Corticosteroid Injection for Common Upper Extremity Problems

NCT ID: NCT00438672

Last Updated: 2012-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2010-05-31

Brief Summary

The purpose of the study is to compare the effectiveness of a steroid injection to a placebo (inactive substance) in the treatment of lateral elbow pain, deQuervain's tendonitis, or base of the thumb carpometacarpal (CMC) arthritis. We are also trying to identify which personality factors and mindsets influence perceptions of elbow, wrist and hand pain. We hope to enroll 213 subjects in this study.

Detailed Description

Pain at the origin of the extensor carpi radialis is an extremely common problem. Most patients are between 35 and 55 years of age. This problem has been referred to as tennis elbow, but fewer than 10% of patients with this problem play tennis, and it is not a common problem among professional tennis players. The problem is most commonly called lateral epicondylitis in spite of the fact that pathology specimens show no evidence of an inflammatory process. Instead, tissue necrosis and other findings suggestive of a degenerative process are seen. Previous clinical trials have noted improvement in 80% of patients in one year, even in placebo groups, suggesting that this is a self-limited rather than a progressive disorder.

de Quervain's tenosynovitis and carpometacarpal (CMC) arthritis are also very common upper extremity problems. In de Quervain's tendonitis, inflammation in the first dorsal compartment of the wrist causes tenderness and chronic pain in the radial styloid region when forming a fist or using the thumb. CMC arthritis, most common in women 40-70, causes pain at the base of the thumb. Descriptions of the severity of this condition can range from stiffness to disability, and are associated with complaints of discomfort with pinching and gripping.

These are frustrating conditions, particularly for active people. As a consequence, varied treatments are used routinely in spite of limited scientific support. These treatments can be costly, some have risks, and all of them may reinforce the idea that there is a quick fix or miracle cure. Physicians and patients alike favor quick, direct treatments, but these are not always available. In the absence of effective treatment, the role of the physician is to encourage adaptive behaviors based upon an understanding of the nature of the illness.

Lateral elbow pain, de Quervain's tenosynovitis and CMC arthritis are extremely common and not all patients seek a physician's advice-many develop adaptive behaviors and manage well on their own. Our research unit has taken interest in studying psychological factors that may be associated with coming to the doctor and poor adaptation to symptoms and dysfunction. These are certainly a factor in the treatment of these conditions.

A condition that is extremely common; is painful and disabling; and has no clear etiology, pathophysiology, or cure represents a tempting market for products and devices claiming to offer relief. The marketing and application of these devices reinforces patient's desires for a quick fix, miracle cure. It also tends to take advantage of people with less adaptive health behaviors. Conscientious use of treatments in this setting requires strong evidence of their safety and efficacy.

Injection of corticosteroids is a common treatment for lateral elbow pain, de Quervain's tenosynovitis and CMC arthritis. Injections are delivered into the origin of the extensor carpi radialis brevis, into the first dorsal compartment of the wrist or into the trapeziometacarpal (TMC) joint, respectively. Several studies have tested the efficacy of steroid injections, including some prospective randomized trials. However, it is remarkable that only one of these have compared corticosteroid injection to placebo injection, especially in light of the fact that conditions like lateral elbow pain and de Quervain's tenosynovitis may be self-limiting. The psychological factors associated with receiving an injection may be important mediators of any treatment effects.

Conditions

Lateral Elbow Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dequervains

The de Quervain's injection study was terminated due to difficulty with enrollment. A large percentage of patients declined, and DeQuervain's is also fairly uncommon. Therefore, the trial wasn't feasible for this diagnosis.

Group Type: ACTIVE_COMPARATOR

Placebo Injection

Intervention Type: DRUG

Injection without steroid

Steroid (dexamethasone) Injection

Intervention Type: DRUG

Injection with steroid (dexamethasone)

Lateral Epicondylitis

Group Type: ACTIVE_COMPARATOR

Placebo Injection

Intervention Type: DRUG

Injection without steroid

Steroid (dexamethasone) Injection

Intervention Type: DRUG

Injection with steroid (dexamethasone)

CMC Arthritis

The CMC Arthritis injection study was terminated due to difficulty with enrollment. A large percentage of patients declined, and it was decided that the trial wasn't feasible for this diagnosis.

Group Type: ACTIVE_COMPARATOR

Placebo Injection

Intervention Type: DRUG

Injection without steroid

Steroid (dexamethasone) Injection

Intervention Type: DRUG

Injection with steroid (dexamethasone)

Interventions

Placebo Injection

Injection without steroid

Intervention Type: DRUG

Steroid (dexamethasone) Injection

Injection with steroid (dexamethasone)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 to 64 years
• onset of pain within the past 6 months
• willing to try a steroid injection in the elbow

Exclusion Criteria

• systemic inflammatory diseases (e.g., rheumatoid arthritis)
• pregnancy
• prior steroid injection, iontophoresis treatments with corticosteroids, or surgery for their pain
• history of adverse reaction to lidocaine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David C. Ring, MD

Director of Research, Hand Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Ring, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2003-P-000322

Identifier Type: -

Identifier Source: org_study_id