Lateral Epicondylitis, Tennis Elbow
Conditions
Keywords
tennis elbow, lateral epicondylitis
Brief 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. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.
Interventions
DRUGPlacebo Injection
Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
BEHAVIORALPhysical Therapy
Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.
Participants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine.
DRUGProlotherapy
Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.
Sponsors
Christine M. Kleinert Institute for Hand and Microsurgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom Severity in pre intervention assessments | 12 months |
| Symptom severity in post-intervention assessments | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional status score pre-intervention | 12 months | The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention. |
| Functional status score severity- post intervention | 12 months | The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention |
Countries
United States
Contacts
Primary ContactTuna Ozyurekoglu, MD
Backup ContactMillicent L Horn, BS
Outcome results
None listed