Localized Neuropathic PainDIDOCAPNCT02869867

Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP

A study testing refrigerated cushion in people with Localized Neuropathic Pain, run by Centre Hospitalier Departemental Vendee at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Nursing study, prospective, randomized, two-center open-label. Patients will be randomized into two groups during their first laying Qutenza®: Patients receiving the laying of Qutenza® without refrigerated cushion Patients receiving the laying of Qutenza® associated with a refrigerated cushion The objective of the… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Localized Neuropathic Pain
What is being tested?: refrigerated cushion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 3 sitesFrance
Study dates: 2 Mar 2017to 4 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Major
Do not opposing the participation in the study
Monitoring in the case of localized neuropathic pain
Diagnostic with neuropathic pain score ≥ 4
Neuropathic pain conventional treatment failure of first-line
Front advantage of laying a first patch Qutenza®
With ability to understand the proposed study

Who cannot join

Patch Installation on the feet, face, mucous membranes
Eutectic mixture of local anesthetics (EMLA) Pose premedication
Having Already received prior to the installation of a patch of Qutenza®
Allergy to components Qutenza®
Known and poorly stabilized hypertension
Known cryoglobulinaemia

Show all 11Show fewer

Pregnant or lactating women
Patient enjoying a measure of legal protection (guardianship, guardianship ...)
Private Patient freedom
No affiliation to a social security scheme.
Refusal to participate in the study

Trial locations and contacts

3 sites in 1 country.

France3 sites

CHLVO de Challans
Challans, 85300
CHD Vendée de la Roche sur Yon
La Roche-sur-Yon, 85925
Clinique Brétéché
Nantes, 44000

Other trials in France

About this study

Nursing study, prospective, randomized, two-center open-label.

Patients will be randomized into two groups during their first laying Qutenza®:

Patients receiving the laying of Qutenza® without refrigerated cushion
Patients receiving the laying of Qutenza® associated with a refrigerated cushion

The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.

Conditions: Localized Neuropathic Pain
Being tested: refrigerated cushion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

refrigerated cushionOther
refrigerated cushion

Study groups in NCT02869867
Study group	Role	What they receive
Qutenza® without refrigerated cushion	No intervention	Qutenza® without refrigerated cushion
Qutenza® with refrigerated cushion	Experimental	Qutenza® with refrigerated cushion Receives: Other: refrigerated cushion

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Pain Scale (Burning Pain)
Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10.
The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?
Measured: after 1 hour of installation of Qutenza patch

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20174 Dec 2020

First posted17 Aug 2016 (estimated)
Study start2 Mar 2017
Primary completion4 Dec 2020
Study completion4 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Localized Neuropathic PainStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02869867
Sponsor's protocol ID: CHD049-16
Acronym: DIDOCAP
Status last verified: Nov 2025
First submitted: 12 Aug 2016
Last updated: 3 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tailliez N, Planche L, Dorion A, Kacki N, Dimet J, Pluchon YM. Effect of Cooling Capsaicin Application Site on Reducing Burning Sensation in Neuropathic Pain Patients: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Apr;26(2):e159-e164. doi: 10.1016/j.pmn.2024.09.001. Epub 2024 Nov 12.
PubMed 39532578

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
Myofacial Pain Syndrome, Chronic Neck Pain
Active, not recruiting
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
Active, not recruitingPhase 1
Low Intensity Focused Ultrasound Modulation of Thalamic Nuclei for Central Neuropathic Pain.
Central Neuropathic Pain
Active, not recruitingObservational study
Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:
Essential Tremor, Parkinson's Disease

All Localized Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
ClinicalTrials.gov ID: NCT02869867
Acronym / sponsor ID: DIDOCAP / CHD049-16
Conditions: Localized Neuropathic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Centre Hospitalier Departemental VendeeUniversity, hospital or other
Study start: 2 Mar 2017 (actual)
Primary completion: 4 Dec 2020 (actual)
Study completion: 4 Dec 2020 (actual)
First posted: 17 Aug 2016 (estimated)
Results: Posted 15 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Nursing study, prospective, randomized, two-center open-label.

Patients will be randomized into two groups during their first laying Qutenza®:

Patients receiving the laying of Qutenza® without refrigerated cushion
Patients receiving the laying of Qutenza® associated with a refrigerated cushion

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Qutenza® without refrigerated cushion	No intervention	–Qutenza® without refrigerated cushion
Qutenza® with refrigerated cushion	Experimental	Other: refrigerated cushionQutenza® with refrigerated cushion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Major
Do not opposing the participation in the study
Monitoring in the case of localized neuropathic pain
Diagnostic with neuropathic pain score ≥ 4
Neuropathic pain conventional treatment failure of first-line

Key exclusion criteria (11 listed)

Patch Installation on the feet, face, mucous membranes
Eutectic mixture of local anesthetics (EMLA) Pose premedication
Having Already received prior to the installation of a patch of Qutenza®
Allergy to components Qutenza®
Known and poorly stabilized hypertension

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
refrigerated cushionrefrigerated cushion	Other	Qutenza® with refrigerated cushion

Primary outcome

Visual Analogue Pain Scale (Burning Pain)
Time frame: after 1 hour of installation of Qutenza patch
Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10. The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?

Results and safety

Results posted to the registry on 15 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Qutenza® without refrigerated cushion	50	44
Qutenza® with refrigerated cushion	50	45

Primary outcome: Visual Analogue Pain Scale (Burning Pain)

Time frame: after 1 hour of installation of Qutenza patch. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Qutenza® without refrigerated cushion n = 49	Qutenza® with refrigerated cushion n = 50
Value	6.99 (6.2 to 7.77)	3.78 (3 to 4.56)

Qutenza® without refrigerated cushion vs Qutenza® with refrigerated cushion: Mean Difference (Final Values): 3.20 (95% CI 2.09 to 4.31), p <0.001, Mixed Models Analysis

Population analysed: Intent to treat Population (all participants who received a Qutenza patch)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Qutenza® without refrigerated cushion	0 of 0	0 of 0	0
Qutenza® with refrigerated cushion	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39532578Tailliez N, Planche L, Dorion A, Kacki N, Dimet J, Pluchon YM. Effect of Cooling Capsaicin Application Site on Reducing Burning Sensation in Neuropathic Pain Patients: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Apr;26(2):e159-e164. doi: 10.1016/j.pmn.2024.09.001. Epub 2024 Nov 12.

Related trials for Localized Neuropathic Pain

Not yet recruiting
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
Myofacial Pain Syndrome, Chronic Neck Pain
Active, not recruiting
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
Active, not recruitingPhase 1
Low Intensity Focused Ultrasound Modulation of Thalamic Nuclei for Central Neuropathic Pain.
Central Neuropathic Pain
Active, not recruitingObservational study
Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:
Essential Tremor, Parkinson's Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing refrigerated cushion in people with Localized Neuropathic Pain, run by Centre Hospitalier Departemental Vendee at 3 sites 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Visual Analogue Pain Scale (Burning Pain) (time frame: after 1 hour of installation of Qutenza patch). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02869867, which also lists 1 linked publication.

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 3 Dec 2025.