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The study will address the gaps in the pain experience measurement in those with lateral elbow tendinopathy (LET) by building on the current body of literature, as well as applying modern pain science measures. The comprehensive measurement of various biomedical, psychological, and psychosocial constructs will provide pain profiles that will allow for the subclassification of LET to better inform loading prescriptions based on the systemic effects from LET.
Methods: Subjects complete the eight patient reported questionnaires as well as go through 4 clinical examination procedures. Through this cross-sectional design and single session of testing, the investigator seeks to identify associations amongst constructs and variables in order to sub classify patients with LET based on their pain experience.
Study aim 1: The goal of this study is to determine the associations among the various measurements of the pain experience, psychological, psychosocial, and biomedical domains in those with LET.
Research Questions
Hypotheses
Background and Significance
Lateral elbow tendinopathy (LET) is a condition characterized by pain limiting upper extremity function that is not always easily managed, underscoring limits in the understanding and application of pain science. The problems with conservative management of LET appear to be rooted in the understudied and underutilized measurement of pain experience. This lack of research in the application of pain science in those with LET presents an opportunity when determining the appropriate loading of an injured tendon based on different subclassifications.
The complexity of tendinopathy pathogenesis and individual factors influencing the pain experience in those with LET requires a comprehensive series of measures to investigate what is unknown in this area. The use of novel or minimally investigated pain classification and psychological measures will provide insight into their influence on the pain experience to assist with subclassification. Quantitative sensory test (QST) gold standard tests (PPT and PFGS), as well as emerging tests (TPD and laterality), will provide clinical tests that may impact the pain experience and further support the current systematic theoretical mechanisms of tendinopathy. Using a cross-sectional study design will allow for higher recruitment numbers and improve the feasibility of the study. The investigator will investigate the known challenges in the pain measurement of LET and explore how they contribute to the lack of optimal loading in those with LET with respect to the biomedical, psychological, and psychosocial domains.
Subjects will be recruited from clinics in the Philadelphia, PA region. Convenience sampling will be employed through clinical staff to identify eligible subjects using the inclusion and exclusion criteria below. Recruitment will be through flyers and the Office of Recruitment Enhancement services at Thomas Jefferson University utilizing electronic medical record system notifications and emails. Subjects will be screened for eligibility and, if willing to participate, be provided informed consent by the investigator before participation.
Subjects will provide demographic information, and all patient-reported outcome measures (Patient-Specific Functional Scale (PSFS), Numeric Pain Rating Scale (NPRS), Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Central Sensitization Inventory (CSI), Multidimensional Health Locus of Control-C (MHLOC), Pain Catastrophizing Scale (PCS), Fear Avoidance Belief Questionnaire (FABQ), and Hospital Anxiety and Depression Scale (HADS). Subjects will then be tested on the physical measures (Two-Point Discrimination (TPD), Pressure Pain Threshold (PPT), Pain-Free Grip Strength (PFGS), and Laterality).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LET | Patients with tennis elbow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Experience Measures | Diagnostic Test | Patient reported outcomes measures, quantitative sensory testing, and physical examination measures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Form-McGill Pain Questionnaire-2 |
| Baseline |
| Patient Specific Functional Scale |
| Baseline |
| Central Sensitization Inventory |
| Baseline |
| Multidimensional health locus of control scale form C |
| Baseline |
| Pain Catastrophizing Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Pain Threshold |
|
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Inclusion Criteria:
Exclusion Criteria:
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Outpatient orthopedic clinics and those located throughout the Philadelphia region.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia Hand to Shoulder Clinic | Cape May | New Jersey | 08210 | United States | ||
| Philadelphia Hand to Shoulder Center |
Pending discussion with TJU console.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2023 | Aug 18, 2023 |
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|
| Baseline |
| Fear Avoidance Belief Questionnaire |
| Baseline |
| Hospital Anxiety and Depression Scale |
| Baseline |
| Baseline |
| Two Point Discrimination |
| Baseline |
| Laterality |
| Baseline |
| Pain-Free Grip Strength |
| Baseline |
| Cherry Hill |
| New Jersey |
| 08003 |
| United States |
| Philadelphia Hand to Shoulder Center | Collegeville | Pennsylvania | 19426 | United States |
| Jefferson Rehabilitation | Fairless Hills | Pennsylvania | 19030 | United States |
| Philadelphia Hand to Shoulder Center | Glen Mills | Pennsylvania | 19342 | United States |
| Philadelphia Hand to Shoulder Center | King of Prussia | Pennsylvania | 19406 | United States |
| Philadelphia Hand to Shoulder Center | Langhorne | Pennsylvania | 19047 | United States |
| Philadelphia Hand to Shoulder Center | Lansdale | Pennsylvania | 19446 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107-5084 | United States |
| Philadelphia Hand to Shoulder Clinic | Philadelphia | Pennsylvania | 19112 | United States |
| Jefferson Rehabilitation | Philadelphia | Pennsylvania | 19130 | United States |
| Philadelphia Hand to Shoulder Center | Rockledge | Pennsylvania | 19046 | United States |
| Jefferson Rehabilitation | Torresdale | Pennsylvania | 19114 | United States |
| Jefferson Rehabilitation | Warminster | Pennsylvania | 18974 | United States |
| Jefferson Rehabilitation | Willow Grove | Pennsylvania | 19090 | United States |
| Philadelphia Hand to Shoulder Center | Willow Grove | Pennsylvania | 19090 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D013716 | Tennis Elbow |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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