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

NCT06251882 | Completed DMC

• 1 other identifier: 2024PHB019-001(2)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meralgia Paresthetica

Keywords

ultrasound; meralgia paresthetica; D5W

Outcome Measures

Primary Outcomes (1)

• visual analogue scale(VAS)

  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 Outcomes (1)

• cross-sectional area(CSA) of the nerve

  baseline as well as 1month, 3 month, 6 months post-injection

Study Arms (1)

D5W group

EXPERIMENTAL

The patients received one session of ultrasound-guided 10ml D5W injection around the lateral femoral cutaneous nerve as it exited the pelvis.

Other: injection

Interventions

injection OTHER

10ml D5W injection for MP patients

D5W group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (3)

• Scholz C, Hohenhaus M, Pedro MT, Uerschels AK, Dengler NF. Meralgia Paresthetica: Relevance, Diagnosis, and Treatment. Dtsch Arztebl Int. 2023 Sep 29;120(39):655-661. doi: 10.3238/arztebl.m2023.0170.

  PMID: 37534445 BACKGROUND

• Agarwal N, Mistry JB, Khandge PV, Hansberry DR, Goldstein IM. Meralgia Paresthetica After Spine Surgery on the Jackson Table. Clin Spine Surg. 2018 Mar;31(2):53-57. doi: 10.1097/BSD.0000000000000593.

  PMID: 29135610 BACKGROUND

• Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.

  PMID: 30187524 BACKGROUND

MeSH Terms

Conditions

Femoral Neuropathy

Interventions

Injections

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jiaan Zhu, Dr

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: January 30, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)