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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02487368

Acronym

NRM_2009

Enrollment

166

Registered

2015-07-01

Start date

2009-10-31

Completion date

2010-12-31

Last updated

2015-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain, Recurrent Low Back Pain

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.

Detailed description

see above

Interventions

DEVICENeedle stimulation pad

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity	day 14	Visual analogue scale

Secondary

Measure	Time frame	Description
Oswestry Low Back Pain Disability Index	Day 14	—
Short Form 36 Health Survey Questionnaire (SF-36)	Day 14	—
Fear Avoidance Beliefs Questionnaire (FABQ)	Day 14	—
Pain intensity	Week 14	Visual analogue scale
Medication use	Day 14	Use of medication, daily log
Number of any adverse events	Day 14	—
Pain intensity measured immediately after the application, visual analogue scale	5 minutes	—
Experiences with the intervention	Day 14	Open question: please indicate observed changes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026