Postherpetic NeuralgiaNCT04099706
Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
A study testing Autologous Fat Grafting / Fat Transplant in people with Postherpetic Neuralgia and Shingles, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This randomized clinical trial investigates the possible beneficial effect of autologous fat grafting on postherpetic neuralgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Shingles, Varicella Zoster
- What is being tested?
- Autologous Fat Grafting / Fat Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Sep 2019to 1 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A Randomized Clinical Trial
This randomized clinical trial investigates the possible beneficial effect of autologous fat grafting on postherpetic neuralgia.
Read the detailed 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.
- Conditions
- Postherpetic Neuralgia, Shingles, Varicella Zoster, Herpes Zoster, Chronic Pain
- Being tested
- Autologous Fat Grafting / Fat Transplant
- Keywords
- Chronic pain, Postherpetic Neuralgia
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat Grafting / Fat TransplantProcedure or surgery
See arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Autologous Fat Grafting / Fat Transplant |
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 posted23 Sep 2019
- Study start19 Sep 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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 Ahm Sorensen, Prof, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099706
- Sponsor's protocol ID
- S-20190112
- Status last verified
- Mar 2023
- First submitted
- 27 Aug 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04099706
- Acronym / sponsor ID
- S-20190112
- Conditions
- Postherpetic Neuralgia, Shingles, Varicella Zoster, Herpes Zoster, Chronic Pain
- Keywords
- Chronic pain, Postherpetic Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 23 Sep 2019 (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 randomized clinical trial investigates the possible beneficial effect of autologous fat grafting on postherpetic neuralgia.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Fat grafting | Experimental | Procedure: Autologous Fat Grafting / Fat TransplantThe 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. |
| Control - Saline | Sham comparator | Procedure: Autologous Fat Grafting / Fat TransplantThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 (1 listed)
- Psychiatric illness that could potentially affect the study.
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 |
|---|---|---|
| Autologous Fat Grafting / Fat TransplantSee arm descriptions. | Procedure or surgery | Control - Saline, Intervention - Fat grafting |
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 22 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Postherpetic Neuralgia
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Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
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Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
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 Ahm Sorensen, Prof 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 Autologous Fat Grafting / Fat Transplant in people with Postherpetic Neuralgia and Shingles, 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 1 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 22 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
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 22 Mar 2023.