Chronic Low Back PainNRM_2009NCT02487368
Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
A study testing Needle stimulation pad in people with Chronic Low Back Pain and Recurrent Low Back Pain, run by Universität Duisburg-Essen.
Trial summary
The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain, Recurrent Low Back Pain
- What is being tested?
- Needle stimulation pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Dec 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic or recurrent low back pain in the past 12 months
- average pain intensity 4 out of 10 points
Who cannot join
- malignant back pain
- congenital deformities of the spine
- dystonia or other movement disorders
- spinal surgery within 12 months prior
- pregnancy
- dermatological diseases in the areas treated
Show all 9Show fewer
- tendency for hemorrhages
- severe mental illness
- recent treatment with anticoagulation, corticoid medication, acupuncture
About this study
The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment.
Patients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included the Oswestry disability index (ODI), health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic medication consumption and safety.
Read the detailed description
see above
- Conditions
- Chronic Low Back Pain, Recurrent Low Back Pain
- Being tested
- Needle stimulation pad
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle stimulation padDevice
Also called Shakti mat, Bed of nails
| Study group | Role | What they receive |
|---|---|---|
| Needle stimulation pad | Experimental | a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days. Receives: Device: Needle stimulation pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual analogue scale
Measured: day 14
Secondary outcomes (11)
Pain intensity
Visual analogue scale
Measured: Week 14
Oswestry Low Back Pain Disability Index
Measured: Day 14
Oswestry Low Back Pain Disability Index
Measured: Week 14
Short Form 36 Health Survey Questionnaire (SF-36)
Measured: Day 14
Short Form 36 Health Survey Questionnaire (SF-36)
Measured: Week 14
Fear Avoidance Beliefs Questionnaire (FABQ)
Measured: Day 14
Fear Avoidance Beliefs Questionnaire (FABQ)
Measured: Week 14
Experiences with the intervention
Open question: "please indicate observed changes"
Measured: Day 14
Medication use
Use of medication, daily log
Measured: Day 14
Number of any adverse events
Measured: Day 14
Pain intensity measured immediately after the application, visual analogue scale
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens-Betriebskrankenkasse
- Responsible party
- Principal investigator, Gustav Dobos, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Professor, Principal investigator, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487368
- Sponsor's protocol ID
- NRM_2009
- Acronym
- NRM_2009
- Status last verified
- Jul 2015
- First submitted
- 29 Jun 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02487368
- Acronym / sponsor ID
- NRM_2009 / NRM_2009
- Conditions
- Chronic Low Back Pain, Recurrent Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Siemens-Betriebskrankenkasse
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Jul 2015 (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.
The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment.
Patients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included the Oswestry disability index (ODI), health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic medication consumption and safety.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Needle stimulation pad | Experimental | Device: Needle stimulation pada self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic or recurrent low back pain in the past 12 months
- average pain intensity 4 out of 10 points
Key exclusion criteria (9 listed)
- malignant back pain
- congenital deformities of the spine
- dystonia or other movement disorders
- spinal surgery within 12 months prior
- 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 |
|---|---|---|
| Needle stimulation padAlso: Shakti mat, Bed of nails | Device | Needle stimulation pad |
Primary outcome
Pain intensity
Time frame: day 14
Visual analogue scale
11 secondary outcomes
Pain intensity
Time frame: Week 14
Oswestry Low Back Pain Disability Index
Time frame: Day 14
Oswestry Low Back Pain Disability Index
Time frame: Week 14
Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Day 14
Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Week 14
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Day 14
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Week 14
Experiences with the intervention
Time frame: Day 14
Medication use
Time frame: Day 14
Number of any adverse events
Time frame: Day 14
Pain intensity measured immediately after the application, visual analogue scale
Time frame: 5 minutes
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 2 Jul 2015.
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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.
Gustav Dobos, Professor principal investigator
University of Duisburg-Essen
Questions about this trial
What is this clinical trial studying?
A study testing Needle stimulation pad in people with Chronic Low Back Pain and Recurrent Low Back Pain, run by Universität Duisburg-Essen.
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 9 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 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain intensity (time frame: day 14). 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 2 Jul 2015.