Trial · NCT02437383
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Weekly Mean Pain Index After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary and divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome. |
| Secondary | Change in the Weekly Mean Pain Intensity After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | Weekly mean pain intensity computed as the arithmetic mean of daily pain intensity values during the week prior to randomization and prior to each study visit. Daily pain intensity is measured on 0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") as reported in the Daily Symptom Diary. A higher score means a worse outcome. |
| Secondary | Change in the Weekly Mean Pain Duration After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | Weekly mean pain duration computed as the arithmetic mean of daily pain duration values during the week prior to randomization and prior to each study visit. Daily pain duration is measured on 0-100 percentage scale where percent = "percent of waking day you had facial pain" as reported in the Daily Symptom Diary. A higher score means a worse outcome. |
| Secondary | Change in the SF-McGill Pain Questionnaire Affective Component After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The SF-McGill Pain Questionnaire contains 4 affective descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe." The item scores are summed to yield a total score ranging from 0 to 12. A higher score means a worse outcome. |
| Secondary | Change in the SF-McGill Pain Questionnaire Sensory Component After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The SF-McGill Pain Questionnaire contains 11 sensory descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe." The item scores are summed to yield a total score ranging from 0 to 33. A higher score means a worse outcome. |
| Secondary | Change in the SF-McGill Pain Questionnaire Present Facial Pain Intensity After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | Self-reported present intensity of facial pain at the moment of assessment scored on a descriptive scale where 1 = "no pain' and 6 = "excruciating pain." A higher score means worse outcome. |
| Secondary | Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Intensity After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | Self-reported average facial pain intensity for the last week scored on 0-100 numerical rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable". A higher score means a worse outcome. |
| Secondary | Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Duration After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | Self-reported average facial pain duration for the last week scored on 0-100 percentage scale where percent = "percent of waking day you had facial pain". A higher score means a worse outcome. |
| Secondary | Change in the SF-McGill Pain Questionnaire Weekly Fatigue After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | Self-reported average fatigue for the last week scored on 0-100 numerical rating scale where 0 = "no fatigue" and 100 = "the greatest imaginable." A higher score means a worse outcome. |
| Secondary | Number of Participants Stratified Per Graded Chronic Pain Scale (GCPS) Grade After 9 Weeks of Treatment | Visit 4 (study day 63 +/-7) | Individuals were classified into 6 chronic pain grades: 0 = no pain; I = low pain intensity and low pain-related disability; IIa = high pain intensity and low pain-related disability; IIb = high pain intensity and high activity interference; III = moderate pain-related disability; and IV = severe pain-related disability. For analyses, this variable was dichotomized: grades 0-IIa were combined in one category and all higher grades in another. A higher grade means a worse outcome. |
| Secondary | Change in the Jaw Functional Limitation Scale (JFLS) Global Score After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation." The Global Score is computed as the mean response for all items and ranges from 0 to 10. A higher score means a worse outcome. |
| Secondary | Change in the Headache Impact Test (HIT-6) Global Score After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The HIT-6 contains 6 items and assesses headache-related disability by the frequency of daily activity limitations ranging from "never" to "always." The 6 item scores are summed to yield a global score ranging from 36 to 78. A higher score means a worse outcome. |
| Secondary | Change in the Pittsburgh Sleep Quality Index (PSQI) Global Score After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale, The 7 component scores are summed to yield a global PSQI score, which has a range of 0-21. A higher score means a worse outcome. |
| Secondary | Number of Participants Stratified Per Dichotomized Score From the Patient Global Impression of Change (PGIC) Scale After 9 Weeks of Treatment | Visit 4 (study day 63 +/-7) | The PGIC scale assesses patient overall change in the severity of illness following treatment. Participants rate how they feel now compared with how they felt before receiving study drug on a 7-point scale where 0 = "No change or condition has got worse" and 6 = "A great deal better." A higher score means a better outcome. For analyses, this variable was dichotomized: scores from 0 to 3 were combined in one category of "No" (no significant improvement) and scores from 4 to 6 were combined in another category of "Yes" (significant improvement with the study treatment). |
| Secondary | Change in the Perceived Stress Scale (PSS) Global Score After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The PSS assesses the frequency of 14 sources of stress on a scale from 0 = "never" to 4 = "very often." The item scores are summed to yield a global score ranging from 0 to 56. A higher score means a worse outcome. |
| Secondary | Change in the Hospital Anxiety and Depression Scale (HADS) Depression Score After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = "not at all" to 3 = "very often indeed". Responses are summed to provide separate scores for anxiety and depression with a range from 0 to 21. A higher score means a worse outcome. |
| Secondary | Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Score After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = "not at all" to 3 = "very often indeed". Responses are summed to provide separate scores for anxiety and depression with a range from 0 to 21. A higher score means a worse outcome. |
| Secondary | Change in the Symptom Checklist 90-Revised (SCL-90R) Somatization Scale Score After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The SCL-90R Somatization Scale is a 12-item assessment of somatic symptom distress over the past 7 days rated from 0 = "not at all" to 4 = "extremely." The scale score is computed as the mean for all items. The score range is from 0 to 4. A higher score means a worse outcome. |
| Secondary | Change in the SF-12 Health Survey v2 (SF-12v2) Physical Component Summary (PCS) After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: "excellent" to "poor" (for general health); "yes, limited a lot" to "no, not limited at all" (for functional level); and "all of the time" to "none of the time" (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). summary (MCS). The range for each component is 0-100 and a higher score means a better outcome. |
| Secondary | Change in the SF-12 Health Survey v2 (SF-12v2) Mental Component Summary (MCS) After 9 Weeks of Treatment | Visit 1 (study day 0) and Visit 4 (study day 63 +/-7) | The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: "excellent" to "poor" (for general health); "yes, limited a lot" to "no, not limited at all" (for functional level); and "all of the time" to "none of the time" (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). The range for each component is 0-100 and a higher score means a better outcome. |
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.
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