Orofacial PainNCT06754917
Feasibility Testing of the "Face-Forward-Web" Program for Chronic Orofacial Pain
A study testing Face-Forward-Web in people with Orofacial Pain and Facial Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Orofacial Pain, Facial Pain
- What is being tested?
- Face-Forward-Web
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18
- English fluency and literacy
- Nonmalignant chronic (>3 months) orofacial pain
- Ability and willingness to participate in the Face-Forward web-platform intervention
- Free of concurrent psychotropic medication 2 week prior to participation OR stable psychotropic medication dose and type for ≥ 6 weeks
- Pain score ≥4/10 on the Numerical Rating Scale
- Owns (or has easy access to) a device with internet access
Who cannot join
- Practice of mindfulness > 45 minutes/week in the past 3 months
- Participation in mind-body or cognitive-behavioral therapy in the past 3 months
- Severe untreated mental health disorder (e.g., psychosis)
- Active suicidal ideation with plan or intent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the detailed description
Aim: Conduct a feasibility open pilot study (N=Up to 20) with exit interviews of Face-Forward-Web among adults with various chronic orofacial pain (COP). The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of Face-Forward-Web and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
Face-Forward-Web, adapted from GetActive (a mind-body program for patients with chronic musculoskeletal pain), is a mind-body program for COP and consists of 5 on-demand sessions over a web platform, each being approximately 30 minutes long. The program will teach relaxation (deep breething), mindfulness, and cognitive-behavioral skills to reduce pain and improve emotional welbeing in patients with COP. At the conclusion of each session, an interactive quiz covering the session's content is given to foster a stronger, and more long term, understanding of the material. Throughout the program, encouragements to practice and track the use of Face-Forward-Web skills are disseminated outside and/or between sessions through a variety of means (e.g, text, phone call, email), depending on individual preferenes. Home practice materials include Web-based audio and video clips (e.g., 5 min mindfulness of pain for COP) but, engagement in self-guided skill practice is also permitted.
Following program completion, there will be a one-time 15-30 minute exit interview to elicit subject perceptions of Face-Forward-Web and any recommendations to improve intervention quality. This information will be used to further adapt and optimize Face-Forward-Web prior to future efficacy testing.
Assessments: Baseline (0 weeks), post-test (5 weeks), and 3-month follow-up (17 weeks) survey assessments.
- Conditions
- Orofacial Pain, Facial Pain
- Being tested
- Face-Forward-Web
- Keywords
- Chronic orofacial pain, Facial Pain, Mindfulness, web-based delivery
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-Forward-WebBehavioural
This is a self-administered web-based mind-body intervention that consists of 5 30-minute video sessions disseminating tailored relaxation, mindfulness, and cognitive-behavioral skills for COP. Ultimately, the Face-Forward-Web program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive coping behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Face-Forward-Web | Experimental | 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. Receives: Behavioral: Face-Forward-Web |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire
Assessed using the Credibility and Expectancy Questionnaire which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their COP and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.
Measured: Baseline (0 Weeks)
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Measured: Post-Test (5 Weeks)
Feasibility of recruitment
The percent of eligible patients approached that agree to participate.
Measured: Baseline (0 Weeks)
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
This measure will assess how well patients like the Wed-based program content and delivery. Total raw scores range from 22 to 110 with higher scores indicating greater satisfaction with the platform.
Measured: Post-Test (5 Weeks)
Rate at which program was accepted, measured by number of completed program sessions
The proportion of participants who complete > or = 3 of 5 sessions.
Measured: Post-Test (5 Weeks)
Adherence to homework
Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study
Measured: Collected during intervention, an average of 5 weeks
Feasibility of Assessments at Baseline
Rate of participant's completion of self-report measures, with no measures missing.
Measured: Baseline (0 Weeks)
Feasibility of Assessments at Post-Test
Rate of participant's completion of self-report measures, with no measures missing.
Measured: Post-Test (5 Weeks)
Feasibility of Assessments at Follow-Up
Rate of participant's completion of self-report measures, with no measures missing.
Measured: Follow-Up (17 Weeks)
Adverse Events
Any self-reported or observed negative events related to participation
Measured: Collected during intervention, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start15 Sep 2025
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- NIH Stage Model for Behavioral Intervention Development
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Jonathan Greenberg, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754917
- Sponsor's protocol ID
- 2024P003501
- Other IDs
- 1R21DE033502-01A1
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The digital qualitative and quantitative data associated with this study will be shared by depositing these data in the Vivli database. Vivli is one of the recommended databases for similar NIH-funded chronic pain studies (including as part of the NIH HEAL initiative), with data types similar to the current study. Documentation and de-identified data will be deposited, including qualitative and quantitative data as well as demographics. Submitted data will conform with relevant data and terminology standards.
Publications
Lovette BC, Bakhshaie J, Kulich R, Shaefer JR, Cheng HT, He S, Vranceanu AM, Greenberg J. Development of a Novel Web-Based Intervention Targeting Pain-Related Outcomes in Individuals With Chronic Orofacial Pain: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2025 Aug 20;14:e71839. doi: 10.2196/71839.
PubMed 40835226
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of the "Face-Forward-Web" Program for Chronic Orofacial Pain
- ClinicalTrials.gov ID
- NCT06754917
- Acronym / sponsor ID
- 2024P003501
- Conditions
- Orofacial Pain, Facial Pain
- Keywords
- Chronic orofacial pain, Facial Pain, Mindfulness, web-based delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Aim: Conduct a feasibility open pilot study (N=Up to 20) with exit interviews of Face-Forward-Web among adults with various chronic orofacial pain (COP). The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of Face-Forward-Web and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
Face-Forward-Web, adapted from GetActive (a mind-body program for patients with chronic musculoskeletal pain), is a mind-body program for COP and consists of 5 on-demand sessions over a web platform, each being approximately 30 minutes long. The program will teach relaxation (deep breething), mindfulness, and cognitive-behavioral skills to reduce pain and improve emotional welbeing in patients with COP. At the conclusion of each session, an interactive quiz covering the session's content is given to foster a stronger, and more long term, understanding of the material. Throughout the program, encouragements to practice and track the use of Face-Forward-Web skills are disseminated outside and/or between sessions through a variety of means (e.g, text, phone call, email), depending on individual preferenes. Home practice materials include Web-based audio and video clips (e.g., 5 min mindfulness of pain for COP) but, engagement in self-guided skill practice is also permitted.
Following program completion, there will be a one-time 15-30 minute exit interview to elicit subject perceptions of Face-Forward-Web and any recommendations to improve intervention quality. This information will be used to further adapt and optimize Face-Forward-Web prior to future efficacy testing.
Assessments: Baseline (0 weeks), post-test (5 weeks), and 3-month follow-up (17 weeks) survey assessments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- NIH Stage Model for Behavioral Intervention Development
| Arm | Type | Receives |
|---|---|---|
| Face-Forward-Web | Experimental | Behavioral: Face-Forward-WebA 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 may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥18
- English fluency and literacy
- Nonmalignant chronic (>3 months) orofacial pain
- Ability and willingness to participate in the Face-Forward web-platform intervention
- Free of concurrent psychotropic medication 2 week prior to participation OR stable psychotropic medication dose and type for ≥ 6 weeks
Key exclusion criteria (5 listed)
- Practice of mindfulness > 45 minutes/week in the past 3 months
- Participation in mind-body or cognitive-behavioral therapy in the past 3 months
- Severe untreated mental health disorder (e.g., psychosis)
- Active suicidal ideation with plan or intent
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-Forward-WebThis is a self-administered web-based mind-body intervention that consists of 5 30-minute video sessions disseminating tailored relaxation, mindfulness, and cognitive-behavioral skills for COP. Ultimately, the Face-Forward-Web program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive coping behaviors. | Behavioural | Face-Forward-Web |
Primary outcome
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire
Time frame: Baseline (0 Weeks)
Assessed using the Credibility and Expectancy Questionnaire which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their COP and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
Time frame: Post-Test (5 Weeks)
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Feasibility of recruitment
Time frame: Baseline (0 Weeks)
The percent of eligible patients approached that agree to participate.
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
Time frame: Post-Test (5 Weeks)
This measure will assess how well patients like the Wed-based program content and delivery. Total raw scores range from 22 to 110 with higher scores indicating greater satisfaction with the platform.
Rate at which program was accepted, measured by number of completed program sessions
Time frame: Post-Test (5 Weeks)
The proportion of participants who complete > or = 3 of 5 sessions.
Adherence to homework
Time frame: Collected during intervention, an average of 5 weeks
Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study
Feasibility of Assessments at Baseline
Time frame: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Feasibility of Assessments at Post-Test
Time frame: Post-Test (5 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Feasibility of Assessments at Follow-Up
Time frame: Follow-Up (17 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Adverse Events
Time frame: Collected during intervention, an average of 5 weeks
Any self-reported or observed negative events related to participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 40835226Lovette BC, Bakhshaie J, Kulich R, Shaefer JR, Cheng HT, He S, Vranceanu AM, Greenberg J. Development of a Novel Web-Based Intervention Targeting Pain-Related Outcomes in Individuals With Chronic Orofacial Pain: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2025 Aug 20;14:e71839. doi: 10.2196/71839.
- Individual participant dataSharing planned: No. The digital qualitative and quantitative data associated with this study will be shared by depositing these data in the Vivli database. Vivli is one of the recommended databases for similar NIH-funded chronic pain studies (including as part of the NIH HEAL initiative), with data types similar to the current study. Documentation and de-identified data will be deposited, including qualitative and quantitative data as well as demographics. Submitted data will conform with relevant data and terminology standards.
Related trials for Orofacial Pain
RecruitingObservational study
Effect Of Orofacial Pain Therapy On Bruxism
Masticatory Myofascial Pain
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Not yet recruitingPhase 4
Botulinum Toxin Type A Versus Triamcinolone for Facial Myalgia
Myofascial Pain Syndrome (MPS)
RecruitingObservational study
Masticatory Muscle Activity Using a 24-Hour Wearable Device
Chronic Masticatory Myofascial Pain
Not yet recruiting
Skills Training and Relief for Orofacial Pain
Chronic Orofacial Pain, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-Forward-Web in people with Orofacial Pain and Facial Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (time frame: Baseline (0 Weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.