NCT04747119

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

February 6, 2021

Last Update Submit

February 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Femoral nerve conduction latency

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

    4 weeks

Secondary Outcomes (2)

  • Pelvic compression test

    four weeks

  • Numeric Pain Rating Scale (NPRS)

    four weeks

Study Arms (2)

study group

EXPERIMENTAL

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

Other: muscle energy techniqueOther: conventional selected physical therapy

control group

EXPERIMENTAL

received the conventional selected exercise program

Other: conventional selected physical therapy

Interventions

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.

study group

1. life style modification 2. Transcutaneous electrical nerve stimulation (TENS) 3. Flexibility stretching exercises to the hip flexors

control groupstudy group

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall the patients were postpartum females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Location

MeSH Terms

Conditions

Femoral Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Lama Saad Mahmoud, PHD

    October 6 University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 10, 2021

Study Start

October 1, 2020

Primary Completion

December 30, 2020

Study Completion

January 30, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations