High-tone External Muscle Stimulation for Pain Reduction (HTEMS)
Primary Purpose
Chronic Radicular Back Pain, Lumboischialgia, Cervico Brachialgia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HTEMS
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Radicular Back Pain focused on measuring back pain, sciatica, electrotherapy, HTEMS, TENS
Eligibility Criteria
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
Sites / Locations
- St. Vinzenz Krankenhaus
- Düsseldorf Catholic Hospital Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HTEMS
TENS
Arm Description
High-tone external muscle stimulation 5 times within 10 days
Transcutaneous electrical nerve stimulation 5 times within 10 days
Outcomes
Primary Outcome Measures
Back pain
Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable
Secondary Outcome Measures
Full Information
NCT ID
NCT02151565
First Posted
May 28, 2014
Last Updated
October 14, 2020
Sponsor
West German Center of Diabetes and Health
Collaborators
gbo Medizintechnik AG
1. Study Identification
Unique Protocol Identification Number
NCT02151565
Brief Title
High-tone External Muscle Stimulation for Pain Reduction
Acronym
HTEMS
Official Title
High-tone External Muscle Stimulation for Treatment of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
gbo Medizintechnik AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Radicular Back Pain, Lumboischialgia, Cervico Brachialgia
Keywords
back pain, sciatica, electrotherapy, HTEMS, TENS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HTEMS
Arm Type
Experimental
Arm Description
High-tone external muscle stimulation 5 times within 10 days
Arm Title
TENS
Arm Type
Active Comparator
Arm Description
Transcutaneous electrical nerve stimulation 5 times within 10 days
Intervention Type
Device
Intervention Name(s)
HTEMS
Other Intervention Name(s)
HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
Dumo 2.4 (CEFAR Medical, Lund, Sweden)
Primary Outcome Measure Information:
Title
Back pain
Description
Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Vinzenz Krankenhaus
City
Düsseldorf
ZIP/Postal Code
40477
Country
Germany
Facility Name
Düsseldorf Catholic Hospital Group
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany
12. IPD Sharing Statement
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High-tone External Muscle Stimulation for Pain Reduction
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