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

C

Christine M. Kleinert Institute for Hand and Microsurgery

Status and phase

Unknown
Phase 2

Conditions

Tennis Elbow
Lateral Epicondylitis

Treatments

Drug: Placebo Injection
Drug: Corticosteroid Injections
Drug: Prolotherapy
Behavioral: Physical Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01897259
11.0566

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 4 patient groups, including a placebo group

Corticosteroid Injections
Active Comparator group
Description:
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.
Treatment:
Drug: Corticosteroid Injections
Prolotherapy
Active Comparator group
Description:
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.
Treatment:
Drug: Prolotherapy
Placebo
Placebo Comparator group
Description:
Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
Treatment:
Drug: Placebo Injection
Physical Therapy
Active Comparator group
Description:
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.
Treatment:
Behavioral: Physical Therapy

Trial contacts and locations

1

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Central trial contact

Millicent L Horn, BS; Tuna Ozyurekoglu, MD

Data sourced from clinicaltrials.gov

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