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High-tone External Muscle Stimulation for Pain Reduction

High-tone External Muscle Stimulation for Treatment of Chronic Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02151565
Acronym
HTEMS
Enrollment
100
Registered
2014-05-30
Start date
2012-11-30
Completion date
2013-11-30
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervico Brachialgia, Chronic Radicular Back Pain, Lumboischialgia

Keywords

back pain, sciatica, electrotherapy, HTEMS, TENS

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.

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.

Interventions

DEVICEHTEMS
DEVICETENS

Sponsors

gbo Medizintechnik AG
CollaboratorUNKNOWN
West German Center of Diabetes and Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Back pain10 daysBack pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026