Early Physical Therapy for Lockjaw
(PRECISE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores ways to assist people with head and neck cancer who might develop trismus, a condition that makes it difficult to open the mouth wide. The focus is on early physical therapy, including exercises and a special jaw-stretching device, to improve jaw movement during cancer treatment. The researchers aim to determine if these early treatments make a difference and whether participants find them helpful. The trial seeks participants who have a specific type of cancer, are receiving radiation therapy, live in Alberta, and speak English. As an unphased trial, it offers a unique opportunity to contribute to innovative approaches that could enhance quality of life during cancer treatment.
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 prior data suggests that this early physical therapy intervention is safe for individuals with head and neck cancer?
Research has shown that starting physical therapy early, including using devices to assist jaw movement, is generally safe for treating trismus (difficulty opening the mouth) in head and neck cancer patients. One study found that a device like the Therabite, which helps stretch the jaw, was both effective and safe for improving jaw movement. Another study involving jaw stretching exercises reported that 114 out of 120 participants completed the program safely. No major safety issues emerged in these studies, suggesting that this method is well-tolerated. These findings provide strong evidence for the safety of early physical therapy in managing trismus.12345
Why are researchers excited about this trial?
Researchers are excited about early physical therapy for trismus because it offers a proactive approach to managing lockjaw. Unlike traditional treatments that often focus on addressing symptoms after they worsen, this method involves weekly monitoring and early intervention. By incorporating physical therapy, home exercises, and a jaw stretching device as soon as a 5% or greater reduction in mouth opening is detected, it aims to prevent significant impairment before it happens. This early intervention strategy could lead to better long-term outcomes and improve quality of life for patients with trismus.
What evidence suggests that early physical therapy is effective for trismus?
Research shows that exercise therapy can help people with trismus, a condition that restricts mouth opening. This trial will focus on early physical therapy intervention for trismus. One study found that a jaw-stretching device called the Dynasplint Trismus System helped people with head and neck cancer open their mouths wider. Another study showed that physiotherapy reduced pain and improved muscle function after treatment. Although one source found no benefit from using jaw-mobilizing devices alone, combining hands-on therapy and exercises appears promising. Overall, starting physical therapy early may improve jaw movement and reduce discomfort.13678
Who Is on the Research Team?
Margaret McNeely, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of trismus, neck disability, and quality of life.
What Are the Treatments Tested in This Trial?
Interventions
- Early Physical Therapy for Trismus
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Alberta Health services
Collaborator