Skip to main content

Table 1 Inclusion and exclusion criteria

From: Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial

Inclusion criteria Exclusion criteria
• Low back pain, lower limb pain is radiatingly distributed and correlates with the involved PNP as proven by MRI • Congenital abnormalities, such as lumbosacral vertebrae crack, spondylolysis and transitional vertebrae, etcetera
• Two of four possible signs of neurological disorders: muscle atrophy, weakness, paresthesia and change in reflection that appeared in the nerve distribution areas • Injury, such as fracture
• Inflammatory and metabolic diseases, such as tuberculosis, ankylosing spondylitis, or osteoporosis
• Either straight leg raising test or femoral nerve traction test is positive • Degenerative diseases, such as degenerative lumbar spondylolisthesis, degenerative lumbar instability, lumbar degenerative scoliosis and lumbar spinal stenosis, etcetera
• EMG or NCV shows nerve root injury correlated with involved segment
• MRI image reveals a PNP of a single lumbar segment in accordance with the nerve root irritation signs detected by the examiner • Vascular and visceral reflex low back pain, such as digestive system diseases, gynecological diseases, or abdominal aortic aneurysm
• Tenderness, swelling and thickness of supraspinous ligament could be palpated on the involved segment. Regional and/or radiating tenderness could be irritated by paraspinal palpation • Spinal tumors from inside and outside spinal canal, such as large spinal arachnoid cysts, or diabetic peripheral neuropathy
• Patients receiving oral medication, physical therapy and other modality
• Participants suffered with acute pain no more than 6 weeks • Patients with foot-drop caused by peroneal nerve paralysis
• NRS score is more than or equal to 6 and ODI score is more than or equal to 40 • Patients with saddle anesthesia or defecation dysfunction caused by CES
• Participants must have no prior experience of being treated by FSM (see below) • Patients with depression, anxiety and other mental disorders
• Participants must sign the informed consent • Patients with open lumbar surgeries
  1. CES, cauda equina syndrome; EMG, electromyogram; FSM, Feng’s Spinal Manipulative Therapy; MRI, magnetic resonance imaging; NCV, nerve conduction velocity; NRS, numerical rating scale; ODI, Oswestry Disability Index; PNP, protruded nucleus pulposus.