Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain (NRM_2009)

Universität Duisburg-Essen

Status: Completed

Conditions: Chronic Low Back Pain; Recurrent Low Back Pain

Treatments: Device: Needle stimulation pad

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02487368

NRM_2009

Details and patient eligibility

About

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.

Full description

see above

Enrollment: 166 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

Needle stimulation pad

Experimental group

Description:

a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days.

Treatment:

Device: Needle stimulation pad