Manual Therapy and Use of the Dynasplint for Trismus in Patients With Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMargaret McNeely, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objectives of this pilot study are to determine the effectiveness of a manual therapy (MT) protocol plus the use of a dynamic jaw opening device on the maximal interincisor distance; on trismus symptoms; on pain-disability outcomes and on the quality of life, anxiety, and depression in subjects with trismus. The proposed pilot study will comprise a single subject design with multiple baseline measures and during treatment phases to determine the effectiveness of the treatment protocol. A minimum sample of 10 subjects will be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will receive a MT protocol plus exercises and the use of the DTS device for 8 weeks. The first two weeks of treatment will involve only MT and opening exercises.After this initial 2 weeks, the DTS will be introduced. The participants will receive a session of 30-45 minutes of MT three/two times per week, for 8 weeks. All participants will be instructed how to use the Dynasplint® Trismus System at home. Analyses: Visual analyses will be performed on participant before, during, and after the intervention. The 2-standard deviation band method will be used to analyze the behavior of each participant on the outcome of interest before, during, and after the treatment. The minimally important difference levels in order to determine clinical relevance will be done. Two effect size indexes will be used: the percentage of non-overlapping data, and the percentage of improvement rate difference.

Eligibility Criteria

Inclusion Criteria

A diagnosis of head and neck cancer;

An oral and an opening of less than 35 mm between the upper and lower incisors (measured with a slide caliper).

Cancer treatment includes surgery and/ or radiation therapy;

Treatment Details

Interventions

Physical therapy and dynasplint (Behavioral Intervention)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Physical therapy and dynasplintExperimental Treatment1 Intervention

Participants with trismus will receive a manual therapy protocol plus exercises and the use of the dynasplint (DTS) device for a duration of 8 weeks. The first two weeks of treatment will include 2 days per week of manual therapy and active jaw opening exercises. Following this initial treatment phase, the DTS will be introduced and the frequency of manual therapy will remain at two times per week.