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

Marmara University

Status: Unknown

Conditions: Cervical Disc Herniation; Pain, Neuropathic

Treatments: Drug: Combination Product: triamcinolone and saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04235478

2017/119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Cervical interlaminar epidural steroid injecion

Experimental group

Description:

Floroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain

Treatment:

Drug: Combination Product: triamcinolone and saline