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

NCT ID: NCT04049812

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pulsed electromagnetic field (PEMF) treatment Group

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

Group Type ACTIVE_COMPARATOR

PEMF

Intervention Type DEVICE

Hot pack

Intervention Type DEVICE

TENS

Intervention Type DEVICE

Sham PEMF treatment Group

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

Group Type SHAM_COMPARATOR

Hot pack

Intervention Type DEVICE

TENS

Intervention Type DEVICE

Sham PEMF

Intervention Type DEVICE

Interventions

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PEMF

Intervention Type DEVICE

Hot pack

Intervention Type DEVICE

TENS

Intervention Type DEVICE

Sham PEMF

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Birkan Sonel Tur

OTHER

Sponsor Role lead

Responsible Party

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Birkan Sonel Tur

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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05-188-16

Identifier Type: -

Identifier Source: org_study_id

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