Pain, PostoperativeCARTODOLNCT02828800
Cartography of Allodynic and Hypoasthetic Territories Following TKA
An observational study of Pain, Postoperative and Neuropathic Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Neuropathic Pain
- What is being tested?
- Cartography of allodynic and hypoasthetic territories
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2016to 18 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patient who received a first setting operation of TKA (total knee arthroplasty)
Who may be able to join
- major patient benefit from a first setting operation of TKA (total knee arthroplasty) by standard medial arthrotomy
- Patient signed an informed consent
- Patients receiving social coverage
Who cannot join
- Patient not wishing to be part of the study, or unable to consent,
- Patient under guardianship or deprived of his liberty
- Patients with neuropathic pain in the territory concerned preoperatively
- Patient who underwent TKA laying by a technique other than standard medial arthrotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cartography of Allodynic and Hypoasthetic Territories Associated With Neuropathic Pain Following Total Knee Arthroplasty (TKA)
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)
Read the 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
- Pain, Postoperative, Neuropathic Pain
- Being tested
- Cartography of allodynic and hypoasthetic territories
- Medical subject headings
- Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartography of allodynic and hypoasthetic territoriesOther
The 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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartography of allodynic and hypoasthetic territories
The 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 .
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start12 Jul 2016
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine SORIOT-THOMAS, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828800
- Sponsor's protocol ID
- PI2015_843_0034
- Acronym
- CARTODOL
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2016
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartography of Allodynic and Hypoasthetic Territories Associated With Neuropathic Pain Following Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT02828800
- Acronym / sponsor ID
- CARTODOL / PI2015_843_0034
- Conditions
- Pain, Postoperative, Neuropathic Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: investigator choice
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patient who received a first setting operation of TKA (total knee arthroplasty)
Key inclusion criteria (3 listed)
- major patient benefit from a first setting operation of TKA (total knee arthroplasty) by standard medial arthrotomy
- Patient signed an informed consent
- Patients receiving social coverage
Key exclusion criteria (4 listed)
- Patient not wishing to be part of the study, or unable to consent,
- Patient under guardianship or deprived of his liberty
- Patients with neuropathic pain in the territory concerned preoperatively
- Patient who underwent TKA laying by a technique other than standard medial arthrotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cartography 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 . | Other | – |
Primary outcome
Cartography of allodynic and hypoasthetic territories
Time frame: week 6
The 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 .
Results and safety
The study was stopped early (reason given: investigator choice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine SORIOT-THOMAS, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Neuropathic Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: investigator choice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartography of allodynic and hypoasthetic territories (time frame: week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.