Trial · NCT03406338
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 | Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) | Change from baseline to 3 months | Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit) |
| Primary | Proportion of patients with worsening in total active extension deficit ≥20 degrees | 24 months compared to 3 months | Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit) |
| Secondary | 11-item disabilities of the arm, shoulder and hand (QuickDASH) score | Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months | A patient-reported outcome measure of activity limitations related to upper extremity disorders, with total score range from 0 (best) to 100 (worst) |
| Secondary | EuroQoL 5-dimensions (EQ-5D) Index | Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months | Health-status and quality-of-life patient-reported measure, consists of 5 items, a single weighted score, the EQ-5D index, is calculated from the 5 dimensions, ranging from -0.594 (worst) to 1.0 (perfect health) |
| Secondary | Pain score | Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months | Visual analog scale of pain in the treated hand, score range from 0 (best) to 100 (worst) |
| Secondary | Satisfaction score | 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months | Visual analog scale of patient satisfaction with treatment outcome, score range from 0 (best) to 100 (worst) |
| Secondary | Adverse events | Anytime during 24 months after treatment | All observed and reported adverse events will be recorded on a standard form. Serious adverse events include nerve, artery or tendon damage, deep infection, complex regional pain syndrome and any complications requiring surgery or hospital admission. |
| Secondary | Costs | From baseline through 24 months | Total treatment cost, direct (medications, surgery, materials, visits etc) and indirect (sick leave related to the treatment) |
| Secondary | Total active motion | Change from baseline to 3 months, 12 months, 24 months and 60 months | Sum of active range of motion of metacarpophalangeal, proximal intephalangeal and distal interphalangeal joints of the treated finger |
| Secondary | Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) | Change from baseline to 12 months, 24 months and 60 months | Active extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit) |
| Secondary | Proportion of patients with worsening in total active extension deficit ≥20 degrees | 60 months compared to 3 months | Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit) |
| Secondary | Palmar pain score | Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months. | 2-item scale inquiring about pain in the palm and related activity limitations, total score range 0 (best) to 100 (worst) |
| Secondary | Cold intolerance symptom severity score | Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months. | 6-item scale inquiring about symptoms of cold intolerance, total score range 4 (best) to 100 (worst) |
| Secondary | Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints) | Change from baseline to 24 months and 60 months | Passive extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit) |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03406338/registered