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

Pain, Neuropathic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04235478
• Other study ID #: 2017/119
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 27, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Patients undergone the procedure were evaluated before and after injection for neuropathic pain, quality of life and disability.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: February 28, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Hernia
• Neuralgia
• Pain, Neuropathic

Intervention

Drug:
• Combination Product: triamcinolone and saline
a mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a)

Locations

Country	Name	City	State
Turkey	Feyza Nur YUCEL	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Rev — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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. In addition upper extremity deep tendon relfex will also evalutaed	before treatment(T0)
Secondary	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. In addition upper extremity deep tendon relfex will also evalutaed	1th month after procedure (T1)
Secondary	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. In addition upper extremity deep tendon relfex will also evalutaed	3th month after procedure (T2)
Secondary	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. In addition upper extremity deep tendon relfex will also evalutaed	6th month after procedure (T3)