Muscle Elasticity Assessment of Postherpetic Neuralgia Using Elasticity Ultrasound

November 18, 2024 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Interventional therapy
Interventional therapy for postherpetic neuralgia includes nerve blocks, pulsed radiofrequency therapy, etc

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
A comparison of muscle elasticity between the affected and contralateral healthy sides across different PHN stages
Time Frame: up to 3 months
up to 3 months
A comparison of the before and after the interventional therapy of SWE measurements
Time Frame: up to 3 months
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
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
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
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xulei Cui, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UEL1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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