Fibromyalgia Study

Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. Researchers believe that fibromyalgia amplifies painful sensations by affecting the way your brain processes pain signals.

Symptoms sometimes begin after a physical trauma, surgery, infection or significant psychological stress. In other cases, symptoms gradually accumulate over time with no single triggering event.

Symptoms of fibromyalgia include:

  • Widespread pain. The pain associated with fibromyalgia often is described as a constant dull ache that has lasted for at least three months. To be considered widespread, the pain must occur on both sides of your body and above and below your waist.
  • Fatigue. People with fibromyalgia often awaken tired, even though they report sleeping for long periods of time. Sleep is often disrupted by pain, and many patients with fibromyalgia have other sleep disorders, such as restless legs syndrome and sleep apnea.
  • Cognitive difficulties. A symptom commonly referred to as “fibro fog” impairs the ability to focus, pay attention and concentrate on mental tasks.
  • Other problems. Many people who have fibromyalgia also may experience depression, headaches, and pain or cramping in the lower abdomen.

Women are much more likely to develop fibromyalgia than are men. Many people who have fibromyalgia also have tension headaches, temporomandibular joint (TMJ) disorders, irritable bowel syndrome, anxiety and depression. While there is no cure for fibromyalgia, a variety of medications can help control symptoms. Exercise, relaxation and stress-reduction measures also may help.

Potential study volunteers must be over the age of 18 and meet the following criteria:

1. History of widespread pain.

Definition. Pain is considered widespread when all of the following are present: pain in the left side of the body, pain in the right side of the body, pain above the waist, and pain below the waist. In addition, axial skeletal pain (cervical spine or anterior chest or thoracic spine or low back) must be present. In this definition, shoulder and buttock pain is considered as pain for each involved side. “Low back” pain is considered lower segment pain.

2. Pain in 11 of 18 tender point sites on digital palpation.

Definition. Pain, on digital palpation, must be present in at least 11 of the following 18 sites:
Occiput: Bilateral, at the suboccipital muscle insertions.
Low cervical: bilateral, at the anterior aspects of the intertransverse spaces at C5-C7.
Trapezius: bilateral, at the midpoint of the upper border.
Supraspinatus: bilateral, at origins, above the scapula spine near the medial border.
Second rib: bilateral, at he second costochondral junctions, just lateral to the junctions on upper surfaces.
Lateral epicondyle: bilateral, 2 cm distal to the epicondyles.
Gluteal: bilateral, in upper outer quadrants of buttocks in anterior fold of muscle.
Greater trochanter: bilateral, posterior to the trochanteric prominence.
Knee: bilateral, at the medial fat pad proximal to the joint line.

Digital palpation should be performed with an approximate force of 4 kg.
For a tender point to be considered “positive” the subject must state that the palpation was painful. “Tender is not to be considered “painful.”

* For classification purposes, patients will be said to have fibromyalgia if both criteria are satisfied. Widespread pain must have been present for at least 3 months. The presence of a second clinical disorder does not exclude the diagnosis of fibromyalgia.

For consideration in the upcoming fibromyalgia clinical trial, please submit your information below or contact the Clinical Study Center at 239-936-4421.