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Head and Neck CancerMaTeONCT06148077

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

A study testing Manual Therapy in people with Head and Neck Cancer and Trismus, run by Universidad de La Frontera at 2 sites in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer, Trismus, Dysfunction
What is being tested?
Manual Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesChile
Study dates
25 Sep 2024to 1 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Barbara Burgos, PhD contact

+56991358814

barbara.burgos@ufrontera.cl

Chile2 sites, 2 recruiting
  • Barbara Burgos Mansilla

    Temuco, Cautin

    Barbara Burgos, PhD, 991358814, barbara.burgos@ufrontera.cl

    Pilar Schneeberger, Md, 997591832, pilar.schneeberger@ufrontera.cl

    Recruiting
  • Universidad de La Frontera

    Temuco, Cautin

    Recruiting

Other trials in Chile

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Manual Therapy, Motor control exercises
Medical subject headings
Head and Neck Neoplasms, Trismus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual TherapyOther

    3 times a week, for 6 weeks.

  • Motor control exercisesOther

    3 times a week, for 6 weeks.

Study groups in NCT06148077
Study groupRoleWhat they receive
Manual TherapyExperimentalManual 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
Receives: Other: Manual Therapy
Motor ControlActive comparatorMotor control (exercise): the session will focus on strengthening and stretching exercises for the cervical, masticatory, and shoulder muscles .
Receives: Other: Motor control exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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

    Measured: 6 weeks

  3. 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

    Measured: 6 weeks

  4. Swallowing difficulty

    A Visual Analogue Scale (VAS) will be used to register swallowing difficulties, ranging from 0 (no problems) to 10 (impossible to swallow)

    Measured: 6 weeks

  5. 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.

    Measured: 6 weeks

Secondary outcomes (13)
  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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)

    Measured: 6 weeks

  5. 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.

    Measured: 6 weeks

  6. 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.

    Measured: 6 weeks

  7. 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.

    Measured: 6 weeks

  8. 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.

    Measured: 6 weeks

  9. Health-related quality of life

    Questionnaire EORTC QLQ-C30 will be used for measuring quality of life

    Measured: 6 weeks

  10. 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

    Measured: 6 weeks

  11. 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

    Measured: 6 weeks

  12. 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.

    Measured: 6 weeks

  13. 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).

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2023
  2. Study start25 Sep 2024
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06148077
Sponsor's protocol ID
DIM23-0023
Acronym
MaTeO
Status last verified
Mar 2025
First submitted
17 Nov 2023
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24842794
  • 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.

    PubMed 35182293
  • 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.

    PubMed 20706851
  • 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.

    PubMed 35297966
  • 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.

    PubMed 36526871
  • 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.

    PubMed 34768520
  • 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.

    PubMed 24175896
  • 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.

    PubMed 35673382
  • Burgos-Mansilla B, Schneeberger-Hitschfeld P, Astete-Barra K, Mendez-Rojas A, Ortiz-Comino L. 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, randomised study (MAnual ThErapy for Oral Opening (MATEO) study). BMJ Open. 2025 Sep 2;15(9):e097131. doi: 10.1136/bmjopen-2024-097131.

    PubMed 40897487

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy in people with Head and Neck Cancer and Trismus, run by Universidad de La Frontera at 2 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Barbara Burgos, PhD (+56991358814, barbara.burgos@ufrontera.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal mouth opening (MMO) (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06148077, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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