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Corticosteroid Injection for Common Upper Extremity Problems
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, September 2009
First Received: February 20, 2007   Last Updated: September 25, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Pain Visual Analogue Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Satisfaction Visual Analog Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • DASH questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grip strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pinch strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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)

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. 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438672

Contacts
Contact: David Ring, MD, PhD 617-724-3953 dring@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

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

Keywords provided by Massachusetts General Hospital:
lateral elbow pain
tennis elbow
deQuervain's tendonitis
CMC arthritis
pain
psychology

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 05, 2009