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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Peking union medical college hospital

    Beijing, Beijing Municipality, 100730

    Heyu Ji, MD, +8618374808445, jiheyu1929@163.com

    Recruiting

Other trials in China

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.

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 groups in NCT05912738
Study groupRoleWhat 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.

  1. 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)
  1. A comparison of muscle elasticity between the affected and contralateral healthy sides across different PHN stages

    Measured: up to 3 months

  2. A comparison of the before and after the interventional therapy of SWE measurements

    Measured: up to 3 months

  3. 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

  4. A comparison of the histopathological data of the muscle samples from the affected and the unaffected sides

    Measured: up to 3 months

  5. 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.

  1. First posted22 Jun 2023
  2. Study start14 Aug 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

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
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

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.

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