Effectiveness of PEMF in Patients With Chronic Radicular Pain Due to Lomber Disc Herniation

Effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on Pain, Functional Status, and Quality of Life in Patients With Chronic Radicular Pain Due to Lumbar Disc Herniation

The aim of this study is to investigate the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Device: TENS; Device: PEMF; Device: Hot pack; Device: Sham PEMF

Detailed Description

Pulsed Electromagnetic Field Therapy (PEMF) is a non-invasive, painless treatment for various injuries, bone related conditions and pains. However, further studies on PEMF effects on low back and radicular pain is needed due to lack of studies in this area.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-65
• Unilateral radicular pain for at least 3 months
• Severity of radicular pain with Visual Analog Score of at least 4/10
• Written informed consent

Exclusion Criteria:

• Pregnancy or lactation
• Cardiac pacemaker, or any metal implants or electronic devices anywhere in the body
• History of surgery or algological procedure of the lumbar region
• Physical therapy within the last year due to back pain
• Previous PEMF treatment
• Malignancy or suspicion
• Polyneuropathy (diabetic or other)
• Connective tissue disease
• Presence of inflammatory joint pain
• Fibromyalgia
• Presence of open surface wound
• Tuberculosis, mycosis, or viral disease
• Presence of pain in another region of the body with higher severity than radicular back pain
• Use of drugs other than paracetamol-derivative simple analgesics (Nonsteroidal Aanti inflammatuar, central effective, or narcotic analgesics), or less than three weeks since the discontinuation of these drugs
• Advanced mood disorder
• Radiographic evidence of Grade 2 spondylolisthesis, presence of spinal instability, and advanced degenerative spondylarthrosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulsed electromagnetic field (PEMF) treatment Group; Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.	Device: TENS; Device: PEMF; Device: Hot pack
Sham Comparator: Sham PEMF treatment Group; Group received routine hot pack, TENS and sham PEMF treatment.	Device: TENS; Device: Hot pack; Device: Sham PEMF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 cm Pain Visual Analogue Scale (VAS)	The patient is asked to indicate their perceived pain intensity along a 10cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.	3 weeks
10 cm Pain Visual Analogue Scale (VAS)	The patient is asked to indicate their perceived pain intensity along a 10 cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.	one month after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability; Roland-Morris Disability Questionnaire (RMDQ)	RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of >1 indicates disability.	3 weeks
Disability; Roland-Morris Disability Questionnaire (RMDQ)	RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of >1 indicates disability.	One month after treatment
Nottingham Health Profile (NHP)	Nottingham Health Profile (NHP) is a questionnaire designed to measure a patient's view of their own health status, in a number of areas. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.	3 weeks
Nottingham Health Profile (NHP)	Nottingham Health Profile (NHP) is a questionnaire designed to measure a patient's view of their own health status, in a number of areas. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation.All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.	One month after treatment

Collaborators and Investigators

• Sponsor: Birkan Sonel Tur

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 05-188-16

Drug and device information, study documents

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