Post Herpetic NeuralgiaNCT03584061
Treatment of Chronic Postherpetic Pain With Fat Grafting
A study testing Fat grafting in people with Post Herpetic Neuralgia and Herpes Zoster, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This study evaluates the possible beneficial effect of fat grafting for post herpetic neuralgia. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Herpetic Neuralgia, Herpes Zoster
- What is being tested?
- Fat grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Psychiatric illness that could potentially affect the study.
- Other indication for fat grafting than pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Chronic Postherpetic Pain With Fat Grafting - A Pilot Study
This study evaluates the possible beneficial effect of fat grafting for post herpetic neuralgia.
Read the detailed description
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.
- Conditions
- Post Herpetic Neuralgia, Herpes Zoster
- Being tested
- Fat grafting
- Keywords
- Chronic Pain, Herpes Zoster, Pain
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat graftingProcedure or surgery
Also called Fat transplant, lipofilling
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.
| Study group | Role | What they receive |
|---|---|---|
| Fat grafting/fat transplant. | Experimental | Each patient receives fat grafting to the site of dermal pain. Fat is to be harvested for either the abdomen or the thigh. Receives: Procedure: Fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 May 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Herpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The five patients included will all receive a fat graft in the area affected by PHN.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Sollie, Odense University Hospital
- Investigators
- Jens A Sørensen, MD. PhD., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584061
- Sponsor's protocol ID
- S-20180007
- Status last verified
- Feb 2021
- First submitted
- 1 May 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sollie M, Thomsen JB, Sorensen JA. Autologous fat grafting seems to alleviate postherpetic neuralgia - a feasibility study investigating patient-reported levels of pain. J Plast Reconstr Aesthet Surg. 2021 Feb;74(2):350-356. doi: 10.1016/j.bjps.2020.08.038. Epub 2020 Aug 21.
PubMed 32917571Sollie M, Sorensen JA. Treatment of chronic post-herpetic neuralgia with autologous fat grafts: a first-in-the-world case report. Br J Pain. 2019 Nov;13(4):239-243. doi: 10.1177/2049463718817570. Epub 2018 Nov 28.
PubMed 31656630
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Postherpetic Pain With Fat Grafting - A Pilot Study
- ClinicalTrials.gov ID
- NCT03584061
- Acronym / sponsor ID
- S-20180007
- Conditions
- Post Herpetic Neuralgia, Herpes Zoster
- Keywords
- Chronic Pain, Herpes Zoster, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the possible beneficial effect of fat grafting for post herpetic neuralgia.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The five patients included will all receive a fat graft in the area affected by PHN.
| Arm | Type | Receives |
|---|---|---|
| Fat grafting/fat transplant. | Experimental | Procedure: Fat graftingEach patient receives fat grafting to the site of dermal pain. Fat is to be harvested for either the abdomen or the thigh. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Psychiatric illness that could potentially affect the study.
- Other indication for fat grafting than pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat graftingAlso: Fat transplant, lipofillingThe 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. | Procedure or surgery | Fat grafting/fat transplant. |
Primary outcome
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.
1 secondary outcome
Quality of life [QUALITY OF LIFE/ SATISFACTION]
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Results publication: PubMed 32917571Sollie M, Thomsen JB, Sorensen JA. Autologous fat grafting seems to alleviate postherpetic neuralgia - a feasibility study investigating patient-reported levels of pain. J Plast Reconstr Aesthet Surg. 2021 Feb;74(2):350-356. doi: 10.1016/j.bjps.2020.08.038. Epub 2020 Aug 21.
- Derived from this study: PubMed 31656630Sollie M, Sorensen JA. Treatment of chronic post-herpetic neuralgia with autologous fat grafts: a first-in-the-world case report. Br J Pain. 2019 Nov;13(4):239-243. doi: 10.1177/2049463718817570. Epub 2018 Nov 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens A Sørensen, MD. PhD. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat grafting in people with Post Herpetic Neuralgia and Herpes Zoster, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain [LEVEL OF PAIN] (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584061, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.