Calcific Tendinitis: Comparing Minimally Invasive Modalities

Lakehead University

Status: Unknown

Conditions: Calcific Tendinitis

Treatments: Procedure: Shockwave therapy; Procedure: Needle decompression; Drug: Depo medrol; Device: Ultrasound device

Study type: Interventional

Funder types: Other

Identifiers

NCT02367560

RP-336-10202014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

NDSSI

Active Comparator group

Description:

Participants in this arm of the trial will be referred for Needle decompression with subacromial steroid (Depo medrol) injection (NDSSI) as their treatment for calcific tendinitis

Treatment:

Drug: Depo medrol

Procedure: Needle decompression

SWT

Active Comparator group

Description:

Participants in this arm of the trial will be referred for Shockwave therapy (SWT) using an Ultrasound device, delivered by a physiotherapist, as their treatment for calcific tendinitis

Treatment:

Procedure: Shockwave therapy

Device: Ultrasound device