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

February 18, 2020 updated by: Marmara University

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

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • İstanbul, Turkey, 34899
        • Feyza Nur YUCEL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
a mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a)
Other Names:
  • kenacort-a

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
before treatment(T0)
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
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.
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.
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.
before treatment(T0)
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.
6th month after procedure (T3)
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.
before treatment(T0)
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)
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
Time Frame: 1th month after procedure (T1)
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)
cervical range of motion (ROM) will be evaluated with a goniometer all directions
6th month after procedure (T3)
upper extremity motor exam
Time Frame: before treatment(T0)
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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Savaş ŞENCAN, Asst. Prof, Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 27, 2017

Primary Completion (ACTUAL)

February 18, 2020

Study Completion (ANTICIPATED)

February 28, 2020

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (ACTUAL)

January 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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