Trial · NCT02437383
Study of Orofacial Pain and PropRANOlol
NCT02437383, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2019-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Orofacial Pain and PropRANOlol. Trials, record NCT02437383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02437383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Orofacial Pain and PropRANOlol
- NCT number
- NCT02437383
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 200 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Temporomandibular Disorders
- Interventions
- Propranolol ER, Placebo
- First posted
- 2015-05-07
- Last updated
- 2019-05-21
- Results first posted
- 2019-05-21
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | units on a scale | LEAST_SQUARES_MEAN | |
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| 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) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Stratified Per Graded Chronic Pain Scale (GCPS) Grade After 9 Weeks of Treatment | Visit 4 (study day 63 +/-7) | All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Weekly Mean Pain Index After 9 Weeks of Treatment | Propranolol ER | -13.9 | 95% Confidence Interval -17.4 to -10.5 | units on a scale | |
| Change in the Weekly Mean Pain Index After 9 Weeks of Treatment | Placebo | -12.1 | 95% Confidence Interval -15.5 to -8.7 | units on a scale | |
| Change in the Weekly Mean Pain Intensity After 9 Weeks of Treatment | Propranolol ER | -17.1 | 95% Confidence Interval -21.1 to -13.1 | units on a scale | |
| Change in the Weekly Mean Pain Intensity After 9 Weeks of Treatment | Placebo | -13.6 | 95% Confidence Interval -17.6 to -9.7 | units on a scale | |
| Change in the Weekly Mean Pain Duration After 9 Weeks of Treatment | Propranolol ER | -17.9 | 95% Confidence Interval -22.8 to -13.0 | units on a scale | |
| Change in the Weekly Mean Pain Duration After 9 Weeks of Treatment | Placebo | -16.6 | 95% Confidence Interval -21.3 to -11.7 | units on a scale | |
| Change in the SF-McGill Pain Questionnaire Affective Component After 9 Weeks of Treatment | Propranolol ER | -2.9 | 95% Confidence Interval -3.7 to -2.0 | score on a scale | |
| Change in the SF-McGill Pain Questionnaire Affective Component After 9 Weeks of Treatment | Placebo | -3.1 | 95% Confidence Interval -3.9 to -2.2 | score on a scale | |
| Change in the SF-McGill Pain Questionnaire Sensory Component After 9 Weeks of Treatment | Propranolol ER | -1.9 | 95% Confidence Interval -2.2 to -1.6 | score on a scale | |
| Change in the SF-McGill Pain Questionnaire Sensory Component After 9 Weeks of Treatment | Placebo | -1.6 | 95% Confidence Interval -1.9 to -1.2 | score on a scale |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Propranolol ER | 100 | |
| Overall Study | STARTED | Placebo | 100 | |
| Overall Study | COMPLETED | Propranolol ER | 87 | |
| Overall Study | COMPLETED | Placebo | 87 | |
| Overall Study | NOT COMPLETED | Propranolol ER | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 13 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Propranolol ER | 20 | 100 | 23 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 18 | 100 | 22 |
| other | Nausea | Gastrointestinal disorders | Propranolol ER | 19 | 100 | 20 |
| other | Nausea | Gastrointestinal disorders | Placebo | 9 | 100 | 9 |
| other | Constipation | Gastrointestinal disorders | Propranolol ER | 10 | 100 | 13 |
| other | Constipation | Gastrointestinal disorders | Placebo | 10 | 100 | 10 |
| other | Vomiting | Gastrointestinal disorders | Propranolol ER | 5 | 100 | 5 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 100 | 3 |
| other | Fatigue | General disorders | Propranolol ER | 32 | 100 | 38 |
| other | Fatigue | General disorders | Placebo | 21 | 100 | 24 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Propranolol ER | 1 | 100 |
| Total, all-cause mortality | Placebo | 0 | 100 |
| Total, other adverse events | Propranolol ER | 86 | 100 |
| Total, other adverse events | Placebo | 75 | 100 |
| Total, serious adverse events | Propranolol ER | 4 | 100 |
| Total, serious adverse events | Placebo | 1 | 100 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DE024169 | Effect of COMT genetic polymorphisms on response to propranolol therapy in Temporomandibular Disorder | TCHIVILEVA, INNA EVGENIEVNA; ARBES, SAMUEL; FILLINGIM, ROGER B; OHRBACH, RICHARD; SLADE, GARY DOUGLAS | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Propranolol ER vs Placebo: deaths from any cause | Trial comparisons |
| Propranolol ER vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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