Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
NRM_2009
1 other identifier
interventional
166
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 29, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedJuly 2, 2015
July 1, 2015
1.2 years
June 29, 2015
July 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity
Visual analogue scale
day 14
Secondary Outcomes (11)
Pain intensity
Week 14
Oswestry Low Back Pain Disability Index
Day 14
Oswestry Low Back Pain Disability Index
Week 14
Short Form 36 Health Survey Questionnaire (SF-36)
Day 14
Short Form 36 Health Survey Questionnaire (SF-36)
Week 14
- +6 more secondary outcomes
Study Arms (1)
Needle stimulation pad
EXPERIMENTALa self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days.
Interventions
Eligibility Criteria
You may qualify if:
- chronic or recurrent low back pain in the past 12 months
- average pain intensity 4 out of 10 points
You may not qualify if:
- 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
- tendency for hemorrhages
- severe mental illness
- recent treatment with anticoagulation, corticoid medication, acupuncture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universität Duisburg-Essenlead
- Siemens-Betriebskrankenkassecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gustav Dobos, Professor
University of Duisburg-Essen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
June 29, 2015
First Posted
July 1, 2015
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 2, 2015
Record last verified: 2015-07