Lateral EpicondylitisPhase 4NCT02613455
Corticosteroid Injection Verses High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis
A Phase 4 study testing extracorporeal shock wave therapy, Kenalog (triamcinolone) and lidocaine 1% (lidocaine HCl 20mg) in people with Lateral Epicondylitis and Tennis Elbow, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to prospectively compare the pain and functional outcomes of patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid injection or high energy extracorporeal shock wave therapy (ESWT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- extracorporeal shock wave therapy, Kenalog (triamcinolone) and lidocaine 1% (lidocaine HCl 20mg)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients presenting to the WRNMMC orthopaedic hand surgery clinic for complaints of lateral elbow pain will be evaluated for inclusion in the study. Inclusions criteria will be:
- Clinical diagnosis of lateral epicondylitis based on primary complaint of lateral elbow pain and either (a) tenderness over the lateral epicondyle with direct palpation, or (b) exacerbation of pain at the lateral elbow with resisted dorsiflexion of the wrist
- Failure of previous trial of non-operative management of at least 4wks duration (to include rest/light duty, non steroidal anti-inflammatory drugs , physical/occupational therapy, home stretching regimen)
Who cannot join
- Age <18yo
- Pregnant or planning to become pregnant during study period (based on verbal questioning)
- Steroid treatment (oral or injectable) within the previous 3mo
- Diagnosis of ipsilateral compressive neuropathy
- Allergy to Kenalog, lidocaine, or conductive ultrasound gel
- Diagnosis of inflammatory arthropathy or rheumatoid conditions
- Diagnosis of fibromyalgia, chronic fatigue syndrome, complex regional pain syndrome, or other chronic widespread pain syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed National Military Medical Ceneter
Bethesda, Maryland, 20889
Scott M Tintle, MD, 301-295-4290, Scott.M.Tintle.mil@mail.mil
About this study
Official title: Prospective Randomize Trial Comparing Corticosteroid Injection to High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis
The purpose of this study is to prospectively compare the pain and functional outcomes of patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid injection or high energy extracorporeal shock wave therapy (ESWT).
Read the detailed description
Corticosteroid injections and high energy ESWT are standard therapies for lateral epicondylitis at Walter Reed National Military Medical Center. While corticosteroid injections have been shown to be moderately effective in the short term for the condition, a significant minority of patients remains symptomatic. Low energy ESWT has mixed results in the orthopaedic literature, but to date no study has specifically examined the effects of high energy ESWT. The investigators plan to randomize a total of 80 patients with the diagnosis of lateral epicondylitis to either corticosteroid injection or high energy ESWT, and follow them for a total of 12 months. Primary outcomes will be Disabilities of the Arm, Shoulder, and Hand (DASH) score, Patient Reported Tennis Elbow Evaluation (PRTEE) score, Mayo Elbow Score, Veterans Rand-36, and return-to-work status. Patients will be surveyed at baseline, 6 weeks, 3 months, and 6 months. All assessments will be done by an independent physician examiner who is blinded to the treatment received.
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- extracorporeal shock wave therapy, Kenalog (triamcinolone), lidocaine 1% (lidocaine HCl 20mg)
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave therapyProcedure or surgery
Also called ESWT
Following clearance, patients will be booked for ESWT in the operating room either WRNMMC or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24kV, which is the standard dose utilized by our clinic in treatment of this condition. The range is necessary to account for differing size of the soft tissue envelope depending on patient habitus. The final dose utilized will be at the surgeon's discretion.
Kenalog (triamcinolone)Drug
Also called Steriod, Corticosteroid
patients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic.
lidocaine 1% (lidocaine HCl 20mg)Drug
Also called lidocaine
patients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic.
| Study group | Role | What they receive |
|---|---|---|
| Kenalog (triamcinolone ) | Active comparator | Patients assigned to the corticosteroid arm will receive an intratendinous injection of 1cc Kenalog-40 (triamcinolone-40mg) + 2cc lidocaine 1% by an attending orthopaedic hand surgeon in clinic. They will be provided a home stretching regimen for lateral epicondylitis. They will be discouraged from using nonsteroidal anti-inflammatory drugs . No additional physical or occupational therapy will prescribed. Receives: Drug: Kenalog (triamcinolone); Drug: lidocaine 1% (lidocaine HCl 20mg) |
| extracorporeal shock wave therapy | Active comparator | Following clearance, patients will be booked for ESWT in the operating room either Walter Reed National Military Medical Center (WRNMMC) or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24 kilovolts, which is the standard dose utilized by our clinic in treatment of this condition. The range is necessary to account for differing size of the soft tissue envelope depending on patient habitus. The final dose utilized will be at the surgeon's discretion. Receives: Procedure: extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS is a measurement instrument to quantify pain. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Measured: 6 months
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH is a questionnaire to measure upper extremity symptoms and ability to perform activities. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Measured: 6 months
Mayo Elbow Score
Mayo Elbow score is an elbow focused outcome score. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Measured: 6 months
Veteran Rand 36 Item Health Survey (VR-36)
VR-36 is a 36 item health survey widely used in the veteran population. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Measured: 6 months
Patient-Related Tennis Elbow Evaluation (PRTEE)
PRTEE is a questionnaire to measure pain and disability in patients with lateral epicondylitis. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Measured: 6 months
Secondary outcomes (1)
Grip Strength
Difference in grip strength between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy will be determined at six months following intervention.
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 posted24 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott M Tintle, MD, Principal investigator, WRNMMC Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613455
- Sponsor's protocol ID
- 405072-2
- Status last verified
- Nov 2015
- First submitted
- 28 Oct 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomize Trial Comparing Corticosteroid Injection to High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT02613455
- Acronym / sponsor ID
- 405072-2
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
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 this study is to prospectively compare the pain and functional outcomes of patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid injection or high energy extracorporeal shock wave therapy (ESWT).
Detailed description
Corticosteroid injections and high energy ESWT are standard therapies for lateral epicondylitis at Walter Reed National Military Medical Center. While corticosteroid injections have been shown to be moderately effective in the short term for the condition, a significant minority of patients remains symptomatic. Low energy ESWT has mixed results in the orthopaedic literature, but to date no study has specifically examined the effects of high energy ESWT. The investigators plan to randomize a total of 80 patients with the diagnosis of lateral epicondylitis to either corticosteroid injection or high energy ESWT, and follow them for a total of 12 months. Primary outcomes will be Disabilities of the Arm, Shoulder, and Hand (DASH) score, Patient Reported Tennis Elbow Evaluation (PRTEE) score, Mayo Elbow Score, Veterans Rand-36, and return-to-work status. Patients will be surveyed at baseline, 6 weeks, 3 months, and 6 months. All assessments will be done by an independent physician examiner who is blinded to the treatment received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kenalog (triamcinolone ) | Active comparator | Drug: Kenalog (triamcinolone), Drug: lidocaine 1% (lidocaine HCl 20mg)Patients assigned to the corticosteroid arm will receive an intratendinous injection of 1cc Kenalog-40 (triamcinolone-40mg) + 2cc lidocaine 1% by an attending orthopaedic hand surgeon in clinic. They will be provided a home stretching regimen for lateral epicondylitis. They will be discouraged from using nonsteroidal anti-inflammatory drugs . No additional physical or occupational therapy will prescribed. |
| extracorporeal shock wave therapy | Active comparator | Procedure: extracorporeal shock wave therapyFollowing clearance, patients will be booked for ESWT in the operating room either Walter Reed National Military Medical Center (WRNMMC) or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24 kilovolts, which is the standard dose utilized by our clinic in treatment of this condition. The range is necessary to account for differing size of the soft tissue envelope depending on patient habitus. The final dose utilized will be at the surgeon's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients presenting to the WRNMMC orthopaedic hand surgery clinic for complaints of lateral elbow pain will be evaluated for inclusion in the study. Inclusions criteria will be:
- Clinical diagnosis of lateral epicondylitis based on primary complaint of lateral elbow pain and either (a) tenderness over the lateral epicondyle with direct palpation, or (b) exacerbation of pain at the lateral elbow with resisted dorsiflexion of the wrist
- Failure of previous trial of non-operative management of at least 4wks duration (to include rest/light duty, non steroidal anti-inflammatory drugs , physical/occupational therapy, home stretching regimen)
Key exclusion criteria (7 listed)
- Age <18yo
- Pregnant or planning to become pregnant during study period (based on verbal questioning)
- Steroid treatment (oral or injectable) within the previous 3mo
- Diagnosis of ipsilateral compressive neuropathy
- Allergy to Kenalog, lidocaine, or conductive ultrasound gel
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 |
|---|---|---|
| extracorporeal shock wave therapyAlso: ESWTFollowing clearance, patients will be booked for ESWT in the operating room either WRNMMC or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24kV, which is the standard dose utilized by our clinic in treatment of this condition. The range is necessary to account for differing size of the soft tissue envelope depending on patient habitus. The final dose utilized will be at the surgeon's discretion. | Procedure or surgery | extracorporeal shock wave therapy |
| Kenalog (triamcinolone)Also: Steriod, Corticosteroidpatients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic. | Drug | Kenalog (triamcinolone ) |
| lidocaine 1% (lidocaine HCl 20mg)Also: lidocainepatients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic. | Drug | Kenalog (triamcinolone ) |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 6 months
VAS is a measurement instrument to quantify pain. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 6 months
DASH is a questionnaire to measure upper extremity symptoms and ability to perform activities. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Mayo Elbow Score
Time frame: 6 months
Mayo Elbow score is an elbow focused outcome score. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Veteran Rand 36 Item Health Survey (VR-36)
Time frame: 6 months
VR-36 is a 36 item health survey widely used in the veteran population. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Patient-Related Tennis Elbow Evaluation (PRTEE)
Time frame: 6 months
PRTEE is a questionnaire to measure pain and disability in patients with lateral epicondylitis. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
1 secondary outcome
Grip Strength
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Scott M Tintle, MD principal investigator
WRNMMC Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing extracorporeal shock wave therapy, Kenalog (triamcinolone) and lidocaine 1% (lidocaine HCl 20mg) in people with Lateral Epicondylitis and Tennis Elbow, run by Walter Reed National Military Medical Center 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 7 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: status not confirmed, as of the sponsor's last update on 24 Nov 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott M Tintle, MD (301-295-4290, Scott.M.Tintle.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 6 months). The study lists 5 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 24 Nov 2015.