Meralgia ParestheticaNCT04004052
Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica
A study testing Ultrasound guided injection and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Meralgia Paresthetica, run by Fatih Sultan Mehmet Training and Research Hospital.
Trial summary
Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), where conservative treatment options are not always sufficient. The aim of this study was to evaluate the efficacy of ultrasound (US) guided lateral femoral cutaneous nerve injection in the management of meralgia… Read more about this study
- Who is it for?
- Ages 42 to 64 years
- Conditions the study is for
- Meralgia Paresthetica
- What is being tested?
- Ultrasound guided injection and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2015
- 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 42 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with LFCN entrapment confirmed by clinical and electrophysiological findings
Who cannot join
- Secondary entrapment neuropathy
- Malignancy
- Pregnancy
- Infection in the inguinal region or dermatitis
- Lumbar radiculopathy
- Cardiac pacemakers
- Polyneuropathy
About this study
Official title: Conservative Treatment Versus Ultrasound Guided Injection in Management of Meralgia Paresthetica: A Randomized Controlled Trial
Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), where conservative treatment options are not always sufficient.
The aim of this study was to evaluate the efficacy of ultrasound (US) guided lateral femoral cutaneous nerve injection in the management of meralgia paresthetica by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham transcutaneous electrical nerve stimulation therapy.
Read the detailed description
In this prospective, randomized, sham-controlled study, fifty four patients (23 female and 31 male, the mean age 53.61±11.99 years) with lateral femoral cutaneous nerve compression with clinical and electrophysiological findings were enrolled. Patients were randomly assigned to three groups: 1) Ultrasound-guided injection group, 2) TENS group, 3) Sham TENS group. The blockage of the lateral femoral cutaneous nerve was performed for therapeutic meralgia paresthetica management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days a week for 2 weeks, for 20 minutes per daily session in Group 2, and sham TENS was applied to group 3 with the same protocol.
Visual Analog Scale (VAS), painDETECT questionnaire (PD-Q), Semmes Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI) and health-related quality of life (SF 36), at onset (T1), 15 days after treatment (T2) and 1 month after treatment (T3) were used for evaluation.
- Conditions
- Meralgia Paresthetica
- Being tested
- Ultrasound guided injection, Transcutaneous Electrical Nerve Stimulation (TENS), Sham Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Meralgia paresthetica, Ultrasound-guided injection, Transcutaneous electrical nerve stimulation
- Medical subject headings
- Femoral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided injectionOther
Transcutaneous Electrical Nerve Stimulation (TENS)Other
Sham Transcutaneous Electrical Nerve Stimulation (TENS)Other
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Blockade of the LFCN is performed for therapeutic management of MP in group 1. Receives: Other: Ultrasound guided injection |
| Group 2 | Active comparator | Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks. Receives: Other: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Group 3 | Sham comparator | Sham TENS was applied to the group 3 with the same protocol. Receives: Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The VAS was used to record each patient's current level of pain with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced. Using a ruler marked in centimeters, the examiner obtained the exact values along a 10-cm VAS line.
Measured: 1 months
painDETECT questionnaire
It consists of seven items evaluating pain qualities, one evaluating the course of pain, and one evaluating pain radiation. Additionally, the questionnaire contains three numerical rating scales (NRSs) of 0-10 for current, worst, and average pain severity. An overall score is generated that summarizes everything but the pain intensity NRS, which ranges between -1 and 38. An overall score of >18 indicates likely Neuropathic pain, 13-18 possible Neuropathic pain, and < 13 unlikely Neuropathic pain.
Measured: 1 months
Semmes-Weinstein monofilament test
Cutaneous pressure threshold was measured by touch test using a device with nylon Semmes-Weinstein monofilaments (SWMt) embedded in a plastic handle. A small pushing force is applied anterolateral femoral skin area for 1-1,5 seconds to push the filaments. A medical staff member presses the filaments at an angle of approximately 90° against the patient's thigh. This test is useful for medical staff because it is simple and easy. The threshold was defined as the lightest filament that the subject responses correctly at least two out of the three trials. The filaments are labeled with a numerical marking, which is a log to the base ten of the force in tenth of milligrams. Applications was made where the most symptoms has been observed in the patient's anterolateral thigh.
Measured: 1 months
Secondary outcomes (2)
Short Form (SF-36) Health Questionnaire
Assessment of health-related quality of life Health status was measured using the 36-Item Short Form (SF-36) Health Survey, version 2 (SF-36v2), which assesses eight different aspects of health. Item scores can be aggregated into physical component (PC) summary and mental component (MC) summary score.
Measured: 1 months
Pittsburgh Sleep Quality Index (PSQI)
PSQI is a 19-item self-reported instrument designed to measure a person's sleep quality and sleep patterns over 1-month time interval. It consists of seven items evaluating sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. The 7 component scores are evaluated between 0 and 3 points. 3 reflects the negative extreme on the Likert Scale. The global score ranges from 0 to 21 points. Higher scores indicate worst sleep quality. A global score of >5 indicates poor sleep quality.
Measured: 1 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jan 2014
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gülcan Öztürk, MD, Principal investigator, Fatih Sultan Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004052
- Sponsor's protocol ID
- ozturk84
- Status last verified
- Feb 2020
- First submitted
- 17 May 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was a prospective, randomized, sham controlled study. Patients were randomly distributed into three groups: 1)US-guided injection group, 2)TENS group, 3)Sham TENS group. Blockade of the LFCN is performed for therapeutic management of MP in group 1. Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks while sham TENS was applied to the group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT score, The Semmes-Weinstein monofilaments test (SWMt), The Pittsburgh Sleep Quality Index (PSQI), and assessment of health-related quality of life (SF 36) were used for evaluation at baseline (T1), post-treatment 15ᵗʰ day (T2), and 1st month post-treatment (T3).
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment Versus Ultrasound Guided Injection in Management of Meralgia Paresthetica: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04004052
- Acronym / sponsor ID
- ozturk84
- Conditions
- Meralgia Paresthetica
- Keywords
- Meralgia paresthetica, Ultrasound-guided injection, Transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 1 Jul 2019 (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 an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), where conservative treatment options are not always sufficient.
The aim of this study was to evaluate the efficacy of ultrasound (US) guided lateral femoral cutaneous nerve injection in the management of meralgia paresthetica by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham transcutaneous electrical nerve stimulation therapy.
Detailed description
In this prospective, randomized, sham-controlled study, fifty four patients (23 female and 31 male, the mean age 53.61±11.99 years) with lateral femoral cutaneous nerve compression with clinical and electrophysiological findings were enrolled. Patients were randomly assigned to three groups: 1) Ultrasound-guided injection group, 2) TENS group, 3) Sham TENS group. The blockage of the lateral femoral cutaneous nerve was performed for therapeutic meralgia paresthetica management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days a week for 2 weeks, for 20 minutes per daily session in Group 2, and sham TENS was applied to group 3 with the same protocol.
Visual Analog Scale (VAS), painDETECT questionnaire (PD-Q), Semmes Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI) and health-related quality of life (SF 36), at onset (T1), 15 days after treatment (T2) and 1 month after treatment (T3) were used for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Ultrasound guided injectionBlockade of the LFCN is performed for therapeutic management of MP in group 1. |
| Group 2 | Active comparator | Other: Transcutaneous Electrical Nerve Stimulation (TENS)Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks. |
| Group 3 | Sham comparator | Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS)Sham TENS was applied to the group 3 with the same protocol. |
Who may qualify
- Ages
- 42 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with LFCN entrapment confirmed by clinical and electrophysiological findings
Key exclusion criteria (7 listed)
- Secondary entrapment neuropathy
- Malignancy
- Pregnancy
- Infection in the inguinal region or dermatitis
- 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 |
|---|---|---|
| Ultrasound guided injection | Other | Group 1 |
| Transcutaneous Electrical Nerve Stimulation (TENS) | Other | Group 2 |
| Sham Transcutaneous Electrical Nerve Stimulation (TENS) | Other | Group 3 |
Primary outcome
Visual Analog Scale
Time frame: 1 months
The VAS was used to record each patient's current level of pain with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced. Using a ruler marked in centimeters, the examiner obtained the exact values along a 10-cm VAS line.
painDETECT questionnaire
Time frame: 1 months
It consists of seven items evaluating pain qualities, one evaluating the course of pain, and one evaluating pain radiation. Additionally, the questionnaire contains three numerical rating scales (NRSs) of 0-10 for current, worst, and average pain severity. An overall score is generated that summarizes everything but the pain intensity NRS, which ranges between -1 and 38. An overall score of >18 indicates likely Neuropathic pain, 13-18 possible Neuropathic pain, and < 13 unlikely Neuropathic pain.
Semmes-Weinstein monofilament test
Time frame: 1 months
Cutaneous pressure threshold was measured by touch test using a device with nylon Semmes-Weinstein monofilaments (SWMt) embedded in a plastic handle. A small pushing force is applied anterolateral femoral skin area for 1-1,5 seconds to push the filaments. A medical staff member presses the filaments at an angle of approximately 90° against the patient's thigh. This test is useful for medical staff because it is simple and easy. The threshold was defined as the lightest filament that the subject responses correctly at least two out of the three trials. The filaments are labeled with a numerical marking, which is a log to the base ten of the force in tenth of milligrams. Applications was made where the most symptoms has been observed in the patient's anterolateral thigh.
2 secondary outcomes
Short Form (SF-36) Health Questionnaire
Time frame: 1 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 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 20 Feb 2020.
- Individual participant dataSharing planned: No. This was a prospective, randomized, sham controlled study. Patients were randomly distributed into three groups: 1)US-guided injection group, 2)TENS group, 3)Sham TENS group. Blockade of the LFCN is performed for therapeutic management of MP in group 1. Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks while sham TENS was applied to the group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT score, The Semmes-Weinstein monofilaments test (SWMt), The Pittsburgh Sleep Quality Index (PSQI), and assessment of health-related quality of life (SF 36) were used for evaluation at baseline (T1), post-treatment 15ᵗʰ day (T2), and 1st month post-treatment (T3).
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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.
Gülcan Öztürk, MD principal investigator
Fatih Sultan Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided injection and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Meralgia Paresthetica, run by Fatih Sultan Mehmet Training and Research Hospital.
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 1 inclusion and 7 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Analog Scale (time frame: 1 months). The study lists 3 primary outcomes in all. 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 20 Feb 2020.