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Recruiting NCT04376333

Individualized Assessment and Treatment for TMD

No phase Interventional Temporomandibular Joint Disorders Orofacial Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-Behavioral Treatment, Individualized Assessment and Treatment Program, Standard Conservative Care.
Who it may be relevant to
Registry conditions: Temporomandibular Joint Disorders, Orofacial Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism

Overview

Temporomandibular/orofacial pain disorders (TMD) are a group of painful conditions with multiple determinants.This proposal has two main goals: 1) to test a highly individualized, adaptive treatment for TMD that has potential to be more effective than other psychosocial treatments; and 2) to discover the mechanisms by which psychosocial treatments work in chronic pain. TMD patients (N=160) will be randomized to receive standard care (STD) + an individualized assessment and treatment program (IATP) or to standard care + conventional cognitive-behavioral treatment (STD+CBT). It is expected that the STD+IATP treatment will yield lower pain, depression and interference scores over time than STD+CBT, and that changes in coping ability will mediate the treatment effects on outcomes.

Detailed description

Temporomandibular/orofacial pain disorders (TMD) are a group of painful conditions with multiple determinants. A number of psychosocial treatments for TMD have been developed, but overall effectiveness has been limited, and the mechanisms of treatment are unknown. This proposal has two main goals: 1) to test a highly individualized, adaptive treatment for TMD that has potential to be more effective than other psychosocial treatments; and 2) to discover the mechanisms by which psychosocial treatments work in chronic pain. Patients with TMD-related pain of at least 3 months duration (N=160) will be randomly assigned to either a Standard Conservative Treatment +Cognitive Behavioral coping skills treatment (STD+CBT), or to an Individualized Assessment and cognitive-behavioral Treatment Program (IATP) for patients with TMD pain. Treatment in IATP will be based on a very detailed functional analysis of the patient's pain experience, in context, as derived from Experience Sampling (ES). The ES procedure will be conducted via smartphone app at a rate of 4 records per day, and will be used to gather information on patients' pain, momentary cognitions, affects, and coping behaviors, for a 2-week monitoring period prior to the beginning of treatment. Therapists will use this information to develop an individual functional analysis of pain and non-pain episodes, and determine what thoughts, feelings and actions are effective for that patient at managing pain and which are not. The information will be used to help develop adaptive coping tactics in a 6-session treatment program, offering skills training tailored to specific patient needs. During-treatment ES will allow adjustment of the treatment goals and procedures, making the treatment adaptive and able to change with changing circumstances and patient needs. This experimental treatment (IATP) will be added to a standard conservative splint-based treatment for TMD pain (STD). The combination (STD+IATP) will be compared to a STD treatment supplemented with a 6 session conventional cognitive-behavioral program not based on in-vivo assessment of pain and coping. In the STD+CBT condition ES data will be collected but will not be used to inform treatment, but will control for measurement reactivity. ES data collected prior to, during, and following both treatments (out to 12 months) will allow very precise measurement of cognitions, affects, and coping skills, as they occur in patients' home environments, and how they change over time. Outcomes will include measures of pain, interference, and depressive symptoms. It is expected that the STD+IATP treatment will yield lower pain, depression and interference scores over time than STD+CBT, and that changes in coping ability will mediate the treatment effects on outcomes. The study will be able to tailor treatment based on patient experiences measured in near-real time at pain episodes, allow for adaptation of treatment as it progresses, and measure the impact on outcomes of coping changes over the long-term. The results will shed light on active mechanisms of treatment for TMD and may have implications for the management of other chronic pain conditions.

Interventions

  • Behavioral Cognitive-Behavioral Treatment
    Cognitive-behavioral coping skills training
  • Behavioral Individualized Assessment and Treatment Program
    Experience-sampling based cognitive behavioral coping skills assessment and training
  • Other Standard Conservative Care
    Standard conservative dental care for orofacial pain

Primary outcome measures

  • Change in pain from baseline as measured by the 11-point Characteristic Pain Intensity Index at each follow-up point [Time frame: Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months]
  • Change in interference with activities from Baseline as measured at all follow-up points by the 10-item Interference scale from the Multidimensional Pain Inventory (MPI; Kerns, Turk, & Rudy, 1985). [Time frame: Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months]
  • Change in Depressive Symptoms from baseline as measured by the 20-item Center for Epidemiological Studies Depression scale Revised (CESD-R) at each follow-up point [Time frame: Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months]
Secondary outcome measures (3)
  • Change in pain coping ability from baseline will be measured at each follow-up point using the Brief Pain Coping Inventory (BCPI; McCracken et al., 2005). [Time frame: Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months]
  • Change in pain self-efficacy from baseline as measured using the Facial Pain Self-Efficacy Scale (Brister, Turner, Aaron, & Mancl, 2006) at each follow-up point. [Time frame: Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months]
  • Change in pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS; Sullivan et al., 1995) at each follow-up point [Time frame: Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Jaw pain > 3 mo; > 3/10 on pain scale
  • Positive Axis I diagnosis on the Diagnostic Criteria for temporomandibular disorders (DC/TMD), with or without disc displacement
  • Positive on > 1 of:
  • Any myalgia diagnosis
  • Any myofascial diagnosis
  • Arthralgia
  • TMD-related Headache

Exclusion criteria

  • Lack of fluency in English
  • Previous invasive surgery for TMD, not including arthrography or arthrocentesis
  • Extensive anatomical destruction or deterioration of the TM joint
  • Diagnosed as having pain of neuropathic or odontogenic origin
  • Carrying a diagnosis of psychosis
  • Taking narcotic pain medication
  • Any comorbid condition necessitating use of an intraoral appliance (e.g., obstructive sleep apnea)
  • Pregnancy (excluded due to prescription of NSAIDs)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UConn Health — Farmington

Identifiers

NCT: NCT04376333 · 20-045-2 · U01DE028520

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗