Lumbar Spinal StenosisNCT04379765
Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Exercise and physical therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Oct 2023
- Phase
- Observational
- 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 85 years
- All sexes
- Adult, Older adult
Study population: It is planned to take 60 patients with a diagnosis of spinal stenosis to perform physical therapy models and exercise for 30 patients and surgical treatment for 30 patients. Patients between the ages of 40-85 will be admitted and no difference will be made in terms of gender. The child patient will not be included in the study.
Who may be able to join
- To be between 40-85 years old
- Defining neurogenic claudication in patient anamnesis
- Diagnosis of lumbar stenosis in MR and / or CT imaging
- The duration of the symptom should be at least 4 weeks
- Other causes of low back pain have been ruled out
Who cannot join
- Having had lumbar surgery before
- Physical therapy for lumbar spinal stenosis less than 3 months ago
- Any lumbar injection has been applied before
- Patients with inflammatory low back pain
- Patients with spinal stenosis due to spondylolysis and / or spondylolisthesis
- Patients with a history of trauma and suspected Vertebral fracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Science Health University Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, 34100
About this study
Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.
Read the detailed description
Patients between 40-85 years old who are hospitalized and treated with the diagnosis of LSS in Physical Medicine and rehabilitation, Orthopedics and Neurosurgery Clinics will be included in the study. The diagnosis of LSS will be made by MR and / or CT and neurogenic claudication history.
Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment, and the duration of the study is considered to be 24 months. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.
Clinical evaluation will be done by the same physician. In patients with spinal stenosis, pain (movement, rest, night) VAS, functional status walking distance and ILBDI (Istanbul waist pain disability index) inquiry form, Nottingham Extended Life Profile will be used.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Exercise and physical therapy
- Keywords
- Lumbar Spinal Stenosis, Rehabilitation, Surgery, Exercise
- Medical subject headings
- Spinal Stenosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and physical therapyBehavioural
Also called Surgery
Decompression operation
| Study group | Role | What they receive |
|---|---|---|
| Grup 1: Exercise and physical therapy programme | 30 patients with lumbar spinal stenosis will receive hot pack, transcutaneous electrical nerve stimulation and deep warming as a physical therapy modality , and lumber flexion and strengthening exercises were performed for 7 times/week for 3 weeks. Receives: Behavioral: Exercise and physical therapy | |
| Grup 2: Surgical procedure programme | 30 patients with lumbar spinal stenosis underwent decompression operation of the relevant level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation VAS (visual analog scale) for pain assessment
Clinical evaluation will be done by the same physician. In patients with spinal stenosis, VAS (visual analog scale) for pain assessment will be used.
Measured: 1st month
Clinical Evaluation 2 functional status walking distance
In patients with spinal stenosis, functional status walking distance will be used.
Measured: 1st month
Clinical Evaluation 3 Istanbul waist pain disability index
In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.
Measured: 1st month
Clinical Evaluation 4 Nottingham Extended Life Profile
In patients with spinal stenosis, Nottingham Extended Life Profile will be used.
Measured: 1st month
Secondary outcomes (4)
Clinical Evaluation 5
In patients with spinal stenosis, VAS will be used in 3rd , 6th and 12th month.
Measured: 12th month
Clinical Evaluation 6
In patients with spinal stenosis, functional status walking distance will be used in 3rd , 6th and 12th month.
Measured: 12th month
Clinical Evaluation 7
In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used in 3rd , 6th and 12th month.
Measured: 12th month
Clinical Evaluation 8
In patients with spinal stenosis, Nottingham Extended Life Profile will be used in 3rd , 6th and 12th month.
Measured: 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Mar 2020
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Figen Yılmaz, Prof. Dr., Principal investigator, Şişli Hamidiye Etfal Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379765
- Sponsor's protocol ID
- 2373
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsubosaka M, Kaneyama S, Yano T, Kasahara K, Kanemura A, Takabatake M, Hirata H, Sumi M. The factors of deterioration in long-term clinical course of lumbar spinal canal stenosis after successful conservative treatment. J Orthop Surg Res. 2018 Sep 18;13(1):239. doi: 10.1186/s13018-018-0947-2.
PubMed 30227869
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT04379765
- Acronym / sponsor ID
- 2373
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar Spinal Stenosis, Rehabilitation, Surgery, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 7 May 2020 (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.
Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.
Detailed description
Patients between 40-85 years old who are hospitalized and treated with the diagnosis of LSS in Physical Medicine and rehabilitation, Orthopedics and Neurosurgery Clinics will be included in the study. The diagnosis of LSS will be made by MR and / or CT and neurogenic claudication history.
Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment, and the duration of the study is considered to be 24 months. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.
Clinical evaluation will be done by the same physician. In patients with spinal stenosis, pain (movement, rest, night) VAS, functional status walking distance and ILBDI (Istanbul waist pain disability index) inquiry form, Nottingham Extended Life Profile will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grup 1: Exercise and physical therapy programme | – | Behavioral: Exercise and physical therapy30 patients with lumbar spinal stenosis will receive hot pack, transcutaneous electrical nerve stimulation and deep warming as a physical therapy modality , and lumber flexion and strengthening exercises were performed for 7 times/week for 3 weeks. |
| Grup 2: Surgical procedure programme | – | –30 patients with lumbar spinal stenosis underwent decompression operation of the relevant level. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- It is planned to take 60 patients with a diagnosis of spinal stenosis to perform physical therapy models and exercise for 30 patients and surgical treatment for 30 patients. Patients between the ages of 40-85 will be admitted and no difference will be made in terms of gender. The child patient will not be included in the study.
Key inclusion criteria (5 listed)
- To be between 40-85 years old
- Defining neurogenic claudication in patient anamnesis
- Diagnosis of lumbar stenosis in MR and / or CT imaging
- The duration of the symptom should be at least 4 weeks
- Other causes of low back pain have been ruled out
Key exclusion criteria (6 listed)
- Having had lumbar surgery before
- Physical therapy for lumbar spinal stenosis less than 3 months ago
- Any lumbar injection has been applied before
- Patients with inflammatory low back pain
- Patients with spinal stenosis due to spondylolysis and / or spondylolisthesis
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 |
|---|---|---|
| Exercise and physical therapyAlso: SurgeryDecompression operation | Behavioural | Grup 1: Exercise and physical therapy programme |
Primary outcome
Clinical Evaluation VAS (visual analog scale) for pain assessment
Time frame: 1st month
Clinical evaluation will be done by the same physician. In patients with spinal stenosis, VAS (visual analog scale) for pain assessment will be used.
Clinical Evaluation 2 functional status walking distance
Time frame: 1st month
In patients with spinal stenosis, functional status walking distance will be used.
Clinical Evaluation 3 Istanbul waist pain disability index
Time frame: 1st month
In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.
Clinical Evaluation 4 Nottingham Extended Life Profile
Time frame: 1st month
In patients with spinal stenosis, Nottingham Extended Life Profile will be used.
4 secondary outcomes
Clinical Evaluation 5
Time frame: 12th month
Clinical Evaluation 6
Time frame: 12th month
Clinical Evaluation 7
Time frame: 12th month
Clinical Evaluation 8
Time frame: 12th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Results publication: PubMed 30227869Tsubosaka M, Kaneyama S, Yano T, Kasahara K, Kanemura A, Takabatake M, Hirata H, Sumi M. The factors of deterioration in long-term clinical course of lumbar spinal canal stenosis after successful conservative treatment. J Orthop Surg Res. 2018 Sep 18;13(1):239. doi: 10.1186/s13018-018-0947-2.
- 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.
Figen Yılmaz, Prof. Dr. principal investigator
Şişli Hamidiye Etfal Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Nov 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Evaluation VAS (visual analog scale) for pain assessment (time frame: 1st month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379765, which also lists 1 linked publication.
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 27 Nov 2023.