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Recruiting NCT06148077

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

No phase Interventional Head and Neck Cancer Trismus Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual Therapy, Motor control exercises.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Trismus, Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Chile
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

Overview

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

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.

Interventions

  • Other Manual Therapy
    3 times a week, for 6 weeks.
  • Other Motor control exercises
    3 times a week, for 6 weeks.

Primary outcome measures

  • Maximal mouth opening (MMO) [Time frame: 6 weeks]
  • Temporomandibular disorders (TMD) [Time frame: 6 weeks]
  • Swallowing function [Time frame: 6 weeks]
  • Swallowing difficulty [Time frame: 6 weeks]
  • Dysphagia [Time frame: 6 weeks]
Secondary outcome measures (12)
  • Shoulder active range of motion (AROM) [Time frame: 6 weeks]
  • Cervical active range of motion (AROM) [Time frame: 6 weeks]
  • Deep cervical flexors endurance [Time frame: 6 weeks]
  • Muscle Function Test [Time frame: 6 weeks]
  • Isometric handgrip strength [Time frame: 6 weeks]
  • Pain Intensity [Time frame: 6 weeks]
  • Pressure pain thresholds [Time frame: 6 weeks]
  • Shoulder pain and disability perception [Time frame: 6 weeks]
  • Health-related quality of life [Time frame: 6 weeks]
  • Health-related quality of life 2 [Time frame: 6 weeks]
  • Physical Fitness [Time frame: 6 weeks]
  • Satisfaction with the treatment [Time frame: 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Chile · 2 centers
  • Barbara Burgos Mansilla — Temuco
  • Universidad de La Frontera — Temuco

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35673382

Identifiers

NCT: NCT06148077 · DIM23-0023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗