Manual Therapy on Oral Opening, Swallow Function and Upper Quarter Mobility on Head and Neck Cancer Survivors (MaTeO)

Effects of Manual Therapy on Oral Opening, Swallow Function, and Upper Quarter Mobility in Chilean Survivors of Head and Neck Cancer: A Study Protocol for a Controlled, Randomized Study (MATEO Study, MAnual ThErapy for Oral Opening).

Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients.

The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on Oral Opening, Swallow Function, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors.

Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises and b) motor control exercises (usual care).

The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Trismus; Dysfunction
• Intervention / Treatment: Other: Manual Therapy; Other: Motor control exercises

Detailed Description

Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Burgos, PhD; Phone Number: +56991358814; Email: barbara.burgos@ufrontera.cl

Study Locations

• Chile
  • Cautin
    • Temuco, Cautin, Chile
      • Recruiting
      • Barbara Burgos Mansilla
      • Contact: Barbara Burgos, PhD; Phone Number: 991358814; Email: barbara.burgos@ufrontera.cl
      • Contact: Pilar Schneeberger, Md; Phone Number: 997591832; Email: pilar.schneeberger@ufrontera.cl
    • Temuco, Cautin, Chile
      • Recruiting
      • Universidad de La Frontera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• individuals with HNC
• individuals over 18 years of age
• individuals who have undergone oncological surgery of the head and neck and/or radiotherapy
• having finished oncological medical treatment between 3 and 36 months before inclusion
• having a medical diagnosis of trismus and/or TMD and/or cervical or shoulder dysfunction
• Spanish native speakers

Exclusion Criteria:

• sequelae of previous stroke
• structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs
• active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area
• tracheostomized individuals
• metastasis or active cancer
• refuse to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Therapy; Manual Therapy-based intervention: the session will be performed with the patient in a supine position. If they cannot reach this position, it can be done with the patient sitting in a chair to receive the treatment. The selected maneuvers will focus on cervical, masticatory, and shoulder regions. Besides, intraoral maneuvers will be made using latex gloves, for masseter, medial, and lateral pterygoid muscles. Subsequently, motor control exercises will be performed	Other: Manual Therapy; 3 times a week, for 6 weeks.
Active Comparator: Motor Control; Motor control (exercise): the session will focus on strengthening and stretching exercises for the cervical, masticatory, and shoulder muscles .	Other: Motor control exercises; 3 times a week, for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal mouth opening (MMO)	MMO will be assessed with a sliding calliper measuring the inter-incisor distance asking the patients to open the mouth as maximum as possible.	6 weeks
Temporomandibular disorders (TMD)	TMD will be assessed with the Fonseca Anamneses Index, that classifies TMD as no dysfunction, light dysfunction, moderate dysfunction or severe dysfunction	6 weeks
Swallowing function	Eating Assessment Tool (EAT-10) will be used to evaluate self-reported swallowing impairments. It is a 5 point Likert scale rating from no impairment to severe problem. The sum of all items contained on the questionnaire is used as the overall score, suggesting an abnormal swallowing when score is higher than 3	6 weeks
Swallowing difficulty	A Visual Analogue Scale (VAS) will be used to register swallowing difficulties, ranging from 0 (no problems) to 10 (impossible to swallow)	6 weeks
Dysphagia	Water Swallow Test, subject will be ask to drink 100 mL of water as quickly as is comfortably possible. The time to swallow this 100 mL (in seconds) and the number of swallows will be count.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder active range of motion (AROM)	The active range of motion (AROM) of flexion, abduction, and external and internal rotations will be assessed bilaterally. For measurement, a manual goniometer with two arms and a range of 360º will be used.	6 weeks
Cervical active range of motion (AROM)	The active range of motion (AROM) of cervical flexion, extension, lateral flexion, and rotation will be assessed. For this purpose, a cervical range of motion instrument (CROM) will be used.	6 weeks
Deep cervical flexors endurance	Endurance of deep cervical flexor muscles will be assessed with the deep cervical flexor endurance test, with the patient in a supine lying position with the examiner's hands under his/her head and being told to fold the chin completely to the sternum and raising the head as minimum as possible without touching examiner's hands. Time is counted from when the patient lift his/her head until when he/she can no longer maintain the position.	6 weeks
Muscle Function Test	Defined for the upper fibers of the trapezius, will be used as a test to assess shoulder muscle strength. With the subject in a seated position and arms at both sides of the trunk, they will be asked to push caudally-cranially against the evaluator's hand, placed on their shoulder. The muscle function scale ranges from 0 (complete absence of muscle contraction) to 5 (normal muscle response)	6 weeks
Isometric handgrip strength	A digital dynamometer with adjustable grip will be used to assess handgrip strength. The patient will be asked, while in a seated position, holding a dynamometer, with the elbow flexed at 90° and the shoulder in a neutral position, to perform a grip with maximum effort. Three attempts will be made with each hand (a total of 6 attempts), with a 1-minute rest between each attempt. The average of the three attempts will be calculated for data analysis.	6 weeks
Pain Intensity	At the cervical and temporomandibular joint levels (bilaterally), assessment will be conducted using a validated Visual Analog Scale (VAS): a horizontal line measuring 10 cm in length, with "no pain" at its left end (score 0) and "maximum pain" at its right end (score 10). Patients will be asked to mark the intensity of perceived pain during their day-to-day activities by placing a cross on the line.	6 weeks
Pressure pain thresholds	Pressure algometry will be assessed over the temporalis, masseter, upper trapezius and levator scapulae muscles and the C5-C6 zygapophyseal joint, the sternoclavicular joint and the tibialis anterior muscle as a distant reference muscle.Each point to be evaluated will be analyzed three times with a 30-second interval between assessments, and the arithmetic mean of the three measurements will be used for subsequent statistical analysis.	6 weeks
Shoulder pain and disability perception	Shoulder pain and disability index (SPADI) will be used to evaluate pain and disability perception of the patients at shoulder level.	6 weeks
Health-related quality of life	Questionnaire EORTC QLQ-C30 will be used for measuring quality of life	6 weeks
Health-related quality of life 2	Questionnaire EORTC QLQ-H&N43 will be used for measuring quality of life specifically in survivors of head and neck cancer	6 weeks
Physical Fitness	International Fitness Scale (IFIS) will be used to evaluate perceived physical fitness. It contains 4 physical fitness elements (cardiorespiratory endurance, muscular strength, speed/agility and flexibility) to categorize into 5 options, from very poor to very good	6 weeks
Satisfaction with the treatment	It will be determined through a pre-designed questionnaire consisting of 6 items, including 1 item for overall satisfaction with scores ranging from 0 to 10, and 5 dichotomous response items (yes/no), where the patient can provide reasons for their response. This instrument has been previously used for this purpose.	6 weeks
Adverse Events (AE)	Safety will be recorded in terms of adverse events, defined as any unfavorable change in health that occurs during the intervention. Each adverse event will be characterized based on severity (Grade 1 [mild] to 5 [death]), expectation (expected or unexpected), and potential relationship with study participation (unrelated, possibly related, or related to the study) using the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).	6 weeks

Collaborators and Investigators

• Sponsor: Universidad de La Frontera
• Investigators: Principal Investigator: Barbara Burgos, PhD, Universidad de La Frontera

Publications and helpful links

General Publications

• Pauli N, Fagerberg-Mohlin B, Andrell P, Finizia C. Exercise intervention for the treatment of trismus in head and neck cancer. Acta Oncol. 2014 Apr;53(4):502-9. doi: 10.3109/0284186X.2013.837583. Epub 2013 Oct 31.
• Wissinger E, Griebsch I, Lungershausen J, Foster T, Pashos CL. The economic burden of head and neck cancer: a systematic literature review. Pharmacoeconomics. 2014 Sep;32(9):865-82. doi: 10.1007/s40273-014-0169-3.
• Parke SC, Langelier DM, Cheng JT, Kline-Quiroz C, Stubblefield MD. State of Rehabilitation Research in the Head and Neck Cancer Population: Functional Impact vs. Impairment-Focused Outcomes. Curr Oncol Rep. 2022 Apr;24(4):517-532. doi: 10.1007/s11912-022-01227-x. Epub 2022 Feb 19.
• Kamstra JI, Jager-Wittenaar H, Dijkstra PU, Huisman PM, van Oort RP, van der Laan BF, Roodenburg JL. Oral symptoms and functional outcome related to oral and oropharyngeal cancer. Support Care Cancer. 2011 Sep;19(9):1327-33. doi: 10.1007/s00520-010-0952-4. Epub 2010 Aug 13.
• McMillan H, Barbon CEA, Cardoso R, Sedory A, Buoy S, Porsche C, Savage K, Mayo L, Hutcheson KA. Manual Therapy for Patients With Radiation-Associated Trismus After Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):418-425. doi: 10.1001/jamaoto.2022.0082.
• Ortiz-Comino L, Martin-Martin L, Galiano-Castillo N, Castro-Martin E, Fernandez-Gualda MA, Lozano-Lozano M, Fernandez-Lao C. The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial. Support Care Cancer. 2022 Dec 17;31(1):49. doi: 10.1007/s00520-022-07482-9.
• Castro-Martin E, Galiano-Castillo N, Fernandez-Lao C, Ortiz-Comino L, Postigo-Martin P, Arroyo-Morales M. Myofascial Induction Therapy Improves the Sequelae of Medical Treatment in Head and Neck Cancer Survivors: A Single-Blind, Placebo-Controlled, Randomized Cross-Over Study. J Clin Med. 2021 Oct 27;10(21):5003. doi: 10.3390/jcm10215003.
• Pattanshetty RB, Patil SN. Role of Manual Therapy for Neck Pain and Quality of Life in Head and Neck Cancer Survivors: A Systematic Review. Indian J Palliat Care. 2022 Jan-Mar;28(1):99-112. doi: 10.25259/IJPC_10_2021. Epub 2021 Dec 18.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Spasm; Head and Neck Neoplasms; Trismus
• Other Study ID Numbers: DIM23-0023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No