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Treatment of Chronic Postherpetic Pain With Fat Grafting

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03584061
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
13
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fat grafting
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The five patients included will all receive a fat graft in the area affected by PHN.The five patients included will all receive a fat graft in the area affected by PHN.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Chronic Postherpetic Pain With Fat Grafting - A Pilot Study
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: 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.
Other Names:
  • Fat transplant, lipofilling

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neuropathic pain [LEVEL OF PAIN] [6 months]

      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.

    Secondary Outcome Measures

    1. Quality of life [QUALITY OF LIFE/ SATISFACTION] [6 months]

      Short Form 36 (SF-36), Questionnaire. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per a scoring key. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. After this, items in the same scale are averaged together to create the 8 scale scores. The eight health concepts are: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Funen Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

    • Principal Investigator: Jens A Sørensen, MD. PhD., Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martin Sollie, Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT03584061
    Other Study ID Numbers:
    • S-20180007
    First Posted:
    Jul 12, 2018
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Martin Sollie, Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery, Odense University Hospital
    Chronic Pain
    Herpes Zoster
    Pain
    Additional relevant MeSH terms:
    Herpes Zoster
    Neuralgia
    Neuralgia, Postherpetic

    Study Results

    No Results Posted as of Feb 9, 2021