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.
see above
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Pain intensity
Visual analogue scale
Time frame: day 14
Pain intensity
Visual analogue scale
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
Open question: "please indicate observed changes"
Time frame: Day 14
Medication use
Use of medication, daily log
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
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