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Trial · NCT04884763

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryBrief Pain Inventory (BPI) Pain Severity at 20 Weeks20 weeks.
Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (secondary outcome).
SecondaryBrief Pain Inventory (BPI) Pain Interference at 20 Weeks20 weeks
Assessment of pain interference using the Brief Pain Inventory (BPI) 7-item pain intensity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
SecondaryAverage Daily Reported Pain Scores at 20 Weeks20 weeks
Assessment of pain using average of daily reported pain scores at 20 weeks; average of daily reported scores from days \> week 16 and \<= week 20. Pain scale: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Secondary% of Days Taking Medication for Pain at 20 Weeks20 weeks
Assessment of pain using the % of days taking medication for pain at 20 weeks; percentage of days calculated from days \> week 16 and \<= week 20.Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
SecondaryPain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks20 weeks
Assessment of pain improvement using the patient global impression of change in pain scale at 20 weeks: 1 (Better) - 7 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
SecondaryJaw Function Limitation Scale (JFLS-8) at 20 Weeks20 weeksJaw Function Limitation Scale (JFLS-8) at 20 weeks: 0 (Better) - 10 (Worse).Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
SecondaryPatient Health Questionnaire (PHQ-4) at 20 Weeks20 weeks
Depressive and Anxiety symptoms using Patient Health Questionnaire (PHQ-4) at 20 weeks: 0 (Better) - 12 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
SecondarySomatic Symptoms Scale (SSS-8) at 20 Weeks20 weeks
Assessment of somatic symptoms using the Somatic Symptoms Scale (SSS-8) at 20 weeks: 0 (Better) - 32 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
SecondaryBrief Pain Inventory (BPI) Pain Severity at 24 Weeks24 weeks.
Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 24 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (primary outcome).
SecondaryBrief Pain Inventory (BPI) Pain Interference at 24 Weeks24 weeks
Assessment of pain interference using the Brief Pain Inventory (BPI) 7-item pain intensity scale at 24 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
SecondaryAverage Daily Reported Pain Scores at 24 Weeks24 weeks
Assessment of pain using average of daily reported pain scores at 24 weeks; average of daily reported scores from days \> week 20 and \<= week 24. Pain scale: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Secondary% of Days Taking Medication for Pain at 24 Weeks24 weeks
Assessment of pain using the % of days taking medication for pain at 24 weeks; percentage of days calculated from days \> week 20 and \<= week 24. Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
SecondaryPain Improvement Using the Patient Global Impression of Change in Pain at 24 Weeks24 weeks
Assessment of pain improvement using the patient global impression of change in pain scale at 24 weeks: 1 (Better) - 7 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
SecondaryJaw Function Limitation Scale (JFLS-8) at 24 Weeks24 weeksJaw Function Limitation Scale (JFLS-8) at 24 weeks: 0 (Better) - 10 (Worse).Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
SecondaryPatient Health Questionnaire (PHQ-4) at 24 Weeks24 weeks
Depressive and Anxiety symptoms using Patient Health Questionnaire (PHQ-4) at 24 weeks: 0 (Better) - 12 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
SecondarySomatic Symptoms Scale (SSS-8) at 24 Weeks24 weeks
Assessment of somatic symptoms using the Somatic Symptoms Scale (SSS-8) at 24 weeks: 0 (Better) - 32 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary 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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