Recruiting

Minimally Invasive Modalities

Sponsor:

Lakehead University

Code:

NCT02367560

Conditions

Calcific Tendinitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Needle decompression

Shockwave therapy

Depo medrol

Ultrasound device

Study Details

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.

Conditions

Calcific Tendinitis

Study ID

NCT02367560

Start date

Jul, 2015

Status verified date

Jun, 2020

Completion date

Jun, 2022

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Needle decompression

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

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.

Depo medrol

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

Ultrasound device

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

Primary outcome measure

  • Change of Range of Motion [ Time Frame: Baseline, 3 months, 1 year ]
  • Change of Western Ontario Rotator Cuff (WORC) score [ Time Frame: Baseline, 3 months, 1 year ]
  • Change of Gartland Classification of X-ray [ Time Frame: Baseline, 3 months, 1 year ]

Central Contacts and Locations

Central contacts

Jubin Payandeh, MD

(807) 344-1123payandej@tbh.net

Aaron Burkhart, MD

807-767-7677aburkhart@nosm.ca

Locations

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B6V4

Contacts

Shalyn L Littlefield, MSc

807-684-6608littlefs@tbh.net

Principal Investigator:

Jubin Payandeh, MD

More Information

Sponsor

Lakehead University

Last update posted

Jun 24, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lakehead University on 2020-06-24.