Treatment of Chronic Postherpetic Pain With Fat Grafting

Not Applicable

Completed

• Conditions: Herpes Zoster; Post Herpetic Neuralgia
• Interventions: Procedure: Fat grafting

• Registration Number: NCT03584061
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-12
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Funen, Denmark