NCT04049812

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

July 12, 2019

Last Update Submit

August 7, 2019

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Disability; Roland-Morris Disability Questionnaire (RMDQ)

    3 weeks

  • Disability; Roland-Morris Disability Questionnaire (RMDQ)

    One month after treatment

  • Nottingham Health Profile (NHP)

    3 weeks

  • Nottingham Health Profile (NHP)

    One month after treatment

Study Arms (2)

Pulsed electromagnetic field (PEMF) treatment Group

ACTIVE COMPARATOR

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

Device: PEMFDevice: Hot packDevice: TENS

Sham PEMF treatment Group

SHAM COMPARATOR

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

Device: Hot packDevice: TENSDevice: Sham PEMF

Interventions

PEMFDEVICE
Pulsed electromagnetic field (PEMF) treatment Group
Hot packDEVICE
Pulsed electromagnetic field (PEMF) treatment GroupSham PEMF treatment Group
TENSDEVICE
Pulsed electromagnetic field (PEMF) treatment GroupSham PEMF treatment Group
Sham PEMFDEVICE
Sham PEMF treatment Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2019

First Posted

August 8, 2019

Study Start

March 1, 2016

Primary Completion

February 28, 2018

Study Completion

March 31, 2018

Last Updated

August 8, 2019

Record last verified: 2019-08