Trial to Test the Efficacy of Using Magnetic Fields to Stimulate the Back to Treat Chronic Lower Back Pain.

ConditionLower Back Pain Chronic

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-64

SponsorJoe X. Zhang

About this trial

The goal of this study is to see if a new way to treat back pain without the use of medications is effective. We plan use Transcranial Magnetic Stimulation (TMS), a wand-like device, to excite the nerves of people with lower back pain to see if we can decrease pain and improve quality of life.

This study will have two groups and randomly assign participants to a group. One group will have their back nerves stimulated with the TMS device and the other group will not.

Participants will also need to do back exercises at home once a day, and complete questionnaires at each visit before and after each treatment. The total time commitment will be 5 to10 visits with one visit occurring each weekday and each visit lasting up to 30 minutes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with chronic low back pain (greater than or equal to 12 weeks) with or without concurrent neck pain.

Low back pain in the paraspinal region (L1-S2) by asking the patient to point to their area of pain.

18 - 64 years old (on the day of informed consent)

Willing and able to attend all study visits.

Disqualifiers

Diagnosed with low back pain of less than 12 weeks duration

History of back fractures or surgical repair of the back

History of depression with vagus nerve stimulation

Any type of transcranial magnetic stimulation (TMS), or rPMS treatment prior to study enrollment.

Trial design

Design model

Crossover

Treatments tested in this trial

peripheral magnetic stimulation
Device
Our stimulation protocol is ssing approximately 0.3 tesla to 0.58 tesla of magnetic power using a variable stimulation frequency between 11ms and 14ms with center value of 13ms between pulses. This translates to estimated values of lower bounds of 71.43 Hz, central value of 83 Hz, and maximum value of 99 Hz .
Home exercise
Behavioral
All patients will receive a home exercise guide and recommended to perform the stated number of repetitions of those exercises. Exercises include Neutral Curl Up with Straight Leg, Plank on Elbow, and Bird Dog positions.

Treatment groups

88 Participants

are divided into 2 treatment groups

Group A: Treatment ArmExperimental treatment 2 interventions

Group B: Sham ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

Visual Analog Scale

Visual Analog Scale or VAS is a common self reported pain measurement scale from 0 - 100 with 0 being pain free and 100 being most pain possible.

Time frame

VAS numbers are obtained at: Baseline, pre-intervention. Immediately before each intervention Immediately after each intervention

Secondary outcomes

ODI

Oswestry Disability Index (ODI) is a set of questions used to identify participant's functional status as related to activities of daily living.

Time frame

Scores are obtained at: Baseline, pre-intervention. Immediately after intervention session 2 Immediately after intervention session 5 Immediately after intervention session 10 for those that elect to opt in for open label portion of study

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joe X. Zhang

Lead sponsor

Madigan Army Medical Center

Sponsor institution

Source ClinicalTrials.gov

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