Low Back PainNCT03821350
The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection
A study testing Information leaflet in people with Low Back Pain and Radiculopathy, run by Hitit University.
Trial summary
Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular pain is thought to be caused by inflammation of the spinal nerve roots near the intervertebral disc injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Radiculopathy
- What is being tested?
- Information leaflet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2013to 25 Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lumbar radiculopathy due to lumbar disc herniation,
- unresponsive to conservative treatments,
- duration of pain is less than 3 months,
- patients scheduled for the first time with TFESI.
Who cannot join
- the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...),
- underwent epidural injection in the last 6 months,
- to have a history of lumbar spinal surgery,
- inflammatory diseases (rheumatoid arthritis, spondyloarthropathy),
- spinal infection or malignancy,
- to benefit from six-week medical treatment,
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- be reluctant to participate in the work and follow up,
- who are illiterate,
- the patients with psychiatric disease
About this study
Official title: The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection
Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular pain is thought to be caused by inflammation of the spinal nerve roots near the intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation in recent years.
The assessment of comorbid psychiatric conditions such as depression, anxiety, and somatization disorder and given the detailed and visual information to patients who will be undergone TFESI could affect the result of the treatment in a good way. The pain questionnaire used for objectively evaluating injection outcomes is personality dependent and there are many factors that can affect it.
Read the detailed description
Although information leaflets given to patients prior to surgical or non-surgical interventions have not yet been used as a standard in each clinic, the effects on patients have been frequently researched in recently. A detailed description of the treatment, the devices to be used and the disclosure of the steps of the procedure may have an effect on the result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect of the written and visual informative form given before the injection of the lumbosacral TFESI.
- Conditions
- Low Back Pain, Radiculopathy
- Being tested
- Information leaflet
- Keywords
- Transforaminal epidural steroid injection, Radicular pain
- Medical subject headings
- Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information leafletOther
The written and visual information form prepared specifically for the patients was aimed to provide detailed information by clearly expressing the procedure, the suggestions that will be needed before and after injection (what to bring next, what circumstances may not be done, the control visit day after the procedure etc.) to be applied on before the injection day.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group was given verbal information |
| Leaflet Group | Experimental | The second group was given verbal information and a detailed information leaflet with written and visual content Receives: Other: Information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale
The patient is asked to give a score between 1 and 10 to explain the pain level.
Measured: 3 months
Oswestry disability index
The oswestry disability index is a survey designed to investigate how lumbar and leg pain affects their daily lives. It consists of 10 questions investigating the general life activity of the patient. The patient receives at least 0 points and at most 5 points from each question. The higher scores indicate that increased disability.
Measured: 3 months
Secondary outcomes (2)
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale is an easy-to-use questionnaire consisting of 14 questions that examines the symptoms of depression with 7 questions and anxiety with 7 questions.
Measured: 3 months
Somatosensory Amplification Scale
The Somatosensory Amplification Scale is a scale consisting of 10 items. The items include a series of disturbing bodily sensations that do not present a disease.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start30 Dec 2013
- Primary completion30 Dec 2014
- Study completion25 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Bahar Ozdemir, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821350
- Sponsor's protocol ID
- 09.2014.0089
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.
PubMed 12537268Sivaganesan A, Chotai S, Parker SL, Asher AL, McGirt MJ, Devin CJ. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology. Spine J. 2016 Aug;16(8):928-34. doi: 10.1016/j.spinee.2015.11.058. Epub 2015 Dec 9.
PubMed 26689476
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection
- ClinicalTrials.gov ID
- NCT03821350
- Acronym / sponsor ID
- 09.2014.0089
- Conditions
- Low Back Pain, Radiculopathy
- Keywords
- Transforaminal epidural steroid injection, Radicular pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 30 Dec 2013 (actual)
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 25 Dec 2015 (actual)
- First posted
- 29 Jan 2019 (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.
Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular pain is thought to be caused by inflammation of the spinal nerve roots near the intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation in recent years.
The assessment of comorbid psychiatric conditions such as depression, anxiety, and somatization disorder and given the detailed and visual information to patients who will be undergone TFESI could affect the result of the treatment in a good way. The pain questionnaire used for objectively evaluating injection outcomes is personality dependent and there are many factors that can affect it.
Detailed description
Although information leaflets given to patients prior to surgical or non-surgical interventions have not yet been used as a standard in each clinic, the effects on patients have been frequently researched in recently. A detailed description of the treatment, the devices to be used and the disclosure of the steps of the procedure may have an effect on the result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect of the written and visual informative form given before the injection of the lumbosacral TFESI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group was given verbal information |
| Leaflet Group | Experimental | Other: Information leafletThe second group was given verbal information and a detailed information leaflet with written and visual content |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lumbar radiculopathy due to lumbar disc herniation,
- unresponsive to conservative treatments,
- duration of pain is less than 3 months,
- patients scheduled for the first time with TFESI.
Key exclusion criteria (9 listed)
- the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...),
- underwent epidural injection in the last 6 months,
- to have a history of lumbar spinal surgery,
- inflammatory diseases (rheumatoid arthritis, spondyloarthropathy),
- spinal infection or malignancy,
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 |
|---|---|---|
| Information leafletThe written and visual information form prepared specifically for the patients was aimed to provide detailed information by clearly expressing the procedure, the suggestions that will be needed before and after injection (what to bring next, what circumstances may not be done, the control visit day after the procedure etc.) to be applied on before the injection day. | Other | Leaflet Group |
Primary outcome
Numeric rating scale
Time frame: 3 months
The patient is asked to give a score between 1 and 10 to explain the pain level.
Oswestry disability index
Time frame: 3 months
The oswestry disability index is a survey designed to investigate how lumbar and leg pain affects their daily lives. It consists of 10 questions investigating the general life activity of the patient. The patient receives at least 0 points and at most 5 points from each question. The higher scores indicate that increased disability.
2 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: 3 months
Somatosensory Amplification Scale
Time frame: 3 months
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 29 Jan 2019.
- Background: PubMed 12537268Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.
- Background: PubMed 26689476Sivaganesan A, Chotai S, Parker SL, Asher AL, McGirt MJ, Devin CJ. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology. Spine J. 2016 Aug;16(8):928-34. doi: 10.1016/j.spinee.2015.11.058. Epub 2015 Dec 9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Information leaflet in people with Low Back Pain and Radiculopathy, run by Hitit University.
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 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: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Numeric rating scale (time frame: 3 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?
On the ClinicalTrials.gov record for NCT03821350, which also lists 2 linked publications.
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 29 Jan 2019.