Ankle Spine Syndrome "RAFFET Syndrome II

Sponsor
Noha Khaled Shoukry (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06140862
Collaborator
(none)
1,000
1
2
14.8
67.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: calf muscle strengthening and streching
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ipsilateral Calf Muscle Weakness Induces Contralateral Radiculopathy , Where is the Clinical Biomechanics? "Part I"
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 25, 2023
Anticipated Study Completion Date :
Nov 25, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Oswestry Disability Index (ODI) known as Oswestry Low Back Pain Disability Questionnaire [six month]

      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

    Secondary Outcome Measures

    1. back pain was assessed using Numerical Pain Rating Scale (NPRS) [6 month]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Physical Therapy Giza Cairo University Egypt 12613

    Sponsors and Collaborators

    • Noha Khaled Shoukry

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha Khaled Shoukry, lecturer, Cairo University
    ClinicalTrials.gov Identifier:
    NCT06140862
    Other Study ID Numbers:
    • CUniv
    First Posted:
    Nov 20, 2023
    Last Update Posted:
    Nov 20, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Noha Khaled Shoukry, lecturer, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 20, 2023