Calcific Tendinitis: Comparing Minimally Invasive Modalities

Sponsor

Lakehead University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02367560

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Calcific Tendinitis	Procedure: Needle decompression Procedure: Shockwave therapy Drug: Depo medrol Device: Ultrasound device	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Calcific Tendinitis: Comparing Minimally Invasive Modalities

Actual Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Procedure: Needle decompression Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist. Drug: Depo medrol Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression. Other Names: methylprednisolone acetate Injectable Suspension
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	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. Device: Ultrasound device Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.

Arm

Intervention/Treatment

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

Procedure: Needle decompression

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

Drug: Depo medrol

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

Other Names:

methylprednisolone acetate Injectable Suspension

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

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.

Device: Ultrasound device

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

Outcome Measures

Primary Outcome Measures

Change of Range of Motion [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 [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 [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 Outcome Measures

The change in overall health as measured by the SF-8 [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.