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

• Sponsor: Universität Duisburg-Essen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02487368
• Collaborator: Siemens-Betriebskrankenkasse (Industry)
• Enrollment: 166
• Arm: 1
• Duration (Months): 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain; Recurrent Low Back Pain	Device: Needle stimulation pad	N/A

Detailed Description

see above

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain intensity [day 14]

   Visual analogue scale

Secondary Outcome Measures

1. Pain intensity [Week 14]

   Visual analogue scale

2. Oswestry Low Back Pain Disability Index [Day 14]

3. Oswestry Low Back Pain Disability Index [Week 14]

4. Short Form 36 Health Survey Questionnaire (SF-36) [Day 14]

5. Short Form 36 Health Survey Questionnaire (SF-36) [Week 14]

6. Fear Avoidance Beliefs Questionnaire (FABQ) [Day 14]

7. Fear Avoidance Beliefs Questionnaire (FABQ) [Week 14]

8. Experiences with the intervention [Day 14]

   Open question: "please indicate observed changes"

9. Medication use [Day 14]

   Use of medication, daily log

10. Number of any adverse events [Day 14]

11. Pain intensity measured immediately after the application, visual analogue scale [5 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universität Duisburg-Essen
• Siemens-Betriebskrankenkasse

Investigators

• Principal Investigator: Gustav Dobos, Professor, University of Duisburg-Essen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustav Dobos, Principle Investigator, Universität Duisburg-Essen
• ClinicalTrials.gov Identifier: NCT02487368
• Other Study ID Numbers: NRM_2009
• First Posted: Jul 1, 2015
• Last Update Posted: Jul 2, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Jul 2, 2015