Thoracic Disc HerniationNCT05313997
The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain
An observational study of Thoracic Disc Herniation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Patients who applied to the Private Medar Hospital between February 2016 and February 2021 with chronic upper back pain and were diagnosed with Thoaracic Disc Herniatin (TDH) (with Thoracic vertebral MRI) and followed up for at least 1 year will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Disc Herniation
- What is being tested?
- Diclofenac Sodium
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2022to 15 Jul 2022
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: * 18-65 years old * admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain. * Diagnosed with TDH as a result of thoracic vertebral MRI
Who may be able to join
- 18-65 years old
- admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain.
- Diagnosed with TDH as a result of thoracic vertebral MRI
Who cannot join
- vertebral fracture,
- developmental spinal deformity,
- spinal infection or tumor,
- chronic widespread pain syndrome such as fibromyalgia,
- diabetes mellitus,
- polyneuropathy
Show all 10Show fewer
- rheumatological disease
- under 18 years old
- over 65 years old
- who have had previous back and neck surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain, A Follow-Up Study
Patients who applied to the Private Medar Hospital between February 2016 and February 2021 with chronic upper back pain and were diagnosed with Thoaracic Disc Herniatin (TDH) (with Thoracic vertebral MRI) and followed up for at least 1 year will be included in the study.
Patients diagnosed with TDH were included in the medical treatment and/or physical therapy program.
Read more
Before and after these treatment programs, the pain intensity of the patients was recorded with the visual analog scale (VAS).
The number of patients who applied to the Physical Medicine and Rehabilitation outpatient clinic with chronic upper back pain between February 2016 and February 2021 will be researched, and the demographic characteristics of those diagnosed with TDH will be selected and recorded in their files, their pre- and post-treatment VAS scores, and the results will be analyzed statistically.
- Conditions
- Thoracic Disc Herniation
- Being tested
- Diclofenac Sodium
- Keywords
- chronic upper back pain, thoracic disc herniation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
Also called physical therapy
at first diclofenac sodium was prescribed to patients with chronic upper back pain.
If the patient's pain persisted, she/he was included in the physical therapy (hotpack 20 minutes, ultrason 5 minutes, Transcutaneous electrical nerve stimulation 20 minutes) program.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. FM patients mark the point on the line that best corresponds to their symptom severity. To this end, they are instructed to put a cross on the straight line at the point that most accurately expresses their degree of agreement. When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. If documented in paper form, the scores can then be simply transferred to a 100- value scale using a millimeter tape measure.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start24 May 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Disc HerniationStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Dundar Ahi, MD, Kocaeli University
- Investigators
- emine dundar ahi, ass professor, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313997
- Sponsor's protocol ID
- 2022-20
- Status last verified
- Aug 2022
- First submitted
- 29 Mar 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain, A Follow-Up Study
- ClinicalTrials.gov ID
- NCT05313997
- Acronym / sponsor ID
- 2022-20
- Conditions
- Thoracic Disc Herniation
- Keywords
- chronic upper back pain, thoracic disc herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Patients who applied to the Private Medar Hospital between February 2016 and February 2021 with chronic upper back pain and were diagnosed with Thoaracic Disc Herniatin (TDH) (with Thoracic vertebral MRI) and followed up for at least 1 year will be included in the study.
Patients diagnosed with TDH were included in the medical treatment and/or physical therapy program.
Before and after these treatment programs, the pain intensity of the patients was recorded with the visual analog scale (VAS).
The number of patients who applied to the Physical Medicine and Rehabilitation outpatient clinic with chronic upper back pain between February 2016 and February 2021 will be researched, and the demographic characteristics of those diagnosed with TDH will be selected and recorded in their files, their pre- and post-treatment VAS scores, and the results will be analyzed statistically.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * 18-65 years old * admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain. * Diagnosed with TDH as a result of thoracic vertebral MRI
Key inclusion criteria (3 listed)
- 18-65 years old
- admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain.
- Diagnosed with TDH as a result of thoracic vertebral MRI
Key exclusion criteria (10 listed)
- vertebral fracture,
- developmental spinal deformity,
- spinal infection or tumor,
- chronic widespread pain syndrome such as fibromyalgia,
- diabetes mellitus,
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 |
|---|---|---|
| Diclofenac SodiumAlso: physical therapyat first diclofenac sodium was prescribed to patients with chronic upper back pain. If the patient's pain persisted, she/he was included in the physical therapy (hotpack 20 minutes, ultrason 5 minutes, Transcutaneous electrical nerve stimulation 20 minutes) program. | Drug | – |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 10 seconds
The Visual Analog Scale (VAS) is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. FM patients mark the point on the line that best corresponds to their symptom severity. To this end, they are instructed to put a cross on the straight line at the point that most accurately expresses their degree of agreement. When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. If documented in paper form, the scores can then be simply transferred to a 100- value scale using a millimeter tape measure.
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 5 Aug 2022.
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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.
emine dundar ahi, ass professor principal investigator
Kocaeli University
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 Thoracic Disc Herniation, run by Kocaeli University 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 3 inclusion and 10 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 5 Aug 2022. 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?
Visual Analog Scale (VAS) (time frame: 10 seconds). 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 5 Aug 2022.