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Treatment of Chronic Postherpetic Pain With Fat Grafting

Primary Purpose

Post Herpetic Neuralgia, Herpes Zoster

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fat grafting
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Herpetic Neuralgia focused on measuring Chronic Pain, Herpes Zoster, Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fat grafting/fat transplant.

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life [QUALITY OF LIFE/ SATISFACTION]
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.

Full Information

First Posted
May 1, 2018
Last Updated
February 4, 2021
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03584061
Brief Title
Treatment of Chronic Postherpetic Pain With Fat Grafting
Official Title
Treatment of Chronic Postherpetic Pain With Fat Grafting - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Herpetic Neuralgia, Herpes Zoster
Keywords
Chronic Pain, Herpes Zoster, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The five patients included will all receive a fat graft in the area affected by PHN.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fat grafting/fat transplant.
Arm Type
Experimental
Arm Description
Each patient receives fat grafting to the site of dermal pain. Fat is to be harvested for either the abdomen or the thigh.
Intervention Type
Procedure
Intervention Name(s)
Fat grafting
Other Intervention Name(s)
Fat transplant, lipofilling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuropathic pain [LEVEL OF PAIN]
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life [QUALITY OF LIFE/ SATISFACTION]
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens A Sørensen, MD. PhD.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32917571
Citation
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.
Results Reference
result
PubMed Identifier
31656630
Citation
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.
Results Reference
derived

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Treatment of Chronic Postherpetic Pain With Fat Grafting

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