NCT02367560

Calcific Tendinitis: Comparing Minimally Invasive Modalities

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lakehead University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Calcific Tendinitis

Interventions

Type	Name	Description
PROCEDURE	Needle decompression	Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.
PROCEDURE	Shockwave therapy	A physiotherapist performs the shockwave therapy procedure. Treatment is completed in 4 weekly sessions. Treatment involves applying soundwaves directly to the affected shoulder area using an ultrasound device.
DRUG	Depo medrol	Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.
DEVICE	Ultrasound device	Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.

Timeline

• Start date: 2015-07-01
• Primary completion: 2021-06-01
• Completion: 2022-06-01
• First posted: 2015-02-20
• Last updated: 2020-06-24

Locations

1 site across 1 country: Canada