Effects of Mouth-opening Training on the Maximum Interincisal Opening

NCT03875118 | Completed Results

• 1 other identifier: 20110818B
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Keywords

Oral cancer; Trismus; Mouth-opening training; Jaw exercise

Outcome Measures

Primary Outcomes (1)

• TheraBite Range-of-Motion Scale

  The TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects with MIO \<35 mm are considered to have trismus.

  Change from Baseline to 3 months

Secondary Outcomes (1)

• Mandibular Function Impairment Questionnaire (MFIQ)

  Change from Baseline to 3 months

Study Arms (2)

The intervention group

EXPERIMENTAL

Subjects in the intervention group 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.

Behavioral: The mouth-opening training with follow-up telephone calls program

The control group

ACTIVE COMPARATOR

Subjects in the control group also 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.

Behavioral: The mouth-opening training without follow-up telephone calls program

Interventions

The mouth-opening training with follow-up telephone calls program BEHAVIORAL

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.

The intervention group

The mouth-opening training without follow-up telephone calls program BEHAVIORAL

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.

The control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Yuan's General Hospital: collaborator

Study Sites (1)

Yuan's General Hospital

Kaohsiung City, 802, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 24478217 BACKGROUND

• 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.

  PMID: 29044879 BACKGROUND

• 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.

  PMID: 27042020 BACKGROUND

• 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.

  PMID: 27900243 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Trismus

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Additional randomized controlled trials with longitudinal designs and larger sample sizes are needed to better define the role of the intervention in the treatment protocol for oral cancer associated trismus. Replicating this study in other settings is also recommended.

Results Point of Contact

• Title: Director of Nursing Department
• Organization: National Taipei University of Nursing Health and Sciences

tsaejyy@ntunhs.edu.tw

886-2-28227101

Study Officials

• Tsae Jyy Wang, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD Professor

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 14, 2019
• Study Start: June 18, 2012
• Primary Completion: March 31, 2014
• Study Completion: March 31, 2014
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)