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Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique" (MET)

Primary Purpose

Meralgia Paresthetica, Femoral Neuropathy

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

muscle energy technique

conventional selected physical therapy

About this trial

This is an interventional treatment trial for Meralgia Paresthetica

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Thirty meralgia paraesthesia postpartum female Patients
with positive Pelvic compression test
age ranging from 25:40 years
post vaginal delivery or post-operative (postpartum) persistent dysthesia in anterolateral thigh (one side or both)
body mass index (20:29.9) Kg/m2

Exclusion Criteria:

difficulty to communicate or to understand program instructions
other conditions that caused pain (for example fibromyalgia and arthritis)
any psychiatric or cognitive symptoms any other musculoskeletal disorders or neurologic diseases of the lower extremities and spine

Sites / Locations

Lama S Mahmoud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

study group

control group

Arm Description

received the conventional selected exercise program in addition to muscle energy technique

received the conventional selected exercise program

Outcomes

Primary Outcome Measures

Femoral nerve conduction latency

Femoral nerve conduction latency measured via the Neuropack S1 MEB9004 EMG device

Secondary Outcome Measures

Pelvic compression test

the therapist applied a downward compression force to the pelvis and maintained a pressure for 45 seconds. If the patients reported an alleviation of symptoms the test is considered positive

Numeric Pain Rating Scale (NPRS)

it includes 11-point numeric scale ranges from no pain with score of "0" to worst pain imaginable with score of "10"

Full Information

NCT ID

NCT04747119

First Posted

February 6, 2021

Last Updated

February 9, 2021

Sponsor

October 6 University

1. Study Identification

Unique Protocol Identification Number

NCT04747119

Brief Title

Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique"

Acronym

MET

Official Title

The Effect of Muscle Energy Technique on Femoral Meralgia Paraesthesia in Postpartum: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

December 30, 2020 (Actual)

Study Completion Date

January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the postpartum female which results in pain and less physical activities. ………HYPOTHESES: This study hypothesized that: muscle energy technique will have a significant effect on Femoral meralgia paraesthesia in postpartum female

Detailed Description

Thirty meralgia paraesthesia postpartum females will participate in this study. The patients will randomly be divided into two equal groups; the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique, three times per week for four weeks. The evaluation methods by Femoral nerve conduction velocity will be measured via the Neuropack S1 MEB9004 EMG device before the exercise program and after finishing the exercise program, and also the Pelvic compression test and Pain numeric rating scale

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meralgia Paresthetica, Femoral Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Arm Description

received the conventional selected exercise program in addition to muscle energy technique

Arm Title

control group

Arm Type

Experimental

Arm Description

received the conventional selected exercise program

Intervention Type

Other

Intervention Name(s)

muscle energy technique

Intervention Description

the patient was supine and the therapist fix the lower limb of the affected side then ask the patient to perform isometric contraction for abductors maintained for 3-5 seconds, then the patient was instructed to stop, exhale and relax then the therapist perform further adducted the patient's knee of the affected side as a stretching exercise for Three to five repetitions of these directions were performed.

Intervention Type

Other

Intervention Name(s)

conventional selected physical therapy

Intervention Description

life style modification Transcutaneous electrical nerve stimulation (TENS) Flexibility stretching exercises to the hip flexors

Primary Outcome Measure Information:

Title

Femoral nerve conduction latency

Description

Femoral nerve conduction latency measured via the Neuropack S1 MEB9004 EMG device

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Pelvic compression test

Description

the therapist applied a downward compression force to the pelvis and maintained a pressure for 45 seconds. If the patients reported an alleviation of symptoms the test is considered positive

Time Frame

four weeks

Title

Numeric Pain Rating Scale (NPRS)

Description

it includes 11-point numeric scale ranges from no pain with score of "0" to worst pain imaginable with score of "10"

Time Frame

four weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

all the patients were postpartum females

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Thirty meralgia paraesthesia postpartum female Patients with positive Pelvic compression test age ranging from 25:40 years post vaginal delivery or post-operative (postpartum) persistent dysthesia in anterolateral thigh (one side or both) body mass index (20:29.9) Kg/m2 Exclusion Criteria: difficulty to communicate or to understand program instructions other conditions that caused pain (for example fibromyalgia and arthritis) any psychiatric or cognitive symptoms any other musculoskeletal disorders or neurologic diseases of the lower extremities and spine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lama Saad Mahmoud, PHD

Organizational Affiliation

October 6 University

Official's Role

Study Chair

Facility Information:

Facility Name

Lama S Mahmoud

City

Al Jīzah

State/Province

Select State

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique"

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