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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02151565
Other study ID # HTEMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date November 2013

Study information

Verified date October 2020
Source West German Center of Diabetes and Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Device:
HTEMS

TENS


Locations

Country Name City State
Germany Düsseldorf Catholic Hospital Group Düsseldorf
Germany St. Vinzenz Krankenhaus Düsseldorf

Sponsors (2)

Lead Sponsor Collaborator
West German Center of Diabetes and Health gbo Medizintechnik AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Back pain Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable 10 days