Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00044109
Other study ID # 020274
Secondary ID 02-D-0274
Status Completed
Phase Phase 2
First received August 17, 2002
Last updated June 23, 2006
Start date August 2002
Est. completion date June 2006

Study information

Verified date June 2006
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility - INCLUSION CRITERIA:

1. Low back pain of 3 months duration or longer present at least 5 out of 7 days a week

2. Age between 28-80 at the start of the study

3. Men and women of all ethnicities

4. Signs and symptoms of lumbar radiculopathy. In this study chronic lumbar radicular signs and symptoms are defined as pain located in the lower lumbar spine corresponding to L1 and below for at least 3 months with radicular characteristics, i.e. pain described as sharp, burning, with numbness and/or tingling.

5. Ability to understand the study measures and mentally capable to give consent to participate in the study (based on an 8th grade education level)

6. Willingness to refrain from making changes in non-study medications taken for sciatica

7. Patients with failed back syndrome.

8. Pain level of at least 4/10 on average on a scale of 0 to 10 for the past month

9. Pain not attributable to malignancy, inflammatory arthritis such as rheumatoid arthritis, or infection by previous examinations or by laboratory testing

10. Patients' agreement to keeping a log of their pain level and documentation of compliance with wearing of back device.

11. Patients' agreement not to make changes in pain medication type of dosing during the study.

12. Women of reproductive age agreeing to undergo a pregnancy test at baseline.

EXCLUSION CRITERIA:

1. Patients with pacemakers

2. Patients with mechanical heart pumps

3. Pregnancy or breast feeding

4. Presence of pain of greater intensity in any other location than the low back or the leg

5. History of fibromyalgia as described by Wolfe F et al. (1990) (a minimum of 11 out of 18 points of tenderness must be present to satisfy criteria for fibromyalgia)

6. History of spinal unstability (as defined by X-ray, CT scan or MRI of grade II spondylolisthesis or greater)

7. Cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits

8. Unwillingness to use adequate contraception excluding oral contraceptive medications (such as barrier methods with spermicide simultaneously) for women

9. Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease

10. History of inflammation arthritis (rheumatoid arthritis, SLE)

11. Presence of active cancer

12. History of spinal infection

13. Patients s/p spinal fusion with spinal rods over the lower lumbar spine

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Magnets


Locations

Country Name City State
United States National Institute of Dental And Craniofacial Research (NIDCR) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blank M, Soo L. Optimal frequencies for magnetic acceleration of cytochrome oxidase and Na,K-ATPase reactions. Bioelectrochemistry. 2001 Mar;53(2):171-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.
Secondary Baseline and end of period 1 and 2 of Phase II: Pain symptoms, Pain level with walking, Use of pain meds, Use of other non-medication treatments, questionnaire: SF 36, Oswestry and Beck Depression, Days of disability. End of Study: Patient preference.
See also
  Status Clinical Trial Phase
Completed NCT03916705 - Thoraco-Lumbar Fascia Mobility N/A
Completed NCT04007302 - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT04284982 - Periodized Resistance Training for Persistent Non-specific Low Back Pain N/A
Recruiting NCT05600543 - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain N/A
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed NCT03673436 - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed NCT02546466 - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain N/A
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05156242 - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain. N/A
Recruiting NCT04673773 - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. N/A
Completed NCT06049251 - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises N/A
Completed NCT06049277 - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain N/A
Completed NCT04980469 - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle N/A
Completed NCT04055545 - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects N/A
Recruiting NCT05552248 - Assessment of the Safety and Performance of a Lumbar Belt
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Completed NCT05801588 - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life N/A
Completed NCT05811143 - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.