Clinical trial NCT03875118: Effects of Mouth-opening Training on the Maximum Interincisal Opening
Official title: Effects of Mouth-opening Training With Follow-up Telephone Calls on the Maximum Interincisal Opening and Mandibular Function of Postoperative Oral Cancer Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Keywords: Oral cancer
Trismus
Mouth-opening training
Jaw exercise
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Yuan's General Hospital
First posted: 2019-03-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: PURPOSE:The purpose of the study was to investigate the effect of mouth-opening training with follow-up telephone calls for reducing postoperative trismus in patients with oral cancer.

METHODS:The study is a randomized clinical trial using repeated measures. Sixty-eight patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited and randomly assigned to either the intervention or control group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months. Subjects in the intervention group received additional 6 follow-up phone calls to enhance mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire.

Detailed description: The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group.

The study is a randomized clinical trial using repeated measures. A convenience sample of 68 oral cancer patients was recruited and randomly assigned to either the intervention or control group according to a list generated by the Random Allocation Software. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected.

All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).

Eligibility criteria: Inclusion Criteria:

1. aged 18 years or older
2. diagnosed with oral cancer
3. scheduled for a primary curative oral cancer surgery
4. able to communicate in Mandarin or Taiwanese
5. obtained medical clearance from the patient's attending physician to participate in the study

Exclusion Criteria:

1. diagnosed with lip or tongue cancers which were less relevant to trismus
2. had central incisors extracted during the surgery

Primary outcomes:
measure: TheraBite Range-of-Motion Scale
timeFrame: Change from Baseline to 3 months
Secondary outcomes:
measure: Mandibular Function Impairment Questionnaire (MFIQ)
timeFrame: Change from Baseline to 3 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Yuan's General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsae Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wetzels JW, Merkx MA, de Haan AF, Koole R, Speksnijder CM. Maximum mouth opening and trismus in 143 patients treated for oral cancer: a 1-year prospective study. Head Neck. 2014 Dec;36(12):1754-62. doi: 10.1002/hed.23534. Epub 2014 Jan 30.
citation: Kamstra JI, van Leeuwen M, Roodenburg JLN, Dijkstra PU. Exercise therapy for trismus secondary to head and neck cancer: A systematic review. Head Neck. 2017 Nov;39(11):2352-2362. doi: 10.1002/hed.24859. Epub 2017 Jul 14.
citation: Chen M, Li P, Lin F. Influence of structured telephone follow-up on patient compliance with rehabilitation after total knee arthroplasty. Patient Prefer Adherence. 2016 Mar 3;10:257-64. doi: 10.2147/PPA.S102156. eCollection 2016.
citation: Agarwal P, Shiva Kumar HR, Rai KK. Trismus in oral cancer patients undergoing surgery and radiotherapy. J Oral Biol Craniofac Res. 2016 Nov;6(Suppl 1):S9-S13. doi: 10.1016/j.jobcr.2016.10.004. Epub 2016 Oct 22.