Meralgia ParestheticaNCT06251882
Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia
A study testing injection in people with Meralgia Paresthetica, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Meralgia Paresthetica
- What is being tested?
- injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100032
About this study
Official title: 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.
- Conditions
- Meralgia Paresthetica
- Being tested
- injection
- Keywords
- ultrasound, meralgia paresthetica, D5W
- Medical subject headings
- Femoral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectionOther
10ml D5W injection for MP patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline as well as 1month, 3 month, 6 months post-injection
Secondary outcomes (1)
cross-sectional area(CSA) of the nerve
CSA could reflect the compression of the nerve, to some extent
Measured: baseline as well as 1month, 3 month, 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meralgia ParestheticaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Jiaan, Peking University People's Hospital
- Investigators
- Jiaan Zhu, Dr, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251882
- Sponsor's protocol ID
- 2024PHB019-001(2)
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37534445Agarwal 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.
PubMed 29135610Wu 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.
PubMed 30187524
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6-month Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia
- ClinicalTrials.gov ID
- NCT06251882
- Acronym / sponsor ID
- 2024PHB019-001(2)
- Conditions
- Meralgia Paresthetica
- Keywords
- ultrasound, meralgia paresthetica, D5W
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D5W group | Experimental | Other: injectionThe patients received one session of ultrasound-guided 10ml D5W injection around the lateral femoral cutaneous nerve as it exited the pelvis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection10ml D5W injection for MP patients | Other | D5W group |
Primary outcome
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).
1 secondary outcome
cross-sectional area(CSA) of the nerve
Time frame: baseline as well as 1month, 3 month, 6 months post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 37534445Scholz 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.
- Background: PubMed 29135610Agarwal 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.
- Background: PubMed 30187524Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiaan Zhu, Dr study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection in people with Meralgia Paresthetica, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale(VAS) (time frame: baseline as well as 1month, 3 month, 6 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06251882, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.