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Are Stabilization Exercises Effective After Epidural Steroid Injection in Patients With Cervical Radiculopathy?

Primary Purpose

Pain, Neck, Cervical Radiculopathy, Pain, Radiating

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervical Interlaminar Epidural Steroid Injection
Neck Stabilization Exercises
Neck and Scapular Stabilization Exercises
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neck focused on measuring Pain, cervical radiculopathy, cervical interlaminar epidural steroid injection, stabilization exercises

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

GROUP 1 (CIESI Only)

GROUP 2 (CIESI plus NECK STABILIZATION EXERCISES)

GROUP 3 ( CIESI plus NECK and SCAPULAR STABILIZATION EXERCISES)

Arm Description

Only interlaminar epidural steroid injection will be administered to patients in this arm with the same method as in the other arms (one session, week 0). Staying active will be the only recommendation, and no exercise prescription will be provided.

After the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest.

After the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest.

Outcomes

Primary Outcome Measures

Change of pain severity from baseline to each checkpoints
The numerical rating scale (NRS) is widely used in research and clinical settings to represent pain intensity. NRS is defined as 0 for the absence of pain and 10 as the worst possible pain. The NRS is moderately reliable and has a clinically important difference (CID) value of 1.0.

Secondary Outcome Measures

Change of functionality from baseline to each checkpoints
The Neck Disability Index (NDI) is a validated 10-item questionnaire that measures a patient's self-reported disability due to neck pain. The score ranges from 0 (no disability) to 100 (completely disabled). The minimum detectable change (MDC) for patients with cervical radiculopathy is 10 points, and the clinically important difference (CID) is 14 points.
Change of life quality from baseline to each checkpoints
Short Form-12 (SF-12) is a scale that was developed in 1994 to evaluate the quality of life for the last four weeks without focusing on a specific age and disease group. It consists of 12 questions, all selected from the SF-36 Health Questionnaire. SF-12 consists of physical functionality, physical role, pain, general health, emotional role, mental health, social functionality, and vitality sub-components.

Full Information

First Posted
March 22, 2022
Last Updated
May 17, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05307211
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
April 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neck, Cervical Radiculopathy, Pain, Radiating
Keywords
Pain, cervical radiculopathy, cervical interlaminar epidural steroid injection, stabilization exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1 (CIESI Only)
Arm Type
Active Comparator
Arm Description
Only interlaminar epidural steroid injection will be administered to patients in this arm with the same method as in the other arms (one session, week 0). Staying active will be the only recommendation, and no exercise prescription will be provided.
Arm Title
GROUP 2 (CIESI plus NECK STABILIZATION EXERCISES)
Arm Type
Experimental
Arm Description
After the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest.
Arm Title
GROUP 3 ( CIESI plus NECK and SCAPULAR STABILIZATION EXERCISES)
Arm Type
Experimental
Arm Description
After the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest.
Intervention Type
Procedure
Intervention Name(s)
Cervical Interlaminar Epidural Steroid Injection
Intervention Description
Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 ccs 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the restroom after the procedure and followed up for any complications.
Intervention Type
Other
Intervention Name(s)
Neck Stabilization Exercises
Intervention Description
The physiotherapist will design an exercise protocol for neck stabilization. Each exercise will be applied three days a week throughout a 4-week program, accompanied by a physiotherapist, and will begin with 7 to 10 repetitions at first, increasing to 10 to 15 repetitions in the following weeks, taking into account the patient's condition. After the physiotherapist-assisted exercises are completed, the protocol will continue as home-based exercises until the assessments are completed.
Intervention Type
Other
Intervention Name(s)
Neck and Scapular Stabilization Exercises
Intervention Description
The physiotherapist will design an exercise protocol for neck and scapular stabilization. Each exercise will be applied three days a week throughout a 4-week program, accompanied by a physiotherapist, and will begin with 7 to 10 repetitions at first, increasing to 10 to 15 repetitions in the following weeks, taking into account the patient's condition. After the physiotherapist-assisted exercises are completed, the protocol will continue as home-based exercises until the assessments are completed.
Primary Outcome Measure Information:
Title
Change of pain severity from baseline to each checkpoints
Description
The numerical rating scale (NRS) is widely used in research and clinical settings to represent pain intensity. NRS is defined as 0 for the absence of pain and 10 as the worst possible pain. The NRS is moderately reliable and has a clinically important difference (CID) value of 1.0.
Time Frame
from pre-interventional time to post-interventional 1st hour, 1st month, 3rd month
Secondary Outcome Measure Information:
Title
Change of functionality from baseline to each checkpoints
Description
The Neck Disability Index (NDI) is a validated 10-item questionnaire that measures a patient's self-reported disability due to neck pain. The score ranges from 0 (no disability) to 100 (completely disabled). The minimum detectable change (MDC) for patients with cervical radiculopathy is 10 points, and the clinically important difference (CID) is 14 points.
Time Frame
from pre-interventional time to post-interventional 1st month, 3rd month
Title
Change of life quality from baseline to each checkpoints
Description
Short Form-12 (SF-12) is a scale that was developed in 1994 to evaluate the quality of life for the last four weeks without focusing on a specific age and disease group. It consists of 12 questions, all selected from the SF-36 Health Questionnaire. SF-12 consists of physical functionality, physical role, pain, general health, emotional role, mental health, social functionality, and vitality sub-components.
Time Frame
from pre-interventional time to post-interventional 1st month, 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savaş Şencan, MD
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University, Faculty of Medicine
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
34890
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Are Stabilization Exercises Effective After Epidural Steroid Injection in Patients With Cervical Radiculopathy?

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