TSATSANCT03021096
Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
An observational study of TSA and Bruise, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial. The investigators believe that with using HSS's current protocol, many patients have postoperative pain that is no worse than their preoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- TSA, Bruise, Pain, Postoperative
- What is being tested?
- Surveys
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2017to 22 Mar 2018
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures
Who may be able to join
- All patients eligible for the standardized anesthetic for TSA
- Patients who are capable to provide informed consent and answer questions in English (Study involves questionnaires validated in English)
- Age 18-80
Who cannot join
- Incapable to provide informed consent
- Contraindications for regional anesthesia (anticoagulation, infection at injection site)
- Patients undergoing TSA for Trauma or Rheumatoid Arthritis
- Revision TSA (previous non-TSA surgery is not an exclusion)
- Conversion of hemiarthroplasty to TSA
- Planned use of tranexamic acid
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
This study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial. The investigators believe that with using HSS's current protocol, many patients have postoperative pain that is no worse than their preoperative pain. Previous HSS anesthesia protocols for total shoulder arthroplasty patients have not formally followed patients past their hospital discharge, and the investigators believe that some patients do experience moderate to severe subacute postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain scores at 14 days after surgery. Future studies will look at measures of preventing bruising and subsequent pain after shoulder replacement.
Read the detailed description
This is a pilot study, with the goals of
- developing data for a subsequent randomized trials
- describing the pain trajectory after total shoulder arthroplasty given comprehensive multimodal perioperative analgesia
- gathering preliminary data about which shoulder arthroplasty patients are at high risk for moderate or severe postoperative pain (NRS with movement, POD14, moderate >= 4- 6; Gerbershagen 2011; severe >= 7-10, Krebs 2007) Potential factors include fibromyalgia score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use
- gathering preliminary data on the potential association between the predictors listed in (c) and NRS pain score with movement on POD 14.
- estimating incidence and severity of postoperative bruising on POD 14
- Conditions
- TSA, Bruise, Pain, Postoperative
- Being tested
- Surveys
- Medical subject headings
- Contusions, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
The study is just using validated surveys to assess pain and mood states after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale Pain Scores at Post-operative Day 14
Quantifying patients' pain at a sub-acute time point after surgery at rest and with movement.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Measured: 14 days after surgery for each patient
Secondary outcomes (9)
Numeric Rating Scale (NRS) Pain With Movement and at Rest.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". A lower score is a better outcome.
Measured: Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery
Opioid Consumption (in Past 24 Hours)
Measured in milligrams taken. A lower consumption is a better outcome.
Measured: Days 1 day, 3 days, 7 days after surgery
Opioid Related Symptom Distress Scale
The Opioid-Related Symptom Distress Scale (ORSDS) is calculated by taking the average of the three symptom distress dimensions. Frequency will be assessed using a 4 point scale: 1, rarely 2, occasionally 3, frequently 4, almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: 1, slight 2, moderate 3, severe 4, very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: 1, not at all 2, a little bit 3, somewhat 4, quite a bit 5, very much with 1 being the lowest and 5 being the highest.
A higher score indicates worse outcomes. The total score for each participant is calculated and the median score for all participants is reported.
Measured: Day 1 after surgery
Range of Motion
Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.
Measured: Day 14 after surgery and 3 months after surgery
Severity of Bruising
Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.
Measured: Day 14 after surgery
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression in a general medical population of patients. a lower score is a better outcome. Each item on the questionnaire is scored from 0-3 and a person's total score can ranged from 0 = normal and 21 = abnormal for either anxiety or depression.
Scale range:
0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
A total score for each participant was calculated and then all participants' scores were averaged.
Measured: Day 1 after surgery
PainOUT Questionnaire
The PainOUT questionnaire assess pain intensity, quality of pain, and satisfaction with pain management. The questionnaire measured the following:
- Worst pain: On a 0-10 scale, where 0 means "no pain" and 10 means "worst possible pain". Higher scores reflect more severity.
- Pain severity: On a scale 0-10, where 0 means "very unsatisfied" and 10 means "very satisfied". Higher scores means more satisfaction.
- Interference with sleep: Rated on a 0-10 scale, where 0 means "does not interfere" and 10 means "completely interfere" A higher rating means more interference.
- Nausea \& Itching: Both rated on a 0-10 scale, where 0 means "none" and 10 means "severe". A higher rating means more severe.
- Drowsiness: Rated on a 0-10 scale, where 0 means "not at all" and 10 means "extremely". A higher rating means more severe.
Each question score for each participant was added up and divided by the total number of participants to obtain an average score of 0-10 at each timepoint.
Measured: Day 1 and 14 after surgery
Pain Catastrophizing Scale (PCS)
The pain catastrophizing scale (PCS) evaluates a person's pain experience by asking them how they feel and what they think about when they are in pain.
The questionnaire uses a 5-point Likert scale, with answers ranging from 0 (never) to 4. (always). The total score is the sum of the individual item scores and ranges from 0 to 52. A lower score indicates a more positive outcome.
Measured: Day of Surgery
Fibromyalgia Scale. a Lower Score is a Better Outcome.
The symptom severity (SS) scale assesses four symptoms that are thought to be defining in a fibromyalgia diagnosis.
The four symptoms assessed by the criteria are as follows:
- Fatigue
- Waking from sleep feeling unrefreshed
- Cognitive symptoms (including trouble concentrating, confusion, disorientation, and impaired comprehension)
- Somatic symptoms (physical sensations such as pain, dizziness, nausea, fainting, or bowel disorders)
Each of the 4 symptoms is graded on a scale of 0 to 3, with 0 indicating no symptoms, 1 indicating mild symptoms, 2 indicating moderate symptoms, and 3 indicating severe symptoms. The sum of the scores for each of the 4 symptoms is summed to produce the SS total score. The SS total score has a minimum score of 0 and a maximum score of 12.
The higher score means worst outcome. The sum score for each participant is calculated and then the average score for all participants is reported.
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start27 Jan 2017
- Primary completion18 Dec 2017
- Study completion22 Mar 2018
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 (2)Papers the sponsor has linked to this study.
- Other trials for TSAStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques YaDeau, MD, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021096
- Sponsor's protocol ID
- 2016-0779
- Acronym
- TSA
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2017
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Goon AK, Dines DM, Craig EV, Gordon MA, Goytizolo EA, Lin Y, Lin E, YaDeau JT. A clinical pathway for total shoulder arthroplasty-a pilot study. HSS J. 2014 Jul;10(2):100-6. doi: 10.1007/s11420-014-9381-0. Epub 2014 Mar 8.
PubMed 25050091YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14.
PubMed 26814246
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
- ClinicalTrials.gov ID
- NCT03021096
- Acronym / sponsor ID
- TSA / 2016-0779
- Conditions
- TSA, Bruise, Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial. The investigators believe that with using HSS's current protocol, many patients have postoperative pain that is no worse than their preoperative pain. Previous HSS anesthesia protocols for total shoulder arthroplasty patients have not formally followed patients past their hospital discharge, and the investigators believe that some patients do experience moderate to severe subacute postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain scores at 14 days after surgery. Future studies will look at measures of preventing bruising and subsequent pain after shoulder replacement.
Detailed description
This is a pilot study, with the goals of
- developing data for a subsequent randomized trials
- describing the pain trajectory after total shoulder arthroplasty given comprehensive multimodal perioperative analgesia
- gathering preliminary data about which shoulder arthroplasty patients are at high risk for moderate or severe postoperative pain (NRS with movement, POD14, moderate >= 4- 6; Gerbershagen 2011; severe >= 7-10, Krebs 2007) Potential factors include fibromyalgia score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use
- gathering preliminary data on the potential association between the predictors listed in (c) and NRS pain score with movement on POD 14.
- estimating incidence and severity of postoperative bruising on POD 14
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures
Key inclusion criteria (3 listed)
- All patients eligible for the standardized anesthetic for TSA
- Patients who are capable to provide informed consent and answer questions in English (Study involves questionnaires validated in English)
- Age 18-80
Key exclusion criteria (6 listed)
- Incapable to provide informed consent
- Contraindications for regional anesthesia (anticoagulation, infection at injection site)
- Patients undergoing TSA for Trauma or Rheumatoid Arthritis
- Revision TSA (previous non-TSA surgery is not an exclusion)
- Conversion of hemiarthroplasty to TSA
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 |
|---|---|---|
| SurveysThe study is just using validated surveys to assess pain and mood states after surgery | Other | – |
Primary outcome
Numeric Rating Scale Pain Scores at Post-operative Day 14
Time frame: 14 days after surgery for each patient
Quantifying patients' pain at a sub-acute time point after surgery at rest and with movement. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
9 secondary outcomes
Numeric Rating Scale (NRS) Pain With Movement and at Rest.
Time frame: Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery
Opioid Consumption (in Past 24 Hours)
Time frame: Days 1 day, 3 days, 7 days after surgery
Opioid Related Symptom Distress Scale
Time frame: Day 1 after surgery
Range of Motion
Time frame: Day 14 after surgery and 3 months after surgery
Severity of Bruising
Time frame: Day 14 after surgery
Hospital Anxiety and Depression Scale
Time frame: Day 1 after surgery
PainOUT Questionnaire
Time frame: Day 1 and 14 after surgery
Pain Catastrophizing Scale (PCS)
Time frame: Day of Surgery
Fibromyalgia Scale. a Lower Score is a Better Outcome.
Time frame: Day of Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25050091Goon AK, Dines DM, Craig EV, Gordon MA, Goytizolo EA, Lin Y, Lin E, YaDeau JT. A clinical pathway for total shoulder arthroplasty-a pilot study. HSS J. 2014 Jul;10(2):100-6. doi: 10.1007/s11420-014-9381-0. Epub 2014 Mar 8.
- Background: PubMed 26814246YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14.
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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.
Jacques YaDeau, MD, PhD principal investigator
Hospital for Special Surgery, New York
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 TSA and Bruise, run by Hospital for Special Surgery, New York 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 3 inclusion and 6 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 4 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2025). 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?
Numeric Rating Scale Pain Scores at Post-operative Day 14 (time frame: 14 days after surgery for each patient). 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 NCT03021096, which also lists 2 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 4 Mar 2025.