High-tone External Muscle Stimulation for Pain Reduction

NCT ID: NCT02151565

Last Updated: 2020-10-19

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Hospital patients (n=100) with chronic sciatica and stable oral analgesic regimen were included into this randomized controlled cross-over trial. Each intervention was administered for a period of 45 min 5 times within 10 days, with a 3-day wash-out period before cross-over. Health impairments had been assessed using the visual analog scales (VAS) for radicular pain before and after intervention and differences in radicular pain between groups were analysed with the Mann-Whitney test.

Conditions

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Chronic Radicular Back Pain Lumboischialgia Cervico Brachialgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HTEMS

High-tone external muscle stimulation 5 times within 10 days

Group Type EXPERIMENTAL

HTEMS

Intervention Type DEVICE

TENS

Transcutaneous electrical nerve stimulation 5 times within 10 days

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Interventions

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HTEMS

Intervention Type DEVICE

TENS

Intervention Type DEVICE

Other Intervention Names

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HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany) Dumo 2.4 (CEFAR Medical, Lund, Sweden)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* history of drug or alcohol abuse
* cardiac pacemaker or defibrillator
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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gbo Medizintechnik AG

UNKNOWN

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Stephan Martin

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Vinzenz Krankenhaus

Düsseldorf, , Germany

Site Status

Düsseldorf Catholic Hospital Group

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HTEMS

Identifier Type: -

Identifier Source: org_study_id

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