Total Shoulder ArthroplastyNCT06133933
Total Shoulder Arthroplasty Preoperative Pain Threshold and Association With Postoperative Opioid Consumption
An observational study of Total Shoulder Arthroplasty and Postoperative Pain, run by Cooper Norcross Health at 1 site in United States.
Trial summary
The purpose of this prospective research study is to evaluate the effects of preoperative pain threshold using a pressure algometer and its effects on postoperative patient satisfaction, return to work, and opioid consumption following Total Shoulder Arthroplasty (TSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Shoulder Arthroplasty, Postoperative Pain, Opioid Use
- What is being tested?
- Pain Threshold using algometer/dolorimeter
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 21 May 2026
- Phase
- Observational
- 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
Study population: This is a prospective, non-randomized observational study. There will only be one group, the treatment group, consisting of patients undergoing Total Shoulder Arthroplasty (TSA). We will recruit patients using a screen for patients who meet inclusion criteria in EPIC or recruit patients via physician referral. Inclusion criteria includes all patients over 18 years of age who are undergoing TSA. When an eligible patient is selected, we will first obtain approval to approach from the treating physician. Once approval is received, a co-investigator will approach them over the phone to inform the patient about a study he or she is eligible for or approach them in-person during their visit.
Who may be able to join
- Patients 18 years or older
- Patients who are scheduled to undergo a Total Shoulder Arthroplasty
Who cannot join
- Patients younger than 18 years
- Patients who are scheduled to undergo a Total Shoulder Arthroplasty
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
About this study
Official title: Total Shoulder Arthroplasty Preoperative Pain Threshold Prospective
The purpose of this prospective research study is to evaluate the effects of preoperative pain threshold using a pressure algometer and its effects on postoperative patient satisfaction, return to work, and opioid consumption following Total Shoulder Arthroplasty (TSA). Participants will have their pain threshold measured at the preoperative visit. Postoperatively, they will be followed for 3 months and complete a pain journal for 2 weeks, record their medications consumed, and complete surveys at 2 weeks, 6 weeks, and 3 months. The study team will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcome.
Read the detailed description
Prior to undergoing total shoulder arthroplasty (TSA), it is important to counsel the patient on what the postoperative period will look like. Important factors that patients must consider include recovery time, amount of experienced pain, and risks for complications. A lower preoperative pain level has been shown to be a strong predictor of less postoperative pain, less opioid consumption, and greater patient satisfaction. However, pain is relative and typically quantified on a scale of 1-10. The pressure pain algometer is a tool that allows for the quantification of pain threshold and has demonstrated strong reliability with low inter-observer error. The pressure pain algometer has been used to determine preoperative pain thresholds in previous human studies and has been regarded as a suitable tool for assessing pain. Despite the use of this technique in the current literature, data on the application of this tool in Total Shoulder Arthroplasty (TSA) is lacking. There is no current study that has studied the use of preoperative pain thresholds using a pressure pain algometer and its correlation of patient satisfaction, and opioid consumption in TSA patients. This study will be important in closing the knowledge gap in the current literature and provide a better understanding of the usefulness of assessing preoperative pain thresholds with a pressure pain algometer on determining postoperative patient satisfaction, and opioid consumption in patients undergoing total shoulder arthroplasty.
This is a prospective, non-randomized observational study. There will only be one group, the treatment group, consisting of patients undergoing Total Shoulder Arthroplasty (TSA). The study team will recruit patients using a screen for patients who meet inclusion criteria in the institutional electronic medical record platform, EPIC, or recruit patients via physician referral. Inclusion criteria include all patients over 18 years of age who are undergoing TSA. When an eligible patient is selected, the study team will first obtain approval to approach the patient from the treating physician. Once approval is received, a co-investigator will approach them over the phone to inform the patient about a study he or she is eligible for or approach them in person during their visit. All patient eligibility data will be kept in a secure file that is password protected and secured on the Cooper secure network, in a drive behind a firewall. Only study personnel will have access to this information and the documents.
There will be four visits involved in this study, all of which follow the standard of care visit schedule:
Visit 1 is the consenting visit \& patients will be consented by the study doctors or co-investigators in the clinic. The preoperative pain threshold score will be obtained.
Visit 2 is the surgery visit the patient will undergo all typical procedures as if they were not in the study. Algometer pain scores and all questionnaires (Demographics, The Tobacco, Alcohol, Prescription medications, and other Substance [TAPS] 1, Visual Analogue Scale [VAS], The 12-item Short Form Survey[SF-12], The Single Assessment Numeric Evaluation [SANE] ) must be completed by this time, either in person at Visit 1, over the phone, via REDCap , or by email prior to this visit, or in pre-op holding where they will sign official consents. The opioid consumption journal will be given to the patient for the patient to record his or her daily opioid intake immediately following TSA. The study team will ask the patients to record their daily opioid consumption in the journal for the first two weeks. Prior to prescribing any prescription narcotics post-operatively, per standard of care, The study team will utilize the Prescription Monitoring Program (PMP) to determine what prescription narcotics the patient is currently on. With the patient's permission, and on the consent form, The study team will check the patient's PMP at 3 months to record opioid consumption.
Visit 3 is the 2-week follow-up visit post-surgery. The subject's standard of care data points will be obtained at this visit, in addition to the VAS, SF-12, and SANE, again which are strictly for research purposes.
Visit 4 is the 6-week follow-up visit post-surgery. The subject would have this visit even if they were not in the study and the same procedures will be conducted during the visit as standard of care. The subject's standard of care data points will be obtained at this visit, in addition to the VAS, SF-12, and SANE, again which are strictly for research purposes.
Visit 5 is the 3-month follow-up visit post-surgery. The subject would have this visit even if they were not in the study and the same procedures will be conducted during the visit as standard of care. The subject's standard of care data points will be obtained at this visit, in addition to the VAS, SF-12, SANE, and Satisfaction Survey again which is strictly for research purposes. The hard copies of the opioid consumption journal will be collected at the final visit. The study team will not need another algometer pain score post-operative as it has already been established in the pre-operative scores.
The study team will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and postoperative outcomes. All Protected Health Information (PHI) will be kept on a secure coded document that is password encrypted and stored on the secure Cooper secure network, in a drive behind a firewall. The rest of the study-specific data will be kept on REDCap, where each patient will have a specific study identifier (ID) that corresponds with their research records. there will be no PHI stored on REDCap.
- Conditions
- Total Shoulder Arthroplasty, Postoperative Pain, Opioid Use
- Being tested
- Pain Threshold using algometer/dolorimeter
- Keywords
- Total Shoulder Arthroplasty, Postoperative Pain, Postoperative Satisfaction, Opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Threshold using algometer/dolorimeterDevice
These patients who consent to participation in the study will receive a preoperative pain threshold measured using a pain algometer/dolorimeter. We will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Patients will have their preoperative pain threshold measured and complete postoperative pain journal, pill count, VAS, SF-12, SANE, and Satisfaction Survey in addition to the routine standard of care following perioperative management of total shoulder arthroplasty patients. Receives: Device: Pain Threshold using algometer/dolorimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
compare preoperative pain threshold with postoperative opioid consumption. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with opioid consumption, both by self-reporting and by accessing the Prescription Monitoring Program (PMP). Opioid consumption will be quantified using milligrams of morphine equivalents (MME).
Measured: 3 months
Postoperative satisfaction
compare preoperative pain threshold with postoperative satisfaction. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with patient satisfaction. Patients will be asked how satisfied they are with their pain control. They can answer on a 1-4 scale, with 1 being the lowest satisfaction and 4 being the highest degree of satisfaction.
Measured: 3 months
Postoperative return to work
compare preoperative pain threshold with postoperative return to work time in days.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start21 May 2021
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Total Shoulder ArthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Fedorka MD, Cooper Norcross Health
- Investigators
- Catherine J Fedorka, MD, Principal investigator, Cooper University Hospital Department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133933
- Sponsor's protocol ID
- IRB 21-087
- Status last verified
- Nov 2026
- First submitted
- 26 Jul 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang MMH, Hartley RL, Leung AA, Ronksley PE, Jette N, Casha S, Riva-Cambrin J. Preoperative predictors of poor acute postoperative pain control: a systematic review and meta-analysis. BMJ Open. 2019 Apr 1;9(4):e025091. doi: 10.1136/bmjopen-2018-025091.
PubMed 30940757Friedman RJ, Eichinger J, Schoch B, Wright T, Zuckerman J, Flurin PH, Bolch C, Roche C. Preoperative parameters that predict postoperative patient-reported outcome measures and range of motion with anatomic and reverse total shoulder arthroplasty. JSES Open Access. 2019 Nov 18;3(4):266-272. doi: 10.1016/j.jses.2019.09.010. eCollection 2019 Dec.
PubMed 31891024Kim MS, Koh IJ, Sung YG, Park DC, Yoon EJ, In Y. Influence of increased pain sensitivity on patient-reported outcomes following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):782-790. doi: 10.1007/s00167-021-06455-5. Epub 2021 Jan 24.
PubMed 33486560Palanisami DR, Reddy DA, Huggi V, Rajasekaran RB, Natesan R, Shanmuganathan R. Assessing Preoperative Pain Sensitivity Predicts the Postoperative Analgesic Requirement and Recovery after Total Knee Arthroplasty: A Prospective Study of 178 Patients. J Arthroplasty. 2020 Dec;35(12):3545-3553. doi: 10.1016/j.arth.2020.07.029. Epub 2020 Jul 18.
PubMed 32773269Nickel BT, Klement MR, Byrd WA, Attarian DE, Seyler TM, Wellman SS. The James A. Rand Young Investigator's Award: Battling the Opioid Epidemic with Prospective Pain Threshold Measurement. J Arthroplasty. 2018 Jul;33(7S):S3-S7. doi: 10.1016/j.arth.2018.02.060. Epub 2018 Feb 21.
PubMed 29567001Shigematsu-Locatelli M, Kawano T, Kitamura S, Nishigaki A, Yamanaka D, Aoyama B, Tateiwa H, Yokoyama M. Does preoperative patient's estimated acceptable pain affect the satisfaction with postoperative pain management? JA Clin Rep. 2017;3(1):5. doi: 10.1186/s40981-016-0075-0. Epub 2017 Jan 10.
PubMed 29492444Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
PubMed 22506152Buchanan HM, Midgley JA. Evaluation of pain threshold using a simple pressure algometer. Clin Rheumatol. 1987 Dec;6(4):510-7. doi: 10.1007/BF02330587.
PubMed 3449302Chesterton LS, Sim J, Wright CC, Foster NE. Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain. 2007 Nov-Dec;23(9):760-6. doi: 10.1097/AJP.0b013e318154b6ae.
PubMed 18075402Hinarejos P, Goicoechea N, Gidi M, Leal-Blanquet J, Torres-Claramunt R, Sanchez-Soler J, Monllau JC. Pressure algometry is a suitable tool to assess anterior knee pain in osteoarthritic patients. Eur J Orthop Surg Traumatol. 2019 Jul;29(5):1089-1093. doi: 10.1007/s00590-019-02391-w. Epub 2019 Feb 7.
PubMed 30734099Sayed-Noor AS, Englund E, Wretenberg P, Sjoden GO. Pressure-pain threshold algometric measurement in patients with greater trochanteric pain after total hip arthroplasty. Clin J Pain. 2008 Mar-Apr;24(3):232-6. doi: 10.1097/AJP.0b013e3181602159.
PubMed 18287829
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Shoulder Arthroplasty Preoperative Pain Threshold Prospective
- ClinicalTrials.gov ID
- NCT06133933
- Acronym / sponsor ID
- IRB 21-087
- Conditions
- Total Shoulder Arthroplasty, Postoperative Pain, Opioid Use
- Keywords
- Total Shoulder Arthroplasty, Postoperative Pain, Postoperative Satisfaction, Opioid consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 18 Nov 2023 (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.
The purpose of this prospective research study is to evaluate the effects of preoperative pain threshold using a pressure algometer and its effects on postoperative patient satisfaction, return to work, and opioid consumption following Total Shoulder Arthroplasty (TSA). Participants will have their pain threshold measured at the preoperative visit. Postoperatively, they will be followed for 3 months and complete a pain journal for 2 weeks, record their medications consumed, and complete surveys at 2 weeks, 6 weeks, and 3 months. The study team will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcome.
Detailed description
Prior to undergoing total shoulder arthroplasty (TSA), it is important to counsel the patient on what the postoperative period will look like. Important factors that patients must consider include recovery time, amount of experienced pain, and risks for complications. A lower preoperative pain level has been shown to be a strong predictor of less postoperative pain, less opioid consumption, and greater patient satisfaction. However, pain is relative and typically quantified on a scale of 1-10. The pressure pain algometer is a tool that allows for the quantification of pain threshold and has demonstrated strong reliability with low inter-observer error. The pressure pain algometer has been used to determine preoperative pain thresholds in previous human studies and has been regarded as a suitable tool for assessing pain. Despite the use of this technique in the current literature, data on the application of this tool in Total Shoulder Arthroplasty (TSA) is lacking. There is no current study that has studied the use of preoperative pain thresholds using a pressure pain algometer and its correlation of patient satisfaction, and opioid consumption in TSA patients. This study will be important in closing the knowledge gap in the current literature and provide a better understanding of the usefulness of assessing preoperative pain thresholds with a pressure pain algometer on determining postoperative patient satisfaction, and opioid consumption in patients undergoing total shoulder arthroplasty.
This is a prospective, non-randomized observational study. There will only be one group, the treatment group, consisting of patients undergoing Total Shoulder Arthroplasty (TSA). The study team will recruit patients using a screen for patients who meet inclusion criteria in the institutional electronic medical record platform, EPIC, or recruit patients via physician referral. Inclusion criteria include all patients over 18 years of age who are undergoing TSA. When an eligible patient is selected, the study team will first obtain approval to approach the patient from the treating physician. Once approval is received, a co-investigator will approach them over the phone to inform the patient about a study he or she is eligible for or approach them in person during their visit. All patient eligibility data will be kept in a secure file that is password protected and secured on the Cooper secure network, in a drive behind a firewall. Only study personnel will have access to this information and the documents.
There will be four visits involved in this study, all of which follow the standard of care visit schedule:
Visit 1 is the consenting visit \& patients will be consented by the study doctors or co-investigators in the clinic. The preoperative pain threshold score will be obtained.
Visit 2 is the surgery visit the patient will undergo all typical procedures as if they were not in the study. Algometer pain scores and all questionnaires (Demographics, The Tobacco, Alcohol, Prescription medications, and other Substance [TAPS] 1, Visual Analogue Scale [VAS], The 12-item Short Form Survey[SF-12], The Single Assessment Numeric Evaluation [SANE] ) must be completed by this time, either in person at Visit 1, over the phone, via REDCap , or by email prior to this visit, or in pre-op holding where they will sign official consents. The opioid consumption journal will be given to the patient for the patient to record his or her daily opioid intake immediately following TSA. The study team will ask the patients to record their daily opioid consumption in the journal for the first two weeks. Prior to prescribing any prescription narcotics post-operatively, per standard of care, The study team will utilize the Prescription Monitoring Program (PMP) to determine what prescription narcotics the patient is currently on. With the patient's permission, and on the consent form, The study team will check the patient's PMP at 3 months to record opioid consumption.
Visit 3 is the 2-week follow-up visit post-surgery. The subject's standard of care data points will be obtained at this visit, in addition to the VAS, SF-12, and SANE, again which are strictly for research purposes.
Visit 4 is the 6-week follow-up visit post-surgery. The subject would have this visit even if they were not in the study and the same procedures will be conducted during the visit as standard of care. The subject's standard of care data points will be obtained at this visit, in addition to the VAS, SF-12, and SANE, again which are strictly for research purposes.
Visit 5 is the 3-month follow-up visit post-surgery. The subject would have this visit even if they were not in the study and the same procedures will be conducted during the visit as standard of care. The subject's standard of care data points will be obtained at this visit, in addition to the VAS, SF-12, SANE, and Satisfaction Survey again which is strictly for research purposes. The hard copies of the opioid consumption journal will be collected at the final visit. The study team will not need another algometer pain score post-operative as it has already been established in the pre-operative scores.
The study team will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and postoperative outcomes. All Protected Health Information (PHI) will be kept on a secure coded document that is password encrypted and stored on the secure Cooper secure network, in a drive behind a firewall. The rest of the study-specific data will be kept on REDCap, where each patient will have a specific study identifier (ID) that corresponds with their research records. there will be no PHI stored on REDCap.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Device: Pain Threshold using algometer/dolorimeterPatients will have their preoperative pain threshold measured and complete postoperative pain journal, pill count, VAS, SF-12, SANE, and Satisfaction Survey in addition to the routine standard of care following perioperative management of total shoulder arthroplasty patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, non-randomized observational study. There will only be one group, the treatment group, consisting of patients undergoing Total Shoulder Arthroplasty (TSA). We will recruit patients using a screen for patients who meet inclusion criteria in EPIC or recruit patients via physician referral. Inclusion criteria includes all patients over 18 years of age who are undergoing TSA. When an eligible patient is selected, we will first obtain approval to approach from the treating physician. Once approval is received, a co-investigator will approach them over the phone to inform the patient about a study he or she is eligible for or approach them in-person during their visit.
Key inclusion criteria (2 listed)
- Patients 18 years or older
- Patients who are scheduled to undergo a Total Shoulder Arthroplasty
Key exclusion criteria (2 listed)
- Patients younger than 18 years
- Patients who are scheduled to undergo a Total Shoulder Arthroplasty
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 |
|---|---|---|
| Pain Threshold using algometer/dolorimeterThese patients who consent to participation in the study will receive a preoperative pain threshold measured using a pain algometer/dolorimeter. We will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcomes. | Device | Study Cohort |
Primary outcome
Postoperative opioid consumption
Time frame: 3 months
compare preoperative pain threshold with postoperative opioid consumption. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with opioid consumption, both by self-reporting and by accessing the Prescription Monitoring Program (PMP). Opioid consumption will be quantified using milligrams of morphine equivalents (MME).
Postoperative satisfaction
Time frame: 3 months
compare preoperative pain threshold with postoperative satisfaction. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with patient satisfaction. Patients will be asked how satisfied they are with their pain control. They can answer on a 1-4 scale, with 1 being the lowest satisfaction and 4 being the highest degree of satisfaction.
Postoperative return to work
Time frame: 3 months
compare preoperative pain threshold with postoperative return to work time in days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 30940757Yang MMH, Hartley RL, Leung AA, Ronksley PE, Jette N, Casha S, Riva-Cambrin J. Preoperative predictors of poor acute postoperative pain control: a systematic review and meta-analysis. BMJ Open. 2019 Apr 1;9(4):e025091. doi: 10.1136/bmjopen-2018-025091.
- Background: PubMed 31891024Friedman RJ, Eichinger J, Schoch B, Wright T, Zuckerman J, Flurin PH, Bolch C, Roche C. Preoperative parameters that predict postoperative patient-reported outcome measures and range of motion with anatomic and reverse total shoulder arthroplasty. JSES Open Access. 2019 Nov 18;3(4):266-272. doi: 10.1016/j.jses.2019.09.010. eCollection 2019 Dec.
- Background: PubMed 33486560Kim MS, Koh IJ, Sung YG, Park DC, Yoon EJ, In Y. Influence of increased pain sensitivity on patient-reported outcomes following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):782-790. doi: 10.1007/s00167-021-06455-5. Epub 2021 Jan 24.
- Background: PubMed 32773269Palanisami DR, Reddy DA, Huggi V, Rajasekaran RB, Natesan R, Shanmuganathan R. Assessing Preoperative Pain Sensitivity Predicts the Postoperative Analgesic Requirement and Recovery after Total Knee Arthroplasty: A Prospective Study of 178 Patients. J Arthroplasty. 2020 Dec;35(12):3545-3553. doi: 10.1016/j.arth.2020.07.029. Epub 2020 Jul 18.
- Background: PubMed 29567001Nickel BT, Klement MR, Byrd WA, Attarian DE, Seyler TM, Wellman SS. The James A. Rand Young Investigator's Award: Battling the Opioid Epidemic with Prospective Pain Threshold Measurement. J Arthroplasty. 2018 Jul;33(7S):S3-S7. doi: 10.1016/j.arth.2018.02.060. Epub 2018 Feb 21.
- Background: PubMed 29492444Shigematsu-Locatelli M, Kawano T, Kitamura S, Nishigaki A, Yamanaka D, Aoyama B, Tateiwa H, Yokoyama M. Does preoperative patient's estimated acceptable pain affect the satisfaction with postoperative pain management? JA Clin Rep. 2017;3(1):5. doi: 10.1186/s40981-016-0075-0. Epub 2017 Jan 10.
- Background: PubMed 22506152Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
- Background: PubMed 3449302Buchanan HM, Midgley JA. Evaluation of pain threshold using a simple pressure algometer. Clin Rheumatol. 1987 Dec;6(4):510-7. doi: 10.1007/BF02330587.
- Background: PubMed 18075402Chesterton LS, Sim J, Wright CC, Foster NE. Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain. 2007 Nov-Dec;23(9):760-6. doi: 10.1097/AJP.0b013e318154b6ae.
- Background: PubMed 30734099Hinarejos P, Goicoechea N, Gidi M, Leal-Blanquet J, Torres-Claramunt R, Sanchez-Soler J, Monllau JC. Pressure algometry is a suitable tool to assess anterior knee pain in osteoarthritic patients. Eur J Orthop Surg Traumatol. 2019 Jul;29(5):1089-1093. doi: 10.1007/s00590-019-02391-w. Epub 2019 Feb 7.
- Background: PubMed 18287829Sayed-Noor AS, Englund E, Wretenberg P, Sjoden GO. Pressure-pain threshold algometric measurement in patients with greater trochanteric pain after total hip arthroplasty. Clin J Pain. 2008 Mar-Apr;24(3):232-6. doi: 10.1097/AJP.0b013e3181602159.
- Individual participant dataSharing planned: No
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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.
Catherine J Fedorka, MD principal investigator
Cooper University Hospital Department of Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Shoulder Arthroplasty and Postoperative Pain, run by Cooper Norcross Health 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 2 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 5 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative opioid consumption (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT06133933, which also lists 11 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 5 Nov 2026.