- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235478
Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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İstanbul, Turkey, 34899
- Feyza Nur YUCEL
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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..)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cervical interlaminar epidural steroid injecion
Floroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain
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a mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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before treatment(T0)
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Pain relief
Time Frame: 1th month after procedure (T1)
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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
|
1th month after procedure (T1)
|
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
|
3th month after procedure (T2)
|
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
|
6th month after procedure (T3)
|
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.
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before treatment(T0)
|
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.
|
1th month after procedure (T1)
|
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.
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3th month after procedure (T2)
|
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.
|
6th month after procedure (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life-Short form-12
Time Frame: before treatment(T0)
|
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.
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before treatment(T0)
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Quality of life-Short form-12
Time Frame: 1th month after procedure (T1)
|
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.
|
1th month after procedure (T1)
|
Quality of life-Short form-12
Time Frame: 3th month after procedure (T2)
|
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.
|
3th month after procedure (T2)
|
Quality of life-Short form-12
Time Frame: 6th month after procedure (T3)
|
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.
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6th month after procedure (T3)
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Disability-Neck pain and disability scale (NPAD)
Time Frame: before treatment(T0)
|
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.
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before treatment(T0)
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Disability-Neck pain and disability scale (NPAD)
Time Frame: 1th month after procedure (T1)
|
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.
|
1th month after procedure (T1)
|
Disability-Neck pain and disability scale (NPAD)
Time Frame: 3th month after procedure (T2)
|
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.
|
3th month after procedure (T2)
|
Disability-Neck pain and disability scale (NPAD)
Time Frame: 6th month after procedure (T3)
|
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.
|
6th month after procedure (T3)
|
cervical range of motion (ROM) will be evaluated with a goniometer
Time Frame: before treatment(T0)
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cervical range of motion (ROM) will be evaluated with a goniometer all directions
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before treatment(T0)
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cervical range of motion (ROM) will be evaluated with a goniometer
Time Frame: 1th month after procedure (T1)
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cervical range of motion (ROM) will be evaluated with a goniometer all directions
|
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 all directions
|
3th month after procedure (T2)
|
cervical range of motion (ROM) will be evaluated with a goniometer
Time Frame: 6th month after procedure (T3)
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cervical range of motion (ROM) will be evaluated with a goniometer all directions
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6th month after procedure (T3)
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upper extremity motor exam
Time Frame: before treatment(T0)
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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
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before treatment(T0)
|
upper extremity motor exam
Time Frame: 1th month after procedure (T1)
|
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
|
1th month after procedure (T1)
|
upper extremity motor exam
Time Frame: 3th month after procedure (T2)
|
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
|
3th month after procedure (T2)
|
upper extremity motor exam
Time Frame: 6th month after procedure (T3)
|
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
|
6th month after procedure (T3)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Savaş ŞENCAN, Asst. Prof, Marmara University
Publications and helpful links
General 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.
- Yucel 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.
- Sanal-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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Pathological Conditions, Anatomical
- Spinal Diseases
- Bone Diseases
- Hernia
- Neuralgia
- Intervertebral Disc Displacement
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
Other Study ID Numbers
- 2017/119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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