Chronic Low-back Pain Clinical Trial
Official title:
Foot Spine Syndrome "RAFFET Syndrome" New Critical Implication in Clinical Biomechanics
Verified date | December 2023 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022.
Status | Active, not recruiting |
Enrollment | 11 |
Est. completion date | December 25, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: - patients with a history of chronic low back pain (CLBP) did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side Exclusion Criteria: - any structural deformity (wedge fracture) or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Systematic disorder (Rheumatoid) Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Physical Therapy | Giza |
Lead Sponsor | Collaborator |
---|---|
Noha Khaled Shoukry |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | numerical pain rating scale | considered the gold standard for back pain assessment | three months | |
Primary | Oswestry disability index | It is a valid, reliable and responsive clinical tool used to determine the level of functional disability associated with CLBP | three months |
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