High-tone External Muscle Stimulation for Pain Reduction

Not Applicable

Completed

• Conditions: Chronic Radicular Back Pain; Lumboischialgia; Cervico Brachialgia
• Interventions: Device: HTEMS; Device: TENS

• Registration Number: NCT02151565
• Lead Sponsor: West German Center of Diabetes and Health

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HTEMS	HTEMS	High-tone external muscle stimulation 5 times within 10 days
TENS	TENS	Transcutaneous electrical nerve stimulation 5 times within 10 days

Primary Outcome Measures

Name	Time	Method
Back pain	10 days	Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable

Trial Locations

Locations (2)

Düsseldorf Catholic Hospital Group; 🇩🇪 Düsseldorf, Germany

St. Vinzenz Krankenhaus; 🇩🇪 Düsseldorf, Germany