Trial · NCT07210515
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in pain intensity from baseline to Week 12. | Week 12 | Assessed on an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 representing the worst possible pain. |
| Secondary | At least a 50% reduction from baseline to Week 12 in pain intensity. | Week 12 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | Change from baseline in CRPS Severity Score (CSS) to Week 12. | Week 12 | Assessed using the CRPS CSS, a 0-16 scale where higher scores denotes greater CRPS symptom severity and lower scores reflect milder symptoms. |
| Secondary | Patient Global Impression of Change (PGI-C) in CRPS-Related Health. | Week 12 | Assessed using the PGI-C, a 7-point numerical rating scale where 1 indicates "very much improved" and 7 indicates "very much worse." |
| Secondary | Change from baseline in the Short Form 36 (SF-36) Item Health Survey Physical Functioning domain. | Week 12 | Assessed using the SF-36, a validated 36-item self-reported questionnaire that measures health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100, with higher scores indicating better health status. |
| Secondary | Change from baseline over time in pain intensity. | Day 10, Weeks 3, 6, and 9 | Assessed on an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 representing the worst possible pain. |
| Secondary | At least a 50% reduction from baseline in pain intensity. | Day 10, Weeks 3, 6, and 9 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | At least a 30%, 70%, and 90% reduction from baseline in pain intensity. | Day 10, Weeks 3, 6, 9, and 12 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | Time to onset of analgesic improvement. | daily assessment up to week 12 | Assessed as the time to onset of analgesic improvement, defined by a ≥30% reduction in pain intensity from baseline on the 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. The improvement must be sustained for a minimum of one week. |
| Secondary | Time to at least a 50%, 70%, and 90% reduction from baseline in pain intensity. | 7-day average | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | Change from baseline in the 7-day mean of daily "pain now". | Day 10, Weeks 3, 6, 9, and 12 | Assessed on an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 representing the worst possible pain. |
| Secondary | At least a 30%, 50%, 70%, and 90% reduction from baseline in pain intensity. | Day 10, Weeks 3, 6, 9, and 12 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | Change from baseline in 7-day average mean of daily "worst pain" assessment. | Day 10, Weeks, 3, 6, 9, 12 | Assessed using the average score from the 11-point Numerical Rating Scale (NRS), where 0 denotes no pain and 10 denotes the worst possible pain |
| Secondary | At least a 30%, 50%, 70%, and 90% reduction from baseline in pain intensity | Day 10, Weeks, 3, 6, 9, 12 | Assessed using the average score of daily "worst pain" from the 11-point Numerical Rating Scale (NRS), where 0 denotes no pain and 10 denotes the worst possible pain |
| Secondary | Change from baseline in pain evoked by active motion. | Day 10, Weeks 3, 6, and 12 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain in the CRPS affected limb. |
| Secondary | At least a 50% reduction from baseline in pain evoked by active motion. | Day 10, Weeks 3, 6, 12 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain in the affected limb. |
| Secondary | Change from baseline in active range of motion (AROM) of affected limb vs. contralateral limb. | Day 10, Weeks 3, 6, 12 | Assessed by measuring range of motion of selected joints using a goniometer, and calculating the change from baseline for each joint assessed. |
| Secondary | Change from baseline in the CRPS Severity Score (CSS) and in the individual elements of the CRPS Severity Score. | Days 4, 7, 10, Weeks 3, and 6 | CRPS severity score is a series of 17, 0-1 questions (where 0 is that the sign/symptom is not displayed and 1 is that the sign/symptom is displayed) and scored for a total score of 0 (no CRPS signs/symptoms) to 17 (worse CRPS severity). |
| Secondary | Change from baseline in the CSS self-report (CSS-SR) | Week 12 | CSS-SR is a patient, self-report questionnaire that assess the same 13 concepts of the CSS using yes/no items. Responses are coded as present (1) or absent (0) and summed to yield a total score (range 0-13) |
| Secondary | Change from base line in edema of affected limb | Days 4, 7, 10, Weeks 3, 6, and 12 | Assessed using the "edema" using 4-point numerical rating scale where 0 is no edema and 3 is severe edema. |
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/NCT07210515/registered