Lateral Elbow PainNCT00438672
Corticosteroid Injection for Common Upper Extremity Problems
A study testing Steroid (dexamethasone) Injection in people with Lateral Elbow Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Elbow Pain
- What is being tested?
- Steroid (dexamethasone) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 64 years
- onset of pain within the past 6 months
- willing to try a steroid injection in the elbow
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Lateral Elbow Pain
- Being tested
- Placebo Injection, Steroid (dexamethasone) Injection
- Keywords
- lateral elbow pain, tennis elbow, pain, psychology
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo InjectionDrug
Injection without steroid
Steroid (dexamethasone) InjectionDrug
Injection with steroid (dexamethasone)
| Study group | Role | What they receive |
|---|---|---|
| Dequervains | Active comparator | 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. Receives: Drug: Placebo Injection; Drug: Steroid (dexamethasone) Injection |
| Lateral Epicondylitis | Active comparator | Not described Receives: Drug: Placebo Injection; Drug: Steroid (dexamethasone) Injection |
| CMC Arthritis | Active comparator | 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. Receives: Drug: Placebo Injection; Drug: Steroid (dexamethasone) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startApr 2003
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lateral Elbow PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438672
- Sponsor's protocol ID
- 2003-P-000322
- Status last verified
- Apr 2012
- First submitted
- 20 Feb 2007
- Last updated
- 28 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Injection for Common Upper Extremity Problems
- ClinicalTrials.gov ID
- NCT00438672
- Acronym / sponsor ID
- 2003-P-000322
- Conditions
- Lateral Elbow Pain
- Keywords
- lateral elbow pain, tennis elbow, pain, psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dequervains | Active comparator | Drug: Placebo Injection, Drug: Steroid (dexamethasone) InjectionThe 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. |
| Lateral Epicondylitis | Active comparator | Drug: Placebo Injection, Drug: Steroid (dexamethasone) Injection |
| CMC Arthritis | Active comparator | Drug: Placebo Injection, Drug: Steroid (dexamethasone) InjectionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 64 years
- onset of pain within the past 6 months
- willing to try a steroid injection in the elbow
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo InjectionInjection without steroid | Drug | CMC Arthritis, Dequervains, Lateral Epicondylitis |
| Steroid (dexamethasone) InjectionInjection with steroid (dexamethasone) | Drug | CMC Arthritis, Dequervains, Lateral Epicondylitis |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time frame: 6 months
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lateral Elbow Pain
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Lateral Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial
Lateral Epicondylitis
Not yet recruiting
Mulligan Mobilization in Lateral Elbow Tendinopathy
Lateral Elbow Tendinopathy (Tennis Elbow)
Not yet recruitingObservational study
Illness Perception and Treatment Expectations in Lateral Elbow Pain
Lateral Elbow Pain, Lateral Epicondylitis
Recruiting
Assessment of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) After Effect in Patients With and Without Tennis Elbow (TE)
Tennis Elbow, Health Adult Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ring, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid (dexamethasone) Injection in people with Lateral Elbow Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.