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

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Device: PEMF; Device: TENS; Device: Hot pack; Device: Sham PEMF

• Registration Number: NCT04049812
• Lead Sponsor: Birkan Sonel Tur

Brief Summary

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.

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 Timeline

• Study Start: 2016-03-01
• Primary Completion: 2018-02-28
• Study Completion: 2018-03-31
• Study First Submitted: 2019-07-12
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-07
• Last Update Submitted: 2019-08-07
• Study First Posted: 2019-08-08
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham PEMF treatment Group	TENS	Group received routine hot pack, TENS and sham PEMF treatment.
Sham PEMF treatment Group	Sham PEMF	Group received routine hot pack, TENS and sham PEMF treatment.
Pulsed electromagnetic field (PEMF) treatment Group	TENS	Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.
Pulsed electromagnetic field (PEMF) treatment Group	Hot pack	Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.
Sham PEMF treatment Group	Hot pack	Group received routine hot pack, TENS and sham PEMF treatment.
Pulsed electromagnetic field (PEMF) treatment Group	PEMF	Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.

Primary Outcome Measures

Name	Time	Method
10 cm Pain Visual Analogue Scale (VAS)	one month after treatment	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'.

Secondary Outcome Measures

Name	Time	Method
Nottingham Health Profile (NHP)	One month after treatment	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.
Disability; Roland-Morris Disability Questionnaire (RMDQ)	One month after treatment	RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of \>1 indicates disability.