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

NCT04235478 | Unknown

• 1 other identifier: 2017/119
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Disc Herniation; Pain, Neuropathic

Keywords

cervical disc herniation; epidural injection; radicular pain; neuropathic pain

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (16)

• Quality of life-Short form-12

  before treatment(T0)

• Quality of life-Short form-12

  1th month after procedure (T1)

• Quality of life-Short form-12

  3th month after procedure (T2)

• Quality of life-Short form-12

  6th month after procedure (T3)

• Disability-Neck pain and disability scale (NPAD)

  before treatment(T0)

Study Arms (1)

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

Drug: Combination Product: triamcinolone and saline

Interventions

Combination Product: triamcinolone and saline DRUG

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

Also known as: kenacort-a

Cervical interlaminar epidural steroid injecion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Feyza Nur YUCEL

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 25675059 RESULT

• 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.

  PMID: 15501424 RESULT

• 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.

  PMID: 33655971 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Sodium Chloride; Triamcinolone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Savaş ŞENCAN, Asst. Prof

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 22, 2020
• Study Start: December 27, 2017
• Primary Completion: February 18, 2020
• Study Completion: February 28, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)