Trial Outcomes & Findings for TMD Online Program for Pain Management (NCT NCT05862870)

Last Updated: 2025-01-17

Results Overview

Treatment is deemed feasible if 20 persons are recruited with 8 months and complete the program. This number of patients recruited over this time period would indicate that the program is attractive to the target patient population. If this number finish the program, it would indicate that the program was a feasible means of intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

8 months

Results posted on

2025-01-17

Participant Flow

21 persons with TMD/orofacial pain of at least 3mo duration were recruited through advertisements and referrals from local dentists

Participant milestones

Participant milestones
Measure	painTRAINER Pain Management Web Application This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application
Overall Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	painTRAINER Pain Management Web Application This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application
Overall Study Lost to Follow-up	3

Baseline Characteristics

TMD Online Program for Pain Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	painTRAINER Pain Management Web Application n=21 Participants This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	42.0 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Graded Chronic Pain Scale	5.17 units on a scale STANDARD_DEVIATION 2.02 • n=5 Participants

PRIMARY outcome

Timeframe: 8 months

Population: 21 persons were recruited, supporting treatment feasibility

Outcome measures

Outcome measures
Measure	painTRAINER Pain Management Web Application n=21 Participants This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application
Treatment Feasibility	18 Participants

PRIMARY outcome

Timeframe: 3 months

The Treatment Credibility/Expectancy Questionnaire is composed of 4 questions that assess treatment credibility, or the extent to which a treatment seems logical and able to address patient complaints. The credibility scores may range from 4 to 36, with higher scores indicating greater endorsement of credibility.

Outcome measures

Outcome measures
Measure	painTRAINER Pain Management Web Application n=21 Participants This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application
The Treatment Credibility/Expectancy Questionnaire	21 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: baseline to 3 months after treatment

Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) score: GCPS-CPI is made up of 3 questions asking the patient to rate their pain Now, at its worst, and on average over the past 30 days. Scores on the index may range from 0 to 30, with higher scores indicative of greater characteristic pain. Outcome is measured in change from baseline.

Outcome measures

Outcome measures
Measure	painTRAINER Pain Management Web Application n=21 Participants This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application
Patient Pain: Change in Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) Score	1.7 score on a scale: decrease in pain score Standard Deviation 2.0

Adverse Events

painTRAINER Pain Management Web Application

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark D. Litt, PhD

UConn Health

Phone: 860-679-4680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place