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Treatment of Chronic Postherpetic Pain With Fat Grafting

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ClinicalTrials.gov Identifier: NCT03584061
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Martin Sollie, Odense University Hospital

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

Condition or disease Intervention/treatment Phase
Post Herpetic Neuralgia Herpes Zoster Procedure: Fat grafting Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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 Name: Fat transplant, lipofilling




Primary Outcome Measures :
  1. Neuropathic pain [LEVEL OF PAIN] [ Time Frame: 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] [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584061


Contacts
Contact: Martin Sollie, M.D 42755524 ext +45 martin.sollie@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Funen, Denmark, 5000
Contact: Martin Sollie, MD    +45 42 75 55 24    martin.sollie@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Jens A Sørensen, MD. PhD. Professor

Responsible Party: Martin Sollie, Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03584061     History of Changes
Other Study ID Numbers: S-20180007
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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, Odense University Hospital:
Chronic Pain
Herpes Zoster
Pain

Additional relevant MeSH terms:
Neuralgia
Herpes Zoster
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases