Clinical trial NCT04235478: Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability
Official title: The Evaluation of Effect of the Cervical İnterlaminar Epidural Steroid İnjection on Quality of Life, Neuropathic Pain and Disability in Patients With Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Disc Herniation
Pain, Neuropathic
Keywords: cervical disc herniation
epidural injection
radicular pain
neuropathic pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain relief
timeFrame: before treatment(T0)
measure: Pain relief
timeFrame: 1th month after procedure (T1)
measure: Pain relief
timeFrame: 3th month after procedure (T2)
measure: Pain relief
timeFrame: 6th month after procedure (T3)
measure: Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
timeFrame: before treatment(T0)
measure: Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
timeFrame: 1th month after procedure (T1)
measure: Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
timeFrame: 3th month after procedure (T2)
measure: Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
timeFrame: 6th month after procedure (T3)
Secondary outcomes:
measure: Quality of life-Short form-12
timeFrame: before treatment(T0)
measure: Quality of life-Short form-12
timeFrame: 1th month after procedure (T1)
measure: Quality of life-Short form-12
timeFrame: 3th month after procedure (T2)
measure: Quality of life-Short form-12
timeFrame: 6th month after procedure (T3)
measure: Disability-Neck pain and disability scale (NPAD)
timeFrame: before treatment(T0)
measure: Disability-Neck pain and disability scale (NPAD)
timeFrame: 1th month after procedure (T1)
measure: Disability-Neck pain and disability scale (NPAD)
timeFrame: 3th month after procedure (T2)
measure: Disability-Neck pain and disability scale (NPAD)
timeFrame: 6th month after procedure (T3)
measure: cervical range of motion (ROM) will be evaluated with a goniometer
timeFrame: before treatment(T0)
measure: cervical range of motion (ROM) will be evaluated with a goniometer
timeFrame: 1th month after procedure (T1)
measure: cervical range of motion (ROM) will be evaluated with a goniometer
timeFrame: 3th month after procedure (T2)
measure: cervical range of motion (ROM) will be evaluated with a goniometer
timeFrame: 6th month after procedure (T3)
measure: upper extremity motor exam
timeFrame: before treatment(T0)
measure: upper extremity motor exam
timeFrame: 1th month after procedure (T1)
measure: upper extremity motor exam
timeFrame: 3th month after procedure (T2)
measure: upper extremity motor exam
timeFrame: 6th month after procedure (T3)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Feyza Nur YUCEL
Study officials:
affiliation: Marmara University
name: Savaş ŞENCAN, Asst. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.