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

NCT03178110 | Completed

• 1 other identifier: HREBA-CC-17-0164
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

physical therapy; cancer rehabilitation

Outcome Measures

Primary Outcomes (1)

• Minimal Inter-incisor Opening

  Mouth Opening

  8 weeks

Secondary Outcomes (6)

• Gothenburg Trismus Questionnaire

  8 weeks

• Visual Analogue Scale for Pain

  8 weeks

• Hospital Anxiety and Depression Scale

  8 weeks

• Short-Form 36 Health Survey

  8 weeks

• Global Rating Scale

  8 weeks

Study Arms (1)

Physical therapy and dynasplint

EXPERIMENTAL

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.

Behavioral: Physical therapy and dynasplint

Interventions

Physical therapy and dynasplint BEHAVIORAL

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.

Physical therapy and dynasplint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of head and neck cancer;
• Cancer treatment includes surgery and/ or radiation therapy;
• An oral and an opening of less than 35 mm between the upper and lower incisors (measured with a slide caliper).

You may not qualify if:

• years or younger;
• Osteoporosis, osteoradionecrosis or active cancer in the region;
• Serious or uncontrolled co-morbid disease that would interfere with testing or treatment;
• Inability to provide informed consent;
• Inability to comply with the assessment and/ or treatment (i.e. unable to attend treatment sessions due to vacation).

Sponsors & Collaborators

• University of Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (2)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Trismus

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Margaret McNeely, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Susan Olivo, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The methodology of a single subject design will be used with multiple baseline and during treatment measures to determine the effectiveness of the treatment protocol.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: October 4, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 15, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

CA (2)