An interventional study of diagnostic tes for neuropathic pain in Head Cancer, Neck Cancer and Chronic Pain, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
Following preliminary studies carried out in our department on these subject and subjective findings during clinical examinations, it has been shown that pain is a symptom that is rarely reported following treatment. Instead, neurosensory disorders such as hypoesthesia and paresthesia are found.
The objective of the study is to map and qualitatively evaluate neurosensory disorders in patients treated for cancers of the oral cavity and oropharynx.
The protocol, which is done during the usual follow-up consultation of the patient by the maxillo-facial surgeon, is divided into 3 parts:
PART 1: Collection of Data and Consent
Patient Data:
General patient history:
Tumor:
PART 2: Collecting Treatment Data
Operating data:
On the way out:
PART 3: Collection of data related to neurosensory disorders and pain
Mechanical neurosensory disorders will be tested with the Von frey filament and the brush.
Thermal neurosensory disorders will be sought for the skin with the Thermotest and at the level of the oral cavity with the application of standardised test tubes containing water at 4°C stored in the fridge or hot water at 63°C (the protocol consists of heating water at 4°C in the microwave for 30 seconds to obtain the temperature of 63°C); these examinations will allow the evaluation of thermal allodynia and hypoesthesia.
The examination will cover the entire face, the oral cavity, the cervical region and the area where the reconstruction flaps are taken. The pathological areas identified will be delimited on diagrams previously made with a coding according to the sensations collected.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
questionnaire and tests to evaluate neuropathic pain
Diagnostic Test: diagnostic tes for neuropathic pain
Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush
hypoesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Time frame: day 0
anaesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Time frame: day 0
allodynia on surgical site
The measure is a binary measure (positive or negative) by clinical examination
Time frame: day 0
Evaluation of the characteristics of the pain by questionnaire DN4
One standard DN4 with four questions and ten pain characteristics which gave a score from zero to ten points. If DN4 equal or superior of four out of ten the patient seems possible to develop neuropathic pain.
Time frame: Day 0
hyperalgesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Time frame: Day 0
Evaluation of the characteristics of the pain by questionnaire Neuropathic Pain Symptom Inventory (NPSI)
Twelve questions with a score from zero to ten, zero stands for no pain and ten maximal pain scale. A score is given for burning pain (score out of ten), constriction pain (score out of ten), paroxystic pain (score out of ten), evoked pain (score out of ten), paresthesia (score out of ten) and a total score (out of one hundred)
Time frame: Day 0
Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory
Fifteen questions compose the questionnaire, the first one is a binary answer yes or no, the second one is a schema to localize the pain, thirteen following questions are scaled with a score from zero to ten, zero stands for no pain and ten maximal pain scale
Time frame: Day 0
Questionnaire EORTC QLQC30 to assess Quality of life of cancer patients
a score is given for each question, Thirty questions with for each question a score from one (not at all), two (a bit), three (enough) to four (a lot). Two last questions are scale from one (really bad) to seven (excellent)
Time frame: day 0
Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient
a score is given for 34 questions (with for each question a score from one (not at all), two (a bit), three (enough) to four (a lot)), for the last 5 questions there is a binary scale (1 for no answer and 2 for yes).
Time frame: day 0
Quality of life evaluate by the Questionnaire EORTC QLQ-H&N35
a score is given for 34 questions (with for each question a score from one (not at all), two (a bit), three (enough) to four (a lot)), for the last 5 questions there is a binary scale (1 for no answer and 2 for yes)
Time frame: Day 0
Pain Catastrophizing Scale (PCS-CF) to assess the catastrophizing
thirteen questions with for each question a score from zero (not at all), one (a bit), two (moderatly), three (a lot) to four (constantly). A score inferior than thirty mark a moderate risk to develop chronic pain. A score superior than thirty mark a high risk to develop chronic pain.
Time frame: Day 0
Anxious and depression disorder screening using questionnaire Hospital Anxiety and Depression scale (HAD)
Fourteen items scaled from zero to three, seven questions refer to anxiety seven others to depressive dimension Both of them gathered to make a score of twenty-one for maximum
Time frame: day 0
Started Jul 2020 (actual). Primary completion is estimated for Jul 2028, 96 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 96 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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