Lateral Elbow Pain Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06288048 -
Effect of Mirror Therapy on Post-Needling Pain Following Deep Dry Needling of Myofascial Trigger Point in Lateral Elbow Pain
|
Phase 2/Phase 3 |