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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099706
• Other study ID #: S-20190112
• Status: Completed
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia
• Shingles
• Varicella Zoster

Intervention

Procedure:
• Autologous Fat Grafting / Fat Transplant
See arm descriptions.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life [QUALITY OF LIFE/ SATISFACTION]	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.	6 months