Clinical trial: Vibratory Stimulation for the Treatment of Chronic Pain (NCT04069572)

Eligibility criteria:
Inclusion Criteria:

          -  Age greater than or equal to 18 years old.

          -  Diagnosis of either chronic pelvic pain, functional abdominal pain, axial low back
             pain, or migraine with or without aura of at least 3 months duration.

          -  English speaking

          -  Ability and willingness to complete questionnaires and in-person assessments

          -  Current average daily pain score of greater than or equal to 4 on the Numeric Rating
             Scale of Pain (0-10 scale)

          -  For patients with migraine diagnosis they must report at least 2 headaches in the
             baseline headache diary in the 30 days preceding randomization.

        Exclusion Criteria:

          -  Any conditions causing inability to complete assessments (education, cognitive
             ability, mental status, medical status)

          -  Any significant psychiatric problems, including acute confusional state (delirium),
             ongoing psychosis, or clinically significant depression

          -  Any suicidality as assessed by answer of greater than 0 on question 9 the PHQ-9
             assessing suicidal thoughts.

          -  Any current illicit drug or alcohol abuse.

          -  Any history of recurrent or unprovoked seizures.

          -  Participation in another drug, device, or biologics trial concurrently or within the
             preceding 30 days.

          -  Pregnancy, breast-feeding or lack of reliable contraception

          -  Changes in pain medications in the previous 4 weeks

          -  Implanted electrical stimulation device.

          -  Skin infection over stimulation sites.

          -  Any pain interventions in the preceding 6 weeks (epidural steroid injection,
             sympathetic block, peripheral nerve block, lumbar medial branch blocks) Any botulinum
             toxin injection in the previous 3 months

          -  For patients with migraine diagnosis additional exclusion criteria include receipt of
             preventive anti-migraine treatment in the past 3 months, failure on greater than or
             equal to 3 well-conducted preventive drug trials, concurrent medication overuse
             headache diagnosis, and concurrent frequent/chronic tension type headache.

             4. Frequent/chronic tension type headache
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Contradiction