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CompletedNCT04049812Updated Aug 8, 2019

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

An interventional study of PEMF and Hot pack in Lumbar Disc Herniation, sponsored by Birkan Sonel Tur. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Birkan Sonel Tur · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Mar 2016, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lumbar Disc Herniation
03

In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's enrollment of 50 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

This is the only study on the registry with Birkan Sonel Tur as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Pulsed electromagnetic field (PEMF) treatment Group

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

    Device: PEMF · Device: Hot pack · Device: TENS

  • Sham comparator
    Sham PEMF treatment Group

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

    Device: Hot pack · Device: TENS · Device: Sham PEMF

Interventions

  • DevicePEMF
  • DeviceHot pack
  • DeviceTENS
  • DeviceSham PEMF
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What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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: One month after treatment

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04049812
Lead sponsor
Birkan Sonel Tur
Responsible party
Birkan Sonel Tur (Professor, Ankara University) — Sponsor-investigator
First posted
Aug 8, 2019
Start date
Mar 1, 2016
Primary completion
Feb 28, 2018
Completion
Mar 31, 2018
Last update
Aug 8, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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