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NCT00044109 · ClinicalTrials.gov registry record · Phase 2
Magnets in the Treatment of Sciatica
A Phase 2 study of Low Back Pain and Sciatica, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT00044109 is a Phase 2 study of Low Back Pain and Sciatica that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 75 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00044109, a Phase 2 study of Low Back Pain and Sciatica, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials. We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75 who have had signs and symptoms of sciatica for 3 months or more. This is a double-blind, randomized, placebo-control, two phase study. In the first phase, after one week baseline, subjects will be randomized to 4 different treatments in a cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine and left-right across the lumbo-sacral spine), a sham device of similar configuration and a no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes will be broken to select the magnetic device associated with the greatest amount of pain score reduction. During the second phase which will also be double-blinded, subjects will be randomized to wear the selected magnetic device and sham in a cross-over design. Each of the 2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain score in the leg. Daily pain level in the low back and the back and leg combined in addition to the patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck depression inventory.
Conditions Studied
Interventions
- DEVICE Magnets
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2002-08 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00044109
The ClinicalTrials.gov registry entry for NCT00044109 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (85% lower). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 1 intervention - of which Magnets is the first listed.
NCT00044109 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00044109 about?
NCT00044109 is a clinical study titled "Magnets in the Treatment of Sciatica". Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials. We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study ...
What is the current status of trial NCT00044109?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2002-08. Estimated completion is 2006-06.
What conditions does trial NCT00044109 study?
This clinical trial studies the following conditions: Low Back Pain, Sciatica.
What interventions are being tested in trial NCT00044109?
The interventions under investigation include: Magnets (DEVICE).
Who is sponsoring clinical trial NCT00044109?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00044109 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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