Pain In Neuropathy Study (NCT02672059) | Clinical Trial Compass
UnknownNot Applicable
Pain In Neuropathy Study
United Kingdom700 participantsStarted 2011-02
Plain-language summary
In the context of peripheral neuropathy, we will aim to elucidate correlates between sensory symptoms and:
* Sensory nerve dysfunction.
* Cutaneous small nerve fibre innervation density.
* Psychological co-morbidity.
* Circadian rhythm disturbance co-morbidity.
* Functionality and Quality of life.
* Patterns of human brain activity in a subset of patients that consent to participate in the FMRI (functional magnetic resonance imaging) component of PINS.
2\. We will also collect blood samples in this phenotyped cohort of patients. These blood samples coupled with detailed phenotype data will investigate potential gene associations only in the development of painful neuropathy.
3\. Knowledge gained from the study will be used to aid the further development of pain questionnaires, designed to detect patients with painful neuropathy.
4.Knowledge gained from the study will be invaluable in informing on-going investigations of painful peripheral neuropathy in animal models, both in our laboratory and others.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are ≥18 years of age who have a diagnosis of peripheral neuropathy based on a prior clinical assessment combined with supportive clinical investigations such as abnormal nerve conduction studies, reduced intraepidermal nerve or abnormal findings on quantitative sensory testing.
* If supportive clinical investigations (as described above) are not available at entry into the study a neuropathy disability scale ≥3 (Pham et al., 2000).
* And patients with symptoms highly suggestive of neuropathy that in the judgement of the clinical researcher are suitable for the study even if they do not fulfill other inclusion criteria.
* Patients who do not fulfill any of the exclusion criteria.
Exclusion Criteria:
* Subjects who are pregnant.
* 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 complete study questionnaires.
* Subjects with concurrent severe psychological or psychiatric disorders.
* Patients with moderate to severe pain form other causes that may confound assessment or reporting of pain (eg. spinal canal stenosis).
* Patients with central nervous lesions, which may complicate somatosensory testing.
* Who is in the opinion of the investigator unsuitable for participation in the study.
* Skin biopsies will not be conducted on patients that are anticoagulated or who have any other contra-indication to skin biopsy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.