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NCT Number: NCT02151565

High-tone External Muscle Stimulation for Pain Reduction

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.

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Key information

Conditions

Chronic Radicular Back Pain Back Pain Cervico Brachialgia Lumboischialgia Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Düsseldorf Catholic Hospital Group, Düsseldorf, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HTEMS

Device

Other names: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)

TENS

Device

Other names: Dumo 2.4 (CEFAR Medical, Lund, Sweden)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

  • gbo Medizintechnik AG

Registry information

Official study title

High-tone External Muscle Stimulation for Treatment of Chronic Pain

Acronym: HTEMS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 30, 2014
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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