Biopsychosocial Influence on Shoulder Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 5/20/2018 |
| Start Date: | January 2016 |
| End Date: | December 2020 |
| Contact: | Warren H. Greenfield, III, MS |
| Email: | whgiii@phhp.ufl.edu |
| Phone: | 352-273-8964 |
Biopsychosocial Influence on Shoulder Pain: a Randomized, Pre-clinical Trial
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.
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.
Potential subjects will be screened and those meeting the high-risk criteria based on COMT
genotype for high pain sensitivity and pain catastrophizing questionnaire score will be
eligible for randomization into intervention groups (stratified by sex). Exercise induced
shoulder injury will serve as the pain generating mechanism on Day 1 and participants will
receive pharmaceutical and education interventions over Days 1-4, and Days 2-4 respectively.
Statistical analysis will determine whether the combined personalized intervention group
experienced shorter shoulder pain duration, lower peak pain intensity, or decreased
upper-extremity disability and determine which molecular, psychological, and pain sensitivity
regulation mechanisms are associated with pain relief. A preliminary analysis is planned
after the first 300 subjects are equally randomized to the 4 intervention groups. The
comparison of interest for the preliminary analysis is the combined personalized intervention
group with the placebo and general education group for the primary outcome. Depending on the
results of this preliminary analysis the randomization pattern may change, with details of
these changes available in the protocol paper.
genotype for high pain sensitivity and pain catastrophizing questionnaire score will be
eligible for randomization into intervention groups (stratified by sex). Exercise induced
shoulder injury will serve as the pain generating mechanism on Day 1 and participants will
receive pharmaceutical and education interventions over Days 1-4, and Days 2-4 respectively.
Statistical analysis will determine whether the combined personalized intervention group
experienced shorter shoulder pain duration, lower peak pain intensity, or decreased
upper-extremity disability and determine which molecular, psychological, and pain sensitivity
regulation mechanisms are associated with pain relief. A preliminary analysis is planned
after the first 300 subjects are equally randomized to the 4 intervention groups. The
comparison of interest for the preliminary analysis is the combined personalized intervention
group with the placebo and general education group for the primary outcome. Depending on the
results of this preliminary analysis the randomization pattern may change, with details of
these changes available in the protocol paper.
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.
We found this trial at
1
site
Gainesville, Florida 32610
Phone: 352-273-8157
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