Tendinopathy Clinical Trial
Official title:
Measuring Pain Experience in Individuals With Lateral Elbow Tendinopathy
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | April 1, 2025 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - English speaking and reading - Aged 18-75 - Diagnosis of lateral elbow tendinopathy provoked by 2 clinical tests: painful resisted 2nd or 3rd finger extension, painful wrist extension, painful stretching of forearm extensor muscles, or painful gripping. Exclusion Criteria: - Receiving any medical intervention for LET from a physician within 90 days. Medical intervention operationally defined as any intervention requiring a medical state license to administer (injection or surgery) or prescribe (medication applied to or ingested that is not available without a physician script) with the exception of patient education. - Positive mechanical sensitivity of the median nerve (Upper Limb Tension Test a (ULTTa)). - Positive pain provocation of passive elbow flexion. |
Country | Name | City | State |
---|---|---|---|
United States | Philadelphia Hand to Shoulder Clinic | Cape May | New Jersey |
United States | Philadelphia Hand to Shoulder Center | Cherry Hill | New Jersey |
United States | Philadelphia Hand to Shoulder Center | Collegeville | Pennsylvania |
United States | Jefferson Rehabilitation | Fairless Hills | Pennsylvania |
United States | Philadelphia Hand to Shoulder Center | Glen Mills | Pennsylvania |
United States | Philadelphia Hand to Shoulder Center | King Of Prussia | Pennsylvania |
United States | Philadelphia Hand to Shoulder Center | Langhorne | Pennsylvania |
United States | Philadelphia Hand to Shoulder Center | Lansdale | Pennsylvania |
United States | Jefferson Rehabilitation | Philadelphia | Pennsylvania |
United States | Philadelphia Hand to Shoulder Clinic | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Philadelphia Hand to Shoulder Center | Rockledge | Pennsylvania |
United States | Jefferson Rehabilitation | Torresdale | Pennsylvania |
United States | Jefferson Rehabilitation | Warminster | Pennsylvania |
United States | Jefferson Rehabilitation | Willow Grove | Pennsylvania |
United States | Philadelphia Hand to Shoulder Center | Willow Grove | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short Form-McGill Pain Questionnaire-2 | The subject will be asked to rate their pain on a 0-10 scale for 22 different pain descriptors.
Continuous (1, 5, 6, 8, 9, 10), Intermittent (2, 3, 4, 11, 16, 18), Neuropathic (7, 17, 19, 20, 21, 22), and Affective (12, 13, 14, 15) subscales will be calculated by taking the mean of these items scores in addition to total score. The subject will also mark their pain on a numeric pain rating score. Scale is 0-10. Higher score is worse. |
Baseline | |
Primary | Patient Specific Functional Scale | The subject will identify 3 activities that are most limited and meaningful to them.
The subject will rate these activities on an 11-point scale ranging from 0 "unable to perform" to 10 "Able to perform the activity at the same level as before the injury or problem." Scale is 0-30. Higher score is better. |
Baseline | |
Primary | Central Sensitization Inventory | The subject will be asked to assess for the presence of a central sensitization state on 25 questions scored in ordinal fashion 0 (never) - 4 (always).
Data from this instrument will be obtained by recording the total score on a scale of 0-100. Higher score is worse. |
Baseline | |
Primary | Multidimensional health locus of control scale form C | The subject rates their opinion or sense that his/her outcomes are determined by luck, fate, or a random occurrence that controls experiences.
The 6-point Likert scale is rated from strongly agree to strongly disagree, with 18 questions with 3 subscales including different types of loci of control (LOC; internal, chance, and doctors). Chance LOC scores range from 6-36 in an ordinal measurement. Data from this instrument will be obtained by recording the total score on a scale of 6-36. Higher score is worse. |
Baseline | |
Primary | Pain Catastrophizing Scale | The subject will be asked to assess for the presence of a pain catastrophizing on 13 questions scored in ordinal fashion 0 (not at all) - 4 (all the time).
Data from this instrument will be obtained by recording the total score on a scale of 0-52. Higher score is worse. |
Baseline | |
Primary | Fear Avoidance Belief Questionnaire | The subject will be asked to assess for the presence of fear avoidance behavior.
Items are scored on a 6-point Likert scale with questions 2-5 a subscale for work and 6, 7, 9, 10, 11, 12, and 15 for physical activity. Scale is 0-66. Higher score is worse. |
Baseline | |
Primary | Hospital Anxiety and Depression Scale | The subject will be asked to assess for the presence of anxiety or depression on 14 questions scored in 4-point Likert scale.
Data from this instrument will be obtained by recording the total score and subscores for anxiety and depression. Scale is 0-56 Higher score is worse. |
Baseline | |
Secondary | Pressure Pain Threshold | The subject will be seated with their affected arm positioned in a comfortable, relaxed position on the armrest of a chair.
The Commander Echo Algometer will be used to assess the amount of pressure that can be applied at the lateral epicondyle before the onset of pain. The applicator (1 cm) will be positioned over the insertion of the forearm musculature at the lateral epicondyle. The subject will be instructed to verbally indicate when the pain begins by saying "stop." The tester will gradually apply an increasing amount of force at 1kg/second until the subject says "stop." This measure will be taken 3x in an alternating manner, in both arms, starting with the left with a 15 second rest between tests. |
Baseline | |
Secondary | Two Point Discrimination | Affected elbow will be tested with two point discrimination.
Subject will be seated in a neutral position with the elbow resting on the arm of a chair. Subjects will be asked to close their eyes to avoid additional stimulus and input. Calipers will be applied with pressure sufficient to blanch skin along the extensor mass of the elbow. The subject will report after each application "one", if one point is felt or "two", if two points are felt. If unsure, the subject is to report one point. Assessment will begin at 20 mm. The distance between the two points will gradually increase by 1 mm until the subject discerns two points. The distance that the subject first reports two points will be recorded. Measures will be take in both elbows. |
Baseline | |
Secondary | Laterality | Subject will be seated and given a handheld device to hold.
The subject will be instructed to review the images on the screen and as quickly and as accurately as they can, select whether the upper extremity on the screen is either left or right. The subject will complete the test after 25 images and the speed (seconds) and accuracy (%) of the test will be reported. |
Baseline | |
Secondary | Pain-Free Grip Strength | In a seated position with the affected elbow flexed to 90ยบ and wrist in a neutral position, the subject squeezes the Commander Echo Wireless Grip Strength tester as hard as they can until their elbow pain is reproduced.
This procedure will be conducted at each rung position until the grip reproduces the subject's pain. Once the point of a painful grip is reached, the subject can rest for 30 seconds before testing. Subjects will be taken through painful grip testing 3x in each hand in an alternating manner with 15 second breaks between attempts starting in the left hand. Each painful grip measure of kg will be recorded |
Baseline |
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