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Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

Primary Purpose

Lumbar Disc Herniation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electromagnetic field therapy
selected physical therapy program
Therapeutic ultrasound therapy
Transcutaneous Electrical Nerve Stimulation
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ranging from 30:45
  2. sciatica due to lumbar disc prolapse mild to moderate disc prolapse according to magnetic resonance image (MRI).
  3. Body mass index (18.5 to 29.9) Kg/m2.

Exclusion Criteria:

  • The patients will be excluded if they have one of the followings:

    1. lumbar myelopathy.
    2. Patients with previous spinal surgery.
    3. Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
    4. Any other neurological or musculoskeletal disorders of the spine or upper extremity.
    5. Patient with cardiopulmonary disease or diabetes mellitus

Sites / Locations

  • Lama S MahmoudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

electromagnetic field therapy

the selected exercise program

Outcomes

Primary Outcome Measures

visual analogue scale
which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).
Multi-Directional Reach test
Multi-Directional Reach test (MDRT) is an assessment method used to evaluate the limits of stability of individuals in four directions "forward, backward, right and left". The normal Scores of the multi-directional reach test for individuals with age ranging from (20 to 39 cm) years are as follow: forward reach (28 cm); backward reach (17 to 18 cm); leftward reach (17 to 21 cm) and rightward reach (18 to 20 cm)
time up and go test
To determine fall risk and measure the progress of balance, sit to stand and walking. Simple screening test that is a sensitive and specific measure of probability for falls among older adults An older adult who takes ≥12 seconds to complete the TUG is at risk for falling
Oswestry Low Back Pain Disability Questionnaire
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. I

Secondary Outcome Measures

The McGill Pain Questionnaire
The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Seven words are selected from the following categories: dimension 1 to 10 (pain descriptors), three words; dimensions 11 to 15 (affective components of pain), dimension 16 (evaluation of pain) one word, and dimension 17 to 20 (miscellaneous) one word. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain). Qualitative differences in pain may be reflected in respondent's word choice

Full Information

First Posted
September 26, 2022
Last Updated
November 25, 2022
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05559723
Brief Title
Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients
Official Title
Effect of Electromagnetic Field Therapy on Sciatica and Postural Control in Lumbar Disc Prolapse Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients BACKGROUND: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders
Detailed Description
Thirty-four patients with lumbar disc prolapse The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), ) multidirectional reach test, McGill pain Questionnaire, time up and go test and Oswestry Low Back Pain Disability Questionnaire

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
electromagnetic field therapy
Arm Title
control group
Arm Type
Experimental
Arm Description
the selected exercise program
Intervention Type
Device
Intervention Name(s)
electromagnetic field therapy
Intervention Description
Three times a week for four weeks, the study group got electromagnetic fields (EMFs) therapy and the selected physical therapy program. The EMFs therapy was applied using an electromagnetic field therapy device (Magner Plus Astar) . From the prone lying position the device will be adjusted around the lumbar area at a low frequency (50 Hz), with the intensity of 2.5 MT, field shape and applicator type rectangular csl60/csp60), and the application time will be10 minutes
Intervention Type
Other
Intervention Name(s)
selected physical therapy program
Intervention Description
in the form of Hot packs will be placed paravertebral on the lumbar region for 5 minutes from a prone lying position selected physical therapy exercises in form of Static exercise for back and abdominal muscles, stretching exercises for both lower limbs, 10 times each exercise
Intervention Type
Device
Intervention Name(s)
Therapeutic ultrasound therapy
Intervention Description
Therapeutic ultrasound therapy using ultrasound device Chattanooga, model 2760, serial number T11238, 120-240V, 50/60Hz, made in Mexico . That will be applied paravertebral on the lumbar region from the prone lying position, with pulsed mode, frequency 1 MHz, intensity 0.5 W/cm2 and will be applied by circular moving technique at a rate of 4 cm/s for 10 minutes.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
Transcutaneous Electrical Nerve Stimulation (TENS): from the prone lying position, the electrodes will be placed on the course of pain detected by the patient, with an asymmetrical rectangular biphasic form, at a pulse repetition frequency of 100Hz and duty cycle of 250 microseconds; the intensity was set at a level that each patient could feel, for 15 minutes .
Primary Outcome Measure Information:
Title
visual analogue scale
Description
which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).
Time Frame
4 weeks
Title
Multi-Directional Reach test
Description
Multi-Directional Reach test (MDRT) is an assessment method used to evaluate the limits of stability of individuals in four directions "forward, backward, right and left". The normal Scores of the multi-directional reach test for individuals with age ranging from (20 to 39 cm) years are as follow: forward reach (28 cm); backward reach (17 to 18 cm); leftward reach (17 to 21 cm) and rightward reach (18 to 20 cm)
Time Frame
4 weeks
Title
time up and go test
Description
To determine fall risk and measure the progress of balance, sit to stand and walking. Simple screening test that is a sensitive and specific measure of probability for falls among older adults An older adult who takes ≥12 seconds to complete the TUG is at risk for falling
Time Frame
4 weeks
Title
Oswestry Low Back Pain Disability Questionnaire
Description
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. I
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The McGill Pain Questionnaire
Description
The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Seven words are selected from the following categories: dimension 1 to 10 (pain descriptors), three words; dimensions 11 to 15 (affective components of pain), dimension 16 (evaluation of pain) one word, and dimension 17 to 20 (miscellaneous) one word. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain). Qualitative differences in pain may be reflected in respondent's word choice
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ranging from 30:45 sciatica due to lumbar disc prolapse mild to moderate disc prolapse according to magnetic resonance image (MRI). Body mass index (18.5 to 29.9) Kg/m2. Exclusion Criteria: The patients will be excluded if they have one of the followings: lumbar myelopathy. Patients with previous spinal surgery. Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis Any other neurological or musculoskeletal disorders of the spine or upper extremity. Patient with cardiopulmonary disease or diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lama Saad El-Din ED Mahmoud
Phone
01157592636
Email
lamaelsedawyy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama Saad El-Din Mahmoud, PHD
Organizational Affiliation
October 6 University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
KEROLOS AWAD HABIB SAEED, masters
Organizational Affiliation
October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lama S Mahmoud
City
Al Jīzah
State/Province
Select State
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud
Phone
01157592636
Email
lamaelsedawyy@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

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