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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049812
• Other study ID #: 05-188-16
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: August 2019
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Device:
• PEMF

• Hot pack

• TENS

• Sham PEMF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Birkan Sonel Tur

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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