Calcific TendinitisNCT02367560
Calcific Tendinitis: Comparing Minimally Invasive Modalities
A study testing Needle decompression, Shockwave therapy and Depo medrol in people with Calcific Tendinitis, run by Lakehead University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcific Tendinitis
- What is being tested?
- Needle decompression, Shockwave therapy and Depo medrol
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of symptomatic calcific tendinitis of the shoulder
- Seeking treatment for diagnosis
- ≥ 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B6V4
Shalyn L Littlefield, MSc, 807-684-6608, littlefs@tbh.net
Jubin Payandeh, MD
About this study
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.
Read the 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.
- Conditions
- Calcific Tendinitis
- Being tested
- Needle decompression, Shockwave therapy, Depo medrol, Ultrasound device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle decompressionProcedure or surgery
Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.
Shockwave therapyProcedure or surgery
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.
Depo medrolDrug
Also called methylprednisolone acetate Injectable Suspension
Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.
Ultrasound deviceDevice
Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Shockwave therapy; Device: Ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 1 year
Secondary outcomes (1)
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.
Measured: Baseline, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcific TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jubin Payandeh, Lakehead University
- Investigators
- Jubin Payandeh, MD, Principal investigator, Thunder Bay Regional Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367560
- Sponsor's protocol ID
- RP-336-10202014
- Status last verified
- Jun 2020
- First submitted
- 21 Jan 2015
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcific Tendinitis: Comparing Minimally Invasive Modalities
- ClinicalTrials.gov ID
- NCT02367560
- Acronym / sponsor ID
- RP-336-10202014
- Conditions
- Calcific Tendinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NDSSI | Active comparator | Procedure: Needle decompression, Drug: Depo medrolParticipants 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 |
| SWT | Active comparator | Procedure: Shockwave therapy, Device: Ultrasound deviceParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New diagnosis of symptomatic calcific tendinitis of the shoulder
- Seeking treatment for diagnosis
- ≥ 18 years of age
Key exclusion criteria (6 listed)
- Pre-existing diagnosis of rotator cuff tear or arthropathy
- Previous minimally invasive or surgical therapy
- Systemic Inflammatory disease
- Blood dyscrasia
- Peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle decompressionDirect manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist. | Procedure or surgery | NDSSI |
| Shockwave therapyA 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. | Procedure or surgery | SWT |
| Depo medrolAlso: methylprednisolone acetate Injectable SuspensionSubacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression. | Drug | NDSSI |
| Ultrasound deviceUltrasound device is applied directly to the shoulder at 0.2 mJ/mm2. | Device | SWT |
Primary outcome
Change of Range of Motion
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
The change in overall health as measured by the SF-8
Time frame: Baseline, 3 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Calcific Tendinitis
Recruiting
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis
Calcific Tendinitis of Shoulder
Recruiting
The Effect of Doppler Ultrasound on Calcified Tendinitis
Calcific Tendinitis of Shoulder
Not yet recruiting
Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
Calcific Tendinitis
RecruitingObservational study
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
Calcific Tendinitis of Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jubin Payandeh, MD principal investigator
Thunder Bay Regional Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle decompression, Shockwave therapy and Depo medrol in people with Calcific Tendinitis, run by Lakehead University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jubin Payandeh, MD ((807) 344-1123, payandej@tbh.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Range of Motion (time frame: Baseline, 3 months, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.