Chronic Postoperative PainNCT06507995
The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection
A study testing thoracic interlaminar epidural injection in people with Chronic Postoperative Pain and Chest Pain, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain. Read more about this study
- Who is it for?
- Ages 18 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Postoperative Pain, Chest Pain, Back Pain
- What is being tested?
- thoracic interlaminar epidural injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 30 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 18 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old
- > 6 months pain duration
- Failed conservative management (including medication, physical therapy, and exercise programs)
- Facet joint pain ruled out (confirmed through diagnostic blocks)
Who cannot join
- < 18 years old
- Having a psychological illness
- Allergies to local anesthetics or steroids
- Thoracic facet joint pain
- Significant disc herniation
- Infection ( which were ruled out by pre-procedure blood tests and C-reactive protein levels)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain.
Materials and Methods One hundred patients were randomly divided into two groups, each consisting of 50 patients. Group I received only a local anesthetic, while Group II received a combination of local anesthetic and steroids. The random assignment to either Group I or Group II was determined using a simple computer-generated sequence.
Read more
Outcomes were evaluated using the Numeric Rating Scale (NRS) and the revised Oswestry Disability Index (rODI). Patients who showed significant improvement for more than four weeks after the first two procedures were deemed successful. Those who did not were classified as failed participants. Significant improvement was defined as a reduction of more than 50% in both NRS and rODI scores, with assessments conducted at baseline and at 3, 6, and 12 months post-treatment.
The center where the study was conducted: Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Division of Algology, Ankara, Turkey
- Conditions
- Chronic Postoperative Pain, Chest Pain, Back Pain
- Being tested
- thoracic interlaminar epidural injection
- Keywords
- Chronic thoracic pain, chest wall pain, thoracic interlaminar epidural injections
- Medical subject headings
- Pain, Postoperative, Chest Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic interlaminar epidural injectionDrug
. Injections were administered under sedation and sterile conditions, with all patients positioned prone and monitored. A single physician performed all injections using an 18 gauge Tuohy needle, employing the loss of resistance technique and confirming the epidural space placement with 5 mL of nonionic contrast.
| Study group | Role | What they receive |
|---|---|---|
| Local Group | Other | Group I received thoracic interlaminar epidural injections of 6 mL of 2% preservative-free prilocaine. Receives: Drug: thoracic interlaminar epidural injection |
| Local+steroid Group | Other | Group II received injections of 4 mL of 2% preservative-free prilocaine combined with 2 mL or 8 mg of dexamethasone, totaling 6 mL Receives: Drug: thoracic interlaminar epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of thoracic epidural injection on upper back pain
Change in Visual Analog Score after the procedure. The visual analog scale (VAS) of pain intensity consists of a line, most often 100 mm long, with 2 descriptors representing extremes of pain intensity (eg, no pain and extreme pain)at each end. The findings suggested that 100-mm VASratings of 0 to 4 mmcanbeconsidered nopain; 5 to 44mm,mildpain; 45 to 74mm, moderate pain; and 75 to 100 mm, severe pain.
Measured: 1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Change The Oswestry Disability Index (ODI) after the procedure:
ODI is an index used by clinicians and researchers to quantify disability for low back pain and quality of life. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. 0% -20%: Minimal disability;21%-40%: Moderate Disability;41%-60%: Severe Disability;61%-80%: Crippling back pain;81%-100%;The patient is either bed-bound or has an exaggeration of their symptoms.
Measured: 1 year
Secondary outcomes (3)
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Body mass index difference between groups
Measured: 1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Difference between groups in duration of pain
Measured: 1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Gender difference between groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start15 Aug 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalı Alıyev, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507995
- Sponsor's protocol ID
- i7-487-21
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 18 Jul 2024
- 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection
- ClinicalTrials.gov ID
- NCT06507995
- Acronym / sponsor ID
- i7-487-21
- Conditions
- Chronic Postoperative Pain, Chest Pain, Back Pain
- Keywords
- Chronic thoracic pain, chest wall pain, thoracic interlaminar epidural injections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 Jul 2024 (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 primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain.
Materials and Methods One hundred patients were randomly divided into two groups, each consisting of 50 patients. Group I received only a local anesthetic, while Group II received a combination of local anesthetic and steroids. The random assignment to either Group I or Group II was determined using a simple computer-generated sequence.
Outcomes were evaluated using the Numeric Rating Scale (NRS) and the revised Oswestry Disability Index (rODI). Patients who showed significant improvement for more than four weeks after the first two procedures were deemed successful. Those who did not were classified as failed participants. Significant improvement was defined as a reduction of more than 50% in both NRS and rODI scores, with assessments conducted at baseline and at 3, 6, and 12 months post-treatment.
The center where the study was conducted: Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Division of Algology, Ankara, Turkey
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Group | Other | Drug: thoracic interlaminar epidural injectionGroup I received thoracic interlaminar epidural injections of 6 mL of 2% preservative-free prilocaine. |
| Local+steroid Group | Other | Drug: thoracic interlaminar epidural injectionGroup II received injections of 4 mL of 2% preservative-free prilocaine combined with 2 mL or 8 mg of dexamethasone, totaling 6 mL |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years old
- > 6 months pain duration
- Failed conservative management (including medication, physical therapy, and exercise programs)
- Facet joint pain ruled out (confirmed through diagnostic blocks)
Key exclusion criteria (6 listed)
- < 18 years old
- Having a psychological illness
- Allergies to local anesthetics or steroids
- Thoracic facet joint pain
- Significant disc herniation
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 interlaminar epidural injection. Injections were administered under sedation and sterile conditions, with all patients positioned prone and monitored. A single physician performed all injections using an 18 gauge Tuohy needle, employing the loss of resistance technique and confirming the epidural space placement with 5 mL of nonionic contrast. | Drug | Local Group, Local+steroid Group |
Primary outcome
The effect of thoracic epidural injection on upper back pain
Time frame: 1 year
Change in Visual Analog Score after the procedure. The visual analog scale (VAS) of pain intensity consists of a line, most often 100 mm long, with 2 descriptors representing extremes of pain intensity (eg, no pain and extreme pain)at each end. The findings suggested that 100-mm VASratings of 0 to 4 mmcanbeconsidered nopain; 5 to 44mm,mildpain; 45 to 74mm, moderate pain; and 75 to 100 mm, severe pain.
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Time frame: 1 year
Change The Oswestry Disability Index (ODI) after the procedure: ODI is an index used by clinicians and researchers to quantify disability for low back pain and quality of life. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. 0% -20%: Minimal disability;21%-40%: Moderate Disability;41%-60%: Severe Disability;61%-80%: Crippling back pain;81%-100%;The patient is either bed-bound or has an exaggeration of their symptoms.
3 secondary outcomes
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Time frame: 1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Time frame: 1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
Time frame: 1 year
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 18 Jul 2024.
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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 thoracic interlaminar epidural injection in people with Chronic Postoperative Pain and Chest Pain, run by Ankara 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 4 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 18 Jul 2024. 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?
The effect of thoracic epidural injection on upper back pain (time frame: 1 year). 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 18 Jul 2024.