PHN - Post-Herpetic NeuritisPhase 1NCT05444413
Platelet-rich Plasma in the Treatment of Intractable Postherpetic Neuralgia
A Phase 1 study testing ultrasound-guided platelet rich plasma nerve block in people with PHN - Post-Herpetic Neuritis, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
used ultrasound-guided platelet rich plasma nerve block to treat Intractable Postherpetic Neuralgia. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PHN - Post-Herpetic Neuritis
- What is being tested?
- ultrasound-guided platelet rich plasma nerve block
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2022to 1 Jul 2022
- Phase
- Phase 1
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of PHN: have a history of acute herpes zoster, the pain lasts for more than half a year, and there is paroxysmal pain in the affected nerve distribution area;
- Preoperative visual analog scale (VAS) score ≥ 5;
- Those who can cooperate with the treatment;
- We agreed to inject platelet rich plasma into nerve block under the guidance of ultrasound, and signed the informed consent form.
Who cannot join
- Systemic infection or puncture local infection;
- Serious disturbance of cardiovascular and cerebrovascular function;
- Abnormal bleeding and coagulation function or complicated with blood system diseases;
- Mental disorders;
- Severe dysfunction of important organs in the body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound-guided Platelet-Rich Plasma Nerve Block Combined With Drugs in the Treatment of Intractable Postherpetic Neuralgia
used ultrasound-guided platelet rich plasma nerve block to treat Intractable Postherpetic Neuralgia.
Read the detailed description
Postherpetic neuralgia (PHN) is a kind of pain caused by varicella zoster virus invading the human body and infecting the corresponding ganglia. The affected ganglia are inflamed or even necrotic, affecting the nerve endings, the dorsal horn of the spinal cord and the sensory nerve tissues below, and the course of the disease is more than one month or more. Most patients can avoid PHN by timely and effective treatment in the acute herpes zoster period. However, some patients with intractable postherpetic neuralgia fail to receive timely and effective pain control treatment in the early stage of the disease, and the current commonly used clinical treatment methods often fail to achieve effective treatment results. Such patients often have a long course of disease, which can last for three to five years or even longer, Nerve damage is also more serious. Long term pain has seriously affected the quality of life of such patients. Therefore, how to quickly and effectively control pain has become the diagnosis and treatment goal of such patients with intractable post herpetic neuralgia. Platelet rich plasma (PRP) was widely used in muscle and bone repair due to its function of promoting tissue repair in the early stage. Recently, it was found that PrP can also promote nerve repair. Therefore, in order to further explore the therapeutic effect of PRP on refractory PHN patients, our department used ultrasound-guided platelet rich plasma nerve block to treat Intractable PHN.
- Conditions
- PHN - Post-Herpetic Neuritis
- Being tested
- ultrasound-guided platelet rich plasma nerve block
- Keywords
- platelet-rich plasma, Intractable postherpetic neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided platelet rich plasma nerve blockBiological
selected persons are treated by ultrasound-guided platelet rich plasma nerve block and the regular medicine
| Study group | Role | What they receive |
|---|---|---|
| ultrasound-guided platelet rich plasma nerve block combined with drugs | Experimental | selected patients were treated by the ultrasound-guided platelet rich plasma nerve block once a week for the 4 consecutive weeks while they were given the regular medicine which are taking pregabalin and amitriptyline hydrochloride orally, and the dosage shall be increased or decreased according to the patient's condition. Receives: Biological: ultrasound-guided platelet rich plasma nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes from degree of pain that patients feel after the treatment are assessed by the numerical rating scale (NRS).
This method is composed of 11 numbers from 0 to 10. Patients use 11 numbers from 0 to 10 to describe the intensity of pain. (0="no pain"and 10=the "worst pain")
Measured: Change from the numerical rating scale at 6 months
Secondary outcomes (2)
The changes from degree of pain that patients feel after the treatment are also assessed by the Short-form McGill Pain Questionnaire(SF-MPQ).
When evaluating item (1), ask the thinker questions one by one, and mark the corresponding level according to the pain level the thinker answers.
When evaluating item (2), vas ruler shall be adopted. This ruler is a 10cm long swimming ruler with 10 graduations marked on one side and "0" and "10" at both ends, indicating no pain,"10" represents the most severe pain that the patient can't bear in his life. During clinical use, the side with scale is turned away from the patient, and the patient is asked to mark the corresponding position representing his pain level in the past day on the ruler. The evaluator evaluates the number of patients according to the position marked by the patient (for example, 5.4cm is 5.4 points), and records it in the table.
When evaluating item (3), mark the corresponding score according to the patient's subjective feelings.
Finally, the total scores of PRI, vas and PPI were evaluated. （The higher the total score, the more severe the pain）
Measured: Change from the total score of Short-form McGill Pain Questionnaire at 6 months
The changes from degree of the patient' sleep quality after the treatment are assessed by the Athens Insomnia Scale.
Ask the examinee to carefully review his sleep experience in the past one month for questions ① - ⑧. If it happens to you at least three times a week, circle the corresponding self-assessment results. Then calculate the total score for evaluation.
Assessment result judgment:
(1) If the total score is less than 4, there is no sleep disorder: (2) if the total score is 4-6, it is suspected that there is a big sleep; (3) If the total score is above 6: Insomnia
Measured: Change from the patient' sleep quality at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start3 Mar 2022
- Primary completion3 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHN - Post-Herpetic NeuritisStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients with Intractable Postherpetic Neuralgia
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Zhou, Affiliated Hospital of Nantong University
- Investigators
- yuan zhou, doctor, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444413
- Sponsor's protocol ID
- 2022-K036
- Status last verified
- Sep 2022
- First submitted
- 23 Jun 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Platelet-Rich Plasma Nerve Block Combined With Drugs in the Treatment of Intractable Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT05444413
- Acronym / sponsor ID
- 2022-K036
- Conditions
- PHN - Post-Herpetic Neuritis
- Keywords
- platelet-rich plasma, Intractable postherpetic neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Jul 2022 (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.
used ultrasound-guided platelet rich plasma nerve block to treat Intractable Postherpetic Neuralgia.
Detailed description
Postherpetic neuralgia (PHN) is a kind of pain caused by varicella zoster virus invading the human body and infecting the corresponding ganglia. The affected ganglia are inflamed or even necrotic, affecting the nerve endings, the dorsal horn of the spinal cord and the sensory nerve tissues below, and the course of the disease is more than one month or more. Most patients can avoid PHN by timely and effective treatment in the acute herpes zoster period. However, some patients with intractable postherpetic neuralgia fail to receive timely and effective pain control treatment in the early stage of the disease, and the current commonly used clinical treatment methods often fail to achieve effective treatment results. Such patients often have a long course of disease, which can last for three to five years or even longer, Nerve damage is also more serious. Long term pain has seriously affected the quality of life of such patients. Therefore, how to quickly and effectively control pain has become the diagnosis and treatment goal of such patients with intractable post herpetic neuralgia. Platelet rich plasma (PRP) was widely used in muscle and bone repair due to its function of promoting tissue repair in the early stage. Recently, it was found that PrP can also promote nerve repair. Therefore, in order to further explore the therapeutic effect of PRP on refractory PHN patients, our department used ultrasound-guided platelet rich plasma nerve block to treat Intractable PHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with Intractable Postherpetic Neuralgia
| Arm | Type | Receives |
|---|---|---|
| ultrasound-guided platelet rich plasma nerve block combined with drugs | Experimental | Biological: ultrasound-guided platelet rich plasma nerve blockselected patients were treated by the ultrasound-guided platelet rich plasma nerve block once a week for the 4 consecutive weeks while they were given the regular medicine which are taking pregabalin and amitriptyline hydrochloride orally, and the dosage shall be increased or decreased according to the patient's condition. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria of PHN: have a history of acute herpes zoster, the pain lasts for more than half a year, and there is paroxysmal pain in the affected nerve distribution area;
- Preoperative visual analog scale (VAS) score ≥ 5;
- Those who can cooperate with the treatment;
- We agreed to inject platelet rich plasma into nerve block under the guidance of ultrasound, and signed the informed consent form.
Key exclusion criteria (5 listed)
- Systemic infection or puncture local infection;
- Serious disturbance of cardiovascular and cerebrovascular function;
- Abnormal bleeding and coagulation function or complicated with blood system diseases;
- Mental disorders;
- Severe dysfunction of important organs in the body
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 |
|---|---|---|
| ultrasound-guided platelet rich plasma nerve blockselected persons are treated by ultrasound-guided platelet rich plasma nerve block and the regular medicine | Biological | ultrasound-guided platelet rich plasma nerve block combined with drugs |
Primary outcome
The changes from degree of pain that patients feel after the treatment are assessed by the numerical rating scale (NRS).
Time frame: Change from the numerical rating scale at 6 months
This method is composed of 11 numbers from 0 to 10. Patients use 11 numbers from 0 to 10 to describe the intensity of pain. (0="no pain"and 10=the "worst pain")
2 secondary outcomes
The changes from degree of pain that patients feel after the treatment are also assessed by the Short-form McGill Pain Questionnaire(SF-MPQ).
Time frame: Change from the total score of Short-form McGill Pain Questionnaire at 6 months
The changes from degree of the patient' sleep quality after the treatment are assessed by the Athens Insomnia Scale.
Time frame: Change from the patient' sleep quality at 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 8 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for PHN - Post-Herpetic Neuritis
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A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Postherpetic Neuralgia.
PHN - Post-Herpetic Neuritis
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.
yuan zhou, doctor study director
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ultrasound-guided platelet rich plasma nerve block in people with PHN - Post-Herpetic Neuritis, run by Affiliated Hospital of Nantong University at 1 site in China.
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 4 inclusion and 5 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 8 Sep 2022. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The changes from degree of pain that patients feel after the treatment are assessed by the numerical rating scale (NRS). (time frame: Change from the numerical rating scale at 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 8 Sep 2022.