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

NCT03178110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Neoplasms, Head and Neck
  • Trismus

Interventions

BEHAVIORAL

Physical therapy and dynasplint

Participants will receive a session of 30-45 minutes of manual therapy two times per week, for eight weeks. All participants will be instructed how to use the Dynasplint® Trismus System at home. Participants will start the use of the DTS for 10-30 minutes three times per day, every day. If the exercises are well tolerated, time will be progressively increased to 30 minutes and then intensity (force) will be increased.

Sponsors & Collaborators

  • Cross Cancer Institute

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Margaret McNeely, PhD · University of Alberta

  • Susan Olivo, PhD · University of Alberta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2019-12-31
Completion
2020-07-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03178110 on ClinicalTrials.gov