Clinical trial NCT05307211: Are Stabilization Exercises Effective After Epidural Steroid Injection in Patients With Cervical Radiculopathy?
Official title: Evaluation of the Effect of Stabilization Exercises on Interlaminar Epidural Steroid Injection Treatment Results in Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Neck
Cervical Radiculopathy
Pain, Radiating
Keywords: Pain
cervical radiculopathy
cervical interlaminar epidural steroid injection
stabilization exercises
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervical radiculopathy was first described in 1943 by researchers named Semmes and Murphy, years later than lumbosacral radiculopathy. It is a neurological condition caused by dysfunction in the cervical spinal nerves, nerve roots, or both. This compression occurs as a result of disc herniation, spondylosis, trauma, spinal tumors, etc. As the first symptom, it manifests as pain. When pain radiates from the neck to the shoulder and arm and is accompanied by sensory complaints and motor weakness, cervical radiculopathy should be suspected. It is a significant cause of morbidity and disability in both men and women, and it occurs in middle age. As a result, clinicians must quickly diagnose and determine the best treatment method. The majority of the information in the literature on the incidence of cervical radiculopathy is based on the findings of a large population-based study conducted between 1976 and 1990 by the Mayo Clinic in Rochester, Minnesota. The incidence rate of cervical radiculopathy was reported to be 83.2 per 100,000 per year in this study, which included 561 cases. The primary goals of treatment are to alleviate pain, restore neurological function, and prevent a recurrence. According to the literature, cervical radiculopathy recurs at a rate of 31.7%, and 26% of them go to surgery. Treatment options vary depending on whether the symptoms are acute or chronic and their severity. In the treatment of cervical radiculopathy, either conservative (non-operative) or surgical treatments are used. In patients with chronic neck pain with or without radiculopathy, a cervical epidural steroid injection is one of the most frequently used interventional therapeutic options. Chronic neck pain or radicular pain caused by disc herniation, spinal stenosis, or discogenic pain can also be treated with cervical epidural injections. Cervical stability training is an exercise program that is used to strengthen the cervical spine, relieve pain, and improve functionality. Changes in dynamic scapula stabilization are observed in patients with chronic neck pain. The scapula connects the neck and shoulder, so it plays an important role in stabilizing the neck and shoulder complex. Because of the interaction between the neck and the scapula, scapular stability becomes more important in these patients.

Detailed description: Many studies in the literature separately investigate the effectiveness of Cervical Interlaminar Epidural Steroid Injection (CIESI) in radiculopathy due to cervical disc herniation or the effectiveness of stabilization exercises and physical therapy modalities in these patients. However, there have been no studies on the effectiveness of post-injection exercise training as far as we are aware. Our study aims to investigate the benefit of stabilization exercises after interlaminar epidural steroid injection in patients with radiculopathy caused by cervical disc herniation, add a new study to the literature, and guide future research.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65
* Cervical radiculopathy has caused neck and arm pain for at least three months.
* Sign a consent form and volunteer to take part in the study.

Exclusion Criteria:

* Previous surgical/interventional procedure for the cervical region
* Presence of other musculoskeletal disorders (such as lateral epicondylitis, tendinitis, entrapment neuropathy) that may cause diagnostic confusion in terms of pain pattern and localization
* Signs of trauma, fracture, malignancy, or active infection
* Rheumatological (RA, AS, etc.), endocrinological (such as osteoporosis, Paget's disease), or another systemic disease that may change the anatomical or physiological structure of the relevant regions Presence of coagulopathy
* History of whiplash injury, cervical spinal stenosis, cervical spondylosis
* Being pregnant and breastfeeding
* Presence of mental deterioration or psychiatric/neurological disease that can affect the flow of the study.
* Having a history of allergic reactions to the injectables that will be used.
* Presence of cardiopulmonary disease that may lead to exercise intolerance (heart failure, chronic obstructive pulmonary disease, etc.)
* Failure to implement the exercise program regularly.

Primary outcomes:
measure: Change of pain severity from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 1st hour, 1st month, 3rd month
Secondary outcomes:
measure: Change of functionality from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 1st month, 3rd month
measure: Change of life quality from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 1st month, 3rd month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Faculty of Medicine
state: Pendik
Study officials:
affiliation: Marmara University
name: Savaş Şencan, MD
role: PRINCIPAL_INVESTIGATOR
References: