NCT06180408

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

December 5, 2023

Last Update Submit

December 21, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

manual therapy for the big toe

EXPERIMENTAL

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

lumbar stabilization exercise

EXPERIMENTAL

core training and myofascial release therapy

Other: lumbar stabilization exercise

Interventions

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

manual therapy for the big toe

core training and myofascial release therapy

lumbar stabilization exercise

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12556, Egypt

Location

MeSH Terms

Conditions

Hallux Rigidus

Interventions

Musculoskeletal ManipulationsExercise

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 22, 2023

Study Start

January 1, 2022

Primary Completion

June 30, 2023

Study Completion

December 25, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations