Rotator Cuff TearPhase 4NCT03319784
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
A Phase 4 study testing Ketorolac and Triamcinolone Acetonide in people with Rotator Cuff Tear and Rotator Cuff Injury, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Sixty patients will be identified in the clinic with rotator cuff tendonitis or a low-grade partial-thickness tear of the rotator cuff that are either insulin-dependent or insulin-independent diabetics. Patients will be informed about the current prospective study and written consent will be obtained. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Injury, Rotator Cuff Tendinitis
- What is being tested?
- Ketorolac and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 5 Oct 2020
- Phase
- Phase 4
- 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
- Patients that are 18 years old or older that have rotator cuff tendinitis and a low-grade partial thickness tear of the rotator cuff confirmed with an imaging study (ultrasound or MRI) with either insulin dependent or insulin independent diabetes.
Who cannot join
- Patients whom are younger than 18 years old, pregnant women, and prisoners will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: A Randomized Single Blinded Prospective Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
Sixty patients will be identified in the clinic with rotator cuff tendonitis or a low-grade partial-thickness tear of the rotator cuff that are either insulin-dependent or insulin-independent diabetics. Patients will be informed about the current prospective study and written consent will be obtained. Patient information about kidney function, current diabetic medication type, dose and frequency will be obtained in clinic. If there is a diagnosed kidney function abnormality, the patient will be excluded from the study. Patients will be asked about their most recent HbA1C. If HbA1C has not been checked within the past 3 months, the patient will have HbA1C checked in the lab either same day as the injection or the following day. Patients will be randomized into two patient groups: Toradol (Ketorolac) injection group (n=30) and or Steroid injection group (n=30). The randomization will be done using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm.
Patients assigned to Toradol group will receive 60mg of Toradol (Ketorolac) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Those assigned to Steroid group will receive 80mg of Kenalog (Triamcinolone Acetonide) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.
Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. Continuous blood glucose measurement will be started in an hour within the injection. An instructional session about continuous glucose monitoring will be given to the patients by our research team immediately following the injection. The blood glucose levels will be monitored for 1 week following the injection. The data will be collected on the patient's return to clinic in 2 weeks. Pain score based on a visual analog scale will be obtained prior to injection, 5 min, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection. Shoulder range of motion, patient satisfaction, QuickDash score, and ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.
Read the detailed description
Day 1: Patient will be seen in the clinic. Patient will be provided information about the study, consented and recruited to the study. Obtain pre-injection HbA1c. If no previous HbA1c, obtain a new one on the following day in the morning Injection will be administered to the patient. Pain score will be obtained prior to injection and 5 min after injection. Blood glucose measurement will be started in an hour of the injection and will last for one week after the injection.
Day 3: Patients will be contacted by phone for pain score.
1 Week: Patients will be contacted by phone for pain score. 2 Weeks: Patient will be seen at clinic for a follow up and for pain score. 4 Weeks: Patient will be seen at clinic for pain score and for range of motion, QuickDASH, and ASES scores.
6 Weeks: Patients will be contacted by phone for pain score. 8 Weeks: Patient will be seen at clinic for pain score and for range of motion, QuickDASH, and ASES scores.
12 Weeks: Patient will be seen at clinic for pain score and for range of motion, QuickDASH, and ASES scores.
- Being tested
- Ketorolac, Triamcinolone Acetonide
- Medical subject headings
- Rotator Cuff Injuries, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Patients assigned to Toradol group will receive a single dose of 60mg of Ketorolac (Toradol) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.
Triamcinolone AcetonideDrug
Also called Kenalog
Patients assigned to Steroid group will receive 80mg of Triamcinolone Acetonide (Kenalog) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac (Toradol) Injection Group | Active comparator | Patients will be randomized into two patient groups: Ketorolac (Toradol) injection group (n=30) and or Steroid injection group (n=30). Patients assigned to Ketorolac group will receive a single dose of 60mg of Ketorolac (Toradol) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. Receives: Drug: Ketorolac |
| Steroid Injection Group | Active comparator | Patients will be randomized into two patient groups: Ketorolac (Toradol) injection group (n=30) and or Steroid injection group (n=30). Patients assigned to Steroid group will receive a single dose of 80mg of Triamcinolone Acetonide (Kenalog) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose level
The peak and average glucose levels, and duration of the increase will be used as the surrogates of the primary outcome. The peak and average glucose levels will both share the same unit of measure (mg/dL). The duration of the increase will measure the number of hours that the patient experienced an increasing level of glucose.
Measured: Participants' blood glucose will be measured 5 minutes after injection and three times daily for one week following injection; Alternatively, using Continuous Glucose Monitoring sensors, blood glucose will be monitored for 1 week following injection.
Secondary outcomes (5)
Visual Analog Scale
Pain scores will be measured using the Visual Analog Scale. Scale: 0 - 10 0 - No pain; 5- Moderate pain; 10 - Extreme pain Lower values = better outcome No subscales will be used
Measured: Pain scores will be obtained prior to injection, 5 min, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection.
Shoulder Range of Motion
Measured: Shoulder range of motion will be measured in clinic 4, 8, and 12 weeks after injection.
Patient Satisfaction
Patients will be asked to fill out a questionnaire asking their satisfaction level regarding the treatment.
Measured: Patient satisfaction will be measured in clinic 4, 8, and 12 weeks after injection.
QuickDASH
The QuickDASH is a shortened version of the DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Measured: QuickDash score will be measured in clinic 4, 8, and 12 weeks after injection.
American Shoulder and Elbow Surgeon (ASES) Shoulder Score
The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living.
For this study, we will not be using the physician-rated questionnaire and no subscales will be used.
ASES Patient-rated questionnaire
Total of 100 maximum points (Weighted 50% for pain and 50% for function) -Higher the score, better the outcome
Pain portion:
-The final pain score (maximum 50 points) is calculated by subtracting the Visual Analog Scale (VAS) from 10 and multiplying by five.
Functional portion:
- 10 questions rated on a 4-point ordinal scale (from 0-3)
- Maximum of 30 points. The raw score is multiplied by 5/3 to make the maximal functional score out of 50 possible points. The pain and functional portions are then summed to obtain the final ASES score.
Measured: ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start5 Sep 2018 (estimated)
- Primary completion5 Sep 2020 (estimated)
- Study completion5 Oct 2020 (estimated)
Why it stopped: never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H Mike Kim, Milton S. Hershey Medical Center
- Investigators
- H. Mike Kim, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319784
- Sponsor's protocol ID
- STUDY00008014
- Status last verified
- Feb 2019
- First submitted
- 16 Sep 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Blinded Prospective Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03319784
- Acronym / sponsor ID
- STUDY00008014
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 5 Sep 2018 (estimated)
- Primary completion
- 5 Sep 2020 (estimated)
- Study completion
- 5 Oct 2020 (estimated)
- First posted
- 24 Oct 2017 (actual)
- 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.
Sixty patients will be identified in the clinic with rotator cuff tendonitis or a low-grade partial-thickness tear of the rotator cuff that are either insulin-dependent or insulin-independent diabetics. Patients will be informed about the current prospective study and written consent will be obtained. Patient information about kidney function, current diabetic medication type, dose and frequency will be obtained in clinic. If there is a diagnosed kidney function abnormality, the patient will be excluded from the study. Patients will be asked about their most recent HbA1C. If HbA1C has not been checked within the past 3 months, the patient will have HbA1C checked in the lab either same day as the injection or the following day. Patients will be randomized into two patient groups: Toradol (Ketorolac) injection group (n=30) and or Steroid injection group (n=30). The randomization will be done using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm.
Patients assigned to Toradol group will receive 60mg of Toradol (Ketorolac) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Those assigned to Steroid group will receive 80mg of Kenalog (Triamcinolone Acetonide) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.
Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. Continuous blood glucose measurement will be started in an hour within the injection. An instructional session about continuous glucose monitoring will be given to the patients by our research team immediately following the injection. The blood glucose levels will be monitored for 1 week following the injection. The data will be collected on the patient's return to clinic in 2 weeks. Pain score based on a visual analog scale will be obtained prior to injection, 5 min, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection. Shoulder range of motion, patient satisfaction, QuickDash score, and ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.
Detailed description
Day 1: Patient will be seen in the clinic. Patient will be provided information about the study, consented and recruited to the study. Obtain pre-injection HbA1c. If no previous HbA1c, obtain a new one on the following day in the morning Injection will be administered to the patient. Pain score will be obtained prior to injection and 5 min after injection. Blood glucose measurement will be started in an hour of the injection and will last for one week after the injection.
Day 3: Patients will be contacted by phone for pain score.
1 Week: Patients will be contacted by phone for pain score. 2 Weeks: Patient will be seen at clinic for a follow up and for pain score. 4 Weeks: Patient will be seen at clinic for pain score and for range of motion, QuickDASH, and ASES scores.
6 Weeks: Patients will be contacted by phone for pain score. 8 Weeks: Patient will be seen at clinic for pain score and for range of motion, QuickDASH, and ASES scores.
12 Weeks: Patient will be seen at clinic for pain score and for range of motion, QuickDASH, and ASES scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac (Toradol) Injection Group | Active comparator | Drug: KetorolacPatients will be randomized into two patient groups: Ketorolac (Toradol) injection group (n=30) and or Steroid injection group (n=30). Patients assigned to Ketorolac group will receive a single dose of 60mg of Ketorolac (Toradol) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. |
| Steroid Injection Group | Active comparator | Drug: Triamcinolone AcetonidePatients will be randomized into two patient groups: Ketorolac (Toradol) injection group (n=30) and or Steroid injection group (n=30). Patients assigned to Steroid group will receive a single dose of 80mg of Triamcinolone Acetonide (Kenalog) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that are 18 years old or older that have rotator cuff tendinitis and a low-grade partial thickness tear of the rotator cuff confirmed with an imaging study (ultrasound or MRI) with either insulin dependent or insulin independent diabetes.
Key exclusion criteria (1 listed)
- Patients whom are younger than 18 years old, pregnant women, and prisoners will be excluded.
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 |
|---|---|---|
| KetorolacAlso: ToradolPatients assigned to Toradol group will receive a single dose of 60mg of Ketorolac (Toradol) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. | Drug | Ketorolac (Toradol) Injection Group |
| Triamcinolone AcetonideAlso: KenalogPatients assigned to Steroid group will receive 80mg of Triamcinolone Acetonide (Kenalog) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. | Drug | Steroid Injection Group |
Primary outcome
Change in blood glucose level
Time frame: Participants' blood glucose will be measured 5 minutes after injection and three times daily for one week following injection; Alternatively, using Continuous Glucose Monitoring sensors, blood glucose will be monitored for 1 week following injection.
The peak and average glucose levels, and duration of the increase will be used as the surrogates of the primary outcome. The peak and average glucose levels will both share the same unit of measure (mg/dL). The duration of the increase will measure the number of hours that the patient experienced an increasing level of glucose.
5 secondary outcomes
Visual Analog Scale
Time frame: Pain scores will be obtained prior to injection, 5 min, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection.
Shoulder Range of Motion
Time frame: Shoulder range of motion will be measured in clinic 4, 8, and 12 weeks after injection.
Patient Satisfaction
Time frame: Patient satisfaction will be measured in clinic 4, 8, and 12 weeks after injection.
QuickDASH
Time frame: QuickDash score will be measured in clinic 4, 8, and 12 weeks after injection.
American Shoulder and Elbow Surgeon (ASES) Shoulder Score
Time frame: ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.
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 15 Feb 2019.
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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.
H. Mike Kim, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac and Triamcinolone Acetonide in people with Rotator Cuff Tear and Rotator Cuff Injury, run by Milton S. Hershey 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 1 inclusion and 1 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 15 Feb 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in blood glucose level (time frame: Participants' blood glucose will be measured 5 minutes after injection and three times daily for one week following injection; Alternatively, using Continuous Glucose Monitoring sensors, blood glucose will be monitored for 1 week following injection.). 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 15 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.