Trial · NCT02402530
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Pain Intensity Score to Week 12. | Baseline; Week 12 | The Pain Intensity Score is the mean value of current pain intensity ratings, obtained twice-daily for 1 week, using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". All pain intensity ratings for the primary endpoint will be in reference to the CRPS-affected limb. |
| Secondary | Response to treatment: Proportion of Participants With at Least 30 Percent Reduction in the Pain Intensity Score | Baseline; Week 12 | Participants with at least a 30 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint. |
| Secondary | Response to treatment: Proportion of Participants With at Least 50 Percent Reduction in the Pain Intensity Score | Baseline; Week 12 | Participants with at least a 50 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint. |
| Secondary | Change in the Brief Pain Inventory (BPI) Interference Score | Baseline; Week 12 | The BPI Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants will rate their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities. |
| Secondary | Patient Global Impression of Change (PGIC) | Baseline; Week 12 | The PGIC is a self-reported measure of perceived change in overall condition since the start of the study. Participants will select one of seven responses ranging from very much improved to very much worse. A response of very much improved or much improved is generally regarded as a clinically important outcome. |
| Secondary | Change in the EuroQol-5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline; Week 12 | The EQ-5D-5L Index Score describes the participant's overall health status and is derived from self-reported scores in 5 health dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Participants will rate each dimension at one of 5 levels, with level 1 indicating the best health state (no problems) and level 5 indicating worst health state (e.g., unable to walk about). The EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1.0 representing perfect health. |
| Secondary | Change in the EuroQol Visual Analog Scale (EQ VAS) | Baseline; Week 12 | The EQ VAS is a self-reported measure of the participant's overall health "today". Participants will place a mark on a 20 cm vertical scale numbered from 0 to 100, with 0 labeled as "the worst health you can imagine" and 100 labeled as "the best health you can imagine". The EQ VAS ranges from 0 to 100, with higher scores representing better overall health. |
| Other | Change in the Worst Pain Intensity | Baseline; Week 12 | This will be determined as for the primary endpoint, using worst pain intensity ratings. Participants will rate their worst pain intensity during the previous 12 hours twice each day using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". Worst pain intensity ratings are in reference to the CRPS-affected limb. |
| Other | Change in the Average Pain Intensity | Baseline; Week 12 | This will be determined as for the primary endpoint, using average pain intensity ratings. Participants will rate their average pain intensity during the previous 12 hours twice each day using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". Average pain intensity ratings are in reference to the CRPS-affected limb. |
| Other | Change from Baseline in the Pain Intensity Scores at Each Week | Baseline to Week 12 | Pain Intensity Scores will be determined as for the primary endpoint using current pain intensity ratings obtained twice-daily. Mean values will be assessed during each of the first 12 weeks of the study. |
| Other | Response to Treatment: Proportion of Participants with 0 to 100% Decrease in the Pain Intensity Score | Baseline; Week 12 | Pain Intensity Scores will be determined as for the primary endpoint using current pain intensity ratings obtained twice-daily. Participants will be considered to have responded to treatment using increments of 10% decrease in the Pain Intensity Score, starting from 0% (no decrease in the Pain Intensity Score), 10%, 20%, etc., to 100% (Pain Intensity Score at Week 12 = 0). |
| Other | Response to Treatment: Proportion of Participants With at Least a 2 Point Decrease in the Pain Intensity Score | Baseline; Week 12 | Pain Intensity Scores will be determined as for the primary endpoint using current pain intensity ratings obtained twice-daily. Participants will be considered to have responded to treatment if they have at least a 2 point decrease in the Pain Intensity Score. |
| Other | Change in the Pain Anxiety Symptom Scale (PASS) Total Score | Baseline; Week 12 | The PASS Total Score is the sum of 20 self-reported items in the PASS Questionnaire. Participants will rate each item in terms of its frequency, ranging from 0 (never) to 5 (always). The PASS Total Score ranges from 0 to 100, with higher scores indicating greater levels of pain-related anxiety. |
| Other | Change in the Center for Epidemiological Studies Depression (CES-D) Scale Total Score | Baseline; Week 12 | The CES-D Total Score is the sum of 20 self-reported items comprising symptoms associated with depression. Participants will rate each item in terms of its frequency from "rarely or none of the time (less than 1 day)" to "most or all of the time (5 to 7 days)" during the last week. The CES-D Total Score ranges from 0 to 60, with a score over 21 indicating the possibility of major depression. |
| Other | Change in Pain Disability Index (PDI) | Baseline; Week 6; Week 12 | The PDI is the sum of self-reported ratings of disability in 7 categories of activities, including family/home responsibilities, recreation, social activity, self-care, etc. Participants will rate the level of disability that they typically experience due to pain in each of the 7 categories. Ratings are made using a numeric rating scale, with 0 indicating "no disability" and 10 indicating "worst disability". The PDI ranges from 0 to 70, with higher values indicating greater disability due to pain. |
| Other | Change in the Medical Outcomes Study (MOS) Sleep Scale: Sleep Problems Index | Baseline; Week 6; Week 12 | The MOS Sleep Scale Sleep Problems Index is derived from participant's responses to questions related to sleep adequacy, sleep disturbance, daytime somnolence, and other aspects of sleep. Participants will respond to 12 questions in the MOS Sleep Scale Questionnaire. Responses are scored, summed and converted to a 0 to 100 scale, with higher scores indicating worse sleep problems. |
| Other | Change in Pain Medication Score | Baseline; Week 6; Week 12; Month 6; Month 9; Month 12 | The Pain Medication Score will be derived using the Medication Quantification Scale (MQS III) and is based entirely on information available from the participant's prior and concomitant medications. The MQS III algorithm derives a single numerical value representing the amount of pain medications taken by each participant, taking into account the medication class and dosage. |
| Other | Change in the Current Pain Intensity in the Extended Follow-up Period | Baseline; Month 6; Month 9; Month 12 | Participants will rate their current CRPS-related pain intensity at each visit in the extended follow-up period using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". |
| Other | Change in the Average Pain Intensity in the Extended Follow-up Period | Baseline; Month 6; Month 9; Month 12 | Participants will rate their average CRPS-related pain intensity, recalled over the last 24 hours, at each visit in the extended follow-up period using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". |
| Other | Change in the Worst Pain Intensity in the Extended Follow-up Period | Baseline; Month 6; Month 9; Month 12 | Participants will rate their worst CRPS-related pain intensity, recalled over the last 24 hours, at each visit in the extended follow-up period using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". |
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/NCT02402530/registered