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Trial Title:
Manual Therapy for Oral Health and Upper Quarter Mobility on Head and Neck Cancer Survivors
NCT ID:
NCT06148077
Condition:
Head and Neck Cancer
Trismus
Dysfunction
Conditions: Official terms:
Head and Neck Neoplasms
Trismus
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Manual Therapy
Description:
3 times a week, for 6 weeks.
Arm group label:
Manual Therapy
Intervention type:
Other
Intervention name:
Motor control exercises
Description:
3 times a week, for 6 weeks.
Arm group label:
Motor Control
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 health, 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- To have ended their treatment for head and neck cancer
- To have no metastasis or active cancer
- To have trismus (MMO<35 mm)
Exclusion Criteria:
- Stroke survivors.
- 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.
- Individuals with tracheostomies.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Barbara Burgos Mansilla
Address:
City:
Temuco
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Barbara Burgos, PhD
Phone:
991358814
Email:
barbara.burgos@ufrontera.cl
Contact backup:
Last name:
Pilar Schneeberger, Md
Phone:
997591832
Email:
pilar.schneeberger@ufrontera.cl
Facility:
Name:
Universidad de La Frontera
Address:
City:
Temuco
Country:
Chile
Status:
Recruiting
Start date:
September 25, 2024
Completion date:
October 1, 2025
Lead sponsor:
Agency:
Universidad de La Frontera
Agency class:
Other
Source:
Universidad de La Frontera
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06148077
