Clinical trial NCT02367560: Calcific Tendinitis: Comparing Minimally Invasive Modalities
Official title: Calcific Tendinitis: Comparing Minimally Invasive Modalities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Calcific Tendinitis
Lead sponsor: Lakehead University
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current standard of care at the Thunder Bay Regional Health Sciences Centre is referral for treatment by either needle decompression therapy by a radiologist or shockwave therapy by a physiotherapist. The purpose of this study is to compare the efficacies of these treatment options.

Detailed description: Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current guidelines recommend conservative management initially and failing this, a variety of minimally invasive options exist. These include subacromial steroid injection (SSI), needle decompression (ND), and Shock wave therapy (SWT).

Few trials of these methods exist, but generally a benefit is seen with all minimally invasive methods. Most promising results have occurred with needle decompression and shockwave therapy. To date, no direct trials comparing SWT and ND have been published.

The purpose of this trial is to preliminarily establish the comparative efficacies of NDSSI and SWT using a number of outcome measures. Secondarily, the investigators aim to determine prognostic factors for success of minimally invasive therapies. The results of this study will serve as a foundation for more rigorous trials in this area.

Eligibility criteria: Inclusion Criteria:

* New diagnosis of symptomatic calcific tendinitis of the shoulder
* Seeking treatment for diagnosis
* ≥ 18 years of age

Exclusion Criteria:

* Pre-existing diagnosis of rotator cuff tear or arthropathy
* Previous minimally invasive or surgical therapy
* Systemic Inflammatory disease
* Blood dyscrasia
* Peripheral neuropathy
* Active Workplace Safety \& Insurance Board (WSIB) claim for shoulder injury

Primary outcomes:
measure: Change of Range of Motion
timeFrame: Baseline, 3 months, 1 year
measure: Change of Western Ontario Rotator Cuff (WORC) score
timeFrame: Baseline, 3 months, 1 year
measure: Change of Gartland Classification of X-ray
timeFrame: Baseline, 3 months, 1 year
Secondary outcomes:
measure: The change in overall health as measured by the SF-8
timeFrame: Baseline, 3 months, 1 year
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
Study officials:
affiliation: Thunder Bay Regional Health Sciences Centre
name: Jubin Payandeh, MD
role: PRINCIPAL_INVESTIGATOR
References: