Full Text View
Tabular View
No Study Results Posted
Related Studies
Corticosteroid Injection for Common Upper Extremity Problems
This study is currently recruiting participants.
Study NCT00438672   Information provided by Massachusetts General Hospital
First Received: February 20, 2007   Last Updated: September 25, 2009   History of Changes

February 20, 2007
September 25, 2009
April 2003
June 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Pain Visual Analogue Scale
  • Satisfaction Visual Analog Scale
  • DASH questionnaire
Complete list of historical versions of study NCT00438672 on ClinicalTrials.gov Archive Site
  • Grip strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pinch strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Grip strength
  • Pinch strength
 
Corticosteroid Injection for Common Upper Extremity Problems
Corticosteroid Injection for Common Upper Extremity Problems

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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
  • Lateral Elbow Pain
  • deQuervain's Tendonitis
  • CMC Arthritis
  • Drug: Placebo Injection
  • Drug: Steroid (dexamethasone) Injection
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
213
October 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: David Ring, MD, PhD 617-724-3953 dring@partners.org
United States
 
NCT00438672
David C Ring, MD, Massachusetts General Hospital
2003-P-000322
Massachusetts General Hospital
 
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP