Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain

Study Overview
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Brief Summary
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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
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see above

Official Title
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Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain

Conditions
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Chronic Low Back Pain, Recurrent Low Back Pain

Intervention / Treatment
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* Device: Needle stimulation pad


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needle stimulation pad<br>a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days. | Device: Needle stimulation pad<br> <br> * Other names: Shakti mat, Bed of nails;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Visual analogue scale | day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Visual analogue scale | 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 | 
| Fear Avoidance Beliefs Questionnaire (FABQ) |  | Day 14 | 
| Fear Avoidance Beliefs Questionnaire (FABQ) |  | Week 14 | 
| Experiences with the intervention | Open question: please indicate observed changes | Day 14 | 
| Medication use | Use of medication, daily log | Day 14 | 
| Number of any adverse events |  | Day 14 | 
| Pain intensity measured immediately after the application, visual analogue scale |  | 5 minutes |