Chronic Ankle InjuriesNCT06140862
Ankle Spine Syndrome "RAFFET Syndrome II
A study testing calf muscle strengthening and streching in people with Chronic Ankle Injuries and Chronic Low-back Pain, run by Noha Khaled Shoukry at 1 site in Egypt.
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'… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Chronic Ankle Injuries, Chronic Low-back Pain, Lumbar Disc Herniation
- What is being tested?
- calf muscle strengthening and streching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- pain score less than 8 functional disability scores less than 10 red flags as tumor or osteoprosis or bone infection previous back surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Ankle Injuries, Chronic Low-back Pain, Lumbar Disc Herniation, Calf Muscle Weakness
- Being tested
- calf muscle strengthening and streching
- Keywords
- Ankle Spine Syndrome, Raffet Syndrome II, Contralateral Lumber Radiculopathy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calf muscle strengthening and strechingOther
Also called lower back rehabilitation program
lumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: calf muscle strengthening and streching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six month
Secondary outcomes (1)
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start1 Sep 2022
- Primary completion25 Jan 2024 (estimated)
- Study completion25 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Khaled Shoukry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Khaled Shoukry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140862
- Sponsor's protocol ID
- CUniv
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ipsilateral Calf Muscle Weakness Induces Contralateral Radiculopathy , Where is the Clinical Biomechanics? "Part I"
- ClinicalTrials.gov ID
- NCT06140862
- Acronym / sponsor ID
- CUniv
- Conditions
- Chronic Ankle Injuries, Chronic Low-back Pain, Lumbar Disc Herniation, Calf Muscle Weakness
- Keywords
- Ankle Spine Syndrome, Raffet Syndrome II, Contralateral Lumber Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Noha Khaled ShoukryUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Jan 2024 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calf muscle exercise | Experimental | Other: calf muscle strengthening and strechingthe 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 |
| lower back exercise | Other | Other: calf muscle strengthening and strechinglumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- pain score less than 8 functional disability scores less than 10 red flags as tumor or osteoprosis or bone infection previous back surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calf muscle strengthening and strechingAlso: lower back rehabilitation programlumbar stabilization exercises, core strength training, myofascial release therapy for lower back, and stretching exercises for hamstring muscle. | Other | calf muscle exercise, lower back exercise |
Primary outcome
Oswestry Disability Index (ODI) known as Oswestry Low Back Pain Disability Questionnaire
Time frame: 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
1 secondary outcome
back pain was assessed using Numerical Pain Rating Scale (NPRS)
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calf muscle strengthening and streching in people with Chronic Ankle Injuries and Chronic Low-back Pain, run by Noha Khaled Shoukry at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) known as Oswestry Low Back Pain Disability Questionnaire (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.