Back to resultsEfficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
Primary Purpose
Meralgia Paresthetica
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Isotonic dextrose 5% in water solution
Sponsored by
About this trial
This is an interventional treatment trial for Meralgia Paresthetica focused on measuring Meralgia paresthetica, Neural Prolotherapy, lateral femoral cutaneous nerve
Eligibility Criteria
Inclusion Criteria:
- The patients had clinical evidence of meralgia paresthetica which was based on the following: (i) the presence of pain, paraesthesia and numbness over the anterior and lateral aspect of the thigh; (ii) exacerbation of these symptoms on walking, standing and hip extension; and (iii) meralgia paresthetica was confirmed electrophysiologically by nerve conduction study with or without somatosensory evoked potentials.
- The symptoms needed to be present for at least three months.
- The patients should be unresponsive to conservative treatment. The conservative treatment included lifestyle modification including weight reduction, activity modification (avoid the use of seat belts) and avoidance of tight underwear (tight garments such as jeans, uniforms); non-steroidal anti-inflammatory drugs and anticonvulsants for neuropathic pain; and physiotherapy.
Exclusion Criteria:
- Diabetes mellitus.
- Endocrine disorders.
- Metabolic disorders.
- Systemic rheumatologic disorders.
- Neurological disorders including peripheral neuropathy, lumbar radiculopathy and lumbar plexopathy.
- Coagulopathy.
- Anticoagulant treatment.
- Current skin or soft tissue infection at or near the site of injection.
- Prior local injection of corticosteroid in the past year for meralgia paresthetica.
- Prior neural prolotherapy in the past year for meralgia paresthetica.
- Prior surgery in the affected thigh region.
- Patients presented with a systemic active inflammatory condition or infection.
- Pregnancy.
- Patients refused to participate in the study
Sites / Locations
- Faculty of Medicine, Alexandria University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neural prolotherapy
Arm Description
Neural prolotherapy using isotonic dextrose 5% in water solution (about 5 ml). The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.
Outcomes
Primary Outcome Measures
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia) by using visual analogue scale were evaluated collectively by using VAS. It is a 10-cm horizontal scale) which range from 0 (no meralgia paresthetica symptoms), to 10 (severe intolerable symptoms).
Secondary Outcome Measures
Patient assessment of meralgia paresthetica pain
Patient assessment of meralgia paresthetica pain was evaluated by using visual analogue scale. It is a 10-cm horizontal scale which range from 0 (no pain), to 10 (severe intolerable pain).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04499911
Brief Title
Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
Official Title
Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Meralgia paresthetica is an entrapment neuropathy of the lateral femoral cutaneous nerve. Its main manifestation is neuropathic pain on the lateral aspect of the thigh. Neural prolotherapy has shown improvement and relieve of neuropathic pain.
The aim of the current study was to assess the efficacy of neural prolotherapy (subcutaneous perineural injection of dextrose 5% solution) on reliving pain and improvement of function and quality of life in patients with meralgia paresthetica.
Detailed Description
Meralgia paresthetica is a mononeuropathy of the lateral femoral cutaneous nerve (i.e. lateral cutaneous nerve of the thigh). It is known as the lateral cutaneous nerve of the thigh neuralgia. It is due to a lot of etiologies. It is characterized by neuropathic pain, tingling, paresthesia and numbness in the anterolateral aspect of the thigh. The symptoms may be provoked or worsened by prolonged standing and walking. Sitting may alleviate the pain because there is reduction of the tension over the nerve, The treatment of meralgia paresthetica is directed towards the improvement of the symptoms which is mainly pain with subsequent improvement of function and quality of life, as well as, treatment of the etiology. The treatment includes conservative and surgical treatment. Conservative treatment consists of non-pharmacologic treatment and pharmacologic treatment. Surgical treatment takes place in case of failure of the conservative treatment. Surgical options consist of neurolysis and neurectomy.
Neural prolotherapy was reported to improve and relieve of neuropathic pain including that of meralgia paresthetica. Neural prolotherapy is the subcutaneous perineural injection of isotonic dextrose (5%) solution especially at the points of fascial penetration of the sensory nerve. It is the site where the sensory nerve reaches the subcutaneous plane. There are scanty studies assessed this issue.
The aim of the current study was to assess the efficacy of neural prolotherapy (subcutaneous perineural injection of dextrose 5% solution) on reliving pain and improvement of function and quality of life in patients with meralgia paresthetica.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meralgia Paresthetica
Keywords
Meralgia paresthetica, Neural Prolotherapy, lateral femoral cutaneous nerve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neural prolotherapy
Arm Type
Experimental
Arm Description
Neural prolotherapy using isotonic dextrose 5% in water solution (about 5 ml). The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.
Intervention Type
Drug
Intervention Name(s)
Isotonic dextrose 5% in water solution
Other Intervention Name(s)
Subcutaneous nerual prolotherapy
Intervention Description
The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.
Primary Outcome Measure Information:
Title
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)
Description
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia) by using visual analogue scale were evaluated collectively by using VAS. It is a 10-cm horizontal scale) which range from 0 (no meralgia paresthetica symptoms), to 10 (severe intolerable symptoms).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient assessment of meralgia paresthetica pain
Description
Patient assessment of meralgia paresthetica pain was evaluated by using visual analogue scale. It is a 10-cm horizontal scale which range from 0 (no pain), to 10 (severe intolerable pain).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients had clinical evidence of meralgia paresthetica which was based on the following: (i) the presence of pain, paraesthesia and numbness over the anterior and lateral aspect of the thigh; (ii) exacerbation of these symptoms on walking, standing and hip extension; and (iii) meralgia paresthetica was confirmed electrophysiologically by nerve conduction study with or without somatosensory evoked potentials.
The symptoms needed to be present for at least three months.
The patients should be unresponsive to conservative treatment. The conservative treatment included lifestyle modification including weight reduction, activity modification (avoid the use of seat belts) and avoidance of tight underwear (tight garments such as jeans, uniforms); non-steroidal anti-inflammatory drugs and anticonvulsants for neuropathic pain; and physiotherapy.
Exclusion Criteria:
Diabetes mellitus.
Endocrine disorders.
Metabolic disorders.
Systemic rheumatologic disorders.
Neurological disorders including peripheral neuropathy, lumbar radiculopathy and lumbar plexopathy.
Coagulopathy.
Anticoagulant treatment.
Current skin or soft tissue infection at or near the site of injection.
Prior local injection of corticosteroid in the past year for meralgia paresthetica.
Prior neural prolotherapy in the past year for meralgia paresthetica.
Prior surgery in the affected thigh region.
Patients presented with a systemic active inflammatory condition or infection.
Pregnancy.
Patients refused to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel K Saba, MD
Organizational Affiliation
Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Learn more about this trial
Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
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