Clinical Trials Directory

Trials / Terminated

TerminatedNCT02828800

Cartography of Allodynic and Hypoasthetic Territories Following TKA

Cartography of Allodynic and Hypoasthetic Territories Associated With Neuropathic Pain Following Total Knee Arthroplasty (TKA)

Status
Terminated
Phase
Study type
Observational
Enrollment
38 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to realize a cartography of the allodynic and hypoasthetic territories associated with a neuropathic pain appearing in patients who underwent a Total Knee Arthroplasty (TKA)

Detailed description

The occurrence of Post-surgical Pain depends on the surgical procedure performed, the surgical site and patients-dependents characteristics. Post surgical pain became chronic when it persist beyond two month. Chronic post-surgical pain (CPSP) is one of the most common complications after surgery. Nerve injury during surgery has been implicated in the development of CPSP. Some patients with CPSP have neuropathic pain (NP). NP is pain cause by damage or disease affecting the somatosensory nervous system. It may be associated with abnormal cutaneous sensation such as hypoesthesia (partial loss of sensitivity to sensory stimuli) or allodynia (pain from normally non-painful stimuli) Total Knee Arthroplasty (TKA) present a high risk of injury of the infrapatellar branch of the saphenous nerve, thus can cause the appearance of neuropathic post-surgical pain. Only few data are available concerning the skin areas affected after this surgery. The goal of this study is to analyse the localization of allodynic or hypoasthetic territories that may appear after TKA. The investigators will include 200 patients undergoing TKA surgery at the CHU-Amiens-Picardie. Patient will be seen the day before their surgery, and at follow-up visits at 6 weeks, 6 months and one year postoperatively. A DN diagnostic test (DN4 test) will be performed at each visits. The cartography will be performed on each DN4-positive patients. In addition, patients will also complete questionnaires to assess the intensity of pain, quality of life and level of anxiety. Thus, the knowledge of the localization of allodynic or hypoasthetic territories will allow a most efficient an faster detection and relief of post-surgical neuropathic pain.

Conditions

Interventions

TypeNameDescription
OTHERCartography of allodynic and hypoasthetic territoriesThe cartography of allodynic and hypoasthetic territories will be performed by applying a tactile stimulation of an application force of 15g (for allodynia) or 0.7g (for hypoesthesia). Tracings will be plotted on tracing paper layer that will then be evaluated by the VISITRAK® tool (Smith \& Nephew), validated method reproducible and standardized, enabling accurate measurement of the area concerned .

Timeline

Start date
2016-07-12
Primary completion
2019-02-18
Completion
2019-02-18
First posted
2016-07-12
Last updated
2020-07-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02828800. Inclusion in this directory is not an endorsement.