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Corticosteroid Injection for Common Upper Extremity Problems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438672
First received: February 20, 2007
Last updated: April 25, 2012
Last verified: April 2012

February 20, 2007
April 25, 2012
April 2003
May 2010   (final data collection date for primary outcome measure)
  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.
  • Visual Analog Scale for Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pain is measured on a 10 cm long line that starts at 0 on the left and ends with 10 on the right. A score of 0 represents no pain at all, and a score of 10 represents the worst pain ever. The individual score is measured using a measuring rod, measuring the distance from the left border in centimeters.
  • DASH questionnaire
  • Satisfaction Visual Analog Scale
  • Pain Visual Analogue Scale
Complete list of historical versions of study NCT00438672 on ClinicalTrials.gov Archive Site
Not Provided
  • Grip strength
  • Pinch strength
Not Provided
Not Provided
 
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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Lateral Elbow Pain
  • Drug: Placebo Injection
    Injection without steroid
  • Drug: Steroid (dexamethasone) Injection
    Injection with steroid (dexamethasone)
  • Active Comparator: 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.
    Interventions:
    • Drug: Placebo Injection
    • Drug: Steroid (dexamethasone) Injection
  • Active Comparator: Lateral Epicondylitis
    Interventions:
    • Drug: Placebo Injection
    • Drug: Steroid (dexamethasone) Injection
  • Active Comparator: 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.
    Interventions:
    • Drug: Placebo Injection
    • Drug: Steroid (dexamethasone) Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
May 2010
May 2010   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00438672
2003-P-000322
Not Provided
David C. Ring, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
April 2012

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