Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
NCT ID: NCT04099706
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-09-19
2021-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention - Fat grafting
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.
Autologous Fat Grafting / Fat Transplant
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Control - Saline
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.
Autologous Fat Grafting / Fat Transplant
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Interventions
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Autologous Fat Grafting / Fat Transplant
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Martin Sollie
Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery
Principal Investigators
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Jens Ahm Sorensen, Prof
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Odense University Hospital
Odense, Funen, Denmark
Countries
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Other Identifiers
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S-20190112
Identifier Type: -
Identifier Source: org_study_id
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