Understanding Neuropathic Pain After Ankle Fractures
This study is looking at how often people develop neuropathic pain (nerve pain) after an ankle fracture. Researchers want to understand the causes of this type of pain, which can be long-lasting and difficult to manage. You might be able to join if you are between 18 and 85 years old, have had a specific type of ankle fracture that was treated with surgery, and can speak and read English. The study will measure your pain levels using different scales over several months to a year after your injury. This research aims to help doctors better understand and potentially prevent chronic pain after ankle fractures.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include about 250 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain will be assessed at various times, from 2 weeks up to 1 year after your injury.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Roman Natoli, MD, PhD · PRINCIPAL_INVESTIGATOR · Indiana University
Who to contact
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What this trial measures
- Chronic Pain Grading Scale6-9 month
Chronic Pain Grading Scale (CPGS) will be used to determine if fracture patients have pain in the chronic phase of injury (6-9 month visit). The pain intensity subscale will be used to categorize participants into those with and without chronic pain. This score is the sum of three questions (current pain, worst pain, average pain over last month), each scored on an 11-point Likert scale with responses ranging from 0-10 for a maximum of 30 points. The participant will be asked to report only on pain related to the site of fracture. Participants scoring 1-30 on the characteristic pain intensity score in the last month at the site of fracture will be classified as having chronic pain related to the fracture. Patients reporting no pain (0) at the site of fracture in the last month will be classified as having no chronic pain.
- Douleur Neuropathique (Neuropathic Pain) 42 weeks to 1 year
Douleur Neuropathique (Neuropathic Pain) 4 (DN4). The DN4 is a validated and reliable screening tool for neuropathic pain consisting of 10 items. The first 7 items relate to pain quality (i.e., sensory and pain descriptors) are based on interview with the patient. The last 3 items are based on clinical examination and assess hypoesthesia to touch, and hypoesthesia to prick and brushing. The items of the DN4 are scored based on a yes (1 point)/no (0 points) answer. This leads to a score range of 0-10. The cut-off value for the classification of neuropathic pain is a total score of 4 of 10.72 The DN4 has been used to identify NP in ankle fracture patients.
- Assessment of Chronic Regional Pain Syndrome (CRPS)2 weeks to 6-9 months
Assessment of Chronic Regional Pain Syndrome (CRPS). Presence of CRPS will be assessed in study participants beginning at the 6-8 week follow-up visit and all subsequent visits. Assessment of CRPS at earlier timepoints cannot be done rigorously as pain, motor, temperature and other changes comprising in part the CRPS diagnostic criteria can be related to the recent trauma. In addition to the QST procedures, a validated CRPS sign and symptom checklist will be administered by the study coordinator containing items in the 4 symptom and 4 sign categories needed to establish a CRPS diagnosis. For this study the investigators will employ the more rigorous CRPS Research Criteria (all symptom categories positive and 2/4 sign categories).
- Central Sensitization measure5-9 weeks to 6-9 months
Central Sensitization measure: The most common quantitative sensory test used to measure central sensitization in human experimental studies is temporal summation of pain (TS).TS will be administered on the skin proximal to the level of injury and the contralateral uninjured side using a nylon monofilament (Touchtest Sensory Evaluator 6.65) calibrated to bend at 300g of pressure. As in previous studies, participants will rate the perceived pain intensity of a single contact of the monofilament using a 0 to 100 numeric rating scale. Then, participants will provide another pain rating following a series of 10 contacts administered at a rate of 1 contact per second, applied to the body site within an area of 1 cm2. The difference between pain ratings for the single versus multiple contacts reflects temporal summation of mechanical pain. Two trials will be administered.
- Pain Inhibitory Test5-9 weeks to 6-9 months
Pain Inhibitory Test. Conditioned pain modulation (CPM) will be assessed by determining the ability of a cold pressor task to diminish pressure pain thresholds applied at a separate body site. For the conditioning stimulus, participants will immerse their non-affected hand up to the wrist in a cold water bath maintained at 10 degrees C for up to 1 minute or until they report intolerable pain.The test stimulus will be two trials of pressure pain thresholds (PPTs) administered on the left forearm. The experimenter will apply a slow constant rate of pressure and the participant will press a button when the sensation first becomes painful, at which time a device records the pressure. Three consecutive measurements with intervals of 20s will be obtained pre- and post- the conditioning stimulus.