Foot Spine Syndrome "RAFFET Syndrome"

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Low-back Pain; Hallux Rigidus
• Intervention / Treatment: Other: manual therapy and exercise for the big toe; Other: lumbar stabilization exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12556
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: manual therapy 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	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
Experimental: lumbar stabilization exercise; core training and myofascial release therapy	Other: lumbar stabilization exercise; core training and myofascial release therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical pain rating scale	considered the gold standard for back pain assessment	three months
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

Collaborators and Investigators

• Sponsor: Noha Khaled Shoukry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): December 25, 2023

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Back Pain; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Low Back Pain; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: Cairounivers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No