Chronic Pain Clinical Trial
— PCSOfficial title:
Painful Channelopathies Study
NCT number | NCT02696746 |
Other study ID # | 12/LO/0017 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 2012 |
Verified date | February 2019 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To understand the pathophysiological basis of heritable pain syndromes. This will consist of
a number of components:
- Determine the genetic basis for heritable pain syndromes.
- Investigate the pain symptoms, psychological co-morbidity and quality of life in
patients with heritable pain syndromes.
- Use quantitative sensory testing to investigate abnormalities in sensory processing.
- Use imaging modalities to investigate the neural correlates of pain perception in
heritable channelopathies.
- In select patients to perform skin biopsy to determine if there has been any damage to
C-fibres.
- To perform skin biopsy in order to culture fibroblasts and neural crest stem cells for
future studies into the molecular basis of altered pain perception.
- To use neurophysiological tests, the axon reflex, and conditioning challenges to
determine how peripheral nerves, in heritable channelopathies and unusual pain
syndromes, have been altered.
- Microneurographic recordings for directly detecting the function of pain fibres in
peripheral nerves. Knowledge gained from the study will be used to aid the further
development of genetic testing and specific pain questionnaires for the diagnosis of
heritable pain syndromes secondary to channelopathies.
- Ultimately better knowledge of underlying pathophysiology in these heritable pain
conditions may inform the development of novel treatments.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Patients who are =16 years of age who have a set of symptoms that resemble those seen on Paroxysmal Extreme Pain Disorder, Familial Episodic Pain Syndrome or Erythromelalgia. - Patients already with the diagnosis of Paroxysmal Extreme Pain Disorder or Familial Episodic Pain Syndrome or Erythromelalgia. - Patients with reduced pain sensibility. - First degree relatives of patients who meet diagnostic criteria for Paroxysmal Extreme Pain Disorder, Familial Episodic Pain Syndrome, Erythromelalgia or inability to experience pain. - Patients who do not fulfill any of the exclusion criteria. Exclusion Criteria: - Pregnant subjects. - Subjects with insufficient command of English to obtain consent from or to complete the study questionnaires. - Subjects with insufficient mental capacity to obtain consent from or to complete the study questionnaires. - Subjects with concurrent severe psychological or psychiatric disorders, specially those patients with severe claustrophobia. - Patients with moderate to severe pain arising as a consequence of other disorders causing pain but that are not associated with those mentioned before as channelopathies. - Patients with central nervous system diseased that may complicate the somatosensory testing. - The skin biopsy procedure, will not be conducted on those patients with contraindications to do so i.e. anticoagulation therapy, skin infections, etc; that might result in adverse outcomes (if the subject decides to decline the skin biopsy, the inclusion on the study will not be affected). - The functional magnetic resonance imaging (fMRI) component will not be performed in subjects that had medical interventions with any device likely to be damaged or moved from its place, at any moment during the fMRI scanning procedure (including cerebral coils or clips, heart pacemakers or defibrillators, heart valve prosthesis, medicine infusion pumps, inner ear implants, neural stimulators, brain shunts, joint replacements/ large metal implants, stents in the heart or arteries, some implants, or some intra-uterine contraceptive devices. - Those patients that in the concept of the research team unsuitable for participation in the study. - For those undergoing microneurography presence of edema (swelling) or any skin condition at the ankle level that may interfere with the microneurography procedure. - Patients with a history of skin allergy or sensitivity will not undergo testing of axon reflex or conditioning challenges. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nuffield Department of Clinical Neurosciences | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
King's College London | Neuroscience Technologies S.L.P, University of Oxford |
United Kingdom,
Ramirez JD, Habib AM, Cox JJ, Themistocleous AC, McMahon SB, Wood JN, Bennett DL. Null mutation in SCN9A in which noxious stimuli can be detected in the absence of pain. Neurology. 2014 Oct 21;83(17):1577-80. doi: 10.1212/WNL.0000000000000913. Epub 2014 S — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score | Seven days pain diary of 4 or above. Patients will have 7-days pain diaries with a numeric rating scale from 0 to 10. | Day 7 | |
Secondary | Age | Number of years | Day 1 | |
Secondary | Gender | Chromosome gender (male/female) | Day 1 | |
Secondary | Ethnicity | Ethnic group | Day 1 | |
Secondary | Detailed medical history | Number and name of medications that were taken previously by the patient | Day 1 | |
Secondary | Pain related anxiety | Patients will answer the Pain Anxiety Symptoms Scale (PASS-20) | Day 1 | |
Secondary | Measures of quality of life | Patients will answer the 36-Item Short Form Survey -quality of life questionnaire- | Day 1 | |
Secondary | Measures of sleep interference | Sleep quality is assessed through the use of questionnaires | Day 1 | |
Secondary | Nerve Conduction Studies | Neurophysiology will be conducted to assess nerve integrity. Amplitude will be measured in microvolts. | Day 1 | |
Secondary | Nerve Conduction Studies | Neurophysiology will be conducted to assess nerve integrity. Latency will be measured in milliseconds. | Day 1 | |
Secondary | Microneurography Studies | This is a minimally invasive technique in which the activity of single nerve fibre is recorded from peripheral nerves and is for directly detecting the function of pain fibres in peripheral nerves in humans. | Day 1 | |
Secondary | Sensory Thermal Thresholds | Thermal thresholds will be measured in degrees centigrade | Day 1 | |
Secondary | Sensory Mechanical Detection Thresholds | Mechanical Detection Thresholds will be measured in millinewtons | Day 1 | |
Secondary | Intra-Epidermal Nerve Fibre density | Measurement of nerve fibres in the skin of patients (taken depending of the pain related area) | Day 1 | |
Secondary | Skin biopsy | Collection and culture of fibroblasts and neural crest stem cells for assessing differences in the rheobase measured in amperes. | Day 1 | |
Secondary | Axon reflex measurement | Application of agents such as histamine via iontophoresis which will stimulate the peripheral nerve endings of C fibres inducing a vasodilatation, which is visible as a flare response of the skin (area in square centimeters with flare). | Day 1 | |
Secondary | Functional Magnetic Resonance Imaging | Brain activity related to the pain condition | Day 30 | |
Secondary | Blood samples - DNA | Blood samples coupled with detailed phenotype data will investigate potential gene associations in the development of painful or painless conditions. | Within 6 months of visit |
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