Trial · NCT02620579
Biopsychosocial Influence on Shoulder Pain
NCT02620579, Phase 2, Completed, Duke University; results first posted 2023-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Biopsychosocial Influence on Shoulder Pain. Trials, record NCT02620579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02620579
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biopsychosocial Influence on Shoulder Pain
- NCT number
- NCT02620579
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 264 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Shoulder Pain
- Interventions
- Propranolol LA (60 mg), Placebo, Shoulder Anatomy Education, Pain Processing Education
- First posted
- 2015-12-03
- Last updated
- 2023-01-13
- Results first posted
- 2023-01-13
- Limitations and caveats
This trial did not include participants with a clinical conditions. Instead, participants were recruited into this trial and shoulder pain was induced via exercise-induced muscle injury. We then randomly assigned them to 4 different arms, and tested for differences in recovery.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity | Approximately 6 days | The outcome has a range between 0 and 1, the higher scores mean a better outcome. Successful recovery was determined based on meeting the recovery criterion for shoulder pain intensity by at least 6 days. Specifically, recovery (Yes or No) was defined using Brief Pain Inventory (BPI) ratings as a current pain intensity rating of 0/10 and a worst pain intensity rating of less than 2/10. |
| Secondary | Brief Pain Inventory (BPI) for Pain Duration | Daily until recovery criterion met, approximately 5-15 days | The Brief Pain Inventory (BPI) consists of rating pain intensity on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain intensity imaginable). BPI will be recorded daily and the recovery criterion used for this study will be a BPI rating of current pain 0/10 and worst pain rating of less than 2/10. The pain duration is number of days from the date of induced pain to date of recovery. The longer the duration means a worse outcome. |
| Secondary | Brief Pain Inventory (BPI) for Worst Shoulder Pain Intensity (Highest Daily Pain Intensity Rating) Recorded During Recovery. | Day 2 value of the worst pain intensity is reported | The Brief Pain Inventory (BPI) which consists of rating pain intensity on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain intensity imaginable). Participants will rate their current, best, and worst pain intensity on the BPI. This measure will be recorded daily through study completion, an average of 5 days. The worst pain intensity rating at Day 2 (when participants usually had the Peak Shoulder Pain Intensity) is reported. |
| Secondary | Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) | Daily until recovery criterion met, approximately 5-15 days | The abridged version of the DASH (the QuickDASH) which consists of 11 functional items, with total scores ranging from 0 (not disability) to 100 (complete disability) will be used to assess upper-extremity disability. The primary outcome will be the highest DASH score recorded during the pain intensity recovery period. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity | Approximately 6 days | Analysis Population consists of 233 participants. 28 out of 261 randomized participants were excluded due to criteria related to the safety of propranolol administration (eg, abnormal ECG findings) or a candidate not being able to complete the study (eg, change in time commitment). These post-randomization exclusions were made for safety reasons and participants were excluded prior to any baseline data collection, induction of exercise-induced muscle injury, and treatment allocation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Brief Pain Inventory (BPI) for Pain Duration | Daily until recovery criterion met, approximately 5-15 days | Analysis Population consists of 233 participants. 28 out of 261 randomized participants were excluded due to criteria related to the safety of propranolol administration (eg, abnormal ECG findings) or a candidate not being able to complete the study (eg, change in time commitment). These post-randomization exclusions were made for safety reasons and participants were excluded prior to any baseline data collection, induction of exercise-induced muscle injury, and treatment allocation. | days | MEDIAN |
| SECONDARY | Brief Pain Inventory (BPI) for Worst Shoulder Pain Intensity (Highest Daily Pain Intensity Rating) Recorded During Recovery. | Day 2 value of the worst pain intensity is reported | Analysis Population consists of 233 participants. 28 out of 261 randomized participants were excluded due to criteria related to the safety of propranolol administration (eg, abnormal ECG findings) or a candidate not being able to complete the study (eg, change in time commitment). These post-randomization exclusions were made for safety reasons and participants were excluded prior to any baseline data collection, induction of exercise-induced muscle injury, and treatment allocation. | score on a scale | MEAN |
| SECONDARY | Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) | Daily until recovery criterion met, approximately 5-15 days | Analysis Population consists of 233 participants. 28 out of 261 randomized participants were excluded due to criteria related to the safety of propranolol administration (eg, abnormal ECG findings) or a candidate not being able to complete the study (eg, change in time commitment). These post-randomization exclusions were made for safety reasons and participants were excluded prior to any baseline data collection, induction of exercise-induced muscle injury, and treatment allocation. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity | Personalized Pharmaceutical and Education (C) | 39 | Participants | ||
| Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity | Placebo Pharmaceutical, General Education (B) | 32 | Participants | ||
| Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity | Placebo Pharmaceutical, Personalized Education (A) | 32 | Participants | ||
| Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity | Personalized Pharmaceutical, General Education (D) | 32 | Participants | ||
| Brief Pain Inventory (BPI) for Pain Duration | Personalized Pharmaceutical and Education (C) | 4 | Full Range 4 to 9 | days | |
| Brief Pain Inventory (BPI) for Pain Duration | Placebo Pharmaceutical, General Education (B) | 4 | Full Range 1 to 11 | days | |
| Brief Pain Inventory (BPI) for Pain Duration | Placebo Pharmaceutical, Personalized Education (A) | 4 | Full Range 0 to 11 | days | |
| Brief Pain Inventory (BPI) for Pain Duration | Personalized Pharmaceutical, General Education (D) | 4 | Full Range 4 to 9 | days | |
| Brief Pain Inventory (BPI) for Worst Shoulder Pain Intensity (Highest Daily Pain Intensity Rating) Recorded During Recovery. | Personalized Pharmaceutical and Education (C) | 2.9 | Standard Deviation 1.9 | score on a scale | |
| Brief Pain Inventory (BPI) for Worst Shoulder Pain Intensity (Highest Daily Pain Intensity Rating) Recorded During Recovery. | Placebo Pharmaceutical, General Education (B) | 3.2 | Standard Deviation 2.1 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Personalized Pharmaceutical and Education (C) | 62 | |
| Overall Study | STARTED | Placebo Pharmaceutical, General Education (B) | 57 | |
| Overall Study | STARTED | Placebo Pharmaceutical, Personalized Education (A) | 57 | |
| Overall Study | STARTED | Personalized Pharmaceutical, General Education (D) | 57 | |
| Overall Study | COMPLETED | Personalized Pharmaceutical and Education (C) | 62 | |
| Overall Study | COMPLETED | Placebo Pharmaceutical, General Education (B) | 56 | |
| Overall Study | COMPLETED | Placebo Pharmaceutical, Personalized Education (A) | 56 | |
| Overall Study | COMPLETED | Personalized Pharmaceutical, General Education (D) | 56 | |
| Overall Study | NOT COMPLETED | Personalized Pharmaceutical and Education (C) | 0 | |
| Overall Study | NOT COMPLETED | Placebo Pharmaceutical, General Education (B) | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Light headedness | General disorders | Personalized Pharmaceutical and Education (C) | 17 | 62 | 22 |
| other | Light headedness | General disorders | Placebo Pharmaceutical, General Education (B) | 17 | 57 | 28 |
| other | Light headedness | General disorders | Placebo Pharmaceutical, Personalized Education (A) | 18 | 57 | 30 |
| other | Light headedness | General disorders | Personalized Pharmaceutical, General Education (D) | 14 | 57 | 17 |
| other | Slowed heartbeat | Blood and lymphatic system disorders | Personalized Pharmaceutical and Education (C) | 2 | 62 | 6 |
| other | Slowed heartbeat | Blood and lymphatic system disorders | Placebo Pharmaceutical, General Education (B) | 4 | 57 | 4 |
| other | Slowed heartbeat | Blood and lymphatic system disorders | Placebo Pharmaceutical, Personalized Education (A) | 4 | 57 | 4 |
| other | Slowed heartbeat | Blood and lymphatic system disorders | Personalized Pharmaceutical, General Education (D) | 1 | 57 | 1 |
| other | Weakness | Musculoskeletal and connective tissue disorders | Personalized Pharmaceutical and Education (C) | 25 | 62 | 44 |
| other | Weakness | Musculoskeletal and connective tissue disorders | Placebo Pharmaceutical, General Education (B) | 24 | 57 | 56 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Personalized Pharmaceutical and Education (C) | 0 | 62 |
| Total, all-cause mortality | Placebo Pharmaceutical, General Education (B) | 0 | 57 |
| Total, all-cause mortality | Placebo Pharmaceutical, Personalized Education (A) | 0 | 57 |
| Total, all-cause mortality | Personalized Pharmaceutical, General Education (D) | 0 | 57 |
| Total, other adverse events | Personalized Pharmaceutical and Education (C) | 49 | 62 |
| Total, other adverse events | Placebo Pharmaceutical, General Education (B) | 43 | 57 |
| Total, other adverse events | Placebo Pharmaceutical, Personalized Education (A) | 39 | 57 |
| Total, other adverse events | Personalized Pharmaceutical, General Education (D) | 43 | 57 |
| Total, serious adverse events | Personalized Pharmaceutical and Education (C) | 0 | 62 |
| Total, serious adverse events | Placebo Pharmaceutical, General Education (B) | 0 | 57 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AR055899 | Biopsychosocial Influence on Shoulder Pain | GEORGE, STEVEN Z | DUKE UNIVERSITY | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2008 to 2020 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02620579
GET https://conductscience.org/api/trials/v1/NCT02620579/events?page=2