Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a diagnosis of oral, oropharyngeal, or nasopharyngeal cancer

Be scheduled to undergo cancer treatment that includes radiation therapy

Be able to read and understand English

Be an Alberta resident.

Disqualifiers

Previous surgery for the temporomandibular joint that is not related to the HNC diagnosis.

Local cancer recurrence or metastatic disease.

Unable to provide informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • Early physical therapy intervention

    Behavioral

    Physical therapy including manual therapy, home exercises for the neck and jaw, and use of a jaw stretching device.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Prospective Surveillance for Trismus and Early Physical Therapy InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: completion rate

Number of participants completing the study.

Time frame
2 years

Secondary outcomes

1

Feasibility: recruitment rate

Number of participants entering the study by the number of participants eligible.

Time frame
2 years
2

Feasibility: adherence rate

Percentage of sessions completed over the 6-week intervention period.

Time frame
6 weeks.
3

Maximal interincisal opening

The distance from the incisal border of tooth #21 to the middle of incisal border of tooth #31

Time frame
3 months
4

Trismus symptom questionnaire

Revised Gothenburg Trismus Questionnaire (0-100): higher scores indicate higher symptom burden

Time frame
3 months

Other outcomes

Sponsors and contacts

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University of Alberta

Lead sponsor

Alberta Health services

Collaborator