Treatment of Chronic Postherpetic Pain With Fat Grafting

NCT ID: NCT03584061

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-06-01

Brief Summary

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This study evaluates the possible beneficial effect of fat grafting for post herpetic neuralgia.

Detailed Description

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Herpes Zoster (HZ),is a condition caused by Varizella-Zooster virus (VZV), The disease is caused by reactivation of a latent VZV-infection in the sensory ganglia.

Clinically the condition is characterized by a painful, unilateral, vesicular rash. Pain is the most prominent symptom in around 90% of patients. In 10% of patients this pain remains and becomes chronic.

Post-herpetic neuralgia is a chronic pain syndrome that occurs after the dermal manifestations disappears.

Treatment is complex and mainly topical or systemic. For many patients this is not sufficient and they live with constant pain.

Fat grafting has shown promise in treating several different painful conditions such as post mastectomy pain syndrome, painful scars etc.

This study investigates is PHN can be treated by fat grafting.

Conditions

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Post Herpetic Neuralgia Herpes Zoster

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The five patients included will all receive a fat graft in the area affected by PHN.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fat grafting/fat transplant.

Each patient receives fat grafting to the site of dermal pain. Fat is to be harvested for either the abdomen or the thigh.

Group Type EXPERIMENTAL

Fat grafting

Intervention Type PROCEDURE

The area of dermal pain is identified and marked prior to surgery. The surgery starts with liposuction, either on the abdomen or the thigh. The harvested fat is prepared for fat grafting by sedimenting it for 10 minutes. The fat is then injected into the painful area, marked pre-surgery.

Interventions

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Fat grafting

The area of dermal pain is identified and marked prior to surgery. The surgery starts with liposuction, either on the abdomen or the thigh. The harvested fat is prepared for fat grafting by sedimenting it for 10 minutes. The fat is then injected into the painful area, marked pre-surgery.

Intervention Type PROCEDURE

Other Intervention Names

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Fat transplant, lipofilling

Eligibility Criteria

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Inclusion Criteria

* Age over 18
* Pain in area of former VZV-infection.
* Pain present over 3 months after reactivation of VZV and is present at least 4 days a week and of intensity \>3 on the VAS-scale.

Exclusion Criteria

* Psychiatric illness that could potentially affect the study.
* Other indication for fat grafting than pain.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martin Sollie

Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens A Sørensen, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Odense University Hospital

Odense, Funen, Denmark

Site Status

Countries

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Denmark

References

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Sollie M, Thomsen JB, Sorensen JA. Autologous fat grafting seems to alleviate postherpetic neuralgia - a feasibility study investigating patient-reported levels of pain. J Plast Reconstr Aesthet Surg. 2021 Feb;74(2):350-356. doi: 10.1016/j.bjps.2020.08.038. Epub 2020 Aug 21.

Reference Type RESULT
PMID: 32917571 (View on PubMed)

Sollie M, Sorensen JA. Treatment of chronic post-herpetic neuralgia with autologous fat grafts: a first-in-the-world case report. Br J Pain. 2019 Nov;13(4):239-243. doi: 10.1177/2049463718817570. Epub 2018 Nov 28.

Reference Type DERIVED
PMID: 31656630 (View on PubMed)

Other Identifiers

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S-20180007

Identifier Type: -

Identifier Source: org_study_id

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