Calcific Tendinitis: Comparing Minimally Invasive Modalities

NCT ID: NCT02367560

Last Updated: 2020-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2022-06-30

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.

Conditions

Calcific Tendinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NDSSI

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

Group Type: ACTIVE_COMPARATOR

Needle decompression

Intervention Type: PROCEDURE

Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.

Depo medrol

Intervention Type: DRUG

Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.

SWT

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

Group Type: ACTIVE_COMPARATOR

Shockwave therapy

Intervention Type: PROCEDURE

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.

Ultrasound device

Intervention Type: DEVICE

Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.

Interventions

Needle decompression

Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.

Intervention Type: 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.

Intervention Type: PROCEDURE

Depo medrol

Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.

Intervention Type: DRUG

Ultrasound device

Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.

Intervention Type: DEVICE

Other Intervention Names

methylprednisolone acetate Injectable Suspension

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lakehead University

OTHER

Sponsor Role: lead

Responsible Party

Jubin Payandeh

Orthopedic Surgeon, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jubin Payandeh, MD

Role: PRINCIPAL_INVESTIGATOR

Thunder Bay Regional Health Sciences Centre

Locations

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jubin Payandeh, MD

Role: CONTACT

payandej@tbh.net

(807) 344-1123

Aaron Burkhart, MD

Role: CONTACT

aburkhart@nosm.ca

807-767-7677

Facility Contacts

Shalyn L Littlefield, MSc

Role: primary

littlefs@tbh.net

807-684-6608

Other Identifiers

RP-336-10202014

Identifier Type: -

Identifier Source: org_study_id