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Completed

NCT Number: NCT02487368

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

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Recurrent Low Back Pain Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Needle stimulation pad

Device

Other names: Shakti mat, Bed of nails

Primary outcomes

  1. Pain intensity

    Time frame: day 14

    Visual analogue scale

Secondary outcomes

  1. Pain intensity

    Time frame: Week 14

    Visual analogue scale

  2. Oswestry Low Back Pain Disability Index

    Time frame: Day 14

  3. Oswestry Low Back Pain Disability Index

    Time frame: Week 14

  4. Short Form 36 Health Survey Questionnaire (SF-36)

    Time frame: Day 14

  5. Short Form 36 Health Survey Questionnaire (SF-36)

    Time frame: Week 14

  6. Fear Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Day 14

  7. Fear Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Week 14

  8. Experiences with the intervention

    Time frame: Day 14

    Open question: "please indicate observed changes"

  9. Medication use

    Time frame: Day 14

    Use of medication, daily log

  10. Number of any adverse events

    Time frame: Day 14

  11. Pain intensity measured immediately after the application, visual analogue scale

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Siemens-Betriebskrankenkasse

Registry information

Acronym: NRM_2009

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2015
Registry last updated
Jul 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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