Phase 2
N=233
Biopsychosocial Influence on Shoulder Pain
Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT02620579 ↗Enrolled (actual)
233
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity — 39; 32; 32; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Propranolol LA (60 mg) (Drug); Placebo (Drug); Shoulder Anatomy Education (Behavioral); Pain Processing Education (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity |
39; 32; 32; 32 | — |
| SECONDARY Brief Pain Inventory (BPI) for Pain Duration |
4; 4; 4; 4 | — |
| SECONDARY Brief Pain Inventory (BPI) for Worst Shoulder Pain Intensity (Highest Daily Pain Intensity Rating) Recorded During Recovery. |
2.9; 3.2; 2.9; 3.1 | — |
| SECONDARY Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) |
8.2; 10.5; 11.4; 9.4 | — |
Summary
Chronic shoulder pain is a common, costly, and disabling problem for society. The identification of factors predictive of the development of chronic shoulder pain is necessary to develop innovative and effective treatments to reduce the societal impact of shoulder disorders. In previous work the investigators identified a genetic and psychological subgroup that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor 12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study the investigator proposes to test how interventions tailored to the high risk subgroup affect pain responses in a pre-clinical cohort.
The optimal theorized match for the identified high-risk subgroup is a combination of personalized pharmaceutical and education interventions. This combined personalized intervention versus a placebo pharmaceutical and general education intervention group is the primary comparison of interest. Also, an evaluation of the individual effect of personalized pharmaceutical and educational interventions will be part of the study. Such comparisons will provide important information on what the active portion of the combined personalized intervention may be.
Eligibility Criteria
Inclusion Criteria
- English speaking
Exclusion Criteria
- chronic pain (> 3 months) in any area,
- currently experiencing neck or shoulder pain,
- previous history of neck or shoulder pain (operationally defined as experiencing neck or shoulder pain for longer than 48 hours or seeking medical treatment for neck or shoulder pain),
- neurological impairment of the in the upper-extremity (determined by loss of sensation, muscle weakness, and reflex changes),
- regular participation in upper-extremity weight training,
- currently or regular use of pain medication, and
- previous history of upper-extremity surgery.
Additional exclusion criteria for propranolol administration are reported history of or presence of any of the following cardiovascular conditions:
- clinically significant abnormal 12-lead ECG,
- sinus bradycardia (resting heart rate below 55 beats per minute),
- greater than first degree heart block,
- cardiac failure,
- coronary artery disease,
- uncontrolled hypertension (resting systolic blood pressure above 140 mm Hg), or hypotension (resting systolic blood pressure below 90 mm Hg),
- Wolff-Parkinson-White syndrome.
Non-cardiovascular reasons for study exclusion include:
- bronchial asthma,
- nonallergic bronchospasm,
- history of recent major surgery requiring general anesthesia,
- diabetes,
- pregnancy,
- major depression.
Data sourced from ClinicalTrials.gov (NCT02620579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.