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

Brief Title

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

Official Title

Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A Randomized Clinical Trial

Brief Summary

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

Detailed 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.
    


Study Type

Interventional


Primary Outcome

Neuropathic pain [LEVEL OF PAIN]

Secondary Outcome

 Quality of life [QUALITY OF LIFE/ SATISFACTION]

Condition

Postherpetic Neuralgia

Intervention

Autologous Fat Grafting / Fat Transplant

Study Arms / Comparison Groups

 Intervention - Fat grafting
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

40

Start Date

September 19, 2019

Completion Date

October 1, 2021

Primary Completion Date

October 1, 2021

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jens Ahm Sorensen, Prof, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04099706

Organization ID

S-20190112


Responsible Party

Principal Investigator

Study Sponsor

Odense University Hospital


Study Sponsor

Jens Ahm Sorensen, Prof, Principal Investigator, Professor


Verification Date

February 2021