Effects of a Mechanical Needle Stimulation Pad on Chronic... | NCT02487368

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

NCT02487368

Sponsor

Universität Duisburg-Essen

Status

Completed

Last Update Posted

Jul 2, 2015Estimated

Enrollment

166Actual

Phase

Not Applicable

Conditions

Chronic Low Back Pain
Recurrent Low Back Pain

Interventions

Needle stimulation pad

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 29, 2015

First Submission Date that Met QC Criteria

Jun 30, 2015

First Posted Date

Jul 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2015

Last Update Posted Date

Jul 2, 2015Estimated

Name	Class
Siemens-Betriebskrankenkasse	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Needle stimulation pad	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Needle stimulation pad	Device		Needle stimulation pad	Shakti mat, Bed of nails

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity	Visual analogue scale	day 14

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gustav Dobos, Professor	University of Duisburg-Essen	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided