Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

NCT ID: NCT05559723

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2023-07-30

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

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

electromagnetic field therapy

Group Type: EXPERIMENTAL

electromagnetic field therapy

Intervention Type: DEVICE

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

selected physical therapy program

Intervention Type: OTHER

in the form of

1. Hot packs will be placed paravertebral on the lumbar region for 5 minutes from a prone lying position

2. selected physical therapy exercises in form of Static exercise for back and abdominal muscles, stretching exercises for both lower limbs, 10 times each exercise

Therapeutic ultrasound therapy

Intervention Type: DEVICE

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.

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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 .

control group

the selected exercise program

Group Type: EXPERIMENTAL

selected physical therapy program

Intervention Type: OTHER

in the form of

1. Hot packs will be placed paravertebral on the lumbar region for 5 minutes from a prone lying position

2. selected physical therapy exercises in form of Static exercise for back and abdominal muscles, stretching exercises for both lower limbs, 10 times each exercise

Therapeutic ultrasound therapy

Intervention Type: DEVICE

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.

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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 .

Interventions

electromagnetic field therapy

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: DEVICE

selected physical therapy program

in the form of

1. Hot packs will be placed paravertebral on the lumbar region for 5 minutes from a prone lying position

2. 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: OTHER

Therapeutic ultrasound therapy

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

Transcutaneous Electrical Nerve Stimulation

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 .

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Lama Saad El-Din Mahmoud

Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lama Saad El-Din Mahmoud, PHD

Role: STUDY_CHAIR

October 6 University

KEROLOS AWAD HABIB SAEED, masters

Role: PRINCIPAL_INVESTIGATOR

October 6 University

Locations

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Lama Saad El-Din ED Mahmoud

Role: CONTACT

lamaelsedawyy@hotmail.com

01157592636

Facility Contacts

Lama S Mahmoud

Role: primary

lamaelsedawyy@hotmail.com

01157592636

Other Identifiers

P.T. REC/012/004099

Identifier Type: -

Identifier Source: org_study_id