Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT

Odense University Hospital

Status: Completed

Conditions: Postherpetic Neuralgia; Varicella Zoster; Shingles; Chronic Pain; Herpes Zoster

Treatments: Procedure: Autologous Fat Grafting / Fat Transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT04099706

S-20190112

Details and patient eligibility

About

This randomized clinical trial investigates the possible beneficial effect of autologous fat grafting on postherpetic neuralgia.

Full description

Herpes Zoster (HZ), is a condition caused by Varicella-Zoster 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 manifestation disappears. Treatment is complex and mainly topical or systemic. For many patients, this is not sufficient and they live with constant pain.

Autologous fat grafting has shown promise in treating several different painful conditions such as post-mastectomy pain syndrome, painful scars, etc. Our previous pilot study (NCT03584061) investigating the effect of autologous fat grafting on PHN, showed a marked reduction in pain with half of the patients being pain-free after the procedure.

The aim of this study is to test the hypothesis that autologous fat grafting is more effective than a sham operation in treating PHN.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Intervention - Fat grafting

Experimental group

Description:

The participant will undergo the procedure under general anaesthesia. A small amount of fat (20-120 cc) will be harvested using liposuction, from the abdomen or the thighs. Randomized allocation will be made and when allocated to the intervention group, the fat will be purified using decanting and injected into the painful areas of skin.

Treatment:

Procedure: Autologous Fat Grafting / Fat Transplant

Control - Saline

Sham Comparator group

Description:

The participant will undergo the procedure under general anaesthesia. A small amount of fat (20-120 cc) will be harvested using liposuction, from the abdomen or the thighs. Randomized allocation will be made and when allocated to the control group, the fat will be discarded and saline will be injected into the painful areas of skin.

Treatment:

Procedure: Autologous Fat Grafting / Fat Transplant