Face-Forward-Web for Orofacial Pain

Overseen ByNadine Levey, BA

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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Face-Forward-Web for orofacial pain?

The 'About Face' program, which uses psychology and physiotherapy to help people with persistent facial pain, aims to improve their quality of life, suggesting that similar approaches like Face-Forward-Web could be effective.¹ ² ³ ⁴ ⁵

How is the Face-Forward-Web treatment different from other treatments for orofacial pain?

Face-Forward-Web is unique because it combines psychological and physiotherapy techniques to manage persistent facial pain, focusing on skill development to improve quality of life, unlike traditional treatments that may focus solely on medication or physical therapy.¹ ⁵ ⁶ ⁷ ⁸

What is the purpose of this trial?

The goal of this study is to conduct a feasibility open pilot study (N=Up to 20) with exit interviews to assess the feasibility, acceptability, and credibility of the study protocol and Face-Forward-Web; a web-based mind-body intervention for adult patients with COP.Deliverables: \[1\] Adapt and refine open pilot protocol, patient recruitment, and other study materials. \[2\] Assess the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention methodology in preparation for a future efficacy study.This research leverages mixed methods information to evaluate the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention and study methodology in preparation for the subsequent pilot study and again later, for a pilot feasibility randomized control trial (RCT).

Eligibility Criteria

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

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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)

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Timeline

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)

Treatment Details

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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Face-Forward-WebExperimental Treatment1 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.