Adults 18 to 80, any sex, with TSA or Bruise. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Numeric Rating Scale Pain Scores at Post-operative Day 14Primary· 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".
NRS at rest
Group
Value
95% CI
Total Shoulder Surgery Patients
1.6
± 1.8
NRS with movement
Group
Value
95% CI
Total Shoulder Surgery Patients
3.1
± 2.3
Numeric Rating Scale (NRS) Pain With Movement and at Rest.Secondary· Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery
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.
NRS POD1 at rest
Group
Value
95% CI
Total Shoulder Surgery Patients
1.6
± 2.1
NRS POD1 with movement
Group
Value
95% CI
Total Shoulder Surgery Patients
2.7
± 3
NRS POD3 at rest
Group
Value
95% CI
Total Shoulder Surgery Patients
2.8
± 3.3
NRS POD3 with movement
Group
Value
95% CI
Total Shoulder Surgery Patients
4.7
± 2.4
NRS POD7 at rest
Group
Value
95% CI
Total Shoulder Surgery Patients
2.3
± 2.4
NRS POD7 with movement
Group
Value
95% CI
Total Shoulder Surgery Patients
3.9
± 2.3
NRS POD90 at rest
Group
Value
95% CI
Total Shoulder Surgery Patients
0.8
± 1.7
NRS POD90 with movement
Group
Value
95% CI
Total Shoulder Surgery Patients
1.7
± 2.2
Opioid Consumption (in Past 24 Hours)Secondary· Days 1 day, 3 days, 7 days after surgery
Measured in milligrams taken. A lower consumption is a better outcome.
POD1
Group
Value
95% CI
Total Shoulder Surgery Patients
17.5
3.9 – 50.1
POD3
Group
Value
95% CI
Total Shoulder Surgery Patients
30
7.4 – 63.2
POD7
Group
Value
95% CI
Total Shoulder Surgery Patients
10
0 – 37.5
Opioid Related Symptom Distress ScaleSecondary· Day 1 after surgery
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
Group
Value
95% CI
Total Shoulder Surgery Patients
0.3
0.1 – 0.5
Range of MotionSecondary· Day 14 after surgery and 3 months after surgery
Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.
14 days after surgery extension
Group
Value
95% CI
Total Shoulder Surgery Patients
15.8
± 5.8
3 months after surgery extension
Group
Value
95% CI
Total Shoulder Surgery Patients
35
± 21.2
Severity of BruisingSecondary· Day 14 after surgery
Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.
Group
Value
95% CI
Total Shoulder Surgery Patients
1.5
± 1.9
Hospital Anxiety and Depression ScaleSecondary· Day 1 after surgery
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.
Anxiety
Group
Value
95% CI
Total Shoulder Surgery Patients
4.1
± 3.3
Depression
Group
Value
95% CI
Total Shoulder Surgery Patients
3.9
± 2.7
PainOUT QuestionnaireSecondary· Day 1 and 14 after surgery
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:
POD1 - Worst pain
Group
Value
95% CI
Total Shoulder Surgery Patients
2
0 – 5
POD14 - Worst pain
Group
Value
95% CI
Total Shoulder Surgery Patients
4
2 – 6
POD1 - Pain severity
Group
Value
95% CI
Total Shoulder Surgery Patients
0
0 – 0
POD14 - Pain severity
Group
Value
95% CI
Total Shoulder Surgery Patients
0
0 – 10
POD1 - Interference with sleep
Group
Value
95% CI
Total Shoulder Surgery Patients
0
0 – 2
POD14 - Interference with sleep
Group
Value
95% CI
Total Shoulder Surgery Patients
0
0 – 5
POD1 - Nausea
Group
Value
95% CI
Total Shoulder Surgery Patients
0
0 – 0
POD14 - Nausea
Group
Value
95% CI
Total Shoulder Surgery Patients
0
0 – 0
Pain Catastrophizing Scale (PCS)Secondary· Day of Surgery
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.
Group
Value
95% CI
Total Shoulder Surgery Patients
12
± 11.9
Fibromyalgia Scale. a Lower Score is a Better Outcome.Secondary· Day of Surgery
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 ind
Group
Value
95% CI
Total Shoulder Surgery Patients
5.5
± 3.4
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospital for Special Surgery, New York
Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03021096.