Trial · NCT07157852
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 | The proportion of patients achieving pain relief | At the 12-weeks | The proportion of patients achieving pain relief defined as the proportion of patients whose baseline average pain intensity is reduced by at least 50%. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | The average pain intensity | At the weeks 1, 2, 4, 8, and 12 | The average pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | The worst pain intensity | At the weeks 1, 2, 4, 8, and 12 | The worst pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | The average weekly consumption of rescue analgesics | At the weeks 4, 8, and 12 | Acetaminophen is permitted as rescue medication for intolerable FM-related pain. The maximum allowable dose is 1000 mg per administration and not exceeding 3000 mg per day. All rescue medication use will be recorded prospectively in patient diaries, including date, dose, and frequency of administration. |
| Secondary | The Revised FM Impact Questionnaire | At the weeks 4, 8, and 12 | The Revised FM Impact Questionnaire is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. The total score ranges from 0 to 100, with higher values indicating worse health status. |
| Secondary | The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales | At the weeks 4, 8, and 12 | The BPI-S assesses pain intensity over the past 24 hours, including 4 items. The BPI-I evaluates the degree to which pain interferes with daily activities, comprising 7 items. Each BPI item is rated on a 0 to 10 NRS, with 0 represents no pain or does not interfere, and 10 represents worst pain imaginable or interferes completely. Higher scores indicate greater pain severity or interfere. |
| Secondary | The SF-36 is utilized to assess health-related quality of life, encompassing preference across different health states. It evaluates 8 distinct domains, with each domain scored on a scale ranging from 0 to 100, wher | At the weeks 4, 8, and 12 | The short-form 36 Health Survey (SF-36) |
| Secondary | The Medical Outcomes Study Sleep Scale (MOS) | At the weeks 4, 8, and 12 | The MOS uses a 6-point scale to evaluate various dimensions of sleep, consisting of 12 items. A score of 1 indicates persistent presence, with a score of 6 denotes complete absence. |
| Secondary | The Beck Depression Inventory-Ⅱ (BD-Ⅱ) | At the weeks 4, 8, and 12 | The BD-Ⅱ employs a 4-point scale (ranging from 0 to 3) to evaluate the severity of depressive symptoms, comprising 21 items in total. A score of 0 indicates the absence of symptoms, while a score of 3 reflects severe symptomatology. |
| Secondary | The Patient Global Impression of Change (PGIC) Scale | At week 12 | The PGIC is a 7-point patient-reported global rating scale that assesses overall change in health status since the start of treatment. Participants rate their condition as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. |
| Secondary | Adverse Events | Through study completion, an average of 12 weeks | Adverse Events are defined as events that occur the course of treatment, were not present before prior to the intervention, or represent a worsening of pre-existing conditions. These events will be systematically documented and categorized by severity into grades such as mild, moderate, severe, or life-threatening. |
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
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GET https://conductscience.org/api/trials/v1/NCT07157852/registered