Background
Aims
Methods/Design
Study design
Participants
Inclusion criteria | Exclusion criteria |
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• 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 |
Intervention
Basic therapies
Basic therapies | Direction for use |
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Bed rest | Stay in bed for 18 to 20 hours per day including sleeping time. |
Dehydration | 20% Mannitol injection, 250 ml, VD within 30 min, once a day for the first 5 days. |
NSAID | After each SM therapy, the patient will be given 500 mg Paracetamol orally for 2 days (b.i.d.) in order to reduce the adverse regional irritation caused by SM. |
Regional fomentation | Low back fomentation is applied with a hot pack of Chinese herbs* for 20 minutes, twice per day during the observation period. |
Walking exercise | Patient could take a walking exercise with the assistance of a wheeled walker aid if no serious pain has been induced. The walking time should be limited to less than 20 minutes each time and to three times a day. |
Spinal manipulation
Three types of FSM | Different specific procedures |
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SSM (placebo) | No further torsion stress loaded on the involved joint after trunk rotation is ended at the limit of ROM, although the doctor’s thumb is gently located on the lower part of the lumbar spine. |
SMO (mobilization) | After trunk rotation reaches the end of the ROM of the lumbar spine, more torsion stress is gently and slowly loaded on the patient’s shoulder and the involved joint during the rotation within 3 seconds with the feature of LVVA with the help of the doctor’s thumb steadily and firmly pressed against the spinous process of the involved segment accompanied by no cracking sound most of the time. |
SMA (manipulation) | After trunk rotation reaches the end of the ROM of the lumbar spine, more torsion stress is forcefully and quickly loaded on the patient shoulder and the involved joint within 0.5 seconds with the feature of HVLA with the help of the doctor’s thumb swiftly and firmly pressed against the spinous process of the involved segment accompanied by cracking sound some of the time. |