Cervical Disc HerniationNCT04235478
Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability
A study testing Combination Product: triamcinolone and saline in people with Cervical Disc Herniation and Pain, Neuropathic, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effect of cervical interlaminar epidural steroid injections on the neuropathic pain, quality of life and disability patients with cervical radiculopathy. After the clinical and MRG evaluations of patients with neck and arm pain, injection was given to eligible patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Disc Herniation, Pain, Neuropathic
- What is being tested?
- Combination Product: triamcinolone and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2017to 28 Feb 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck pain and / or unilateral arm pain for at least 3 months
- Inadequate response to conservative treatment methods
- Visual analog scale>5
- Treatment of neuropathic pain:
- Patients who received adequate treatment for a sufficient period of time (Gabapentine ( ≥4 wk ve ≥ 1200 mg) or Pregabaline ( ≥4 wk ve ≥ 300mg )) and did not respond adequately
Who cannot join
- Cervical epidural injection history applied in the last 3 months
- Presence of systemic and / or local infection
- Bleeding diathesis
- Pregnancy
- Presence of a history of allergy to contrast agent and local anesthetic agent
- Systemic inflammatory disease ( rheumatoid arthritis, SLE..)
Show all 10Show fewer
- Presence of malignancy
- Presence of polyneuropathy, multiple sclerosis or demyelinating nervous system diseases
- Patients with a history of surgical operations for cervical disc hernia and / or spinal stenosis
- Patients with myelomalacia due to spinal cord compression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Effect of the Cervical İnterlaminar Epidural Steroid İnjection on Quality of Life, Neuropathic Pain and Disability in Patients With Cervical Radiculopathy
To evaluate the effect of cervical interlaminar epidural steroid injections on the neuropathic pain, quality of life and disability patients with cervical radiculopathy. After the clinical and MRG evaluations of patients with neck and arm pain, injection was given to eligible patients.
Patients undergone the procedure were evaluated before and after injection for neuropathic pain, quality of life and disability.
Read the detailed description
Neck and arm pain related to cervical radiculopathy is the second indication for epidural steroid injections after lumbar radiculopathy in the many a pain clinic. In this procedure corticosteroids and local anesthetics were given to the epidural space with fluoroscopy-guided special techniques. The underlying mechanism of action of these epidurally administered medications is not clear and ıt is believed to be due to anti-inflammatory properties of corticosteroids. In addition local anesthetics is thought to be as effective as corticosteroids in spinal pain of various origin. So far, many studies have shown the efficacy of these injections in acute/chronic pain of cervical radiculopathy. Although mixed pain is seen in most of patients, the relationship between pain pattern and treatment response is unclear. This study aims to evaluate the treatment responses of the patients who were diagnosed with neuropathic pain and the patients who weren't by means of LANSS. It is also intended to serach whether the presence of neuropathic pain will help to predict the treatment response or not. In this regard, the patients were evaluated with LANSS, SF-12 and neck pain and disability scale before the procedure. Categorized as the patients with neuropathic pain and the patients without, their treatment responses were compared.
- Conditions
- Cervical Disc Herniation, Pain, Neuropathic
- Being tested
- Combination Product: triamcinolone and saline
- Keywords
- cervical disc herniation, epidural injection, radicular pain, neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Product: triamcinolone and salineDrug
Also called kenacort-a
a mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a)
| Study group | Role | What they receive |
|---|---|---|
| Cervical interlaminar epidural steroid injecion | Experimental | Floroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain Receives: Drug: Combination Product: triamcinolone and saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Measured: before treatment(T0)
Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Measured: 1th month after procedure (T1)
Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Measured: 3th month after procedure (T2)
Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Measured: 6th month after procedure (T3)
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Measured: before treatment(T0)
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Measured: 1th month after procedure (T1)
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Measured: 3th month after procedure (T2)
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Measured: 6th month after procedure (T3)
Secondary outcomes (16)
Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Measured: before treatment(T0)
Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Measured: 1th month after procedure (T1)
Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Measured: 3th month after procedure (T2)
Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Measured: 6th month after procedure (T3)
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Measured: before treatment(T0)
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Measured: 1th month after procedure (T1)
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Measured: 3th month after procedure (T2)
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Measured: 6th month after procedure (T3)
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Measured: before treatment(T0)
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Measured: 1th month after procedure (T1)
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Measured: 3th month after procedure (T2)
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Measured: 6th month after procedure (T3)
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Measured: before treatment(T0)
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Measured: 1th month after procedure (T1)
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Measured: 3th month after procedure (T2)
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Measured: 6th month after procedure (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start27 Dec 2017
- Primary completion18 Feb 2020
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Savaş ŞENCAN, Asst. Prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235478
- Sponsor's protocol ID
- 2017/119
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turner-Bowker D., Hogue S.J. (2014) Short Form 12 Health Survey (SF-12). In: Michalos A.C. (eds) Encyclopedia of Quality of Life and Well-Being Research. Springer, Dordrecht
Manchikanti L, Nampiaparampil DE, Candido KD, Bakshi S, Grider JS, Falco FJ, Sehgal N, Hirsch JA. Do cervical epidural injections provide long-term relief in neck and upper extremity pain? A systematic review. Pain Physician. 2015 Jan-Feb;18(1):39-60.
PubMed 25675059Yucel A, Senocak M, Kocasoy Orhan E, Cimen A, Ertas M. Results of the Leeds assessment of neuropathic symptoms and signs pain scale in Turkey: a validation study. J Pain. 2004 Oct;5(8):427-32. doi: 10.1016/j.jpain.2004.07.001.
PubMed 15501424Sanal-Toprak C, Ozturk EC, Yucel FN, Sencan S, Gunduz OH. Does the presence of neuropathic pain affect the outcomes of the interlaminar epidural steroid injection for cervical disc herniation?: A prospective clinical study. Medicine (Baltimore). 2021 Mar 5;100(9):e25012. doi: 10.1097/MD.0000000000025012.
PubMed 33655971
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Effect of the Cervical İnterlaminar Epidural Steroid İnjection on Quality of Life, Neuropathic Pain and Disability in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT04235478
- Acronym / sponsor ID
- 2017/119
- Conditions
- Cervical Disc Herniation, Pain, Neuropathic
- Keywords
- cervical disc herniation, epidural injection, radicular pain, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 22 Jan 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.
To evaluate the effect of cervical interlaminar epidural steroid injections on the neuropathic pain, quality of life and disability patients with cervical radiculopathy. After the clinical and MRG evaluations of patients with neck and arm pain, injection was given to eligible patients.
Patients undergone the procedure were evaluated before and after injection for neuropathic pain, quality of life and disability.
Detailed description
Neck and arm pain related to cervical radiculopathy is the second indication for epidural steroid injections after lumbar radiculopathy in the many a pain clinic. In this procedure corticosteroids and local anesthetics were given to the epidural space with fluoroscopy-guided special techniques. The underlying mechanism of action of these epidurally administered medications is not clear and ıt is believed to be due to anti-inflammatory properties of corticosteroids. In addition local anesthetics is thought to be as effective as corticosteroids in spinal pain of various origin. So far, many studies have shown the efficacy of these injections in acute/chronic pain of cervical radiculopathy. Although mixed pain is seen in most of patients, the relationship between pain pattern and treatment response is unclear. This study aims to evaluate the treatment responses of the patients who were diagnosed with neuropathic pain and the patients who weren't by means of LANSS. It is also intended to serach whether the presence of neuropathic pain will help to predict the treatment response or not. In this regard, the patients were evaluated with LANSS, SF-12 and neck pain and disability scale before the procedure. Categorized as the patients with neuropathic pain and the patients without, their treatment responses were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical interlaminar epidural steroid injecion | Experimental | Drug: Combination Product: triamcinolone and salineFloroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neck pain and / or unilateral arm pain for at least 3 months
- Inadequate response to conservative treatment methods
- Visual analog scale>5
- Treatment of neuropathic pain:
- Patients who received adequate treatment for a sufficient period of time (Gabapentine ( ≥4 wk ve ≥ 1200 mg) or Pregabaline ( ≥4 wk ve ≥ 300mg )) and did not respond adequately
Key exclusion criteria (10 listed)
- Cervical epidural injection history applied in the last 3 months
- Presence of systemic and / or local infection
- Bleeding diathesis
- Pregnancy
- Presence of a history of allergy to contrast agent and local anesthetic agent
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 |
|---|---|---|
| Combination Product: triamcinolone and salineAlso: kenacort-aa mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a) | Drug | Cervical interlaminar epidural steroid injecion |
Primary outcome
Pain relief
Time frame: before treatment(T0)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
Time frame: 1th month after procedure (T1)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
Time frame: 3th month after procedure (T2)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
Time frame: 6th month after procedure (T3)
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Time frame: before treatment(T0)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Time frame: 1th month after procedure (T1)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Time frame: 3th month after procedure (T2)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Time frame: 6th month after procedure (T3)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
16 secondary outcomes
Quality of life-Short form-12
Time frame: before treatment(T0)
Quality of life-Short form-12
Time frame: 1th month after procedure (T1)
Quality of life-Short form-12
Time frame: 3th month after procedure (T2)
Quality of life-Short form-12
Time frame: 6th month after procedure (T3)
Disability-Neck pain and disability scale (NPAD)
Time frame: before treatment(T0)
Disability-Neck pain and disability scale (NPAD)
Time frame: 1th month after procedure (T1)
Disability-Neck pain and disability scale (NPAD)
Time frame: 3th month after procedure (T2)
Disability-Neck pain and disability scale (NPAD)
Time frame: 6th month after procedure (T3)
cervical range of motion (ROM) will be evaluated with a goniometer
Time frame: before treatment(T0)
cervical range of motion (ROM) will be evaluated with a goniometer
Time frame: 1th month after procedure (T1)
cervical range of motion (ROM) will be evaluated with a goniometer
Time frame: 3th month after procedure (T2)
cervical range of motion (ROM) will be evaluated with a goniometer
Time frame: 6th month after procedure (T3)
upper extremity motor exam
Time frame: before treatment(T0)
upper extremity motor exam
Time frame: 1th month after procedure (T1)
upper extremity motor exam
Time frame: 3th month after procedure (T2)
upper extremity motor exam
Time frame: 6th month after procedure (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- BackgroundTurner-Bowker D., Hogue S.J. (2014) Short Form 12 Health Survey (SF-12). In: Michalos A.C. (eds) Encyclopedia of Quality of Life and Well-Being Research. Springer, Dordrecht
- Results publication: PubMed 25675059Manchikanti L, Nampiaparampil DE, Candido KD, Bakshi S, Grider JS, Falco FJ, Sehgal N, Hirsch JA. Do cervical epidural injections provide long-term relief in neck and upper extremity pain? A systematic review. Pain Physician. 2015 Jan-Feb;18(1):39-60.
- Results publication: PubMed 15501424Yucel A, Senocak M, Kocasoy Orhan E, Cimen A, Ertas M. Results of the Leeds assessment of neuropathic symptoms and signs pain scale in Turkey: a validation study. J Pain. 2004 Oct;5(8):427-32. doi: 10.1016/j.jpain.2004.07.001.
- Derived from this study: PubMed 33655971Sanal-Toprak C, Ozturk EC, Yucel FN, Sencan S, Gunduz OH. Does the presence of neuropathic pain affect the outcomes of the interlaminar epidural steroid injection for cervical disc herniation?: A prospective clinical study. Medicine (Baltimore). 2021 Mar 5;100(9):e25012. doi: 10.1097/MD.0000000000025012.
- Individual participant dataSharing planned: No
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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.
Savaş ŞENCAN, Asst. Prof principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination Product: triamcinolone and saline in people with Cervical Disc Herniation and Pain, Neuropathic, run by Marmara 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 5 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. 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?
Results are not available in the source record.
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?
Pain relief (time frame: before treatment(T0)). The study lists 8 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 NCT04235478, which also lists 4 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 19 Feb 2020.