Individualized Assessment and Treatment for TMD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2026-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Temporomandibular Joint Disorders Orofacial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-group randomized clinical trail

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Neither patient nor therapists can be blinded to treatment condition. The outcomes assessors and the investigators will be blinded.

Study Groups

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STD+CBT

Standard conservative dental orofacial pain care + cognitive-behavioral coping skills treatment

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Treatment

Intervention Type BEHAVIORAL

Cognitive-behavioral coping skills training

Standard Conservative Care

Intervention Type OTHER

Standard conservative dental care for orofacial pain

STD+IATP

Standard conservative dental orofacial pain care + Individualized Assessment and Treatment Program; a highly individualized coping skills training procedure.

Group Type EXPERIMENTAL

Individualized Assessment and Treatment Program

Intervention Type BEHAVIORAL

Experience-sampling based cognitive behavioral coping skills assessment and training

Standard Conservative Care

Intervention Type OTHER

Standard conservative dental care for orofacial pain

Interventions

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Cognitive-Behavioral Treatment

Cognitive-behavioral coping skills training

Intervention Type BEHAVIORAL

Individualized Assessment and Treatment Program

Experience-sampling based cognitive behavioral coping skills assessment and training

Intervention Type BEHAVIORAL

Standard Conservative Care

Standard conservative dental care for orofacial pain

Intervention Type OTHER

Other Intervention Names

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CBT IATP STD

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years
2. Jaw pain \> 3 mo; \> 3/10 on pain scale
3. Positive Axis I diagnosis on the Diagnostic Criteria for temporomandibular disorders (DC/TMD), with or without disc displacement
4. Positive on \> 1 of:

1. Any myalgia diagnosis
2. Any myofascial diagnosis
3. Arthralgia
4. TMD-related Headache

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No