Ensayos clínicos

Inclusion Criteria:

• Age 21-75 years old, inclusive.
• Pain and discomfort of unknown etiology between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs), lasting for more than 12 weeks (measured by patient past history and lumbar physical exam).
• There may be waist muscle weakness, stiffness, limited mobility or reduced spinal coordination. The symptoms of pain are lessened or disappeared after bed rest. While the symptoms of pain are aggravated after bending over, sedentary, or standing for a long time (measured by patient past history and lumbar physical exam).
• Physical examination showed an increase in muscle tension or a significant localized tenderness point (trigger point) in the painful area, with negative straight-leg raising test, and no signs of nerve root lesions.
• Patients with Radiographic results of MRI, CT and X-ray within 1 year.
• Female patients who are of childbearing potential and are likely to become pregnant during the treatment phrase must have a negative pregnancy test (human chorionic gonadotropin (HCG) urine test).

Exclusion Criteria:

• Patients with low back pain associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes and reflexes).
• Patients with severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus) (measured by patient past history and lumbar physical exam).
• Serious spinal pathologies such as fractures, tumors, inflammatory and infectious diseases (measured by patient past history and lumbar physical exam).
• History of lumbar spinal surgery (measured by patient past history).
• Serious cardiovascular or metabolic disorders, such as heart failure, severe osteoporosis (measured by patient past history).
• Patients diagnosed with cognitive issues such as major depression, and moderate to severe dementia severe psychiatric diseases (such as schizophrenia, bipolar affective disorder, paranoid psychosis) (measured by patient past history).
• Women who are pregnant, or who are of childbearing potential and are likely to become pregnant during the treatment phase but are not willing to use a reliable form of contraception.  Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine device, surgical sterilization, and abstinence.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.