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

Conditions

• Lower Back Pain Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

May 2026

Primary completion

Nov 30, 2026

Completion

Feb 28, 2027

Study Design

Enrollment

88 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Arm
  Individuals in this arm receive magnetic stimulation to the area of the lower back where they have pain from sessions 1 through 5. We begin stimulation operation at 20% advancing in 5% increments to maximum of 35% machine power which in our case is approximately 0.3 tesla to 0.58 tesla of power (a typical outpatient MRI is 1.5 to 3 tesla). The power of the unit will be titrated up to the maximum 35% based on patient tolerance by asking participants to "Tell me if you feel a painful muscle contraction". Patients receiving active therapy would be able to feel the stimulus usually described as a vibration sensation. If patients report painful muscle contractions, stop and go back by 5%. Doing this helps ensure that we would not cause any potentially painful muscle contractions and avoid confounding our test data. The first treatment will start at 20% power then increase by 5% until the titrated power level is identified, subsequent treatments will start at the power level last used.
• Sham Comparator: Sham Arm
  The investigators will configure the rPMS device to not utilize any power, then place the treatment wand over the participant's back pain area and hit the start button like they do in the treatment arm. When the power setting is set to zero, the magnetic wand will not generate any power but will still make the customary computer-generated tones as it does in normal operation. The device is set to play a completed tone once 2 minutes and 30 seconds have elapsed just as it does in the normal treatment. The investigator will then replace the wand back to the storage position and notify the patient that the session is completed. Following completion of 5 sessions, the sham group will be offered to receive up to 5 sessions of real rPMS stimulation. The data from the sham treatment and real rPMS treatment for these patients will be tracked separately.

Primary Outcome Measure

Visual Analog Scale [ Time Frame: VAS numbers are obtained at: Baseline, pre-intervention. Immediately before each intervention Immediately after each intervention ]

Central Contacts

• Joe Zhang, MD
  415-619-9997
  [email protected]
• Joshua Ford, PhysD
  661-275-5057
  [email protected]

Locations (1)

Find similar trials in Edwards Air Force Base, CA

Related Studies

• Randomized Trial for cLBP (Gokhale Project)
  Recruiting · Stanford University · Redwood City, California