Clinical trial · Interventional
Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients
Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
NCT01733797CI-TRIAL-00019287completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therabite | Device | — | UNRESOLVED |
| Wooden spatula | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Wooden spatula
- interventionNames
- Device: Wooden spatula
- type
- EXPERIMENTAL
- label
- Therabite
- interventionNames
- Device: Therabite
Primary outcomes (1)
- measure
- Change in Jaw measurement
- timeFrame
- Baseline, 3 months and 6 months at hopsital
- description
- Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed, written informed consent * Aged 18 years and older * Able to read and write English sufficiently to be able to complete questionnaires * Stage 3/4 oral and oropharyngeal cancer patients undergoing: Primary chemoradiotherapy or Surgical free flap plus post operative radiotherapy or post operative chemoradiotherapy * All patients will receive 60-70 Gy in 30-35 fractions over 6 to 7 weeks to the region of the pterygoid muscles. * All patients will have at least some trismus as indicated by subjective tightening in the jaw. Exclusion Criteria: * \<12mm mouth opening (cannot use Therabite) * Anatomically unable to use Therabite for example patients who may only be partially dentate and to use the Therabite would place extreme stress on the existing teeth * Cognitive impairment as judged by the clinicians * International patients treated who will not have routine UK follow up. * Previous surgery or RT to the head and neck prior to this diagnosis * Any patient who has no subjective tightening of the jaw.
References
Publications (2)
- DERIVEDLee R, Molassiotis A, Rogers SN, Edwards RT, Ryder D, Slevin N. Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study. BMJ Open. 2018 Mar 30;8(3):e021938. doi: 10.1136/bmjopen-2018-021938. PMID 29602860
- DERIVEDLee R, Yeo ST, Rogers SN, Caress AL, Molassiotis A, Ryder D, Sanghera P, Lunt C, Scott B, Keeley P, Edwards RT, Slevin N. Randomised feasibility study to compare the use of Therabite(R) with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck. Br J Oral Maxillofac Surg. 2018 May;56(4):283-291. doi: 10.1016/j.bjoms.2018.02.012. Epub 2018 Mar 9. PMID 29526341