An observational study in TSA, Bruise and Pain, Postoperative, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Hospital for Special Surgery, New York · Observational
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.
This is a pilot study, with the goals of
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 108 is close to the median of 102 across 608 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures
Exclusion Criteria:
The study is just using validated surveys to assess pain and mood states after surgery
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".
Time frame: 14 days after surgery for each patient
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. Worst pain: On a 0-10 scale, where 0 means "no pain" and 10 means "worst possible pain". Higher scores reflect more severity. 2. Pain severity: On a scale 0-10, where 0 means "very unsatisfied" and 10 means "very satisfied". Higher scores means more satisfaction. 3. 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. 4. Nausea \& Itching: Both rated on a 0-10 scale, where 0 means "none" and 10 means "severe". A higher rating means more severe. 5. 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.
Time frame: 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.
Time frame: 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: 1. Fatigue 2. Waking from sleep feeling unrefreshed 3. Cognitive symptoms (including trouble concentrating, confusion, disorientation, and impaired comprehension) 4. 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.
Time frame: Day of Surgery
| Milestone | Total Shoulder Surgery Patients |
|---|---|
| Started | 108 |
| Completed | 102 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Protocol violation | 2 |
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".
| score on a scale | Total Shoulder Surgery Patients |
|---|---|
| NRS at rest | 1.6 ± 1.8 |
| NRS with movement | 3.1 ± 2.3 |
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.
| score on a scale | Total Shoulder Surgery Patients |
|---|---|
| NRS POD1 at rest | 1.6 ± 2.1 |
| NRS POD1 with movement | 2.7 ± 3 |
| NRS POD3 at rest | 2.8 ± 3.3 |
| NRS POD3 with movement | 4.7 ± 2.4 |
| NRS POD7 at rest | 2.3 ± 2.4 |
| NRS POD7 with movement | 3.9 ± 2.3 |
| NRS POD90 at rest | 0.8 ± 1.7 |
| NRS POD90 with movement | 1.7 ± 2.2 |
Measured in milligrams taken. A lower consumption is a better outcome.
| oral morphine equivalents (mg) | Total Shoulder Surgery Patients |
|---|---|
| POD1 | 17.5 (3.9 to 50.1) |
| POD3 | 30 (7.4 to 63.2) |
| POD7 | 10 (0 to 37.5) |
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.
| score on a scale | Total Shoulder Surgery Patients |
|---|---|
| Opioid Related Symptom Distress Scale | 0.3 (0.1 to 0.5) |
Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.
| degrees | Total Shoulder Surgery Patients |
|---|---|
| 14 days after surgery extension | 15.8 ± 5.8 |
| 3 months after surgery extension | 35 ± 21.2 |
Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.
| cm | Total Shoulder Surgery Patients |
|---|---|
| Severity of Bruising | 1.5 ± 1.9 |
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.
| score on a scale | Total Shoulder Surgery Patients |
|---|---|
| Anxiety | 4.1 ± 3.3 |
| Depression | 3.9 ± 2.7 |
The PainOUT questionnaire assess pain intensity, quality of pain, and satisfaction with pain management. The questionnaire measured the following: 1. Worst pain: On a 0-10 scale, where 0 means "no pain" and 10 means "worst possible pain". Higher scores reflect more severity. 2. Pain severity: On a scale 0-10, where 0 means "very unsatisfied" and 10 means "very satisfied". Higher scores means more satisfaction. 3. 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. 4. Nausea \& Itching: Both rated on a 0-10 scale, where 0 means "none" and 10 means "severe". A higher rating means more severe. 5. 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.
| score on a scale | Total Shoulder Surgery Patients |
|---|---|
| POD1 - Worst pain | 2 (0 to 5) |
| POD14 - Worst pain | 4 (2 to 6) |
| POD1 - Pain severity | 0 (0 to 0) |
| POD14 - Pain severity | 0 (0 to 10) |
| POD1 - Interference with sleep | 0 (0 to 2) |
| POD14 - Interference with sleep | 0 (0 to 5) |
| POD1 - Nausea | 0 (0 to 0) |
| POD14 - Nausea | 0 (0 to 0) |
| POD1 - Itching | 0 (0 to 0) |
| POD14 - Itching | 0 (0 to 1) |
| POD1 - Drowsiness | 0 (0 to 5) |
| POD14 - Drowsiness | 0 (0 to 2) |
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.
| score on a scale | Total Shoulder Surgery Patients |
|---|---|
| Pain Catastrophizing Scale (PCS) | 12 ± 11.9 |
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: 1. Fatigue 2. Waking from sleep feeling unrefreshed 3. Cognitive symptoms (including trouble concentrating, confusion, disorientation, and impaired comprehension) 4. 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.
| score on a scale | Total Shoulder Surgery Patients |
|---|---|
| Fibromyalgia Scale. a Lower Score is a Better Outcome. | 5.5 ± 3.4 |
Collected over 3 months after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Shoulder Surgery Patients | 0/108 (0%) | 0/108 (0%) | 0/108 (0%) |
| Age, Continuous(years) | Total Shoulder Surgery Patients |
|---|---|
| Mean | 66 ± 9 |
| Sex: Female, Male(Participants) | Total Shoulder Surgery Patients |
|---|---|
| Female | 48 |
| Male | 54 |
| Race and Ethnicity Not Collected(Participants) | Total Shoulder Surgery Patients |
|---|
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital for Special Surgery, New York