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Corticosteroid
dexamethasone for Cervicogenic Radiculopathy
Phase 2
Waitlist Available
Led By Timothy Amrhein, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 week, 3 months, 4 months
Awards & highlights
Study Summary
This trial is comparing two ways of giving epidural steroid injections to see if one is more effective or safe than the other for treating nerve pain in the arm.
Eligible Conditions
- Cervicogenic Radiculopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 week, 3 months, 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 week, 3 months, 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Numerical Rating Scale (averaged over past 24 hours)
Secondary outcome measures
Change in EQ-5D
Change in NRS (averaged over past 24 hours)
Change in Neck Disability Index (NDI)
+13 moreSide effects data
From 2015 Phase 3 trial • 393 Patients • NCT00004228100%
Leukocytes (total WBC)
100%
Hemoglobin (Hgb)
100%
Platelets
98%
Catheter-related infection
98%
Infection without neutropenia
98%
SGPT (ALT)
98%
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
97%
Febrile neutropenia
97%
SGOT (AST)
97%
Serum Creatinine
97%
Seizure(s)
95%
Renal failure
95%
Pancreatitis
95%
Osteonecrosis (avascular necrosis)
95%
Cardiac left ventricular function
95%
CNS cerebrovascular ischemia
95%
Bilirubin
92%
Cardiovascular/Arrhythmia
91%
Infection/Febrile Neutropenia
70%
Neutrophils/granulocytes (ANC/AGC)
45%
Transfusion: pRBCs
22%
Transfusion: Platelets
20%
Lymphopenia
20%
Hyperglycemia
14%
Nausea
14%
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
14%
Headache
13%
Hypokalemia
11%
Dehydration
11%
Hypocalcemia
11%
Thrombosis/embolism
11%
Constipation
11%
Diarrhea (without colostomy)
11%
Vomiting
11%
Anorexia
9%
Abdominal pain or cramping
9%
Pain
8%
Hypomagnesemia
8%
Hypoalbuminemia
8%
Hypophosphatemia
8%
Hyponatremia
8%
Weight gain
8%
Myalgia (muscle pain)
8%
Neuropathic pain
8%
Cough
6%
Hypertension
6%
Hyperkalemia
6%
Allergic reaction/hypersensitivity
6%
Mood alteration-depression
6%
Neuropathy - motor
5%
Rash/desquamation
5%
GGT
5%
Syncope (fainting)
5%
Earache (otalgia)
5%
Fibrinogen
5%
Fatigue (lethargy, malaise, asthenia)
5%
Alopecia
5%
Gastritis
5%
Gastrointestinal
5%
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
5%
Dizziness/lightheadedness
5%
Dyspnea (shortness of breath)
5%
Neuropathy - sensory
5%
Bone pain
5%
Amylase
5%
Arthralgia (joint pain)
3%
Hypermagnesemia
3%
Insomnia
3%
Renal/Genitourinary
3%
Arthritis
3%
Hypoglycemia
3%
Colitis
3%
Typhlitis (inflammation of cecum)
3%
Proteinuria
3%
Neurology
3%
Mood alteration-anxiety, agitation
3%
Endocrine
3%
Seizure
3%
Hypotension
3%
Partial thromboplastin time (PTT)
3%
Coagulation
3%
Weight loss
3%
Hypernatremia
3%
Hypertriglyceridemia
3%
Rectal or perirectal pain
3%
Edema
3%
Bicarbonate
3%
Allergic Rhinitis
3%
Hypoxia
3%
Fever
3%
Dermatology/Skin
3%
Dysuria
3%
Alkaline phosphatase
2%
Personality/behavioral
2%
Sinus tachycardia
2%
Pneumonitis/pulmonary infiltrates
2%
Allergy/Immunology
2%
Hypercholesterolemia
2%
Hematemesis
2%
Hepatic
2%
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
2%
DIC (disseminated intravascular coagulation)
2%
Mouth dryness
2%
Muscle weakness (not due to neuropathy)
2%
Prothrombin time (PT)
2%
Tremor
2%
Pneumothorax
2%
Hemolysis
2%
Melena/GI bleeding
2%
Autoimmune reaction
2%
Headache, Vomiting, Nausea, Pancytopenia, Fever
2%
N/V, Diplopia
2%
Auditory/Hearing
2%
Palpitations
2%
Erythema multiforme
2%
SIADH (syndrome of inappropriate antidiuretic hormone)
2%
Dysphagia, esophagitis, odynophagia (painful swallowing)
2%
Fistula-intestinal
2%
Gastric ulcer
2%
Epistaxis
2%
Infection with unknown ANC
2%
Ataxia (incoordination)
2%
Depressed level of consciousness
2%
Chest pain (non-cardiac and non-pleuritic)
2%
Urinary frequency/urgency
2%
Irregular menses
2%
Dry skin
2%
Wound-infectious
2%
Fistula-rectal/anal
2%
Infection/Febrile Neutropenia (sepsis)
2%
Vasovagal episode
2%
Hematuria (in the absence of vaginal bleeding)
2%
Vision-photophobia
2%
Pleural effusion (non-malignant)
2%
Pulmonary
2%
Tumor lysis syndrome
2%
Musculoskeletal
2%
Extrapyramidal/involuntary movement/restlessness
2%
Ileus
2%
Lipase
2%
Ocular/Visual
2%
Speech impairment
2%
Vision-blurred vision
2%
Vaginal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment
A2 (Disseminated, No CNS - CCG Mod BFM w/Intens
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy
A0 (Localized Disease Stg I/II) Modified CCG BFM
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lateralized Interlaminar Epidural Corticosteroid InjectionsExperimental Treatment1 Intervention
Group II: Transforaminal Cervical Epidural Corticosteroid InjectionsActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dexamethasone
1995
Completed Phase 3
~9860
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,995 Total Patients Enrolled
Timothy Amrhein, MDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your pain level, as measured on a scale from 0 to 10, is higher than 4 before starting the trial.You have nerve pain in one arm that's caused by a problem in your neck.You have received a corticosteroid injection in your neck or arm within the past month.You cannot have a special dye called contrast material injected into your body.
Research Study Groups:
This trial has the following groups:- Group 1: Transforaminal Cervical Epidural Corticosteroid Injections
- Group 2: Lateralized Interlaminar Epidural Corticosteroid Injections
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies for those wishing to participate in this experiment?
"Correct. The clinicaltrials.gov website confirms that this medical experiment, which was first posted on May 1st 2018, is actively recruiting patients to participate. Approximately 116 participants are required from a single site for the study's completion."
Answered by AI
How many participants are joining the trial at this time?
"Yes, according to information posted on clinicaltrials.gov, this medical experiment is actively searching for participants since its inception on May 1st 2018 and the most recent update was made in February 2022. A total of 116 volunteers are necessary from one site only."
Answered by AI
What conditions is dexamethasone typically prescribed to treat?
"Dexamethasone has been proven to be a viable medical treatment for ophthalmia, sympathetic eye disorder, and branch retinal vein occlusion."
Answered by AI
Are there any prior investigations involving dexamethasone?
"Currently, 552 medical trials studying dexamethasone are ongoing worldwide; with 144 of those studies in the final phase of clinical data collection. The majority of these tests take place in Mishawaka, Indiana but there are 18604 locations running such research initiatives."
Answered by AI
What potential risks may be associated with dexamethasone treatment?
"Our team at Power assigned dexamethasone a score of 2 out of 3, as while there is evidence to suggest it is safe, the lack of efficacy data implies greater caution."
Answered by AI
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