Lumbosacral RadiculopathyNCT06167044
Effect of Thoracic Mobilization on Lumbar Radiculopathy
A study testing thoracic mobilization in people with Lumbosacral Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study will be to: To investigate the effect of thoracic mobilization on back and leg pain in patients with lumbosacral radiculopathy. To investigate the effect of thoracic mobilization on functional disability in patients with lumbosacral radiculopathy. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- thoracic mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jul 2023to Feb 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unilateral chronic lumbosacral radiculopathy at L4- L5 or / and L5-S1 levels confirmed by MRI.
- The age of patients will be ranged from 30 to 45 years.
- Duration of pain will be more than 12 weeks.
- Patients with a positive straight leg raising (SLR) test.
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions .
- Patients had to report an average pain level of more than five on the Visual Analogue Scale (VAS) and a lumbar spine range of motion (ROM) of at least 50% of the accepted normal range.
- Patients with body mass index< 30kg/m2
Who cannot join
- Cauda equina syndrome.
- Ankylosing spondylitis, thoracic deformities (pectus carinatum, excavatum), spina bifida, fractures, postoperative spinal conditions, diabetes, inflammatory processes.
- Previous inner ear infection or vestibular disorder with unresolved balance disturbance, history of head trauma with residual neurological deficits.
- Spinal tumor.
- Previous lumbar surgery.
- Sever musculoskeletal disease.
Show all 9Show fewer
- Peripheral mononeuropathies or polyneuropathy.
- Obesity .
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Cairo
About this study
Official title: Effect of Thoracic Spine Mobilization on Pain, Functional Disability and Proprioception in Patients With Lumbosacral Radiculopathy.
The purpose of the study will be to:
- To investigate the effect of thoracic mobilization on back and leg pain in patients with lumbosacral radiculopathy.
- To investigate the effect of thoracic mobilization on functional disability in patients with lumbosacral radiculopathy.
- To investigate the effect of thoracic mobilization on proprioception in patients with lumbosacral radiculopathy.
Read the detailed description
To investigate the effect of thoracic mobilization on back and leg pain, functional disability and proprioception in patients with lumbosacral radiculopathy.
1-Thirty four patients of both sexes with unilateral chronic lumbar radiculopathy at L4-L5 or/ and L5-S1 levels will participate in this study. The patients will be diagnosed as having lumbar radiculopathy based on careful clinical examination by neurologist . The diagnosis will be confirmed by CT scan or MRI.
Patients will be recruited from the outpatient clinic of Faculty of Physical Therapy, Cairo University and private clinics. Patients in this study will be randomly divided into two groups.
- Group (I) which will include 17 patients who will receive manual mobilization exercises in addition to selected physical therapy .
- Group (II) which will include 17 patients who will receive selected physical therapy.
The treatment will conducted 3 sessions per week for 6 weeks.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- thoracic mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic mobilizationOther
Thoracic mobilization will be performed for the thoracic spine mobilization group, thoracic mobilization therapy will be performed for five minutes.
| Study group | Role | What they receive |
|---|---|---|
| thoracic mobilization group | Active comparator | which will include 17 patients who will receive thoracic manual mobilization exercises in addition to selected physical therapy .The treatment will conducted for 45 minutes, 3 sessions per week for 6 weeks. Receives: Other: thoracic mobilization |
| control group | No intervention | which will include 17 patients who will receive selected physical therapy.The treatment will conducted for 45 minutes, 3 sessions per week for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional disability
we will use Oswestry Disability Index (ODI)
Measured: baseline
pain level
we will use Visual analogue scale (VAS)
Measured: baseline
lumbar proprioception
we will use The Biodex System 3 pro isokinetic dynamometer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start19 Jul 2023
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aya abd elmohsen salah eldeen, Cairo University
- Investigators
- Nagwa Ibrahim Rehab, Assistant Professor, Study chair, physical therapy for neuromuscular disorder and its surgeryEbtesam Mohamed Fahmy, Professor, Study chair, faculty of medicineHOSSAM MOHAMMED MOHAMMED, Lecturer, Study chair, physical therapy for neuromuscular disorder and its surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167044
- Sponsor's protocol ID
- thoracic mobilization in LR
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Spine Mobilization on Pain, Functional Disability and Proprioception in Patients With Lumbosacral Radiculopathy.
- ClinicalTrials.gov ID
- NCT06167044
- Acronym / sponsor ID
- thoracic mobilization in LR
- Conditions
- Lumbosacral Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 12 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.
The purpose of the study will be to:
- To investigate the effect of thoracic mobilization on back and leg pain in patients with lumbosacral radiculopathy.
- To investigate the effect of thoracic mobilization on functional disability in patients with lumbosacral radiculopathy.
- To investigate the effect of thoracic mobilization on proprioception in patients with lumbosacral radiculopathy.
Detailed description
To investigate the effect of thoracic mobilization on back and leg pain, functional disability and proprioception in patients with lumbosacral radiculopathy.
1-Thirty four patients of both sexes with unilateral chronic lumbar radiculopathy at L4-L5 or/ and L5-S1 levels will participate in this study. The patients will be diagnosed as having lumbar radiculopathy based on careful clinical examination by neurologist . The diagnosis will be confirmed by CT scan or MRI.
Patients will be recruited from the outpatient clinic of Faculty of Physical Therapy, Cairo University and private clinics. Patients in this study will be randomly divided into two groups.
- Group (I) which will include 17 patients who will receive manual mobilization exercises in addition to selected physical therapy .
- Group (II) which will include 17 patients who will receive selected physical therapy.
The treatment will conducted 3 sessions per week for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thoracic mobilization group | Active comparator | Other: thoracic mobilizationwhich will include 17 patients who will receive thoracic manual mobilization exercises in addition to selected physical therapy .The treatment will conducted for 45 minutes, 3 sessions per week for 6 weeks. |
| control group | No intervention | –which will include 17 patients who will receive selected physical therapy.The treatment will conducted for 45 minutes, 3 sessions per week for 6 weeks. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with unilateral chronic lumbosacral radiculopathy at L4- L5 or / and L5-S1 levels confirmed by MRI.
- The age of patients will be ranged from 30 to 45 years.
- Duration of pain will be more than 12 weeks.
- Patients with a positive straight leg raising (SLR) test.
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions .
Key exclusion criteria (9 listed)
- Cauda equina syndrome.
- Ankylosing spondylitis, thoracic deformities (pectus carinatum, excavatum), spina bifida, fractures, postoperative spinal conditions, diabetes, inflammatory processes.
- Previous inner ear infection or vestibular disorder with unresolved balance disturbance, history of head trauma with residual neurological deficits.
- Spinal tumor.
- Previous lumbar 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 |
|---|---|---|
| thoracic mobilizationThoracic mobilization will be performed for the thoracic spine mobilization group, thoracic mobilization therapy will be performed for five minutes. | Other | thoracic mobilization group |
Primary outcome
functional disability
Time frame: baseline
we will use Oswestry Disability Index (ODI)
pain level
Time frame: baseline
we will use Visual analogue scale (VAS)
lumbar proprioception
Time frame: baseline
we will use The Biodex System 3 pro isokinetic dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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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.
Nagwa Ibrahim Rehab, Assistant Professor study chair
physical therapy for neuromuscular disorder and its surgery
Ebtesam Mohamed Fahmy, Professor study chair
faculty of medicine
HOSSAM MOHAMMED MOHAMMED, Lecturer study chair
physical therapy for neuromuscular disorder and its surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic mobilization in people with Lumbosacral Radiculopathy, run by Cairo University 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 7 inclusion and 9 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 12 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?
Contact aya abd elmohsen, Bachelor's (01122935258, ayamohsen214@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional disability (time frame: baseline). The study lists 3 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 12 Dec 2023.