Calcific Tendinitis: Comparing Minimally Invasive Modalities

NCT02367560 | Unknown

• 1 other identifier: RP-336-10202014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

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

  Baseline, 3 months, 1 year

Study Arms (2)

NDSSI

ACTIVE COMPARATOR

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

SWT

ACTIVE COMPARATOR

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

Interventions

Needle decompression PROCEDURE

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

NDSSI

Shockwave therapy PROCEDURE

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.

SWT

Depo medrol DRUG

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

NDSSI

Ultrasound device DEVICE

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

SWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New diagnosis of symptomatic calcific tendinitis of the shoulder
• Seeking treatment for diagnosis
• ≥ 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Lakehead University: lead

Study Sites (1)

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B6V4, Canada

RECRUITING

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Methylprednisolone Acetate; Ultrasonography

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jubin Payandeh, MD

  Thunder Bay Regional Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jubin Payandeh, MD

CONTACT

(807) 344-1123; payandej@tbh.net

Aaron Burkhart, MD

CONTACT

807-767-7677; aburkhart@nosm.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon, Assistant Professor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 20, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)