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Study Test Battery (Part 1)
The following is a listing of all of the evaluation tools that will be used in this study, for test and placebo subjects alike. For each study phase, the precise tools from this list that will be employed will be specified.
- The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
Reference: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: report of the multicenter criteria committee. Arthritis and Rheumatism. Vol. 3:160-72, No. 2 (February 1990).
For classification purposes, subjects will be said to have fibromyalgia if both criteria below ((1) & (2)) 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.
- History of widespread pain has been present for at least three months
Definition: Pain is considered widespread when all of the following are present:
- Pain in the right side of the body
- Pain in the left side of the body
- Pain above the waist
- Pain below the waist
- Axial skeletal pain (cervical spine, anterior chest, thoracic spine or low back pain) must be present.
N.B.: „Shoulder and buttock pain’ is considered as pain for each involved side. ‘Low back pain is considered lower segment pain.
- Pain present in at least 11 of 18 tender point sites on digital palpation
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.”
The tender point sites to be evaluated are described and illustrated below:
- 1 & 2: Occiput: bilateral, at the suboccipital muscle insertions.
- 3 & 4: Low cervical: bilateral, at the anterior aspects of the intertransverse spaces at C5-C7.
- 5 & 6: Trapezius: bilateral, at the midpoint of the upper border.
- 7 & 8: Supraspinatus: bilateral, at origins, above the scapula spine near the medial border.
- 9 & 10: Second Rib: bilateral, at the second costochondral junctions, just lateral to the junctions on upper surfaces.
- 11 & 12: Lateral epicondyle: bilateral, 2 cm distal to the epicondyles.
- 13 & 14: Gluteal: bilateral, in upper outer quadrants of buttocks in anterior fold of muscle.
- 15 & 16: Greater trochanter: bilateral, posterior to the trochanteric prominence.
- 17 & 18: Knee: bilateral, at the medial fat pad proximal to the joint line.
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