Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Evaluation of Effect of the Cervical İnterlaminar Epidural Steroid İnjection on Quality of Life, Neuropathic Pain and Disability in Patients With Cervical Radiculopathy

Conditions
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Cervical Disc Herniation, Pain, Neuropathic

Intervention / Treatment
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* Drug: Combination Product: triamcinolone and saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical interlaminar epidural steroid injecion<br>Floroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain | Drug: Combination Product: triamcinolone and saline<br>* a mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a)<br>* Other names: kenacort-a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 6th month after procedure (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 6th month after procedure (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical disc herniation, epidural injection, radicular pain, neuropathic pain