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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Recurrent Low Back Pain
• Intervention / Treatment: Device: Needle stimulation pad

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Needle stimulation pad; Other Names: Shakti mat, Bed of nails

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Siemens-Betriebskrankenkasse
• Investigators: Principal Investigator: Gustav Dobos, Professor, University of Duisburg-Essen

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 2, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NRM_2009