Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)

NCT00435318 | Withdrawn

• 1 other identifier: 060984
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• Measuring using questionnaires and therapy measurements.

Interventions

Iontophoresis PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have clinical evidence of Lateral Epicondylitis
• \- Tests: Palpation of Lateral Epicondylitis, Resisted Wrist Extension, Middle Finger Test, Manual Muscle Test
• Patients who have symptoms (patient provided or documented information will be used to determine how long they have had symptoms) of Lateral Epicondylitis for at least a month, but no more than 3 months from most recent episode
• X-rays must show no evidence of post-traumatic or degenerative arthritis. All patients who present to VOI Hand \& Upper Extremity Center complaining of Lateral Epicondylitis Symptoms have radiographs taken.
• Patient selection factors include:
• Ability and willingness to follow instructions
• Patients who are able and willing to return for follow-up evaluations
• Patients of all races and genders
• Patients who are able to follow care instructions

You may not qualify if:

• Patients less than 18 years old, or older than 75 years old
• Patients who to their knowledge our pregnant
• Patients unwillingly or unable to comply with a rehabilitation program, or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol
• Patients who have had non-steroidal anti-inflammatory drugs or systemic corticosteroids/analgesics within three days prior
• Patients who have local therapeutic modalities, such as: Iontophoresis, ultrasound, or heat within the last month
• Patients who have had:
• Injection of steroids within the last year or prior surgery
• Recurrent injury or previous fracture of affected area
• History of Rheumatoid or Degenerative Arthritis, Carpal Tunnel Syndrome, Rotator Cuff abnormalities, neurologic abnormalities, muscular or shoulder dysfunction, peripheral neuropathy, radial nerve entrapment, fracture or tumor to the upper extremity, neck or thoracic pain, or pacemaker use.

Sponsors & Collaborators

• Vanderbilt University: lead

MeSH Terms

Conditions

Tennis Elbow

Interventions

Iontophoresis

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Study Officials

• Donald H Lee, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2007
• First Posted: February 14, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: December 8, 2015

Record last verified: 2015-12