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出境医 / 临床实验 / Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica

Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica

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.


Condition or disease Intervention/treatment Phase
Meralgia Paresthetica Other: Ultrasound guided injection Other: Transcutaneous Electrical Nerve Stimulation (TENS) Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS) Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Treatment Versus Ultrasound Guided Injection in Management of Meralgia Paresthetica: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 1, 2015
Actual Study Completion Date : January 1, 2015
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Group 1
Blockade of the LFCN is performed for therapeutic management of MP in group 1.
Other: Ultrasound guided injection
Active Comparator: Group 2
Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks.
Other: Transcutaneous Electrical Nerve Stimulation (TENS)
Sham Comparator: Group 3
Sham TENS was applied to the group 3 with the same protocol.
Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS)
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Short Form (SF-36) Health Questionnaire [ Time Frame: 1 months ]
    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.

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 1 Months ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   42 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Gülcan Öztürk, MD Fatih Sultan Training and Research Hospital
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE January 1, 2014
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • 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 pain 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 tenths of milligrams. Applications was made where the most symptoms has been observed in the patient's anterolateral thigh.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
  • Short Form (SF-36) Health Questionnaire [ Time Frame: 1 months ]
    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) [ Time Frame: 1 Months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Short Form (SF-36) Health Questionnaire [ Time Frame: 1 months ]
    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) [ Time Frame: 1 Months ]
    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 avaluated 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 inidcate worst sleep quality. An global score of >5 indicates poor sleep quality.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica
Official Title  ICMJE Conservative Treatment Versus Ultrasound Guided Injection in Management of Meralgia Paresthetica: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Meralgia Paresthetica
Intervention  ICMJE
  • Other: Ultrasound guided injection
  • Other: Transcutaneous Electrical Nerve Stimulation (TENS)
  • Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS)
Study Arms  ICMJE
  • Active Comparator: Group 1
    Blockade of the LFCN is performed for therapeutic management of MP in group 1.
    Intervention: Other: Ultrasound guided injection
  • Active Comparator: Group 2
    Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks.
    Intervention: Other: Transcutaneous Electrical Nerve Stimulation (TENS)
  • Sham Comparator: Group 3
    Sham TENS was applied to the group 3 with the same protocol.
    Intervention: Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2019)
54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2015
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004052
Other Study ID Numbers  ICMJE ozturk84
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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).
Responsible Party Fatih Sultan Mehmet Training and Research Hospital
Study Sponsor  ICMJE Fatih Sultan Mehmet Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gülcan Öztürk, MD Fatih Sultan Training and Research Hospital
PRS Account Fatih Sultan Mehmet Training and Research Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP