Foot Spine Syndrome "RAFFET Syndrome"

Chronic Low-back Pain Clinical Trial

Official title:

Foot Spine Syndrome "RAFFET Syndrome" New Critical Implication in Clinical Biomechanics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06180408
• Other study ID #: Cairounivers
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 25, 2023

Study information

• Verified date: December 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Foot pain is usually derived from systemic disorder or local physical issues, such as tendonitis, arthritis, or bursitis. However, in some cases, pain in your foot may be linked to problems in your spine. This 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. The patients suffered from CLBP that 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. Manual therapy for the big toe including; Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Hallux Limitus
• Hallux Rigidus
• Low Back Pain

Intervention

Other:
• manual therapy and exercise for the big toe
Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed
• lumbar stabilization exercise
core training and myofascial release therapy

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Noha Khaled Shoukry

Country where clinical trial is conducted

Egypt, 

Outcome

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