Subacromial BursitisNCT02242630
Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
A study testing Methylprednisolone, 20 mg, Methylprednisolone, 40 mg and Triamcinolone, 20 mg in people with Subacromial Bursitis and Shoulder Pain, run by Keesler Air Force Base Medical Center at 1 site in United States.
Trial summary
It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Bursitis, Shoulder Pain
- What is being tested?
- Methylprednisolone, 20 mg, Methylprednisolone, 40 mg and Triamcinolone, 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older
- History and physical examination consistent with shoulder pain and subacromial bursitis
- At least 2 weeks of shoulder pain and subacromial bursitis
Who cannot join
- Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone
- History or examination suspicious for a humeral head fracture
- History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side
- History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint
- Any shoulder surgery involving the affected arm within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Keesler Medical Center
Keesler Air Force Base, Mississippi, 39534
About this study
Official title: Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.
Read the detailed description
Background: Subacromial bursitis is a common site for patients to report shoulder pain. In some patients it is refractory to conservative therapies such as physical therapy, acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve shoulder pain in subacromial bursitis, however, there are few well done clinical trials guiding which type of corticosteroid and the dose that would be maximally effective and with the least amount of side effects.
Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid injection.
Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder, the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6 weeks).
- Conditions
- Subacromial Bursitis, Shoulder Pain
- Being tested
- Methylprednisolone, 20 mg, Methylprednisolone, 40 mg, Triamcinolone, 20 mg, Triamcinolone, 40 mg
- Keywords
- Subacromial bursitis, Triamcinolone, Methylprednisolone, Shoulder pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone, 20 mgDrug
Also called Depo-Medrol or Solu-Medrol
Compared with intrabursal triamcinolone
Methylprednisolone, 40 mgDrug
Also called Depo-Medrol or Solu-Medrol
Compared with intrabursal triamcinolone
Triamcinolone, 20 mgDrug
Also called Kenalog
Compared with methylprednisolone
Triamcinolone, 40 mgDrug
Also called Kenalog
Compared with methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone, 20 mg | Active comparator | Methylprednisolone, 20 mg, will be injected Receives: Drug: Methylprednisolone, 40 mg |
| Methylprednisolone, 40 mg | Active comparator | Methylprednisolone, 40 mg, will be injected Receives: Drug: Methylprednisolone, 20 mg |
| Triamcinolone, 20 mg | Active comparator | Triamcinolone, 20 mg, will be injected Receives: Drug: Triamcinolone, 40 mg |
| Triamcinolone, 40 mg | Active comparator | Triamcinolone, 40 mg, will be injected Receives: Drug: Triamcinolone, 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Function, as Measured by the QuickDASH ®
The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)
Measured: 6 weeks
Secondary outcomes (1)
Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial BursitisStudies 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
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keesler Air Force Base Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew B Carroll, MD, Principal investigator, Keesler Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242630
- Sponsor's protocol ID
- FKE20140023H
- Status last verified
- Aug 2016
- First submitted
- 14 Sep 2014
- Last updated
- 14 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to release IPD to other researchers
Publications
Carroll MB, Motley SA, Smith B, Ramsey BC, Baggett AS. Comparing Corticosteroid Preparation and Dose in the Improvement of Shoulder Function and Pain: A Randomized, Single-Blind Pilot Study. Am J Phys Med Rehabil. 2018 Jun;97(6):450-455. doi: 10.1097/PHM.0000000000000758.
PubMed 28609319
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
- ClinicalTrials.gov ID
- NCT02242630
- Acronym / sponsor ID
- FKE20140023H
- Conditions
- Subacromial Bursitis, Shoulder Pain
- Keywords
- Subacromial bursitis, Triamcinolone, Methylprednisolone, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Keesler Air Force Base Medical CenterUS federal agency
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Posted 14 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.
Detailed description
Background: Subacromial bursitis is a common site for patients to report shoulder pain. In some patients it is refractory to conservative therapies such as physical therapy, acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve shoulder pain in subacromial bursitis, however, there are few well done clinical trials guiding which type of corticosteroid and the dose that would be maximally effective and with the least amount of side effects.
Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid injection.
Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder, the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone, 20 mg | Active comparator | Drug: Methylprednisolone, 40 mgMethylprednisolone, 20 mg, will be injected |
| Methylprednisolone, 40 mg | Active comparator | Drug: Methylprednisolone, 20 mgMethylprednisolone, 40 mg, will be injected |
| Triamcinolone, 20 mg | Active comparator | Drug: Triamcinolone, 40 mgTriamcinolone, 20 mg, will be injected |
| Triamcinolone, 40 mg | Active comparator | Drug: Triamcinolone, 20 mgTriamcinolone, 40 mg, will be injected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- History and physical examination consistent with shoulder pain and subacromial bursitis
- At least 2 weeks of shoulder pain and subacromial bursitis
Key exclusion criteria (5 listed)
- Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone
- History or examination suspicious for a humeral head fracture
- History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side
- History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint
- Any shoulder surgery involving the affected arm within the last 6 months
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 |
|---|---|---|
| Methylprednisolone, 20 mgAlso: Depo-Medrol or Solu-MedrolCompared with intrabursal triamcinolone | Drug | Methylprednisolone, 40 mg |
| Methylprednisolone, 40 mgAlso: Depo-Medrol or Solu-MedrolCompared with intrabursal triamcinolone | Drug | Methylprednisolone, 20 mg |
| Triamcinolone, 20 mgAlso: KenalogCompared with methylprednisolone | Drug | Triamcinolone, 40 mg |
| Triamcinolone, 40 mgAlso: KenalogCompared with methylprednisolone | Drug | Triamcinolone, 20 mg |
Primary outcome
Change in Shoulder Function, as Measured by the QuickDASH ®
Time frame: 6 weeks
The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)
1 secondary outcome
Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28609319Carroll MB, Motley SA, Smith B, Ramsey BC, Baggett AS. Comparing Corticosteroid Preparation and Dose in the Improvement of Shoulder Function and Pain: A Randomized, Single-Blind Pilot Study. Am J Phys Med Rehabil. 2018 Jun;97(6):450-455. doi: 10.1097/PHM.0000000000000758.
- Individual participant dataSharing planned: No. No plan to release IPD to other researchers
Related trials for Subacromial Bursitis
Enrolling by invitation
AI-Assisted Ultrasound Therapy for Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
Rotator Cuff Related Shoulder Pain, Subacromial Pain Syndrome
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.
Matthew B Carroll, MD principal investigator
Keesler Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone, 20 mg, Methylprednisolone, 40 mg and Triamcinolone, 20 mg in people with Subacromial Bursitis and Shoulder Pain, run by Keesler Air Force Base Medical Center at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 14 Dec 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Function, as Measured by the QuickDASH ® (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02242630, which also lists 1 linked publication.
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 14 Dec 2016.