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
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
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
NCT ID
NCT04004052
First Posted
May 17, 2019
Last Updated
February 18, 2020
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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).
Learn more about this trial
Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica
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