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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain; Recurrent Low Back Pain
• Interventions: Device: Needle stimulation pad

• Registration Number: NCT02487368
• Lead Sponsor: Universität Duisburg-Essen

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

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-06-30
• Status Verified: 2015-07
• Study First Posted: 2015-07-01
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain intensity	day 14	Visual analogue scale

Secondary Outcome Measures

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