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Corticosteroid Injection for Common Upper Extremity Problems

Corticosteroid Injection for Common Upper Extremity Problems

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00438672
Enrollment
64
Registered
2007-02-22
Start date
2003-04-30
Completion date
2010-05-31
Last updated
2012-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Elbow Pain

Keywords

lateral elbow pain, tennis elbow, pain, psychology

Brief summary

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.

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. 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.

Interventions

DRUGPlacebo Injection

Injection without steroid

Injection with steroid (dexamethasone)

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire6 monthsThe 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 Pain6 monthsPain 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Dexamethasone Cohort
Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
31
Placebo (Lidocaine Only) Cohort
Single injection of 2 mL 1% lidocaine
33
Total64

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up79

Baseline characteristics

CharacteristicPlacebo (Lidocaine Only) CohortDexamethasone CohortTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants0 Participants2 Participants
Age, Categorical
Between 18 and 65 years
31 Participants31 Participants62 Participants
Age Continuous49 years
STANDARD_DEVIATION 10
48 years
STANDARD_DEVIATION 8
49 years
STANDARD_DEVIATION 9
Region of Enrollment
United States
33 participants31 participants64 participants
Sex: Female, Male
Female
18 Participants19 Participants37 Participants
Sex: Female, Male
Male
15 Participants12 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 310 / 33
serious
Total, serious adverse events
0 / 310 / 33

Outcome results

Primary

Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Dexamethasone CohortDisabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire18 units on a scaleStandard Deviation 20
Placebo (Lidocaine Only) CohortDisabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire13 units on a scaleStandard Deviation 19
Primary

Visual Analog Scale for Pain

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Dexamethasone CohortVisual Analog Scale for Pain2.4 units on a scaleStandard Deviation 2.9
Placebo (Lidocaine Only) CohortVisual Analog Scale for Pain1.7 units on a scaleStandard Deviation 2.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026