- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025565
Measuring Pain Experience in Individuals With Lateral Elbow Tendinopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
- How is the pain experience in individuals with LET associated with chance locus of control (LOC)?
- What is the impact of fear avoidance on the pain experience in those with LET?
- How does central sensitization alter the pain experience in those with LET?
- Which pain experience measures are associated with functional ability in LET?
Hypotheses
- Individuals with chance locus of control (LOC) will exhibit an increase in pain experience measures.
- Individuals with fear avoidance will have an increase in pain experience measures.
- Individuals with central sensitization (central sensitization inventory (CSI) > 40) will have an increase in pain experience measures.
- Pain-free grip strength will have the largest positive correlation with patient-specific functional scale.
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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christopher Keating, DPT
- Phone Number: 2155031647
- Email: christopher.keating@jefferson.edu
Study Locations
-
-
New Jersey
-
Cherry Hill, New Jersey, United States, 08003
- Recruiting
- Philadelphia Hand to Shoulder Center
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
-
Pennsylvania
-
Collegeville, Pennsylvania, United States, 19426
- Recruiting
- Philadelphia Hand to Shoulder Center
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Fairless Hills, Pennsylvania, United States, 19030
- Recruiting
- Jefferson Rehabilitation
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Glen Mills, Pennsylvania, United States, 19342
- Recruiting
- Philadelphia Hand to Shoulder Center
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
King Of Prussia, Pennsylvania, United States, 19406
- Recruiting
- Philadelphia Hand to Shoulder Center
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Lansdale, Pennsylvania, United States, 19446
- Recruiting
- Philadelphia Hand to Shoulder Center
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Philadelphia, Pennsylvania, United States, 19130
- Recruiting
- Jefferson Rehabilitation
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Philadelphia, Pennsylvania, United States, 19107-5084
- Recruiting
- Thomas Jefferson University
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Torresdale, Pennsylvania, United States, 19114
- Recruiting
- Jefferson Rehabilitation
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Warminster, Pennsylvania, United States, 18974
- Recruiting
- Jefferson Rehabilitation
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
Willow Grove, Pennsylvania, United States, 19090
- Recruiting
- Philadelphia Hand to Shoulder Center
-
Contact:
- Christopher Keating
- Phone Number: 215-503-1647
- Email: christopher.keating@jefferson.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- English speaking and reading
- Aged 18-65
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
LET
Patients with tennis elbow.
|
Patient reported outcomes measures, quantitative sensory testing, and physical examination measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form-McGill Pain Questionnaire-2
Time Frame: Baseline
|
|
Baseline
|
Patient Specific Functional Scale
Time Frame: Baseline
|
|
Baseline
|
Central Sensitization Inventory
Time Frame: Baseline
|
|
Baseline
|
Multidimensional health locus of control scale form C
Time Frame: Baseline
|
|
Baseline
|
Pain Catastrophizing Scale
Time Frame: Baseline
|
|
Baseline
|
Fear Avoidance Belief Questionnaire
Time Frame: Baseline
|
|
Baseline
|
Hospital Anxiety and Depression Scale
Time Frame: Baseline
|
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Pain Threshold
Time Frame: Baseline
|
|
Baseline
|
Two Point Discrimination
Time Frame: Baseline
|
|
Baseline
|
Laterality
Time Frame: Baseline
|
|
Baseline
|
Pain-Free Grip Strength
Time Frame: Baseline
|
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- iRISID-2023-1767
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tendinopathy
-
University of CadizNot yet recruitingTendinopathy | Achilles Tendinopathy | Tendinopathy, Elbow | Patellar Tendinopathy | Tendinopathy Rotator CuffSpain
-
University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
-
Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
-
Brooke Army Medical CenterRecruitingLateral Elbow TendinopathyUnited States
-
Guna S.p.aRecruitingTendinopathy | Achilles Tendinopathy | Insertional Achilles Tendinopathy | PeritendinitisItaly
-
Elif Balevi BaturCompleted
-
Anika Therapeutics, Inc.Completed
-
University of DelawareRecruitingSever's Disease | Achilles Tendinopathy | Insertional Achilles Tendinopathy | Apophysitis; CalcaneusUnited States
-
Gelderse Vallei HospitalRecruiting
-
Maimonides UniversityRecruitingAchilles TendinopathyArgentina
Clinical Trials on Pain Experience Measures
-
Chia Jung LeeShen Gaang Jong Shiaw HospitalRecruitingPain | Orthodontic Appliance Complication | Orthodontic PainSpain
-
NYU Langone HealthCompletedFibromyalgiaUnited States
-
New York City Health and Hospitals CorporationCompletedPain | Intravitreal InjectionUnited States
-
Florida State UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Hospices Civils de LyonUnknown
-
Assistance Publique Hopitaux De MarseilleTerminated
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Institut PasteurInstitut de l'AuditionNot yet recruiting