Tennis ElbowPhase 2NCT01897259
Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
A Phase 2 study testing Physical Therapy, Corticosteroid Injections and Prolotherapy in people with Tennis Elbow and Lateral Epicondylitis, run by Christine M. Kleinert Institute for Hand and Microsurgery at 1 site in United States.
Trial summary
This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis
- What is being tested?
- Physical Therapy, Corticosteroid Injections and Prolotherapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2019
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment
- conservative treatment of tennis elbow is recommended as standard of care treatment
- over the age of 18 and under the age of 65
- ability to give informed consent
Who cannot join
- treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow
- congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months
- immobility casts or splints within the last 6 months for tennis elbow
- co-existing elbow diagnosis (i.e. osteoarthritis or instability)
- pregnant women, women trying to get pregnant, or breastfeeding women
- under the age of 18 or over the age of 65
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Christine M. Kleinert Institute of Hand and Microsurgery
Louisville, Kentucky, 40202
Christina L Kaufman, PhD, 502-562-0390, ckaufman@cmki.org
Millicent L Horn, BS, 502-562-0307, mhorn@cmki.org
About this study
This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Being tested
- Placebo Injection, Physical Therapy, Corticosteroid Injections, Prolotherapy
- Keywords
- tennis elbow, lateral epicondylitis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo InjectionDrug
Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
Physical TherapyBehavioural
Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.
Corticosteroid InjectionsDrug
Participants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine.
ProlotherapyDrug
Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Injections | Active comparator | Patients will receive 1 cc Kenalong 10 mg injection to the site every 6 weeks until clinical symptoms have resolved. They will also receive an anesthetic of 1cc 1% lidocaine in conjunction with the corticosteroid injection. Receives: Drug: Corticosteroid Injections |
| Prolotherapy | Active comparator | Participants receive 1cc 50% Dextrose and 1 cc Sodium Morrhuate to the site every 6 weeks until symptoms resolve. These participants will also receive an anesthetic of 1cc 1% lidocaine. Receives: Drug: Prolotherapy |
| Placebo | Placebo comparator | Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline). Receives: Drug: Placebo Injection |
| Physical Therapy | Active comparator | Participants will be prescribed NSAIDS (Diclofenac 75 mg BID) for 2 weeks. Participants will attend therapy for muscle stretches, soft tissue mobilization, and gradual strengthening. Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity in pre intervention assessments
Measured: 12 months
Symptom severity in post-intervention assessments
Measured: 12 months
Secondary outcomes (2)
Functional status score pre-intervention
The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention.
Measured: 12 months
Functional status score severity- post intervention
The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuna Ozyurekoglu, MD, Principal investigator, Christine M. Kleinert Institute for Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897259
- Sponsor's protocol ID
- 11.0566
- Status last verified
- Jan 2018
- First submitted
- 11 Jun 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT01897259
- Acronym / sponsor ID
- 11.0566
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Keywords
- tennis elbow, lateral epicondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 11 Jul 2013 (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.
This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Injections | Active comparator | Drug: Corticosteroid InjectionsPatients will receive 1 cc Kenalong 10 mg injection to the site every 6 weeks until clinical symptoms have resolved. They will also receive an anesthetic of 1cc 1% lidocaine in conjunction with the corticosteroid injection. |
| Prolotherapy | Active comparator | Drug: ProlotherapyParticipants receive 1cc 50% Dextrose and 1 cc Sodium Morrhuate to the site every 6 weeks until symptoms resolve. These participants will also receive an anesthetic of 1cc 1% lidocaine. |
| Placebo | Placebo comparator | Drug: Placebo InjectionParticipants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline). |
| Physical Therapy | Active comparator | Behavioral: Physical TherapyParticipants will be prescribed NSAIDS (Diclofenac 75 mg BID) for 2 weeks. Participants will attend therapy for muscle stretches, soft tissue mobilization, and gradual strengthening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment
- conservative treatment of tennis elbow is recommended as standard of care treatment
- over the age of 18 and under the age of 65
- ability to give informed consent
Key exclusion criteria (6 listed)
- treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow
- congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months
- immobility casts or splints within the last 6 months for tennis elbow
- co-existing elbow diagnosis (i.e. osteoarthritis or instability)
- pregnant women, women trying to get pregnant, or breastfeeding women
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 InjectionParticipants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline). | Drug | Placebo |
| Physical TherapySubjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections. | Behavioural | Physical Therapy |
| Corticosteroid InjectionsParticipants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine. | Drug | Corticosteroid Injections |
| ProlotherapySubjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections. | Drug | Prolotherapy |
Primary outcome
Symptom Severity in pre intervention assessments
Time frame: 12 months
Symptom severity in post-intervention assessments
Time frame: 12 months
2 secondary outcomes
Functional status score pre-intervention
Time frame: 12 months
Functional status score severity- post intervention
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Tuna Ozyurekoglu, MD principal investigator
Christine M. Kleinert Institute for Hand and Microsurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical Therapy, Corticosteroid Injections and Prolotherapy in people with Tennis Elbow and Lateral Epicondylitis, run by Christine M. Kleinert Institute for Hand and Microsurgery 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 4 inclusion and 6 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 25 Jan 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Tuna Ozyurekoglu, MD (502-561-4286, tozyurekoglu@kleinertkutz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity in pre intervention assessments (time frame: 12 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 25 Jan 2018.