Treatment of Chronic Postherpetic Pain With Fat Grafting
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|ClinicalTrials.gov Identifier: NCT03584061|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post Herpetic Neuralgia Herpes Zoster||Procedure: Fat grafting||Not Applicable|
Herpes Zoster (HZ),is a condition caused by Varizella-Zooster 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 manifestations disappears.
Treatment is complex and mainly topical or systemic. For many patients this is not sufficient and they live with constant pain.
Fat grafting has shown promise in treating several different painful conditions such as post mastectomy pain syndrome, painful scars etc.
This study investigates is PHN can be treated by fat grafting.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The five patients included will all receive a fat graft in the area affected by PHN.|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Chronic Postherpetic Pain With Fat Grafting - A Pilot Study|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
Experimental: Fat grafting/fat transplant.
Each patient receives fat grafting to the site of dermal pain. Fat is to be harvested for either the abdomen or the thigh.
Procedure: Fat grafting
The area of dermal pain is identified and marked prior to surgery. The surgery starts with liposuction, either on the abdomen or the thigh. The harvested fat is prepared for fat grafting by sedimenting it for 10 minutes. The fat is then injected into the painful area, marked pre-surgery.
Other Name: Fat transplant, lipofilling
- Neuropathic pain [LEVEL OF PAIN] [ Time Frame: 6 months ]
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.
- Quality of life [QUALITY OF LIFE/ SATISFACTION] [ Time Frame: 6 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584061
|Contact: Martin Sollie, M.D||42755524 ext +email@example.com|
|Odense University Hospital||Recruiting|
|Odense, Funen, Denmark, 5000|
|Contact: Martin Sollie, MD +45 42 75 55 24 firstname.lastname@example.org|
|Principal Investigator:||Jens A Sørensen, MD. PhD.||Professor|