Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability
- Conditions
- Cervical Disc HerniationPain, Neuropathic
- Registration Number
- NCT04235478
- Lead Sponsor
- Marmara University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 78
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pain relief 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
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS) 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.
- Secondary Outcome Measures
Name Time Method Disability-Neck pain and disability scale (NPAD) 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.
Quality of life-Short form-12 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.
cervical range of motion (ROM) will be evaluated with a goniometer 6th month after procedure (T3) cervical range of motion (ROM) will be evaluated with a goniometer all directions
upper extremity motor exam 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
Trial Locations
- Locations (1)
Feyza Nur YUCEL
🇹🇷İstanbul, Turkey