High-tone External Muscle Stimulation for Pain Reduction (HTEMS)

October 14, 2020 updated by: Stephan Martin, West German Center of Diabetes and Health

High-tone External Muscle Stimulation for Treatment of Chronic Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40477
        • St. Vinzenz Krankenhaus
      • Düsseldorf, Germany, 40591
        • Düsseldorf Catholic Hospital Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HTEMS
High-tone external muscle stimulation 5 times within 10 days
Device: HTEMS
Other Names:
  • HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
Active Comparator: TENS
Transcutaneous electrical nerve stimulation 5 times within 10 days
Device: TENS
Other Names:
  • Dumo 2.4 (CEFAR Medical, Lund, Sweden)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back pain
Time Frame: 10 days
Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Center of Diabetes and Health

Collaborators

gbo Medizintechnik AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTEMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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