Rotator CuffNCT02693444
Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
A study testing Lidocaine and Saline in people with Rotator Cuff and Subacromial Impingement Syndrome, run by Rush University Medical Center.
Trial summary
Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness. The level of pain is often a limiting factor when assessing shoulder range of motion and strength pre-operatively. Pain itself has even been a cause of weakness due to muscle atrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff, Subacromial Impingement Syndrome
- What is being tested?
- Lidocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 27 Apr 2017
- 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
- Patient is determined to have a full thickness rotator cuff tear (1-3 cm), on the pre-operative MRI scan or found arthroscopically, and is scheduled to undergo arthroscopic surgical repair
- Written informed consent is obtained
Who cannot join
- Revision Surgery
- Irreparable tear or partial tear
- Subscapularis involvement
- Any patient lacking decisional capability
About this study
Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness. The level of pain is often a limiting factor when assessing shoulder range of motion and strength pre-operatively. Pain itself has even been a cause of weakness due to muscle atrophy.
The purpose of this study is to further understand the effect pain has by measuring constant shoulder scores in patients before and after ultrasound guided subacromial (the outer end of the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The saline and lidocaine has been approved for use by the U.S. Food and Drug Administration (FDA). The constant shoulder score includes your level of pain, activity level, range of motion and strength measures.
- Conditions
- Rotator Cuff, Subacromial Impingement Syndrome
- Being tested
- Lidocaine, Saline
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Subacromial Lidocaine Injection | Active comparator | Both of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of lidocaine, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded Receives: Drug: Lidocaine |
| Subacromial Saline Injection | Placebo comparator | Both of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of saline, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Shoulder Score
Validated outcome score assessing pain and function of shoulder
Measured: 10 minutes following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start2 Mar 2016
- Primary completion28 Feb 2017
- Study completion27 Apr 2017
Why it stopped: Low pool of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator CuffStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Forsythe, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693444
- Sponsor's protocol ID
- 15081703
- Status last verified
- Dec 2020
- First submitted
- 23 Feb 2016
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Forsythe B, Agarwalla A, Puzzitiello RN, Patel BH, Lu Y, Verma NN, Romeo AA, Cole BJ. Clinical Function Improves After Subacromial Injection of Local Anesthetic in Full-Thickness Rotator Cuff Tears: A Randomized Control Trial. Orthop J Sports Med. 2020 Jan 3;8(1):2325967119892331. doi: 10.1177/2325967119892331. eCollection 2020 Jan.
PubMed 31934594
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT02693444
- Acronym / sponsor ID
- 15081703
- Conditions
- Rotator Cuff, Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low pool of subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 26 Feb 2016 (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.
Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness. The level of pain is often a limiting factor when assessing shoulder range of motion and strength pre-operatively. Pain itself has even been a cause of weakness due to muscle atrophy.
The purpose of this study is to further understand the effect pain has by measuring constant shoulder scores in patients before and after ultrasound guided subacromial (the outer end of the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The saline and lidocaine has been approved for use by the U.S. Food and Drug Administration (FDA). The constant shoulder score includes your level of pain, activity level, range of motion and strength measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subacromial Lidocaine Injection | Active comparator | Drug: LidocaineBoth of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of lidocaine, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded |
| Subacromial Saline Injection | Placebo comparator | Drug: SalineBoth of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of saline, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is determined to have a full thickness rotator cuff tear (1-3 cm), on the pre-operative MRI scan or found arthroscopically, and is scheduled to undergo arthroscopic surgical repair
- Written informed consent is obtained
Key exclusion criteria (4 listed)
- Revision Surgery
- Irreparable tear or partial tear
- Subscapularis involvement
- Any patient lacking decisional capability
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 |
|---|---|---|
| Lidocaine | Drug | Subacromial Lidocaine Injection |
| Saline | Drug | Subacromial Saline Injection |
Primary outcome
Constant Shoulder Score
Time frame: 10 minutes following injection
Validated outcome score assessing pain and function of shoulder
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Derived from this study: PubMed 31934594Forsythe B, Agarwalla A, Puzzitiello RN, Patel BH, Lu Y, Verma NN, Romeo AA, Cole BJ. Clinical Function Improves After Subacromial Injection of Local Anesthetic in Full-Thickness Rotator Cuff Tears: A Randomized Control Trial. Orthop J Sports Med. 2020 Jan 3;8(1):2325967119892331. doi: 10.1177/2325967119892331. eCollection 2020 Jan.
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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.
Brian Forsythe, MD principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Saline in people with Rotator Cuff and Subacromial Impingement Syndrome, run by Rush University Medical Center.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Constant Shoulder Score (time frame: 10 minutes following injection). 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 NCT02693444, 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 3 Dec 2020.