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Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica

Primary Purpose

Meralgia Paresthetica

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound guided injection
Transcutaneous Electrical Nerve Stimulation (TENS)
Sham Transcutaneous Electrical Nerve Stimulation (TENS)
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meralgia Paresthetica focused on measuring Meralgia paresthetica, Ultrasound-guided injection, Transcutaneous electrical nerve stimulation

Eligibility Criteria

42 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Patients diagnosed with LFCN entrapment confirmed by clinical and electrophysiological findings

Exclusion criteria

  • Secondary entrapment neuropathy
  • Malignancy
  • Pregnancy
  • Infection in the inguinal region or dermatitis
  • Lumbar radiculopathy
  • Cardiac pacemakers
  • Polyneuropathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm Description

    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.

    Sham TENS was applied to the group 3 with the same protocol.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    May 17, 2019
    Last Updated
    February 18, 2020
    Sponsor
    Fatih Sultan Mehmet Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04004052
    Brief Title
    Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica
    Official Title
    Conservative Treatment Versus Ultrasound Guided Injection in Management of Meralgia Paresthetica: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2015 (Actual)
    Study Completion Date
    January 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fatih Sultan Mehmet Training and Research Hospital

    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 (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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meralgia Paresthetica
    Keywords
    Meralgia paresthetica, Ultrasound-guided injection, Transcutaneous electrical nerve stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Blockade of the LFCN is performed for therapeutic management of MP in group 1.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks.
    Arm Title
    Group 3
    Arm Type
    Sham Comparator
    Arm Description
    Sham TENS was applied to the group 3 with the same protocol.
    Intervention Type
    Other
    Intervention Name(s)
    Ultrasound guided injection
    Intervention Type
    Other
    Intervention Name(s)
    Transcutaneous Electrical Nerve Stimulation (TENS)
    Intervention Type
    Other
    Intervention Name(s)
    Sham Transcutaneous Electrical Nerve Stimulation (TENS)
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale
    Description
    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.
    Time Frame
    1 months
    Title
    painDETECT questionnaire
    Description
    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.
    Time Frame
    1 months
    Title
    Semmes-Weinstein monofilament test
    Description
    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.
    Time Frame
    1 months
    Secondary Outcome Measure Information:
    Title
    Short Form (SF-36) Health Questionnaire
    Description
    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.
    Time Frame
    1 months
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Description
    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.
    Time Frame
    1 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    42 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria Patients diagnosed with LFCN entrapment confirmed by clinical and electrophysiological findings Exclusion criteria Secondary entrapment neuropathy Malignancy Pregnancy Infection in the inguinal region or dermatitis Lumbar radiculopathy Cardiac pacemakers Polyneuropathy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gülcan Öztürk, MD
    Organizational Affiliation
    Fatih Sultan Training and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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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    Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica

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