Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559723
• Other study ID #: P.T. REC/012/004099
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: November 2022
• Source: October 6 University
• Contact: Lama Saad El-Din ED Mahmoud
• Phone: 01157592636
• Email: lamaelsedawyy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Prolapse

Intervention

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.
• 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 .

Locations

Country	Name	City	State
Egypt	Lama S Mahmoud	Al Jizah	Select State

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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