Chronic Low-back PainNCT06180408
Foot Spine Syndrome "RAFFET Syndrome"
A study testing manual therapy and exercise for the big toe and lumbar stabilization exercise in people with Chronic Low-back Pain and Hallux Rigidus, run by Noha Khaled Shoukry at 1 site in Egypt.
Trial summary
case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Low-back Pain, Hallux Rigidus
- What is being tested?
- manual therapy and exercise for the big toe and lumbar stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 25 Dec 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with a history of chronic low back pain (CLBP) did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side
Who cannot join
- any structural deformity (wedge fracture) or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Systematic disorder (Rheumatoid) Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foot Spine Syndrome "RAFFET Syndrome" New Critical Implication in Clinical Biomechanics
case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022.
Read the detailed description
Foot pain is usually derived from systemic disorder or local physical issues, such as tendonitis, arthritis, or bursitis. However, in some cases, pain in your foot may be linked to problems in your spine. This case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022. The patients suffered from CLBP that did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side. Manual therapy for the big toe including; Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed.
- Conditions
- Chronic Low-back Pain, Hallux Rigidus
- Being tested
- manual therapy and exercise for the big toe, lumbar stabilization exercise
- Medical subject headings
- Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapy and exercise for the big toeOther
Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed
lumbar stabilization exerciseOther
core training and myofascial release therapy
| Study group | Role | What they receive |
|---|---|---|
| manual therapy for the big toe | Experimental | Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed Receives: Other: manual therapy and exercise for the big toe |
| lumbar stabilization exercise | Experimental | core training and myofascial release therapy Receives: Other: lumbar stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical pain rating scale
considered the gold standard for back pain assessment
Measured: three months
Oswestry disability index
It is a valid, reliable and responsive clinical tool used to determine the level of functional disability associated with CLBP
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Jan 2022
- Primary completion30 Jun 2023
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 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
- NCT06180408
- Sponsor's protocol ID
- Cairounivers
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Spine Syndrome "RAFFET Syndrome" New Critical Implication in Clinical Biomechanics
- ClinicalTrials.gov ID
- NCT06180408
- Acronym / sponsor ID
- Cairounivers
- Conditions
- Chronic Low-back Pain, Hallux Rigidus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Noha Khaled ShoukryUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 22 Dec 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.
case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022.
Detailed description
Foot pain is usually derived from systemic disorder or local physical issues, such as tendonitis, arthritis, or bursitis. However, in some cases, pain in your foot may be linked to problems in your spine. This case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022. The patients suffered from CLBP that did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side. Manual therapy for the big toe including; Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual therapy for the big toe | Experimental | Other: manual therapy and exercise for the big toeMaitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed |
| lumbar stabilization exercise | Experimental | Other: lumbar stabilization exercisecore training and myofascial release therapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with a history of chronic low back pain (CLBP) did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side
Key exclusion criteria (1 listed)
- any structural deformity (wedge fracture) or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Systematic disorder (Rheumatoid) Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness.
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 |
|---|---|---|
| manual therapy and exercise for the big toeMaitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed | Other | manual therapy for the big toe |
| lumbar stabilization exercisecore training and myofascial release therapy | Other | lumbar stabilization exercise |
Primary outcome
numerical pain rating scale
Time frame: three months
considered the gold standard for back pain assessment
Oswestry disability index
Time frame: three months
It is a valid, reliable and responsive clinical tool used to determine the level of functional disability associated with CLBP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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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 manual therapy and exercise for the big toe and lumbar stabilization exercise in people with Chronic Low-back Pain and Hallux Rigidus, 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 1 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 22 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?
numerical pain rating scale (time frame: three months). The study lists 2 primary outcomes in all. 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 22 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.