Clinical trial NCT06251882: Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia
Official title: 6-month Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meralgia Paresthetica
Keywords: ultrasound
meralgia paresthetica
D5W
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: visual analogue scale(VAS)
timeFrame: baseline as well as 1month, 3 month, 6 months post-injection
Secondary outcomes:
measure: cross-sectional area(CSA) of the nerve
timeFrame: baseline as well as 1month, 3 month, 6 months post-injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jiaan Zhu, Dr
role: STUDY_CHAIR
References:
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.
citation: 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.
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.