Meralgia ParestheticaNCT06187883
Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve
An observational study of Meralgia Paresthetica, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of PRF of LFCN in refractory MP for 6 months. Secondary outcomes were to identify the clinical and diagnostic features of the MP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Meralgia Paresthetica
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2023to 6 Dec 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients older than 18 years treated with PRF neuromodulation of LFCN for MP and followed up at least 6 months in the pain clinic of the tertiary hospital between January 2020 and August 2023.
Who may be able to join
- older than 18 years treated with PRF neuromodulation of LFCN for MP
- followed up at least 6 months in the pain clinic of the tertiary hospital between January 2020 and August 2023.
Who cannot join
- inadequate follow-up or missing documentation
- If a new analgesic drug was prescribed during the follow-up period that could affect the evaluation of outcomes, the patients were also excluded.
- Patients who missed appointments, or were unable to communicate with; were not included in the study.
- Patients with secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism), malignancy, pregnancy, skin infection in the inguinal region or dermatitis, lumbar radiculopathy, polyneuropathy, and cardiac pacemakers were excluded.
- In the SSEP analysis, when the latency of LFCN was not evaluated in both sides, these patients were not also included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Obesity EffectThe Successful Response to the Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve in Meralgia Parestetica? : A Retrospective Cohort Study
In the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of PRF of LFCN in refractory MP for 6 months. Secondary outcomes were to identify the clinical and diagnostic features of the MP.
Read the detailed description
In the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of PRF of LFCN in refractory MP for 6 months. Secondary outcomes were to identify the clinical and diagnostic features of the MP.
- Conditions
- Meralgia Paresthetica
- Keywords
- meralgia parestetica, pulsed radiofrequency, obesity, dn4, neuropathic pain
- Medical subject headings
- Femoral Neuropathy, Obesity, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients treated with PRFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to PRF
loss of neuropathic pain, lasting at least 6 months was defined as a positive categorical outcome. Neuropathic pain was assessed with Douleur Neuropathique 4 questionnaire (DN4) at baseline, and at 1., 3, 6 months by the pain specialist authors. DN4 consisted of 10 items. The first seven items were associated with the patients' subjective compliants related to pain and sensational variations while the last three items were associated with the clinical findings. Those patients who had a score ≥ 4were considered to have neuropathic pain. Patients with a positive outcome at the 1 or 3 month follow-up,but did not come again were excluded from the study. After the data collection, the patients wer divided into two groups: responders with a positive outcome and nonresponders with a negative outcome.MP for 6 months. Age, sex, body mass index (BMI), employment, tight clothing, belts, carrying things at the back of pants were asked in detail at the initial visit of the Pain Clinic.
Measured: 6 months
Secondary outcomes (1)
Secondary outcomes were to identify the clinical and diagnostic features of the MP
Secondary outcomes were to identify the clinical and diagnostic features of the MP. The outcome was assesed by the clinical and electrophysiological data collected from the hospital records. The data was analyzed deeply.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start21 Nov 2023
- Primary completion30 Nov 2023
- Study completion6 Dec 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Suna Aşkın Turan, Mersin Training and Research Hospital
- Investigators
- Aşkın Turan, MD, Study chair, Mersin Şehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187883
- Sponsor's protocol ID
- MersinTRHlfcn
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Data and materials are available from the corresponding author upon reasonable request and are subject to ethical review.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Obesity EffectThe Successful Response to the Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve in Meralgia Parestetica? : A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06187883
- Acronym / sponsor ID
- MersinTRHlfcn
- Conditions
- Meralgia Paresthetica
- Keywords
- meralgia parestetica, pulsed radiofrequency, obesity, dn4, neuropathic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mersin Training and Research HospitalOther government
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 3 Jan 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.
In the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of PRF of LFCN in refractory MP for 6 months. Secondary outcomes were to identify the clinical and diagnostic features of the MP.
Detailed description
In the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of PRF of LFCN in refractory MP for 6 months. Secondary outcomes were to identify the clinical and diagnostic features of the MP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients treated with PRFT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients older than 18 years treated with PRF neuromodulation of LFCN for MP and followed up at least 6 months in the pain clinic of the tertiary hospital between January 2020 and August 2023.
Key inclusion criteria (2 listed)
- older than 18 years treated with PRF neuromodulation of LFCN for MP
- followed up at least 6 months in the pain clinic of the tertiary hospital between January 2020 and August 2023.
Key exclusion criteria (5 listed)
- inadequate follow-up or missing documentation
- If a new analgesic drug was prescribed during the follow-up period that could affect the evaluation of outcomes, the patients were also excluded.
- Patients who missed appointments, or were unable to communicate with; were not included in the study.
- Patients with secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism), malignancy, pregnancy, skin infection in the inguinal region or dermatitis, lumbar radiculopathy, polyneuropathy, and cardiac pacemakers were excluded.
- In the SSEP analysis, when the latency of LFCN was not evaluated in both sides, these patients were not also included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
response to PRF
Time frame: 6 months
loss of neuropathic pain, lasting at least 6 months was defined as a positive categorical outcome. Neuropathic pain was assessed with Douleur Neuropathique 4 questionnaire (DN4) at baseline, and at 1., 3, 6 months by the pain specialist authors. DN4 consisted of 10 items. The first seven items were associated with the patients' subjective compliants related to pain and sensational variations while the last three items were associated with the clinical findings. Those patients who had a score ≥ 4were considered to have neuropathic pain. Patients with a positive outcome at the 1 or 3 month follow-up,but did not come again were excluded from the study. After the data collection, the patients wer divided into two groups: responders with a positive outcome and nonresponders with a negative outcome.MP for 6 months. Age, sex, body mass index (BMI), employment, tight clothing, belts, carrying things at the back of pants were asked in detail at the initial visit of the Pain Clinic.
1 secondary outcome
Secondary outcomes were to identify the clinical and diagnostic features of the MP
Time frame: 6 months
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 22 Apr 2024.
- Individual participant dataSharing planned: No. The Data and materials are available from the corresponding author upon reasonable request and are subject to ethical review.
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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.
Aşkın Turan, MD study chair
Mersin Şehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meralgia Paresthetica, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 22 Apr 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 Turkey (Türkiye). 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?
response to PRF (time frame: 6 months). 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 22 Apr 2024.