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

NCT ID: NCT06148077

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer Trismus Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Manual Therapy

Intervention Type OTHER

3 times a week, for 6 weeks.

Motor Control

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

Group Type ACTIVE_COMPARATOR

Motor control exercises

Intervention Type OTHER

3 times a week, for 6 weeks.

Interventions

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Manual Therapy

3 times a week, for 6 weeks.

Intervention Type OTHER

Motor control exercises

3 times a week, for 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de La Frontera

OTHER

Sponsor Role lead

Responsible Party

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Barbara Burgos Mansilla

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Burgos, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Locations

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Barbara Burgos Mansilla

Temuco, Cautin, Chile

Site Status RECRUITING

Universidad de La Frontera

Temuco, Cautin, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Barbara Burgos, PhD

Role: CONTACT

+56991358814

Facility Contacts

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Barbara Burgos, PhD

Role: primary

991358814

Pilar Schneeberger, Md

Role: backup

997591832

References

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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.

Reference Type BACKGROUND
PMID: 24842794 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35182293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20706851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35297966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36526871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34768520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24175896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35673382 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40897487 (View on PubMed)

Other Identifiers

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DIM23-0023

Identifier Type: -

Identifier Source: org_study_id

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