NCT06140862

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.

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
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

November 15, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

Ankle Spine SyndromeRaffet Syndrome IIContralateral Lumber Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • back pain was assessed using Numerical Pain Rating Scale (NPRS)

    6 month

Study Arms (2)

calf muscle exercise

EXPERIMENTAL

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

lower back exercise

OTHER

lumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle.

Other: calf muscle strengthening and streching

Interventions

lumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle.

Also known as: lower back rehabilitation program
calf muscle exerciselower back exercise

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Cairo University, 12613, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 20, 2023

Study Start

September 1, 2022

Primary Completion

January 25, 2024

Study Completion

January 25, 2024

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations