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Biopsychosocial Influence on Shoulder Pain

  • Status
    Accepting Candidates
  • Age
    18 Years - 64 Years
  • Sexes
  • Healthy Volunteers
    Accepts Healthy Volunteers


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.


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.


Full study title Biopsychosocial Influence on Shoulder Pain
Protocol number OCR34402 ID NCT02620579
Phase Phase 2


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.

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Mark Bishop
  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.