An interventional study of HTEMS and TENS in Chronic Radicular Back Pain, Lumboischialgia and Cervico Brachialgia, sponsored by West German Center of Diabetes and Health. Completed at 2 sites in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by West German Center of Diabetes and Health · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →West German Center of Diabetes and Health is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
High-tone external muscle stimulation 5 times within 10 days
Device: HTEMS
Transcutaneous electrical nerve stimulation 5 times within 10 days
Device: TENS
Also known as: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
Also known as: Dumo 2.4 (CEFAR Medical, Lund, Sweden)
Back pain
Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable
Time frame: 10 days
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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West German Center of Diabetes and Health