Shear Wave ElastographyNCT05912738
Muscle Elasticity Assessment of Postherpetic Neuralgia Using Elasticity Ultrasound
An observational study of Shear Wave Elastography, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Herpes zoster (HZ), also known as shingles, is caused by the varicella-zoster virus (VZV). Approximately 1/4 of the global population is affected by HZ, with statistics showing that about 90% of shingles patients experience acute neuralgia, and about 1/3 develop postherpetic neuralgia (PHN) after shingles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shear Wave Elastography
- What is being tested?
- Interventional therapy
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2023to 31 May 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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
Study population: Postherpetic neuralgia patients often experience unilateral symptoms, with lesions predominantly occurring on one side of the chest wall. Shear wave elastography (SWE) has been used to study the biomechanical characteristics of skeletal muscles by measuring the propagation speed of shear waves induced by ultrasound to quantify the shear elastic modulus, which characterizes the stiffness of soft tissues. Therefore, the investigators intend to use elastography to observe the elasticity of muscle tissue in the lesions of PHN patients, with the unaffected side serving as a control.
Who may be able to join
- Patients aged 18 years and older, diagnosed with PHN that affects the thoracic nerves and in need of surgical intervention, have been recruited. Written informed consent was obtained from all participants before inclusion. Exclusion Criteria:
- neuromuscular diseases; ongoing use of muscle relaxants and/or other medications that impact muscles; allergy to local anesthetic; a body mass index (BMI) over 30kg/m2; malignant tumors; and pregnancy. Patients who previously had surgery in the PHN-affected area or had another disease causing muscle changes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Beijing Municipality, 100730
Heyu Ji, MD, +8618374808445, jiheyu1929@163.com
About this study
Official title: Preliminary Cohort Study on Muscle Elasticity Ultrasound Evaluation and Pathophysiological Changes in Postherpetic Neuralgia
Herpes zoster (HZ), also known as shingles, is caused by the varicella-zoster virus (VZV). Approximately 1/4 of the global population is affected by HZ, with statistics showing that about 90% of shingles patients experience acute neuralgia, and about 1/3 develop postherpetic neuralgia (PHN) after shingles. In PHN patients, about 30%-50% of the pain can persist for more than one year, and some cases can last for more than 10 years. PHN is a common complication of HZ characterized by intense pain in the area where the rash has healed, often described as burning, electric shock-like, or stabbing pain, severely affecting patients' sleep, emotions, work, and daily life. Additionally, approximately 43% of PHN patients exhibit symptoms of toxic anxiety or depression, significantly impacting their quality of life and increasing the societal burden. Due to the global aging population, the incidence of HZ and PHN is expected to significantly increase in the next 10 years, making effective prevention and treatment of PHN an urgent health issue. Although various treatments are available for PHN, a small number of patients remain unresponsive to multiple therapies, resulting in treatment-resistant chronic pain. The lack of a clear understanding of the underlying mechanisms contributes to the suboptimal treatment outcomes for PHN. Elastography, a technique that quantifies the mechanical properties of tissues by measuring their natural elasticity, trauma, degeneration, and healing processes, has shown promise as an innovative approach. Shear wave elastography (SWE) has been used to study the biomechanical characteristics of skeletal muscles by measuring the propagation speed of shear waves induced by ultrasound to quantify the shear elastic modulus, which characterizes the stiffness of soft tissues. In this study, the investigators intend to use elastography to observe the elasticity of muscle tissue in the lesions of PHN patients, with the unaffected side serving as a control. Elastography offers non-invasive, convenient, and straightforward advantages, further contributing to providing new directions for treatment and revealing the role of muscle tissue in PHN by offering new evidence. It also offers new treatment options and targets for PHN patients. While treatment of PHN is primarily focused on neural mechanisms due to HZ's neurotropism nature, recent evidence suggests that muscle tissues within the affected regions may also experience pathological changes, that contribute to the pain. These changes could reveal novel therapeutic targets and enhance patient prognosis. This study aims to investigate these muscular changes and explore myogenic pain mechanisms in PHN patients. It employs ultrasound elastography to compare muscle elasticity between the affected and unaffected sides and conduct muscle biopsies for pathophysiological analysis to uncover the underlying mechanisms.
- Conditions
- Shear Wave Elastography
- Being tested
- Interventional therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional therapyOther
Interventional therapy for postherpetic neuralgia includes nerve blocks, pulsed radiofrequency therapy, etc
| Study group | Role | What they receive |
|---|---|---|
| PHN Patients (Self-Controlled Design) | This cohort comprises the affected and unaffected side muscles in postherpetic neuralgia (PHN) patients. These muscles will undergo elasticity ultrasound assessment at baseline and post-treatment. Additionally, muscle biopsies will be performed at specific time points during the treatment period, including during interventional therapy, to analyze pathological changes and elucidate the treatment's pathophysiological effects on the affected muscles. Receives: Other: Interventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Elastography
Shear-wave elastography has recently emerged as a promising assessment tool with the potential for diagnosing and monitoring muscle changes and as a noninvasive method to estimate muscle.
Measured: up to 1 month
Secondary outcomes (5)
A comparison of muscle elasticity between the affected and contralateral healthy sides across different PHN stages
Measured: up to 3 months
A comparison of the before and after the interventional therapy of SWE measurements
Measured: up to 3 months
A comparison SWE of measurements between groups receiving conventional treatment alone and those receiving conventional treatment plus targeted muscle relaxation therapy
Measured: up to 3 months
A comparison of the histopathological data of the muscle samples from the affected and the unaffected sides
Measured: up to 3 months
A comparison of the NRS pain scores before and after the treatment, document the number of treatment sessions, and analyze the duration of PHN
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start14 Aug 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shear Wave ElastographyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xulei Cui, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912738
- Sponsor's protocol ID
- UEL1
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Cohort Study on Muscle Elasticity Ultrasound Evaluation and Pathophysiological Changes in Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT05912738
- Acronym / sponsor ID
- UEL1
- Conditions
- Shear Wave Elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 22 Jun 2023 (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.
Herpes zoster (HZ), also known as shingles, is caused by the varicella-zoster virus (VZV). Approximately 1/4 of the global population is affected by HZ, with statistics showing that about 90% of shingles patients experience acute neuralgia, and about 1/3 develop postherpetic neuralgia (PHN) after shingles. In PHN patients, about 30%-50% of the pain can persist for more than one year, and some cases can last for more than 10 years. PHN is a common complication of HZ characterized by intense pain in the area where the rash has healed, often described as burning, electric shock-like, or stabbing pain, severely affecting patients' sleep, emotions, work, and daily life. Additionally, approximately 43% of PHN patients exhibit symptoms of toxic anxiety or depression, significantly impacting their quality of life and increasing the societal burden. Due to the global aging population, the incidence of HZ and PHN is expected to significantly increase in the next 10 years, making effective prevention and treatment of PHN an urgent health issue. Although various treatments are available for PHN, a small number of patients remain unresponsive to multiple therapies, resulting in treatment-resistant chronic pain. The lack of a clear understanding of the underlying mechanisms contributes to the suboptimal treatment outcomes for PHN. Elastography, a technique that quantifies the mechanical properties of tissues by measuring their natural elasticity, trauma, degeneration, and healing processes, has shown promise as an innovative approach. Shear wave elastography (SWE) has been used to study the biomechanical characteristics of skeletal muscles by measuring the propagation speed of shear waves induced by ultrasound to quantify the shear elastic modulus, which characterizes the stiffness of soft tissues. In this study, the investigators intend to use elastography to observe the elasticity of muscle tissue in the lesions of PHN patients, with the unaffected side serving as a control. Elastography offers non-invasive, convenient, and straightforward advantages, further contributing to providing new directions for treatment and revealing the role of muscle tissue in PHN by offering new evidence. It also offers new treatment options and targets for PHN patients. While treatment of PHN is primarily focused on neural mechanisms due to HZ's neurotropism nature, recent evidence suggests that muscle tissues within the affected regions may also experience pathological changes, that contribute to the pain. These changes could reveal novel therapeutic targets and enhance patient prognosis. This study aims to investigate these muscular changes and explore myogenic pain mechanisms in PHN patients. It employs ultrasound elastography to compare muscle elasticity between the affected and unaffected sides and conduct muscle biopsies for pathophysiological analysis to uncover the underlying mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHN Patients (Self-Controlled Design) | – | Other: Interventional therapyThis cohort comprises the affected and unaffected side muscles in postherpetic neuralgia (PHN) patients. These muscles will undergo elasticity ultrasound assessment at baseline and post-treatment. Additionally, muscle biopsies will be performed at specific time points during the treatment period, including during interventional therapy, to analyze pathological changes and elucidate the treatment's pathophysiological effects on the affected muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postherpetic neuralgia patients often experience unilateral symptoms, with lesions predominantly occurring on one side of the chest wall. Shear wave elastography (SWE) has been used to study the biomechanical characteristics of skeletal muscles by measuring the propagation speed of shear waves induced by ultrasound to quantify the shear elastic modulus, which characterizes the stiffness of soft tissues. Therefore, the investigators intend to use elastography to observe the elasticity of muscle tissue in the lesions of PHN patients, with the unaffected side serving as a control.
Key inclusion criteria (2 listed)
- Patients aged 18 years and older, diagnosed with PHN that affects the thoracic nerves and in need of surgical intervention, have been recruited. Written informed consent was obtained from all participants before inclusion. Exclusion Criteria:
- neuromuscular diseases; ongoing use of muscle relaxants and/or other medications that impact muscles; allergy to local anesthetic; a body mass index (BMI) over 30kg/m2; malignant tumors; and pregnancy. Patients who previously had surgery in the PHN-affected area or had another disease causing muscle changes
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Interventional therapyInterventional therapy for postherpetic neuralgia includes nerve blocks, pulsed radiofrequency therapy, etc | Other | PHN Patients (Self-Controlled Design) |
Primary outcome
Shear Wave Elastography
Time frame: up to 1 month
Shear-wave elastography has recently emerged as a promising assessment tool with the potential for diagnosing and monitoring muscle changes and as a noninvasive method to estimate muscle.
5 secondary outcomes
A comparison of muscle elasticity between the affected and contralateral healthy sides across different PHN stages
Time frame: up to 3 months
A comparison of the before and after the interventional therapy of SWE measurements
Time frame: up to 3 months
A comparison SWE of measurements between groups receiving conventional treatment alone and those receiving conventional treatment plus targeted muscle relaxation therapy
Time frame: up to 3 months
A comparison of the histopathological data of the muscle samples from the affected and the unaffected sides
Time frame: up to 3 months
A comparison of the NRS pain scores before and after the treatment, document the number of treatment sessions, and analyze the duration of PHN
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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.
Xulei Cui principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shear Wave Elastography, run by Peking Union Medical College Hospital 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 21 Nov 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heyu Ji, MD (+8618374808445, jiheyu1929@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Elastography (time frame: up to 1 month). 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 21 Nov 2024.