Efficacy Study Image Guided, Auto-Targeted Neurostimulation for the Treatment of Non-Specific Low Back Pain

NCT01132300 | Completed

• 1 other identifier: Approval Pending
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

• Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous Electrical Stimulation (TENS) device for treatment of non-specific low back pain.
• To assess the tolerability and acceptability of the device by the caregiver ("User Friendly").
• To evaluate patients' tolerance by monitoring side effects and tolerability during treatment.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale Pain Questionnaire (VAS)

  Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks

Secondary Outcomes (3)

• Oswestry Disability Questionnaire

  once a week during the study, up to 5 weeks

• Side effect record

  after each treatment session, 2 times a week, up to 5 weeks

• Range of Motion - lower back and pelvic forward flexion

  Baseline, once a week, up to 5 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)

Interventions

Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st) DEVICE

Patients will undergo 2 treatments per week during 4 weeks using the device. During the study Patients are allowed to maintain/continue taking medications/ analgesics for pain relief prescribed to them before the study. Medication use will be recorded.

Also known as: Nervomatrix Ltd. Auto-Targeted Neurostimulation, NeMa-st

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-specific low back pain persisted at least 1 month and no longer than 12 month before the study
• Patients must have a baseline score\>40 mm on the VAS pain scale
• If taking analgesics, patients must agree to maintain a steady regimen for the duration of the study.
• Able to provide written and verbal informed consent.

You may not qualify if:

• Sciatica
• Diagnosed spinal stenosis
• Back Pain potentially attributable to specific underlying diseases or conditions (e.g. pregnancy, metastatic cancer, spondylolisthesis, fractured bones, dislocated joints, disc eruption).
• Unstable medical or severe psychiatric conditions or dementia.
• Previous Back surgery
• Physically unable to undergo treatment
• Patients receiving workers compensation or those involved in litigation
• Minimal pain - less than 40mm score on VAS scale
• History of pacemaker , implantable devices, history of cardiac arrhythmias
• Allergy or intolerance to adhesive materials
• Clinical evidence of cardiovascular, pulmonary, renal, hepatic, neurological , hematological or endocrine abnormalities.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead
• Nervomatrix Ltd. Israel: collaborator

Study Sites (1)

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elad Schiff, MD

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: May 28, 2010
• Study Start: July 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 28, 2010

Record last verified: 2010-05

Locations

IL (1)