Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

NCT05559723 | Unknown

• 1 other identifier: P.T. REC/012/004099
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (4)

• 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).

  4 weeks

• 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)

  4 weeks

• 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

  4 weeks

• 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

  4 weeks

Secondary Outcomes (1)

• The McGill Pain Questionnaire

  four weeks

Study Arms (2)

study group

EXPERIMENTAL

electromagnetic field therapy

Device: electromagnetic field therapy; Other: selected physical therapy program; Device: Therapeutic ultrasound therapy; Device: Transcutaneous Electrical Nerve Stimulation

control group

EXPERIMENTAL

the selected exercise program

Other: selected physical therapy program; Device: Therapeutic ultrasound therapy; Device: Transcutaneous Electrical Nerve Stimulation

Interventions

electromagnetic field therapy 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

study group

selected physical therapy program 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

control group; study group

Therapeutic ultrasound therapy 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.

control group; study group

Transcutaneous Electrical Nerve Stimulation 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; study group

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Magnetic Field Therapy; Ultrasonic Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Diathermy; Hyperthermia, Induced; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Lama Saad El-Din Mahmoud, PHD

  October 6 University

  STUDY CHAIR

• KEROLOS AWAD HABIB SAEED, masters

  October 6 University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lama Saad El-Din ED Mahmoud

CONTACT

01157592636; lamaelsedawyy@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: September 26, 2022
• First Posted: September 29, 2022
• Study Start: November 25, 2022
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)