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

Meralgia Paresthetica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06251882
• Other study ID #: 2024PHB019-001(2)
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neuropathy
• Meralgia Paresthetica
• Paresthesia

Intervention

Other:
• injection
10ml D5W injection for MP patients

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cross-sectional area(CSA) of the nerve	CSA could reflect the compression of the nerve, to some extent	baseline as well as 1month, 3 month, 6 months post-injection