Ankle Spine Syndrome "RAFFET Syndrome II

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06140862
• Other study ID #: CUniv
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 25, 2024

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Asthenia
• Chronic Low-back Pain
• Intervertebral Disc Displacement
• Low Back Pain
• Lumbar Disc Herniation
• Muscle Weakness
• Paresis

Intervention

Other:
• calf muscle strengthening and streching
lumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza	Cairo University

Sponsors (1)

Lead Sponsor	Collaborator
Noha Khaled Shoukry

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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