Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01415856
• Date of registration: 10/08/2011
• Primary sponsor: Center for Joint Surgery and Sports Medicine, Maryland
• Public title: Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain
• Scientific title: A Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Non-Invasive Pulsed Electromagnetic Fields (PEMF) on Postoperative Pain Following Total Knee Arthroplasty
• Date of first enrolment: October 2010
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01415856
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ralph T Salvagno, MD

• Name: Ralph T Salvagno, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age: greater than 18 years

- Weight: less than 300 lbs.

- Diagnosis: osteoarthritis

- Type of Surgery: unilateral knee replacement

Exclusion Criteria:

- No pacemaker or defibrillator.

- No infection of the affected knee.

- No previous open surgery of the affected knee.

- No history of Rheumatoid Arthritis.

- No more than 2 narcotic pills per month in the last 6 months for pain.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Device: Active Device (Torino II)

Device: Sham Device (Torino II)

Primary Outcome(s)

Edema (Swelling) [Time Frame: 2 weeks]

Pain [Time Frame: 2 weeks]

Secondary Outcome(s)

Narcotic Pain Medications [Time Frame: 2 weeks]

Range of Motion [Time Frame: 2 weeks]

Secondary ID(s)

Salvagno 20100977

Source(s) of Monetary Support

Please refer to primary and secondary sponsors