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

NCT06148077 | Recruiting DMC

• 1 other identifier: DIM23-0023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Head and Neck Cancer; Trismus; Dysfunction

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• Shoulder active range of motion (AROM)

  6 weeks

• Cervical active range of motion (AROM)

  6 weeks

• Deep cervical flexors endurance

  6 weeks

• Muscle Function Test

  6 weeks

• Isometric handgrip strength

  6 weeks

Study Arms (2)

Manual Therapy

EXPERIMENTAL

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

Motor Control

ACTIVE COMPARATOR

Motor control (exercise): the session will focus on strengthening and stretching exercises for the cervical, masticatory, and shoulder muscles .

Other: Motor control exercises

Interventions

Manual Therapy OTHER

3 times a week, for 6 weeks.

Manual Therapy

Motor control exercises OTHER

3 times a week, for 6 weeks.

Motor Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (2)

Barbara Burgos Mansilla

Temuco, Cautin, Chile

RECRUITING

Universidad de La Frontera

Temuco, Cautin, Chile

RECRUITING

Related Publications (9)

• 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.

  PMID: 24842794 BACKGROUND

• 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.

  PMID: 35182293 BACKGROUND

• 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.

  PMID: 20706851 BACKGROUND

• 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.

  PMID: 35297966 BACKGROUND

• 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.

  PMID: 36526871 BACKGROUND

• 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.

  PMID: 34768520 BACKGROUND

• 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.

  PMID: 24175896 BACKGROUND

• 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.

  PMID: 35673382 BACKGROUND

• 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.

  PMID: 40897487 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Trismus

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Barbara Burgos, PhD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Burgos, PhD

CONTACT

+56991358814; barbara.burgos@ufrontera.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 28, 2023
• Study Start: September 25, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)