Chronic Low Back Pain Clinical Trial
— NRM_2009Official title:
Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
Verified date | July 2015 |
Source | Universität Duisburg-Essen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 166 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - chronic or recurrent low back pain in the past 12 months - average pain intensity 4 out of 10 points Exclusion Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universität Duisburg-Essen | Siemens-Betriebskrankenkasse |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | Visual analogue scale | day 14 | No |
Secondary | Pain intensity | Visual analogue scale | Week 14 | No |
Secondary | Oswestry Low Back Pain Disability Index | Day 14 | No | |
Secondary | Oswestry Low Back Pain Disability Index | Week 14 | No | |
Secondary | Short Form 36 Health Survey Questionnaire (SF-36) | Day 14 | No | |
Secondary | Short Form 36 Health Survey Questionnaire (SF-36) | Week 14 | No | |
Secondary | Fear Avoidance Beliefs Questionnaire (FABQ) | Day 14 | No | |
Secondary | Fear Avoidance Beliefs Questionnaire (FABQ) | Week 14 | No | |
Secondary | Experiences with the intervention | Open question: "please indicate observed changes" | Day 14 | Yes |
Secondary | Medication use | Use of medication, daily log | Day 14 | No |
Secondary | Number of any adverse events | Day 14 | Yes | |
Secondary | Pain intensity measured immediately after the application, visual analogue scale | 5 minutes | No |
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