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TMD Online Program for Pain Management

Primary Purpose

TMD/Orofacial Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
painTRAINER
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMD/Orofacial Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age at least 18 years Complaint of either bilateral or unilateral pain, scoring > 3 on a 11-point pain scale (scored from 0 to 10), in the area of the temporomandibular joint Pain has persisted for a period of at least 3 months by patient self-report. Pain may be constant or intermittent. Exclusion Criteria: Contraindications to TMD treatment (as determined by the consulting oral surgeon) Inadequate fluency in English History of prior surgery for TMD Receiving concurrent treatment for orofacial pain (including orthodontic or physical therapy) Have a condition that requires the use of an oral appliance (e.g., sleep apnea) Diagnosed as having pain of neuropathic or odontogenic origin History of rheumatoid disease or autoimmune disease (e.g., rheumatoid arthritis; lupus) currently being treated with anti-inflammatory drugs History of kidney disease or current kidney issues Extensive anatomical destruction or deterioration of the TM joint Current treatment of chronic pain issue with anti-inflammatories (e.g., Indomethacin; methotrexate; dexamethasone) or opioid analgesics Carrying a diagnosis of psychosis (as per self-report on Quick Screen) Pregnant or anticipating pregnancy (due to prescription of NSAIDs)

Sites / Locations

  • UConn HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

painTRAINER pain management web application

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment Feasibility
Treatment is deemed feasible if 20 persons are recruited with 8 months and complete the program
Treatment Acceptability/Adherence Scale
Scores on Treatment Acceptability Scale.This is an 8-item scale assessing the extent to which a treatment was manageable or doable, without causing undue distress.Scores on the scale could range from 8 to 36, with higher scores indicating that the treatment was more acceptable.
The Treatment Credibility/Expectancy Questionnaire
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.

Secondary Outcome Measures

Patient Pain: Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) score
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.

Full Information

First Posted
May 8, 2023
Last Updated
May 19, 2023
Sponsor
UConn Health
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT05862870
Brief Title
TMD Online Program for Pain Management
Official Title
Mobile Application Treatment for TMD: Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a proposal for an administrative supplement to the parent study, "Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism" (U01 DE028520). The parent study is currently engaged in exploring the extent to which the training of coping skills per se is an important mechanism of psychosocial treatment. The current project seeks to lay the groundwork for expanding the range of treatment mechanisms examined to include therapeutic relationship factors (therapist support, empathy, acknowledgment). The present supplemental study will provide instruction for individual patient pain management via an online application, with no therapist or counselor assistance. The aim is to determine the extent to which treatment-related outcomes (including adherence and pain) may be influenced by therapist support factors.
Detailed Description
Psychosocial treatments have been effective for temporomandibular disorders (TMD), but the mechanisms of action for these treatments are unclear. Most studies of psychosocial treatment, including the parent U01, have focused on relatively specific psychosocial mechanisms, including coping skills acquisition, pain management self-efficacy, decrease in catastrophizing, increased mindfulness, acceptance, and readiness to change behavior to ameliorate pain. The 2 therapist-delivered treatments in the parent study are packaged CBT or Individualized Assessment and Treatment (IATP). Left untested in this study are common therapeutic factors that often emerge as influential in pain outcome research. These common, non-specific therapeutic factors include (especially): the therapeutic alliance; interpretation and understanding; emotional expression; reinforcement; information; and reassurance and support. Because both conditions of the parent U01 involve similar levels of therapist involvement, therapist support and other treatment-non-specific variables cannot be tested clearly. One way to assess these factors is to introduce a pain treatment that explicitly does not contain these factors; i.e., a treatment that does not employ therapists or require supervision by health care professionals. There are currently no studies published in which therapist-led treatments have been compared to a mobile application-based treatment. The Investigators therefore propose to pilot test a mobile application treatment condition (painTrainer©) added as an additional treatment condition to the parent study, and provided to 20 patients in the coming year. This condition will deliver the content of the CBT condition of the parent study, but will do so with no therapist contact. If this mobile application is found credible and acceptable it may be used in additional comparisons with treatments conducted by therapists. Thus at some point it will be possible to parse the effects of cognitive-behavioral treatment content per se and therapist support factors. An additional benefit of testing such a mobile application is that it might in the future provide a means to expand the reach of pain management professionals to remote and underserved populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMD/Orofacial Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
painTRAINER pain management web application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
painTRAINER
Intervention Description
patient self-administered pain management web application
Primary Outcome Measure Information:
Title
Treatment Feasibility
Description
Treatment is deemed feasible if 20 persons are recruited with 8 months and complete the program
Time Frame
8 months
Title
Treatment Acceptability/Adherence Scale
Description
Scores on Treatment Acceptability Scale.This is an 8-item scale assessing the extent to which a treatment was manageable or doable, without causing undue distress.Scores on the scale could range from 8 to 36, with higher scores indicating that the treatment was more acceptable.
Time Frame
3 months
Title
The Treatment Credibility/Expectancy Questionnaire
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient Pain: Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) score
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age at least 18 years Complaint of either bilateral or unilateral pain, scoring > 3 on a 11-point pain scale (scored from 0 to 10), in the area of the temporomandibular joint Pain has persisted for a period of at least 3 months by patient self-report. Pain may be constant or intermittent. Exclusion Criteria: Contraindications to TMD treatment (as determined by the consulting oral surgeon) Inadequate fluency in English History of prior surgery for TMD Receiving concurrent treatment for orofacial pain (including orthodontic or physical therapy) Have a condition that requires the use of an oral appliance (e.g., sleep apnea) Diagnosed as having pain of neuropathic or odontogenic origin History of rheumatoid disease or autoimmune disease (e.g., rheumatoid arthritis; lupus) currently being treated with anti-inflammatory drugs History of kidney disease or current kidney issues Extensive anatomical destruction or deterioration of the TM joint Current treatment of chronic pain issue with anti-inflammatories (e.g., Indomethacin; methotrexate; dexamethasone) or opioid analgesics Carrying a diagnosis of psychosis (as per self-report on Quick Screen) Pregnant or anticipating pregnancy (due to prescription of NSAIDs)
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Kabela, PhD
Phone
860-679-2745
Email
kabela@uchc.edu
First Name & Middle Initial & Last Name & Degree
Kara Dion, BA
Phone
860-679-4767
Email
kdion@uchc.edu
First Name & Middle Initial & Last Name & Degree
Mark D Litt, Ph.D.
First Name & Middle Initial & Last Name & Degree
HOWARD TENNEN, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Summary data will be made available to interested investigators by the PI

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TMD Online Program for Pain Management

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