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

NCT04099706 | Completed DMC

• 1 other identifier: S-20190112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Chronic pain; Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Neuropathic pain [LEVEL OF PAIN]

  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.

  6 months

Secondary Outcomes (1)

• Quality of life [QUALITY OF LIFE/ SATISFACTION]

  6 months

Study Arms (2)

Intervention - Fat grafting

EXPERIMENTAL

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.

Procedure: Autologous Fat Grafting / Fat Transplant

Control - Saline

SHAM COMPARATOR

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.

Procedure: Autologous Fat Grafting / Fat Transplant

Interventions

Autologous Fat Grafting / Fat Transplant PROCEDURE

See arm descriptions.

Control - Saline; Intervention - Fat grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychiatric illness that could potentially affect the study.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster; Chronic Pain

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jens Ahm Sorensen, Prof

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation will be masked. All patients will undergo the procedure under general anaesthesia. The randomized allocation will take place during surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 23, 2019
• Study Start: September 19, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)