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Completed

NCT Number: NCT06251882

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.

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Key information

Conditions

Meralgia Paresthetica Femoral Neuropathy Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

injection

Other

10ml D5W injection for MP patients

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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