Meralgia ParestheticaNCT04499911
Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
A study testing Isotonic dextrose 5% in water solution in people with Meralgia Paresthetica, run by University of Alexandria at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meralgia Paresthetica
- What is being tested?
- Isotonic dextrose 5% in water solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2018to 30 Sep 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetes mellitus.
- Endocrine disorders.
- Metabolic disorders.
- Systemic rheumatologic disorders.
- Neurological disorders including peripheral neuropathy, lumbar radiculopathy and lumbar plexopathy.
- Coagulopathy.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Meralgia Paresthetica
- Being tested
- Isotonic dextrose 5% in water solution
- Keywords
- Meralgia paresthetica, Neural Prolotherapy, lateral femoral cutaneous nerve
- Medical subject headings
- Femoral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic dextrose 5% in water solutionDrug
Also called Subcutaneous nerual prolotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Neural prolotherapy | Experimental | 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. Receives: Drug: Isotonic dextrose 5% in water solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (1)
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start15 Apr 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meralgia ParestheticaStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Kamal Aziz Saba, University of Alexandria
- Investigators
- Emmanuel K Saba, MD, Principal investigator, Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499911
- Sponsor's protocol ID
- 0303901
- Status last verified
- Aug 2020
- First submitted
- 25 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
- ClinicalTrials.gov ID
- NCT04499911
- Acronym / sponsor ID
- 0303901
- Conditions
- Meralgia Paresthetica
- Keywords
- Meralgia paresthetica, Neural Prolotherapy, lateral femoral cutaneous nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 5 Aug 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural prolotherapy | Experimental | Drug: Isotonic dextrose 5% in water solutionNeural 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- Diabetes mellitus.
- Endocrine disorders.
- Metabolic disorders.
- Systemic rheumatologic disorders.
- Neurological disorders including peripheral neuropathy, lumbar radiculopathy and lumbar plexopathy.
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 |
|---|---|---|
| Isotonic dextrose 5% in water solutionAlso: Subcutaneous nerual prolotherapyThe 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. | Drug | Neural prolotherapy |
Primary outcome
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)
Time frame: 4 weeks
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).
1 secondary outcome
Patient assessment of meralgia paresthetica pain
Time frame: 4 weeks
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 5 Aug 2020.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Related trials for Meralgia Paresthetica
Enrolling by invitation
Percussive vs. Gentle Massage for Recovery After Hip Replacement
Paresthesia, Total Hip Arthroplasty (THA)
Recruiting
The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica
Meralgia Paresthetica
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.
Emmanuel K Saba, MD principal investigator
Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotonic dextrose 5% in water solution in people with Meralgia Paresthetica, run by University of Alexandria at 1 site in Egypt.
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 14 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 5 Aug 2020. 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 Egypt. 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?
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2020.