Treatment of Chronic Postherpetic Pain With Fat Grafting

NCT03584061 | Completed

• 1 other identifier: S-20180007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Herpetic Neuralgia; Herpes Zoster

Keywords

Chronic Pain; Herpes Zoster; Pain

Outcome Measures

Primary Outcomes (1)

• Neuropathic pain [LEVEL OF PAIN]

  Neuropathic Pain Symptom inventory (NPSI), Questionnaire. NPSI consists of 12 items in total: 10 items investigates differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of the 10 descriptors. The descriptors are: Burning, Squeezing, Pressure, Electric Shocks, Stabbing, Provoked by brushing. Provoked by pressure, Evoked by cold stimulation, Pins and needles, Tingling.

  6 months

Secondary Outcomes (1)

• Quality of life [QUALITY OF LIFE/ SATISFACTION]

  6 months

Study Arms (1)

Fat grafting/fat transplant.

EXPERIMENTAL

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

Procedure: Fat grafting

Interventions

Fat grafting 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.

Also known as: Fat transplant, lipofilling

Fat grafting/fat transplant.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Psychiatric illness that could potentially affect the study.
• Other indication for fat grafting than pain.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 32917571 RESULT

• 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.

  PMID: 31656630 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jens A Sørensen, MD. PhD.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery

Model Details: The five patients included will all receive a fat graft in the area affected by PHN.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: July 12, 2018
• Study Start: May 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)