Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

Not Applicable

Recruiting

• Conditions: Lumbar Disc Herniation
• Interventions: Other: selected physical therapy program; Device: electromagnetic field therapy; Device: Therapeutic ultrasound therapy; Device: Transcutaneous Electrical Nerve Stimulation

• Registration Number: NCT05559723
• Lead Sponsor: October 6 University

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

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Status Verified: 2022-11
• Study Start: 2022-11-25
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30
• Primary Completion: 2023-05-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Therapeutic ultrasound therapy	electromagnetic field therapy
study group	Transcutaneous Electrical Nerve Stimulation	electromagnetic field therapy
control group	selected physical therapy program	the selected exercise program
study group	electromagnetic field therapy	electromagnetic field therapy
control group	Therapeutic ultrasound therapy	the selected exercise program
study group	selected physical therapy program	electromagnetic field therapy
control group	Transcutaneous Electrical Nerve Stimulation	the selected exercise program

Primary Outcome Measures

Name	Time	Method
visual analogue scale	4 weeks	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	4 weeks	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	4 weeks	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	4 weeks	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

Name	Time	Method
The McGill Pain Questionnaire	four weeks	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

Trial Locations

Locations (1)

Lama S Mahmoud; 🇪🇬 Al Jīzah, Select State, Egypt