Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

Effect of Electromagnetic Field Therapy on Sciatica and Postural Control in Lumbar Disc Prolapse Patients

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

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Device: electromagnetic field therapy; Other: selected physical therapy program; Device: Therapeutic ultrasound therapy; Device: Transcutaneous Electrical Nerve Stimulation

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

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lama Saad El-Din ED Mahmoud; Phone Number: 01157592636; Email: lamaelsedawyy@hotmail.com

Study Locations

• Egypt
  • Select State
    • Al Jīzah, Select State, Egypt
      • Recruiting
      • Lama S Mahmoud
      • Contact: Lama S Mahmoud; Phone Number: 01157592636; Email: lamaelsedawyy@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; electromagnetic field therapy	Device: 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; Other: selected physical therapy program; 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; Device: 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.; 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 .
Experimental: control group; the selected exercise program	Other: selected physical therapy program; 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; Device: 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.; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	four weeks

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Study Chair: Lama Saad El-Din Mahmoud, PHD, October 6 University; Principal Investigator: KEROLOS AWAD HABIB SAEED, masters, October 6 University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Prolapse
• Other Study ID Numbers: P.T. REC/012/004099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No