Chronic Radicular Back PainHTEMSNCT02151565
High-tone External Muscle Stimulation for Pain Reduction
A study testing HTEMS and TENS in people with Chronic Radicular Back Pain and Lumboischialgia, run by West German Center of Diabetes and Health at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Radicular Back Pain, Lumboischialgia, Cervico Brachialgia
- What is being tested?
- HTEMS and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sciatica due to degenerative spine disorders
- stable oral analgesic regimen
Who cannot join
- history of drug or alcohol abuse
- cardiac pacemaker or defibrillator
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
St. Vinzenz Krankenhaus
Düsseldorf, 40477
Düsseldorf Catholic Hospital Group
Düsseldorf, 40591
About this study
Official title: High-tone External Muscle Stimulation for Treatment of Chronic Pain
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.
Read the 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.
- Being tested
- HTEMS, TENS
- Keywords
- back pain, sciatica, electrotherapy, HTEMS, TENS
- Medical subject headings
- Back Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTEMSDevice
Also called HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
TENSDevice
Also called Dumo 2.4 (CEFAR Medical, Lund, Sweden)
| Study group | Role | What they receive |
|---|---|---|
| HTEMS | Experimental | High-tone external muscle stimulation 5 times within 10 days Receives: Device: HTEMS |
| TENS | Active comparator | Transcutaneous electrical nerve stimulation 5 times within 10 days Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain
Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Radicular Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Collaborators
- gbo Medizintechnik AG
- Responsible party
- Principal investigator, Stephan Martin, West German Center of Diabetes and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151565
- Sponsor's protocol ID
- HTEMS
- Acronym
- HTEMS
- Status last verified
- Oct 2020
- First submitted
- 28 May 2014
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-tone External Muscle Stimulation for Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT02151565
- Acronym / sponsor ID
- HTEMS / HTEMS
- Keywords
- back pain, sciatica, electrotherapy, HTEMS, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- gbo Medizintechnik AG
- Study start
- Nov 2012 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTEMS | Experimental | Device: HTEMSHigh-tone external muscle stimulation 5 times within 10 days |
| TENS | Active comparator | Device: TENSTranscutaneous electrical nerve stimulation 5 times within 10 days |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sciatica due to degenerative spine disorders
- stable oral analgesic regimen
Key exclusion criteria (3 listed)
- history of drug or alcohol abuse
- cardiac pacemaker or defibrillator
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTEMSAlso: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany) | Device | HTEMS |
| TENSAlso: Dumo 2.4 (CEFAR Medical, Lund, Sweden) | Device | TENS |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTEMS and TENS in people with Chronic Radicular Back Pain and Lumboischialgia, run by West German Center of Diabetes and Health at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.