Who is sponsoring NCT03178110?

NCT03178110 is sponsored by University of Alberta.

What drugs are being tested in NCT03178110?

Interventions in NCT03178110: Physical therapy and dynasplint.

What condition does NCT03178110 study?

NCT03178110 studies Neoplasms, Head and Neck, Trismus.

Is NCT03178110 still recruiting?

NCT03178110 is currently completed. Last updated 22 July 2020.

Last reviewed 2020-07-22 · How we verify

NCT03178110

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Manual Therapy and Use of the Dynasplint for Trismus in Patients With Head and Neck Cancer

Completed NA Last updated 22 July 2020

What this trial tests

NA trial testing Physical therapy and dynasplint in Neoplasms, Head and Neck in 10 participants. Completed in 15 July 2020.

Timeline

4 October 2018

Primary endpoint
31 December 2019

15 July 2020

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	4 October 2018
Primary completion	31 December 2019
Estimated completion	15 July 2020
Sites	2 locations across Canada

Drugs / interventions tested

Physical therapy and dynasplint

Conditions studied

Neoplasms, Head and Neck — all drugs for Neoplasms, Head and Neck →
Trismus — all drugs for Trismus →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Neoplasms, Head and Neck or Trismus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objectives of this pilot study are to determine the effectiveness of a manual therapy (MT) protocol plus the use of a dynamic jaw opening device on the maximal interincisor distance; on trismus symptoms; on pain-disability outcomes and on the quality of life, anxiety, and depression in subjects with trismus. The proposed pilot study will comprise a single subject design with multiple baseline measures and during treatment phases to determine the effectiveness of the treatment protocol. A minimum sample of 10 subjects will be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will receive a MT protocol plus exercises and the use of the DTS device for 8 weeks. The first two weeks of treatment will involve only MT and opening exercises.After this initial 2 weeks, the DTS will be introduced. The participants will receive a session of 30-45 minutes of MT three/two times per week, for 8 weeks. All participants will be instructed how to use the Dynasplint® Trismus System at home. Analyses: Visual analyses will be performed on participant before, during, and after the intervention. The 2-standard deviation band method will be used to analyze the behavior of each participant on the outcome of interest before, during, and after the treatment. The minimally important difference levels in order to determine clinical relevance will be done. Two effect size indexes will be used: the percentage of non-overlapping data, and the percentage of improvement rate difference.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Neoplasms, Head and Neck

Currently open trials in the same condition.

NCT06256588 — A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and N · Phase 3 · recruiting
NCT06062420 — A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurre · Phase 2 · active not recruiting

Other University of Alberta trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03178110 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alberta
Last refreshed: 22 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03178110.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing