Calcific Tendinitis: Comparing Minimally Invasive Modalities

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lakehead University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jubin Payandeh, Orthopedic Surgeon, Assistant Professor – Lakehead University
  • Overall Official(s)
    • Jubin Payandeh, MD, Principal Investigator, Thunder Bay Regional Health Sciences Centre
  • Overall Contact(s)
    • Jubin Payandeh, MD, (807) 344-1123, payandej@tbh.net

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.