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Completed

NCT Number: NCT04049812

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

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEMF

Device

Hot pack

Device

TENS

Device

Sham PEMF

Device

Primary outcomes

  1. 10 cm Pain Visual Analogue Scale (VAS)

    Time frame: 3 weeks

    The patient is asked to indicate their perceived pain intensity along a 10cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.

  2. 10 cm Pain Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. Disability; Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 3 weeks

    RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of >1 indicates disability.

  2. Disability; Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 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.

  3. Nottingham Health Profile (NHP)

    Time frame: 3 weeks

    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.

  4. Nottingham Health Profile (NHP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Birkan Sonel Tur

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2019
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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