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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02487368
Other study ID # NRM_2009
Secondary ID
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


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
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