usually
resolves spontaneously within a few weeks. As with all (minimal) invasive
treatments there is a chance of an infection, however this percentage in low
and the same in the two treatment groups. The treatment specific reported
adverse events are minor and temporarily (bruises with ESWT). The patients that
will participate in the current study will have no additional risk compared to
the those patients that are not willing to participate, since the treatments
are part of usual care. Patients will be informed about the known potential
risks of both interventions. Of the participating patients two additional
outpatient clinic visits at 8 weeks and 12 months follow-up will be asked.
During this visits additional radiographs will be made. Besides patients will
be asked to fill in questionnaires (web-based, by email).
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
* age >18 years
• calcifications on conventional x-rays
O type I and II calcifications according to the Gärtner classification.
O minimal diameter 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 medical history
* ESWT or NACD tretament during the last 6 months
• full-thickness lesion of the rotator cuff tendon(s) on sonography
• clinical and radiological signs of acute subacromial bursitis
• clinical and radiological signs of acromioclavicular osteoarthritis
• Rheumatic Arthritis or fibromyalgia
• any contra-indications for the specific treatments (e.g. coagulopathies, malignancies in treated area)
• other intra articular pathology: cartilage lesions, biceps pathology.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60762.015.17 |
| OMON | NL-OMON25891 |