Measuring Pain Experience in Individuals With Lateral Elbow Tendinopathy
1 other identifier
observational
70
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2023
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2023
CompletedStudy Start
First participant enrolled
August 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2025
CompletedJuly 2, 2025
June 1, 2025
1.8 years
August 18, 2023
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Short Form-McGill Pain Questionnaire-2
1. The subject will be asked to rate their pain on a 0-10 scale for 22 different pain descriptors. 2. 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. 3. The subject will also mark their pain on a numeric pain rating score. 4. Scale is 0-10. 5. Higher score is worse.
Baseline
Patient Specific Functional Scale
1. The subject will identify 3 activities that are most limited and meaningful to them. 2. 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." 3. Scale is 0-30. 4. Higher score is better.
Baseline
Central Sensitization Inventory
1. 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). 2. Data from this instrument will be obtained by recording the total score on a scale of 0-100. 3. Higher score is worse.
Baseline
Multidimensional health locus of control scale form C
1. The subject rates their opinion or sense that his/her outcomes are determined by luck, fate, or a random occurrence that controls experiences. 2. 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). 3. Chance LOC scores range from 6-36 in an ordinal measurement. 4. Data from this instrument will be obtained by recording the total score on a scale of 6-36. 5. Higher score is worse.
Baseline
Pain Catastrophizing Scale
1. 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). 2. Data from this instrument will be obtained by recording the total score on a scale of 0-52. 3. Higher score is worse.
Baseline
Fear Avoidance Belief Questionnaire
1. The subject will be asked to assess for the presence of fear avoidance behavior. 2. 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. 3. Scale is 0-66. 4. Higher score is worse.
Baseline
Hospital Anxiety and Depression Scale
1. The subject will be asked to assess for the presence of anxiety or depression on 14 questions scored in 4-point Likert scale. 2. Data from this instrument will be obtained by recording the total score and subscores for anxiety and depression. 3. Scale is 0-56 4. Higher score is worse.
Baseline
Secondary Outcomes (4)
Pressure Pain Threshold
Baseline
Two Point Discrimination
Baseline
Laterality
Baseline
Pain-Free Grip Strength
Baseline
Study Arms (1)
LET
Patients with tennis elbow.
Interventions
Patient reported outcomes measures, quantitative sensory testing, and physical examination measures.
Eligibility Criteria
Outpatient orthopedic clinics and those located throughout the Philadelphia region.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Philadelphia Hand to Shoulder Clinic
Cape May, New Jersey, 08210, United States
Philadelphia Hand to Shoulder Center
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2023
First Posted
September 6, 2023
Study Start
August 18, 2023
Primary Completion
June 14, 2025
Study Completion
June 14, 2025
Last Updated
July 2, 2025
Record last verified: 2025-06