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questionnaire and tests to evaluate neuropathic pain

Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush

diagnostic tes for neuropathic pain

Lise LACLAUTRE

Nathalie PHAM DANG

Laurent DEVOIZE

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:

  * Date of visit and inclusion in the study
  * Patient initials
  * Age
  * Gender (male or female)
  * The weight
  * The size
* Verification of inclusion and non-inclusion criteria:
* General patient history:

  * Patient history
  * Ongoing Treatments
  * Professional activity
* Tumor:

  * Features
  * Location
  * TNM
  * Histological type
* Search for risk factors for peripheral neuropathy
* Check for symptoms of peripheral neuropathy.

PART 2: Collecting Treatment Data

* Operating data:

  * Operation date
  * Type of surgery
  * Duration of surgery
  * Severed sensory nerves
  * Perioperative complications
* On the way out:

  * Adjuvant treatment including radiotherapy and/or chemotherapy.
  * Exit analgesic treatment
  * EN (Numerical Scale)

PART 3: Collection of data related to neurosensory disorders and pain

* Analgesics consumed
* Questionnaire DN4 for each operated area separated according to the curage, lumpectomy and reconstruction if they take place.
* If DN4 positive, completion of the QCD and QEDN questionnaires.
* Clinical examination for sensory disturbances reported on a chart.
* Generic quality of life questionnaire adapted to cancer pathology EORTC QLQC30 and its specific Head and Neck35 add-on module adapted to head and neck cancers.
* Thermotest and hot water, cold water (for the oral cavity)
* HADS Questionnaire
* Catastrophe Questionnaire
* Quantitative sensory testing (QST) for neuropathic patients :

Mechanical neurosensory disorders will be tested with the Von frey filament and the brush.

* Hypoesthesia or mechanical anaesthesia will be sought with the Von Frey filament and the brush.
* Mechanical hypersensitivity, a painful sensation exacerbated by a sharp, non-traumatic object, will be sought with a large calibre Von Frey filament.
* Static Allodynia, felt painful on contact, will be sought at Von Frey's filament.
* Dynamic Allodynia, felt painful when rubbed, will be sought with a wide brush (8 mm) over a distance of several centimetres.

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.

Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)

Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients

The measure is a binary measure (positive or negative)

The measure is a binary measure (positive or negative) by clinical examination

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.

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)

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

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)

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).

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)

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.

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

University Hospital, Clermont-Ferrand

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No intervention is used in this study. The health of muscle is monitored over time.

Seward Rutkove, MD

This study is evaluating the use of two painless, non-invasive technologies in the assessment of muscle health over time in both healthy volunteers and patients who have diseases that affect the nervous system.

Speech and swallowing abnormalities are important symptoms associated with disorders of the central nervous system, motor neuron disease (such as amyotrophic lateral sclerosis), myasthenia gravis, and primary muscle conditions. In addition to characterizing the evolution in muscle architecture that could underlie associated orofacial weakness, identifying new ways to measure these abnormalities is critical to the development and testing of novel treatment approaches. As painless, non-invasive, portable technologies, quantitative ultrasonography (QUS) and electrical impedance myography (EIM) could meet the need for objective measures of speech and swallowing dysfunction.

In QUS, acoustic energy is applied to a muscle of interest; the resultant pictorial data are translated into a single value that reflects the health of the imaged muscle. Similarly, in EIM, a high-frequency, low-intensity alternating electrical current is applied to individual muscles, and the resulting voltages measured. Impedance values reflect changes in muscle architecture, including fiber atrophy, inflammation, and the replacement of muscle with fat or connective tissue. Both of these user-friendly methods can provide sensitive indicators of neuromuscular disease status when applied to the limbs. Although they have also been used to evaluate orofacial muscles in healthy volunteers and patients with primary muscle disorders, they have not yet been systematically studied in patients with a range of neurological conditions.

When applied to muscles of the face and tongue, such tools could 1. Improve accuracy of early diagnosis; 2. Allow monitoring of speech and swallowing dysfunction over time; 3. Help individualize care; and 4. Serve as biomarkers in clinical trials. We propose that QUS and EIM will provide convenient, reliable, clinically meaningful surrogate markers of orofacial dysfunction in a variety of neurologic conditions.

Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders

Quantitative Ultrasonography and Electrical Impedance Myography: Speech and Swallowing Technologies for Use in Neurological Disorders

Selected muscles of the face, limbs, trunk, and tongue will be visualized with painless, non-invasive ultrasound; this measure will be performed in healthy volunteers and participants with neurological conditions

Participants with neurological conditions will answer questions about swallowing

Participants with neurological conditions will be asked to repeat "pepper" and "ticker" ten times as quickly as possible

Participants with neurological conditions will be asked to perform this task if safe

Participants who have been diagnosed with ALS will answer questions about function, including speech and swallowing

Participants who have been diagnosed with Myasthenia Gravis will be asked to perform certain tasks, such as raising the arm, and the findings will be scored by a research team member

Participants who have been diagnosed with Parkinson's Disease will be asked questions about function, including speech and swallowing

Participants who have been diagnosed with ALS will be asked if they are willing to participate in standard needle EMG of selected muscles of the face and tongue

Selected muscles of the face, limbs, trunk, and tongue will be measured using painless, specialized electrode arrays; this measure will be performed in healthy volunteers and participants with neurological conditions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)	NCT04673981	Head Cancer Neck Cancer Chronic Pain	diagnostic tes ...	18 Years -	University Hospital, Clermont-Ferrand
Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)	NCT04673981	Head Cancer Neck Cancer Chronic Pain	diagnostic tes ...	18 Years -	University Hospital, Clermont-Ferrand
Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders	NCT02118805	Amyotrophic Lat... Myasthenia Grav... Myopathies Stroke Parkinson's Dis...		20 Years - 90 Years	Beth Israel Deaconess Medical Center
Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders	NCT02118805	Amyotrophic Lat... Myasthenia Grav... Myopathies Stroke Parkinson's Dis...		20 Years - 90 Years	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for orofacial

Every month we try and update this database with for orofacial cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for orofacial

Every month we try and update this database with for orofacial cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for orofacial cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.