NCT05665413

Brief Summary

The study will focus on non-invasive management options for radiculopathy and functional activity in 3rd trimester women due to lateral cutaneous femoral nerve study. The findings of this study will help future clinicians to develop management plans for these patients that can include non-invasive and non-pharmacological treatment options like Ergon Technique and Stroking based on their effectiveness. The lateral femoral cutaneous nerve is formed by posterior divisions of the anterior rami of spinal nerves to enter the iliac fossa. It continues into the anterolateral thigh by passing either below or through the inguinal ligament, emerging anterior to the Sartorius muscle L2 and L3 In the thigh, it gives rise to two branches, The anterior branch supplies the skin of the anterolateral thigh to the knee and the posterior branch innervates the skin of the lateral aspect of the greater trochanter to the mid-thigh region. It can be compressed due to swelling, trauma or pressure in the surrounding areas. Common causes may include: Tight clothing, obesity or weight gain, and pregnancy. Symptoms may include anterior and lateral thigh burning, tingling, and numbness. It will be a randomized clinical trial aimed to find the comparative effects of stroking and ergon technique on radiculopathy and functional activity in pregnant women. Women who meet the inclusion criteria that is they show positive femoral traction test, two point discrimination, light touch and pin prick maneuver will be recruited from Surya Azeem Hospital and Jinnah Hospital, Lahore. Two groups will be formed 13 patients will be allocated in each group. Before applying the techniques pre treatment reading will taken after that Hot Pack and TENS will be applied as a baseline treatment to both groups while Ergon technique will be applied to group A while stroking will be applied to the patients of group B. Two sessions per week will be given for 8 weeks. After that post treatment reading will be taken on 8th week. Data will be analyzed by using SPSS for windows version 25

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

December 24, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

December 17, 2022

Last Update Submit

December 17, 2022

Conditions

Keywords

numbnessthighpain

Outcome Measures

Primary Outcomes (2)

  • Pain DETECT questionnaire PDQ

    painDETECT (PDQ) is a symptom-based assessment tool. It is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. Total scoring is 35.

    8th week

  • The Lower Extremity Functional Scale (LEFS)

    The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.Total scoring is 80.

    8th week

Study Arms (2)

strocking technique

EXPERIMENTAL
Device: TENS

ergon technique

EXPERIMENTAL
Device: TENS

Interventions

TENSDEVICE

strocking technique, HOT PACK and Ergon instrument

Also known as: HOT PACK, Ergon instrument, strocking technique
ergon techniquestrocking technique

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly pregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant ladies during 3rd trimester.
  • Pregnant ladies of age between 30 to 40 years.
  • Primigravida and Multigravida ladies.

You may not qualify if:

  • Pregnant ladies with any previous hip fracture.
  • Women with high risk pregnancy.
  • Any previous history of disc herniation.
  • Patients with lumbar radiculopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surya Azeem Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

HypesthesiaPain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • fatima tariq, TDPT

    Riphah International University

    STUDY CHAIR

Central Study Contacts

Sadaf Anjum, MS-WHPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2022

First Posted

December 27, 2022

Study Start

December 24, 2021

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations