Short summary

Post-Herpetic Neuralgia (PHN) is a chronic pain syndrome that occurs after an outbreak of herpes zoster/shingles. Approximately 5-30% of patients experiencing an outbreak of shingles will have chronic pain >90 days after the resolution of the rash. No effective treatment or cure excists. Our pilot trial have shown promising results in treating and possibly curing PHN using autologous fat grafting. We therefore aim to further test the procedure in this randomized clinical trial.

Rationale

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 (PHN) 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.

Description of the cohort

Adult patients suffering form PHN are recruited from the relevant departments at Odense University Hospital. Information about the project can also be found on the hospitals website (ouh.dk) and on clinicaltrial.org.

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.

Collaborating researchers and departments

Research Unit for Plastic Surgery, Odense University Hospital

- Professor Jens Ahm Sørensen

Department of Plastic Surgery, Odense University Hospital

- Consultant Jørn Bo Thomsen

Publications associated with the project

Martin Sollie, Jørn Bo Thomsen, Jens Ahm Sørensen, Autologous fat grafting seems to alleviate postherpetic neuralgia - a feasibility study investigating patient-reported levels of pain, Journal of Plastic, Reconstructive & Aesthetic Surgery, https://doi.org/10.1016/j.bjps.2020.08.038.