An interventional study of Needle decompression and Shockwave therapy in Calcific Tendinitis, sponsored by Lakehead University. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-24.
Sponsored by Lakehead University · Not applicable, Interventional, and Treatment
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.
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.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 339 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Lakehead University is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Depo medrol
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 · Device: Ultrasound device
Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.
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.
Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.
Also known as: methylprednisolone acetate Injectable Suspension
Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.
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.
Time frame: Baseline, 3 months, 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.
Time frame: Baseline, 3 months, 1 year
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.
Time frame: Baseline, 3 months, 1 year
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.
Time frame: Baseline, 3 months, 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lakehead University