Calcific Tendinitis: Comparing Minimally Invasive Modalities

Calcific Tendinitis Clinical Trial

Official title:

Calcific Tendinitis: Comparing Minimally Invasive Modalities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02367560
• Other study ID #: RP-336-10202014
• Status: Recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2022

Study information

• Verified date: June 2020
• Source: Lakehead University
• Contact: Jubin Payandeh, MD
• Phone: (807) 344-1123
• Email: payandej[@]tbh.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcific Tendinitis
• Tendinopathy

Intervention

Procedure:
• 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.

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.

Locations

Country	Name	City	State
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lakehead University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Range of Motion	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
Primary	Change of Western Ontario Rotator Cuff (WORC) score	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
Primary	Change of Gartland Classification of X-ray	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	The change in overall health as measured by the SF-8	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