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

West German Center of Diabetes and Health

Status: Completed

Conditions: Cervico Brachialgia; Lumboischialgia; Chronic Radicular Back Pain

Treatments: Device: HTEMS; Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT02151565

HTEMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

HTEMS

Experimental group

Description:

High-tone external muscle stimulation 5 times within 10 days

Treatment:

Device: HTEMS

TENS

Active Comparator group

Description:

Transcutaneous electrical nerve stimulation 5 times within 10 days

Treatment:

Device: TENS