Rotator Cuff Tear ArthropathyNCT02588027
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes
A study testing Ibuprofen in people with Rotator Cuff Tear Arthropathy, run by University of California, San Francisco at 1 site in United States.
Trial summary
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2022
- 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
- Patients 18 years or older
- Patients that undergo arthroscopic rotator cuff repair only
Who cannot join
- Patients less than 18 years of age, pregnant, are incarcerated. Women who are not post-menopause are screened for pregnancy preoperatively with a urine test per our UCSF Orthopaedic Institute preoperative guidelines.
- Patients who are unable to and not willing to comply with the study protocol and follow-up visits
- Patients with a history of prior rotator cuff repair
- Patients with rotator cuff tears that require open repair
- Patients with an allergy to ibuprofen or anti-inflammatory medications
- Patients with a medical chart record or those who report a history of upper gastroenterology bleed or gastric ulcers
- Patients who are currently on warfarin, enoxaparin, heparin, or a factor Xa inhibiting anti-coagulation medication
- Patients with a known past medical history of chronic kidney disease, history of kidney transplant, or eGFR < 60 mL/min per 1.73m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Orthopaedic Institute
San Francisco, California, 94143
About this study
Official title: Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes After Arthroscopic Rotator Cuff Repair
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
Read the detailed description
Patients will be randomized into two cohorts:
- Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.
- Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.
Patients will be screened for the study at the preoperative clinic vist and randomized on the day of surgery if they meet our inclusion criteria.
Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be assessed at every visit. Functional shoulder outcomes including shoulder range of motion and the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be completed at the preoperative visit and final follow-up visit only. We will assess rotator cuff repair integrity with ultrasound study at 1 year after surgery
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- Ibuprofen, Placebo
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Advil, Motrin
Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.
PlaceboDrug
Pharmacy formulated placebo
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Receives: Drug: Ibuprofen |
| Placebo | Placebo comparator | Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo
pain control
Measured: 1 week post operative
Secondary outcomes (8)
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES)
American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities).
Measured: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Assessment of Functional Shoulder Outcome Score: DASH
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome
Measured: preop, 1 year postop
Assessment of Functional Shoulder Outcome Score: SF-12
The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: Preop, 1 year post/op
Post Operative Pain Score (Visual Analog Scale)
Pain scale from 0 (no pain) - 10 (worst)
Measured: 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Range of Motion - Forward Flexion
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Measured: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Range of Motion - Abduction
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Measured: preoperative, 6 weeks, 3 months, 6 months, 1 year
Range of Motion - External Rotation at Side
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Measured: preoperative, 6 weeks, 3 months, 6 months, 1 year
Range of Motion - External Rotation at 90 Degrees Abduction
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Measured: preoperative, 6 weeks, 3 months, 6 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 posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2022
- Study completionSep 2022
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 (8)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tear ArthropathyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C. Benjamin Ma, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588027
- Sponsor's protocol ID
- 15-16665
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2015
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gilson AM, Ryan KM, Joranson DE, Dahl JL. A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002. J Pain Symptom Manage. 2004 Aug;28(2):176-88. doi: 10.1016/j.jpainsymman.2004.01.003.
PubMed 15276196Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
PubMed 23302898Dahl JB, Kehlet H. Non-steroidal anti-inflammatory drugs: rationale for use in severe postoperative pain. Br J Anaesth. 1991 Jun;66(6):703-12. doi: 10.1093/bja/66.6.703. No abstract available.
PubMed 2064886Dahners LE, Mullis BH. Effects of nonsteroidal anti-inflammatory drugs on bone formation and soft-tissue healing. J Am Acad Orthop Surg. 2004 May-Jun;12(3):139-43. doi: 10.5435/00124635-200405000-00001.
PubMed 15161166Cohen DB, Kawamura S, Ehteshami JR, Rodeo SA. Indomethacin and celecoxib impair rotator cuff tendon-to-bone healing. Am J Sports Med. 2006 Mar;34(3):362-9. doi: 10.1177/0363546505280428. Epub 2005 Oct 6.
PubMed 16210573Rouhani A, Tabrizi A, Elmi A, Abedini N, Mirza Tolouei F. Effects of preoperative non-steroidal anti-inflammatory drugs on pain mitigation and patients' shoulder performance following rotator cuff repair. Adv Pharm Bull. 2014 Dec;4(4):363-7. doi: 10.5681/apb.2014.053. Epub 2014 Aug 10.
PubMed 25436192Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.
PubMed 19535272van der Zwaal P, Thomassen BJ, Nieuwenhuijse MJ, Lindenburg R, Swen JW, van Arkel ER. Clinical outcome in all-arthroscopic versus mini-open rotator cuff repair in small to medium-sized tears: a randomized controlled trial in 100 patients with 1-year follow-up. Arthroscopy. 2013 Feb;29(2):266-73. doi: 10.1016/j.arthro.2012.08.022. Epub 2012 Dec 1.
PubMed 23206691
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes After Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT02588027
- Acronym / sponsor ID
- 15-16665
- Conditions
- Rotator Cuff Tear Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
Detailed description
Patients will be randomized into two cohorts:
- Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.
- Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.
Patients will be screened for the study at the preoperative clinic vist and randomized on the day of surgery if they meet our inclusion criteria.
Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be assessed at every visit. Functional shoulder outcomes including shoulder range of motion and the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be completed at the preoperative visit and final follow-up visit only. We will assess rotator cuff repair integrity with ultrasound study at 1 year after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: IbuprofenIbuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years or older
- Patients that undergo arthroscopic rotator cuff repair only
Key exclusion criteria (8 listed)
- Patients less than 18 years of age, pregnant, are incarcerated. Women who are not post-menopause are screened for pregnancy preoperatively with a urine test per our UCSF Orthopaedic Institute preoperative guidelines.
- Patients who are unable to and not willing to comply with the study protocol and follow-up visits
- Patients with a history of prior rotator cuff repair
- Patients with rotator cuff tears that require open repair
- Patients with an allergy to ibuprofen or anti-inflammatory medications
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 |
|---|---|---|
| IbuprofenAlso: Advil, MotrinPatients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator. | Drug | Control |
| PlaceboPharmacy formulated placebo | Drug | Placebo |
Primary outcome
Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo
Time frame: 1 week post operative
pain control
8 secondary outcomes
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES)
Time frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Assessment of Functional Shoulder Outcome Score: DASH
Time frame: preop, 1 year postop
Assessment of Functional Shoulder Outcome Score: SF-12
Time frame: Preop, 1 year post/op
Post Operative Pain Score (Visual Analog Scale)
Time frame: 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Range of Motion - Forward Flexion
Time frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Range of Motion - Abduction
Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year
Range of Motion - External Rotation at Side
Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year
Range of Motion - External Rotation at 90 Degrees Abduction
Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15276196Gilson AM, Ryan KM, Joranson DE, Dahl JL. A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002. J Pain Symptom Manage. 2004 Aug;28(2):176-88. doi: 10.1016/j.jpainsymman.2004.01.003.
- Background: PubMed 23302898Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
- Background: PubMed 2064886Dahl JB, Kehlet H. Non-steroidal anti-inflammatory drugs: rationale for use in severe postoperative pain. Br J Anaesth. 1991 Jun;66(6):703-12. doi: 10.1093/bja/66.6.703. No abstract available.
- Background: PubMed 15161166Dahners LE, Mullis BH. Effects of nonsteroidal anti-inflammatory drugs on bone formation and soft-tissue healing. J Am Acad Orthop Surg. 2004 May-Jun;12(3):139-43. doi: 10.5435/00124635-200405000-00001.
- Background: PubMed 16210573Cohen DB, Kawamura S, Ehteshami JR, Rodeo SA. Indomethacin and celecoxib impair rotator cuff tendon-to-bone healing. Am J Sports Med. 2006 Mar;34(3):362-9. doi: 10.1177/0363546505280428. Epub 2005 Oct 6.
- Background: PubMed 25436192Rouhani A, Tabrizi A, Elmi A, Abedini N, Mirza Tolouei F. Effects of preoperative non-steroidal anti-inflammatory drugs on pain mitigation and patients' shoulder performance following rotator cuff repair. Adv Pharm Bull. 2014 Dec;4(4):363-7. doi: 10.5681/apb.2014.053. Epub 2014 Aug 10.
- Background: PubMed 19535272Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.
- Background: PubMed 23206691van der Zwaal P, Thomassen BJ, Nieuwenhuijse MJ, Lindenburg R, Swen JW, van Arkel ER. Clinical outcome in all-arthroscopic versus mini-open rotator cuff repair in small to medium-sized tears: a randomized controlled trial in 100 patients with 1-year follow-up. Arthroscopy. 2013 Feb;29(2):266-73. doi: 10.1016/j.arthro.2012.08.022. Epub 2012 Dec 1.
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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.
C. Benjamin Ma, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen in people with Rotator Cuff Tear Arthropathy, run by University of California, San Francisco 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 2 inclusion and 8 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 6 Dec 2024. 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. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2024). 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?
Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo (time frame: 1 week post operative). 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 NCT02588027, which also lists 8 linked publications.
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 6 Dec 2024.