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

Birkan Sonel Tur50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lumbar Disc Herniation

Interventions

PEMFDEVICE

Hot packDEVICE

TENSDEVICE

Sham PEMFDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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'.

Time frame: 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'.

Time frame: one month after treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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