Trial · NCT07230171
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in the mean pain intensity | At the week 1. | This outcome is calculated as the average of daily 24-hour pain intensity scores recorded in patient diaries over 7 consecutive days using NRS. |
| Secondary | Average pain intensity | At the weeks 1, 2, 4, 8, and 12 | The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | Proportion of patients achieving pain reduction at 50%; | at weeks 1, 2, 4, 8, and 12 | The proportion of patients achieving a ≥ 50% reduction in mean baseline pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | The median pain relief time | Through study completion, an average of 12 weeks | The median pain relief time, defined as the time of 50% decrease in NRS score from baseline. Pain intensity will be measured using the NRS, where 0 indicates no pain, and 10 represents the worst imaginable pain. |
| Secondary | The Revised FM Impact Questionnaire (FIQR) | At the weeks 4, 8, and 12 | The FIQR is used to assessed health status and functional disablity. FIQR is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. FIQR total score ranges from 0 to 100, with higher values indicating worse health status. |
| Secondary | Hospital Anxiety and Depression scale (HADS) | At the weeks 4, 8, and 12 | The HADS is used to assess anxiety (7 items) and depression (7 items). Scores range from 0 to 21 on each subscale, with higher scores indicating worse symptomatology. |
| Secondary | The short-form 36 Health Survey (SF-36) | At the weeks 4, 8, and 12 | The SF-36 assesses health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status. |
| Secondary | Multidimensional Fatigue Inventory (MFI) | At the weeks 4, 8, and 12 | Fatigue is evaluated using the MFI, a 20-item assessment tool with five domains. Higher scores indicate a higher degree of fatigue. |
| Secondary | Medical Outcomes Study Sleep Scale (MOS) | At the weeks 4, 8, and 12 | The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence). |
| Secondary | The doses of pregabalin and venlafaxine | at weeks 1, 2, 4, 8, and 12 | |
| Secondary | Adverse events | Through study completion, an average of 12 weeks |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07230171/registered