Calcific Tendinitis: Comparing Minimally Invasive Modalities

June 23, 2020 updated by: Jubin Payandeh, Lakehead University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Thunder Bay, Ontario, Canada, P7B6V4
        • Recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Jubin Payandeh, MD
        • Sub-Investigator:
          • David Kisselgoff, MD
        • Sub-Investigator:
          • Aaron Burkhart, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: Needle decompression
Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.
Drug: Depo medrol
Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.
Other Names:
  • methylprednisolone acetate Injectable Suspension
Active Comparator: 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
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.
Device: Ultrasound device
Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Range of Motion
Time Frame: Baseline, 3 months, 1 year
The change in a Participant's Range of Motion as measured by a goniometer (Passive Range of Motion [PROM] and Assistive Range of Motion [AROM]) from baseline to 3 months and 1 year.
Baseline, 3 months, 1 year
Change of Western Ontario Rotator Cuff (WORC) score
Time Frame: Baseline, 3 months, 1 year
Change in a participant's WORC scores from baseline to 3 months and 1 year. WORC is a condition-specific outcome tool for people with rotator cuff disorder. A total score for each domain is calculated (Physical Symptoms/600; Sports and Recreation/400; Work/400 and Lifestyle/400;Emotions/400) and the total score for the domains is summed for an aggregate score out of 2100.
Baseline, 3 months, 1 year
Change of Gartland Classification of X-ray
Time Frame: Baseline, 3 months, 1 year
The change in radiographic resolution as measured by the Gartland Classification scale (1-4) from baseline to 3 months and 1 year.
Baseline, 3 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in overall health as measured by the SF-8
Time Frame: Baseline, 3 months, 1 year
The change in SF-8 from baseline to 3 months and 1 year will be measured. SF-8 is a comprehensive health survey which calculates a score for health in 8 dimensions and as a summed result.
Baseline, 3 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lakehead University

Investigators

  • Principal Investigator: Jubin Payandeh, MD, Thunder Bay Regional Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-336-10202014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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