Face-Forward-Web for Orofacial Pain

Overseen By Kozbi Bayne-Cliff, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic medications

Disqualifiers: Mindfulness practice, Therapy, Severe mental disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new web-based program called Face-Forward-Web, designed to help manage chronic orofacial pain, which affects the face and mouth for more than three months. The main goal is to determine if participants find the program easy to use, acceptable, and credible. This initial study will refine the program and prepare for a larger, more detailed trial in the future. Suitable candidates for this trial are adults who have experienced ongoing face or mouth pain for over three months, rate their pain at least 4 out of 10, and have internet access. As an unphased trial, this study offers participants the chance to contribute to developing an innovative program that could enhance pain management for many.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. If you are on psychotropic medication, you must either stop taking it 2 weeks before joining the study or have been on a stable dose for at least 6 weeks.

What prior data suggests that the Face-Forward-Web protocol is safe for adults with chronic orofacial pain?

Research has shown that Face-Forward-Web is an online program designed to help manage pain and reduce disability from chronic facial pain. Researchers are studying its effectiveness and whether participants find it helpful and trustworthy.

Regarding safety, specific information about side effects is not yet available. However, as an online program, it is less likely to cause physical side effects compared to medication or medical procedures. The study aims to ensure that Face-Forward-Web does not cause any unexpected problems for participants.

The main focus is on making the program easy to use and effective. Participants will help determine if the program is user-friendly and aids in pain management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Face-Forward-Web is unique because it offers a web-based mind-body pain management approach for chronic orofacial pain, focusing on both physical and emotional disability. Traditional treatments for orofacial pain, such as medications or physical therapies, often focus solely on physical symptoms. In contrast, this intervention integrates mental and emotional health aspects, which could provide a more comprehensive solution. Researchers are excited because this method could offer a more holistic and accessible treatment option, potentially leading to improved quality of life for patients by addressing the multifaceted nature of chronic pain.

What evidence suggests that Face-Forward-Web is effective for orofacial pain?

Studies have shown that mind-body techniques can reduce pain and improve quality of life for individuals with long-term health issues. Face-Forward-Web, the treatment under study in this trial, is a new online program designed to ease pain and disability from chronic orofacial pain, which involves ongoing pain in the face and jaw. Early user feedback indicates that the program is easy to use and might help manage pain more effectively. It teaches techniques that involve the mind and body working together to manage pain. Although specific data on its effectiveness is not yet available, similar programs for other types of chronic pain have shown promise. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults with chronic orofacial pain, which includes persistent facial pain. The study aims to include up to 20 participants who are interested in trying a web-based mind-body intervention program called Face-Forward-Web.

Inclusion Criteria

Owns (or has easy access to) a device with internet access

English fluency and literacy

Ability and willingness to participate in the Face-Forward web-platform intervention

Exclusion Criteria

Pregnancy

I have practiced mindfulness for over 45 minutes weekly in the last 3 months.

Severe untreated mental health disorder (e.g., psychosis)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Face-Forward-Web program, consisting of 5 on-demand sessions over a web platform, each approximately 30 minutes long, teaching relaxation, mindfulness, and cognitive-behavioral skills.

5 weeks

5 sessions (web-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a one-time exit interview to gather feedback on the program.

12 weeks

1 exit interview (15-30 minutes)

What Are the Treatments Tested in This Trial?

Interventions

• Face-Forward-Web

Trial Overview The Face-Forward-Web program, a web-based mind-body intervention designed for individuals suffering from chronic orofacial pain, is being tested for its feasibility, acceptability, and credibility through an open pilot study followed by exit interviews.

How Is the Trial Designed?

Group I: Face-Forward-Web Experimental Treatment 1 Intervention

A 5-session web-based mind-body pain management intervention focused on decreasing pain and disability (physical and emotional) among adult patients with chronic orofacial pain.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12409173/

Protocol for a Mixed Methods Study - PMC This study aims to (1) develop Face-Forward-Web with the aid of live video focus groups with adults with COP and (2) optimize Face-Forward-Web ...

2. trialx.com trialx.com/clinical-trials/listings/325319/feasibility-testing-of-the-face-forward-web-program-for-chronic-orofacial-pain/?&geo_lat=42.3709&geo_lng=-71.1828&radius=10&place=Watertown&user_country=United%20States

Feasibility Testing of the "Face-Forward-Web" Program for ... Aim: Conduct a feasibility open pilot study (N=Up to 20) with exit interviews of Face-Forward-Web among adults with various chronic orofacial ...

3. withpower.com withpower.com/trial/face-forward-web-for-orofacial-pain-f7139

Face-Forward-Web for Orofacial Pain · Info for Participants This trial is for adults with chronic orofacial pain, which includes persistent facial pain. The study aims to include up to 20 participants who are interested ...

4. researchprotocols.org researchprotocols.org/2025/1/e71839/PDF

Protocol for This study aims to (1) develop Face-Forward-Web with the aid of live video focus groups with adults with COP and (2) optimize Face-Forward-Web ...

5. researchgate.net researchgate.net/publication/394749876_Development_of_a_novel_web-based_intervention_targeting_pain-related_outcomes_in_chronic_orofacial_pain_Protocol_for_a_mixed_methods_study_Preprint

Development of a novel web-based intervention targeting ... Development of a novel web-based intervention targeting pain-related outcomes in chronic orofacial pain: Protocol for a mixed methods study ( ...