Apply to Trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Early Physical Therapy for Lockjaw
(PRECISE Trial)

Overseen ByMargaret McNeely, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Tmj surgery, Cancer recurrence, Metastatic, others

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

Trial Summary

What is the purpose of this trial?

Trismus, or restricted jaw movement, can occur in individuals with head and neck cancer (HNC) undergoing surgery or radiation therapy. There is a paucity of research examining interventions for trismus. We aim to assess the feasibility of prospective surveillance and early intervention to mitigate trismus in individuals undergoing HNC treatment. Method: The investigators will conduct a pilot single group feasibility study involving 30 individuals with HNC who will be undergoing radiation therapy. Participants will be identified at the HNC new patient clinic. Participants will be seen weekly during radiation therapy and will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5% or greater reduction in jaw opening compared to pre-treatment. The investigators will assess recruitment and completion rates, intervention acceptability, and data collection procedures. Descriptive statistics will summarize feasibility metrics and participant demographics. Findings will inform the design of a larger multicentre trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of early physical therapy for trismus (lockjaw)?

Research shows that using jaw-mobilizing devices like the Therabite can help improve mouth opening in people with trismus, especially after surgery for head and neck cancer. Physical therapy with stretching exercises is also considered an important first step in managing trismus.¹ ² ³ ⁴ ⁵

Is early physical therapy for lockjaw safe for humans?

The research on early physical therapy for trismus (lockjaw) in head and neck cancer patients suggests that using jaw-mobilizing devices is generally safe, but there are reports of poor adherence due to symptoms and intervention burden. Additionally, there is a potential risk of temporomandibular joint dislocation with certain procedures, highlighting the need for careful management.¹ ² ⁵ ⁶ ⁷

How does early physical therapy for trismus differ from other treatments?

Early physical therapy for trismus is unique because it focuses on using physical exercises and possibly mechanical devices to improve jaw mobility, rather than relying on drugs or surgery. This approach can be particularly beneficial in the early stages after surgery or cancer treatment to prevent or manage restricted mouth opening.¹ ² ⁵ ⁸ ⁹

Research Team

Margaret McNeely, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for individuals with head and neck cancer who are about to undergo radiation therapy. They should be new patients at the HNC clinic and willing to participate in a study that could involve additional physical therapy.

Inclusion Criteria

I have been diagnosed with cancer in my mouth, throat, or the upper part of my throat behind the nose.

I am scheduled for cancer treatment that includes radiation.

Ability to read and understand English

See 1 more

Exclusion Criteria

I had surgery on my jaw joint not related to head or neck cancer.

My cancer has returned or spread to other parts of my body.

Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo weekly monitoring of mouth opening and jaw function during radiation therapy. Early intervention is provided if there is a 5% or greater reduction in mouth opening.

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of trismus, neck disability, and quality of life.

3 months

Treatment Details

Interventions

Early Physical Therapy for Trismus

Trial Overview The trial is testing whether early physical therapy can help prevent or reduce trismus (lockjaw) compared to usual care, which involves exercises and referral for physical therapy only after trismus is detected.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Prospective Surveillance for Trismus and Early Physical Therapy InterventionExperimental Treatment1 Intervention

Weekly monitoring of mouth opening and jaw function. Early intervention if the participant presents with 5% or greater reduction in mouth opening compared to pre-treatment measures. Early intervention will comprise: physical therapy, home exercises and use of a jaw stretching device.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Findings from Research

The scoping review of nine studies found that while jaw-mobilizing devices may help manage trismus in head and neck cancer survivors, they did not show effectiveness in preventing trismus.

There is a need for more research led by physical therapists to explore the potential benefits of manual therapy for trismus, as current studies indicate poor adherence and completion rates among survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physiotherapeutic Interventions for Trismus in Head and Neck Cancer: Where Is the Manual Therapy?Nedeljak, J., Armijo-Olivo, S., Hernandez, IA., et al.[2023]

Radiotherapy affecting the temporomandibular joint and pterygoid muscles can lead to a significant reduction in mouth opening (average decrease of 18%), highlighting a common risk factor for trismus in head and neck cancer patients.

Interventions such as exercises with a therabite device and tongue blades have been shown to significantly improve mouth opening, with effect sizes of 2.6 and 1.5 respectively, indicating their potential efficacy in treating trismus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trismus in head and neck oncology: a systematic review.Dijkstra, PU., Kalk, WW., Roodenburg, JL.[2018]

The Dynasplint Trismus System (DTS) effectively increased the maximal incisal opening (MIO) in patients with trismus due to head and neck cancer, with a mean improvement of 32% from 19.3 mm to 25.5 mm over the treatment period.

The most significant improvement occurred in the first 6 weeks, with an initial rate of gain of 0.36 mm/day, indicating that early intervention with DTS is crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynasplint for the management of trismus after treatment of upper aerodigestive tract cancer: a retrospective study.Barañano, CF., Rosenthal, EL., Morgan, BA., et al.[2019]