Official Title

Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    lidocaine triamcinolone ...
  • Study Participants

    200
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 Started
Mar 31
2012
Primary Completion
Jun 30
2019
Anticipated
Study Completion
Jun 30
2019
Anticipated
Last Update
Jan 25
2018

Drug Placebo Injection

Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).

Behavioral Physical Therapy

Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.

Drug 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.

Drug Prolotherapy

Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.

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.

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.

Placebo Placebo Comparator

Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).

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.

Criteria

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
No Results Posted