Ankle Spine Syndrome "RAFFET Syndrome II

Ipsilateral Calf Muscle Weakness Induces Contralateral Radiculopathy , Where is the Clinical Biomechanics? "Part I"

A case series aimed to describe a new clinical condition for the first time in the medical literature called Ankle Spine Syndrome or "RAFFET Syndrome II". This syndrome was reported in 6 patients (2 males and 4 females) out of 1000 patients with a history of chronic ankle injuries affecting their calf muscles' strength throughout the last 3 years. The patients suffered from unresolved CLBP with radiculopathy contralateral to their calf muscle atrophy (i.e., an ipsilateral calf muscle weakness induces contralateral lumbar radiculopathy) that did not respond to physical therapy or any medication for long.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Low-back Pain; Lumbar Disc Herniation; Chronic Ankle Injuries; Calf Muscle Weakness
• Intervention / Treatment: Other: calf muscle strengthening and streching

Detailed Description

There is a large body of research performed to investigate the etiology of contralateral radiculopathy. However, limited information exists to determine its incidence, underlying pathomechanics, and strategies for management. Therefore, this case series aimed to describe a new clinical condition for the first time in the medical literature called Ankle Spine Syndrome or "RAFFET Syndrome II". This syndrome was reported in 6 patients (2 males and 4 females) out of 1000 patients with a history of chronic ankle injuries affecting their calf muscles' strength throughout the last 3 years. The patients suffered from unresolved CLBP with radiculopathy contralateral to their calf muscle atrophy (i.e., an ipsilateral calf muscle weakness induces contralateral lumbar radiculopathy) that did not respond to physical therapy or any medication for long. Open and closed chain strengthening exercises for the calf muscle were performed. The strengthening exercises include; double leg calf raise (i.e., straight and bent knees), single leg calf raise (i.e., straight and bent knee), seated calf raise, and wall sit calf raise. The patients' long-term back pain and function resolved greatly. By including lumbar stabilization exercises, core training, and myofascial release therapy, the symptoms resolved completely. Furthermore, with a follow-up after 6 months of a tailored home exercise program, the clinical outcome measures still resolved completely.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo University
    • Giza, Cairo University, Egypt, 12613
      • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Clinical presentation of lumbar radicular pain (i.e., contralateral radiculopathy) was sharp, distinctive, shooting, or lancinating. It felt like a narrow band of pain (i.e., not more than 5-8 cm wide) throughout the length of the lower limb. It was experienced superficially and deeply.

They had back pain intensity scores that ranged from 8 to 10 indicating a severe degree of pain during dynamic activity while almost all patients scored zero while resting Our patients with this syndrome had functional disability scores that ranged from 10 to 22 indicating mild and moderate degrees of disability.

had a history of physical therapy visits for back pain and sciatica at many specialized centers

Exclusion Criteria:

• pain score less than 8 functional disability scores less than 10 red flags as tumor or osteoprosis or bone infection previous back surgery

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: calf muscle exercise; the initial treatment plane was open and closed chain strengthening exercises for the calf muscle. The strengthening exercises include; double leg calf raise (i.e., straight and bent knees), single leg calf raise (i.e., straight and bent knee), seated calf raise, and wall sit calf raise. Calf stretching exercises were added to maintain the flexibility of the muscle and its Achilles tendon. Gait training protocol was also performed for correction of chronically adapted abnormal gait pattern especially at the mid stance and terminal stance sub-phases of GC	Other: calf muscle strengthening and streching; lumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle.; Other Names: lower back rehabilitation program
Other: lower back exercise; lumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle.	Other: calf muscle strengthening and streching; lumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle.; Other Names: lower back rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI) known as Oswestry Low Back Pain Disability Questionnaire	It is a 10-section, self-report questionnaire to evaluate the impact of back pain on functional activities. Our patients in this syndrome had functional disability scores that ranged from 10 to 22 indicating mild and moderate degrees of disability. It is a valid, reliable and responsive clinical tool used to determine the level of functional disability associated with CLBP	six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
back pain was assessed using Numerical Pain Rating Scale (NPRS)	It is 11-point numeric scale ranges from zero that indicates "no pain" to 10 that indicates "the worst pain possible". The patients were asked to select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours	6 month

Collaborators and Investigators

• Sponsor: Noha Khaled Shoukry

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): January 25, 2024
• Study Completion (Estimated): January 25, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Ankle Spine Syndrome; Raffet Syndrome II; Contralateral Lumber Radiculopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Muscle Weakness; Intervertebral Disc Displacement; Ankle Injuries; Paresis; Asthenia
• Other Study ID Numbers: CUniv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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