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

NCT ID: NCT04235478

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-27
• Study Completion Date: 2020-02-28

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.

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.

Conditions

Cervical Disc Herniation; Pain, Neuropathic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Combination Product: triamcinolone and saline

Intervention Type: DRUG

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

Interventions

Combination Product: triamcinolone and saline

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

Intervention Type: DRUG

Other Intervention Names

kenacort-a

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Savaş ŞENCAN, Asst. Prof

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

Feyza Nur YUCEL

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: 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.

Reference Type: RESULT

PMID: 25675059 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15501424 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33655971 (View on PubMed)

Other Identifiers

2017/119

Identifier Type: -

Identifier Source: org_study_id