Trial · NCT04450316
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Numeric Rating Scale of Pain | Will compare a 7-day average of pre-intervention Numeric Rating Scale of Pain scores to the 7-day average of post-intervention Numeric Rating Scale of Pain Scores after week 8 of treatment. | The Numeric Rating Scale (NRS) of Pain uses an 11-point likert scale. Scores ranges from a minimum of 0 (No pain) to a maximum of 10 (Worst Pain Imaginable). Higher scores indicate greater pain intensityThe proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in the worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment. |
| Secondary | Change in Brief Pain Inventory Score | Comparing the average of 7 days of scores reported pre-intervention and the average of 7 days of score reported 8 weeks after intervention. | The Brief Pain Inventory score ranges from a minimum of 0 to a maximum of 10, with higher scores indicating worse pain intensity. |
| Secondary | Voiding Diary | Prior to treatment and after 8 weeks of treatment. | The Voiding Diary assesses the frequency and amount an individual voids over the course of a 24 hour period. Study subjects indicate number of times they void in an hour and how much they urinate. Study subjects complete daily voiding diaries over the course of a 7 day period before and after the intervention period. Voiding frequency in a 24 hour period was assessed with possible range between 0 to 24 times per day. Participants were asked to complete a 7-day voiding diary at baseline and after 8 weeks of treatment. The average voiding frequency at baseline was compared to follow-up after 8 weeks of treatment. |
| Secondary | Change in Bladder Pain/Interstitial Cystitis Symptom Score | At pre-intervention to week 8 | Total score ranges from 0 to 38. Higher values represent more symptoms of bladder pain associated with interstitial cystitis. |
| Secondary | Change in O'Leary Sant Symptom Scores | At pre-intervention to week 8 | Scores range from 0-20 with higher scores representing more frequency of symptoms associated with interstitial cystitis such as urgency, frequency, nocturia (getting up at night to urinate), and pain or burning in the bladder. |
| Secondary | Change in O'Leary Sant Problem Indices Scores | At pre-intervention to week 8 | Score ranges from 0 to 16 with higher scores representing that symptoms of interstitial cystitis are more problematic to the person with interstitial cystitis. |
| Secondary | Change in Global Response Assessment Scale Score | At pre-intervention to week 8 | Patient-reported outcome measure. 7-point scale (ranging from markedly worse -3 to markedly improved +3), used to evaluate overall symptom change after treatment. |
| Secondary | Change in PROMIS Pain Behavior Score | At pre-intervention to week 8 | Standardized metric (mean 50, standard deviation 10) assessing observable pain indicators, ranging from 20 to 80, with higher scores indicating more severe pain behavior. |
| Secondary | Change in PROMIS Physical Function Score | At pre-intervention to week 8 | Standardized metric (mean 50, standard deviation 10) assessing self-reported capability, ranging from 20 to 80, with higher scores indicating better physical function |
| Secondary | Change in PROMIS Sleep Dysfunction Score | At pre-intervention to week 8 | Standardized metric (mean 50, standard deviation 10) used to quantify self-reported sleep quality, depth, and restoration, ranging from 20 to 80, with a higher score indicating greater sleep disturbance. |
| Secondary | Change in PROMIS Sleep-Related Impairment | At pre-intervention to week 8 | Sleep-related Impairment (SRI) score is a standardized, self-reported measure evaluating daytime alertness, sleepiness, and functional limitations over the past 7 days. It uses a T-score metric (mean of 50, standard deviation of 10), where higher scores indicate greater impairment. Scores range from 20-80. |
| Secondary | Change in PROMIS Pain Interference Score | At pre-intervention to week 8 | The PROMIS Pain Interference (PI) score measures how much pain hinders a person's daily life-including physical, mental, emotional, and social activities-using a T-score metric where 50 is the average, and higher scores (e.g., 60+) indicate greater, more severe interference. Scores range from 20-80 |
| Secondary | Change in PROMIS Fatigue Score | At pre-intervention to week 8 | The PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score is a validated tool measuring the intensity, frequency, and impact of tiredness on daily life over the past seven days. It uses a T-score metric (mean=50, SD=10) where higher scores (e.g., 60+) indicate greater, more severe fatigue. Scores range from 20 to 80. |
| Secondary | Change in PROMIS Anxiety Score | At pre-intervention to week 8 | Standardized metric (mean 50, standard deviation 10) assessing self-reported fear, anxious misery, and hyperarousal over the past 7 days, ranging from 20 to 80, with higher scores indicating more severe anxiety. |
| Secondary | Change in PROMIS Depression Score | At pre-intervention to week 8 | Standardized metric (mean 50, standard deviation 10) assessing mood, self-view, and social cognition, ranging from 20 to 80, with higher scores indicating more severe depressive symptoms. |
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.
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GET https://conductscience.org/api/trials/v1/NCT04450316/registered