NCT02151565

Brief Summary

Sciatica is a common pain problem that affects not only the patient but also constitutes a socioeconomic burden and thus affects the whole society. So far, current pharmacologic therapies are inadequate for many patients. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) on radicular pain associated with sciatica.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

2 active sites

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

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

May 28, 2014

Last Update Submit

October 14, 2020

Conditions

Chronic Radicular Back PainLumboischialgiaCervico Brachialgia

Keywords

back painsciaticaelectrotherapyHTEMSTENS

Outcome Measures

Primary Outcomes (1)

  • Back pain

    Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable

    10 days

Study Arms (2)

HTEMS

EXPERIMENTAL

High-tone external muscle stimulation 5 times within 10 days

Device: HTEMS

TENS

ACTIVE COMPARATOR

Transcutaneous electrical nerve stimulation 5 times within 10 days

Device: TENS

Interventions

HTEMSDEVICE
Also known as: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
HTEMS
TENSDEVICE
Also known as: Dumo 2.4 (CEFAR Medical, Lund, Sweden)
TENS

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sciatica due to degenerative spine disorders
  • stable oral analgesic regimen

You may not qualify if:

  • history of drug or alcohol abuse
  • cardiac pacemaker or defibrillator
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Vinzenz Krankenhaus

Düsseldorf, 40477, Germany

Location

Düsseldorf Catholic Hospital Group

Düsseldorf, 40591, Germany

Location

MeSH Terms

Conditions

Back PainSciatica

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgia

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

DE(2)