Acetaminophen for Shoulder Pain

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Henry Ford Health, Detroit, MI
Shoulder Pain+1 More
Acetaminophen - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty. Patients who receive a multimodal pain control regimen alone (study group) will be compared to patients who receive a multimodal pain control regimen plus a standard prescription of an opioid containing medication (comparison group). The primary outcome is average daily Numerical Rating Scale (NRS) pain score in the first 10 days after surgery. We hypothesize that there will be no significant difference in the primary outcome between the two groups.

Eligible Conditions

  • Shoulder Pain
  • Shoulder Arthropathy

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: To 2 years postoperative

Year 2
Complications
Year 2
Shoulder Range of Motion
Shoulder Strength
Day 10
Pain levels
Patient-Reported Outcomes scores (PROMs) for depression
Patient-Reported Outcomes scores (PROMs) for upper extremity function
Patient-Reported Outcomes scores (PROMs) for upper extremity pain interference
Day 10
Morphine milligram equivalents
To 2 years postoperative
Reoperation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Multimodal Plus Narcotic
1 of 2
Multimodal, Non-Narcotic
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Acetaminophen · No Placebo Group · Phase 4

Multimodal, Non-NarcoticExperimental Group · 11 Interventions: Celecoxib, Ropivicaine, Pregabalin, ketoralac, Tizanidine, Tramadol, magnesium, Ibuprofen, Dexamethasone, Acetaminophen, Epinephrine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Multimodal Plus NarcoticActiveComparator Group · 12 Interventions: Celecoxib, Ropivicaine, Pregabalin, ketoralac, Tizanidine, Tramadol, magnesium, Ibuprofen, Oxycodone Hydrochloride 5 Mg, Acetaminophen 325 Mg Oral Tablet, Dexamethasone, Acetaminophen, Epinephrine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
2002
Completed Phase 3
~1740
Ropivicaine
2014
Completed Phase 4
~430
Pregabalin
2005
Completed Phase 4
~6110
Tizanidine
2016
Completed Phase 4
~630
Tramadol
2014
Completed Phase 4
~3320
magnesium
2010
Completed Phase 4
~390
Ibuprofen
2013
Completed Phase 4
~4950
Dexamethasone
2007
Completed Phase 4
~2420
Acetaminophen
2017
Completed Phase 4
~2160
Epinephrine
2014
Completed Phase 4
~3250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: to 2 years postoperative
Closest Location: Henry Ford Health · Detroit, MI
Photo of henry ford health system 1Photo of henry ford health system 2Photo of henry ford health system 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Shoulder Pain
0 CompletedClinical Trials

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
257 Previous Clinical Trials
2,011,095 Total Patients Enrolled
Stephanie J Muh, MDPrincipal InvestigatorHenry Ford Health
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.