Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia

February 8, 2024 updated by: Zhu Jiaan, Peking University People's Hospital

6-month Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia

Meralgia paresthetica (MP) is one of the most common peripheral entrapment neuropathies of the lower limbs. It is characterized by paresthesia, pain, tingling, numbness, hypersensitivity, or other abnormal skin sensations on the anterolateral aspect of the thigh. The condition results from compression of the lateral femoral cutaneous nerve (LFCN) along its course, often occurring as the nerve exits the pelvis.The injection of 5% dextrose (D5W) under ultrasound guidance is a novel treatment method for peripheral nerve entrapment. However, there is limited evidence about the efficacy of this method for patients with MP. The investigators found D5W was more safe and effective than corticosteroids for patients with MP. Thus, this study aimed to evaluate the 6-month efficacy of ultrasound-guided injection of D5W for MP patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Peking University People's Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

primary care clinic

Description

Inclusion Criteria:

  • patients aged between 18 and 80 years;
  • those diagnosed with MP based on clinical and physical examination, with symptoms persisting for at least 3 months;
  • a high-resolution ultrasound revealing LFCN compression as it exited the pelvis.

Exclusion Criteria:

  • MP resulting from trauma, surgery or occupying lesions affecting the LFCN;
  • pregnancy;
  • concurrent presence of rheumatic immune diseases, hypothyroidism, or diabetes mellitus;
  • a known history of allergy to lidocaine or corticosteroids;
  • L2/3 lumbar radiculopathy;
  • patients who had undergone local injection or surgery for MP within 3 months

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D5W group
The patients received one session of ultrasound-guided 10ml D5W injection around the lateral femoral cutaneous nerve as it exited the pelvis.
Other: injection
10ml D5W injection for MP patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale(VAS)
Time Frame: baseline as well as 1month, 3 month, 6 months post-injection
VAS is one of the most common tool to assess pain severity for patients, ranging from 0(no pain) to 10(most possible pain).
baseline as well as 1month, 3 month, 6 months post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cross-sectional area(CSA) of the nerve
Time Frame: baseline as well as 1month, 3 month, 6 months post-injection
CSA could reflect the compression of the nerve, to some extent
baseline as well as 1month, 3 month, 6 months post-injection

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

Investigators

  • Study Chair: Jiaan Zhu, Dr, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PHB019-001(2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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