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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00438672 |
Purpose
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 CMC (thumb) 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.
| Condition | Intervention |
|---|---|
|
Lateral Elbow Pain deQuervain's Tendonitis CMC Arthritis |
Drug: Placebo Injection Drug: Steroid (dexamethasone) Injection |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Corticosteroid Injection for Common Upper Extremity Problems |
| Estimated Enrollment: | 213 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Dequervains: Active Comparator |
Drug: Placebo Injection
Injection without steroid
Drug: Steroid (dexamethasone) Injection
Injection with steroid (dexamethasone)
|
| Lateral Epicondylitis: Active Comparator |
Drug: Placebo Injection
Injection without steroid
Drug: Steroid (dexamethasone) Injection
Injection with steroid (dexamethasone)
|
| CMC Arthritis: Active Comparator |
Drug: Placebo Injection
Injection without steroid
Drug: Steroid (dexamethasone) Injection
Injection with steroid (dexamethasone)
|
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. Carpometacarpal 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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Ring, MD, PhD | 617-724-3953 | dring@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | David Ring, MD, PhD | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( David C Ring, MD ) |
| Study ID Numbers: | 2003-P-000322 |
| Study First Received: | February 20, 2007 |
| Last Updated: | September 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00438672 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
lateral elbow pain tennis elbow deQuervain's tendonitis |
CMC arthritis pain psychology |
|
Anti-Inflammatory Agents Dexamethasone Tendon Injuries Antineoplastic Agents, Hormonal Antineoplastic Agents Joint Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Wounds and Injuries Disorders of Environmental Origin Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Tendinopathy Muscular Diseases Musculoskeletal Diseases Autonomic Agents Therapeutic Uses Arthritis Peripheral Nervous System Agents Central Nervous System Agents Dexamethasone acetate |