Calcific Tendinitis: Comparing Minimally Invasive Modalities
Primary Purpose
Calcific Tendinitis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Needle decompression
Shockwave therapy
Depo medrol
Ultrasound device
Sponsored by
About this trial
This is an interventional treatment trial for Calcific Tendinitis
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
Sites / Locations
- Thunder Bay Regional Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NDSSI
SWT
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02367560
Brief Title
Calcific Tendinitis: Comparing Minimally Invasive Modalities
Official Title
Calcific Tendinitis: Comparing Minimally Invasive Modalities
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lakehead University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NDSSI
Arm Type
Active Comparator
Arm Description
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
Arm Title
SWT
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Needle decompression
Intervention Description
Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.
Intervention Type
Procedure
Intervention Name(s)
Shockwave therapy
Intervention Description
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
Drug
Intervention Name(s)
Depo medrol
Other Intervention Name(s)
methylprednisolone acetate Injectable Suspension
Intervention Description
Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.
Intervention Type
Device
Intervention Name(s)
Ultrasound device
Intervention Description
Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.
Primary Outcome Measure Information:
Title
Change of Range of Motion
Description
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.
Time Frame
Baseline, 3 months, 1 year
Title
Change of Western Ontario Rotator Cuff (WORC) score
Description
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.
Time Frame
Baseline, 3 months, 1 year
Title
Change of Gartland Classification of X-ray
Description
The change in radiographic resolution as measured by the Gartland Classification scale (1-4) from baseline to 3 months and 1 year.
Time Frame
Baseline, 3 months, 1 year
Secondary Outcome Measure Information:
Title
The change in overall health as measured by the SF-8
Description
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.
Time Frame
Baseline, 3 months, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jubin Payandeh, MD
Phone
(807) 344-1123
Email
payandej@tbh.net
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Burkhart, MD
Phone
807-767-7677
Email
aburkhart@nosm.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jubin Payandeh, MD
Organizational Affiliation
Thunder Bay Regional Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B6V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalyn L Littlefield, MSc
Phone
807-684-6608
Email
littlefs@tbh.net
First Name & Middle Initial & Last Name & Degree
Jubin Payandeh, MD
First Name & Middle Initial & Last Name & Degree
David Kisselgoff, MD
First Name & Middle Initial & Last Name & Degree
Aaron Burkhart, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Calcific Tendinitis: Comparing Minimally Invasive Modalities
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