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

Chronic Low Back Pain Clinical Trial

— NRM_2009  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487368
• Other study ID #: NRM_2009
• Status: Completed
• Phase: N/A
• First received: June 29, 2015
• Last updated: July 1, 2015
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2015
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Recurrent Low Back Pain

Intervention

Device:
• Needle stimulation pad

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Siemens-Betriebskrankenkasse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Visual analogue scale	day 14	No
Secondary	Pain intensity	Visual analogue scale	Week 14	No
Secondary	Oswestry Low Back Pain Disability Index		Day 14	No
Secondary	Oswestry Low Back Pain Disability Index		Week 14	No
Secondary	Short Form 36 Health Survey Questionnaire (SF-36)		Day 14	No
Secondary	Short Form 36 Health Survey Questionnaire (SF-36)		Week 14	No
Secondary	Fear Avoidance Beliefs Questionnaire (FABQ)		Day 14	No
Secondary	Fear Avoidance Beliefs Questionnaire (FABQ)		Week 14	No
Secondary	Experiences with the intervention	Open question: "please indicate observed changes"	Day 14	Yes
Secondary	Medication use	Use of medication, daily log	Day 14	No
Secondary	Number of any adverse events		Day 14	Yes
Secondary	Pain intensity measured immediately after the application, visual analogue scale		5 minutes	No