Trial · NCT07885280
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) from baseline to 1 year | Baseline, 6 weeks, 3 months, 6 months, 1 year | 0 indicates no pain and no disability; 100 indicates worst imaginable pain and significant functional deficit; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint |
| Secondary | Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) at All Other Timepoints | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 0 indicates no pain and no disability; 100 indicates worst imaginable pain and significant functional deficit; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint |
| Secondary | Change in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at Each Timepoint; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 0 indicates no disability; 100 indicates the most severe disability; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint |
| Secondary | Grip Strength | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Change in grip strength (in pounds and kilograms) at 90 degrees of elbow flexion, and at full elbow flexion; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint |
| Secondary | Conversion Rate | Baseline to 2 years after baseline | Rate of conversion to surgery (as a percentage) |
| Secondary | Patient Satisfaction (5-Point Likert Scale) | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Participant-reported satisfaction with treatment outcome using a 5-point Likert scale (minimum 1; maximum 5; higher score indicates greater satisfaction) |
| Secondary | Global Rating of Change | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Participant-reported overall change in symptoms and function (minimum -3 indicating much worse; maximum +3 indicating much better) |
| Secondary | Return to Work/Activities (Self-Reported Work Status) | Baseline to 2 years after baseline | Time, in days, from enrollment (or from surgery, for the surgical arm and crossovers) to return to work, based on participant self-reported work status (working, modified duty, or off work due to symptoms), and to participant-reported return to full activity or sport. |
| Secondary | Complication Rates | 1 year post-op | |
| Secondary | Reoperation Rate | 1 year post-op | |
| Secondary | Meaningful Threshold for Patient-Rated Tennis Elbow Evaluation (PRTEE) Using Change in Patient-Reported Satisfaction as an Anchor | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 0 indicates no pain and no disability; 100 indicates worst imaginable pain and significant functional deficit; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint |
| Secondary | Cozen's Test | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Positive or negative tenderness with resisted dorsiflexion of the wrist |
| Secondary | Mill's Test | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Positive or negative tenderness with elbow extension while the forearm is pronated and the wrist is flexed |
| Secondary | Maudsley's Test | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Positive or negative tenderness with resisted extension of the middle finger |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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