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

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEMF
Hot pack
TENS
Sham PEMF
Sponsored by
Birkan Sonel Tur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Pulsed electromagnetic field (PEMF) treatment Group

    Sham PEMF treatment Group

    Arm Description

    Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.

    Group received routine hot pack, TENS and sham PEMF treatment.

    Outcomes

    Primary Outcome Measures

    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'.
    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'.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    July 12, 2019
    Last Updated
    August 7, 2019
    Sponsor
    Birkan Sonel Tur
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04049812
    Brief Title
    Effectiveness of PEMF in Patients With Chronic Radicular Pain Due to Lomber Disc Herniation
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    February 28, 2018 (Actual)
    Study Completion Date
    March 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Birkan Sonel Tur

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulsed electromagnetic field (PEMF) treatment Group
    Arm Type
    Active Comparator
    Arm Description
    Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.
    Arm Title
    Sham PEMF treatment Group
    Arm Type
    Sham Comparator
    Arm Description
    Group received routine hot pack, TENS and sham PEMF treatment.
    Intervention Type
    Device
    Intervention Name(s)
    PEMF
    Intervention Type
    Device
    Intervention Name(s)
    Hot pack
    Intervention Type
    Device
    Intervention Name(s)
    TENS
    Intervention Type
    Device
    Intervention Name(s)
    Sham PEMF
    Primary Outcome Measure Information:
    Title
    10 cm Pain Visual Analogue Scale (VAS)
    Description
    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
    Title
    10 cm Pain Visual Analogue Scale (VAS)
    Description
    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 Outcome Measure Information:
    Title
    Disability; Roland-Morris Disability Questionnaire (RMDQ)
    Description
    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
    Title
    Disability; Roland-Morris Disability Questionnaire (RMDQ)
    Description
    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
    Title
    Nottingham Health Profile (NHP)
    Description
    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
    Title
    Nottingham Health Profile (NHP)
    Description
    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
    One month after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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