Pilot Study of PEMF Therapy in Treatment of Post-operative Pain Following Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT02211534|
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : October 27, 2017
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post-Operative Pain Following Total Knee Arthroplasty||Device: Pulsed Electromagnetic Field Device (Provant) Device: Sham Pulsed Electromagnetic Field Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in the Treatment of Persistent Post-Operative Pain Following Total Knee Arthroplasty|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: Pulsed Electromagnetic Field Device
Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.
Device: Pulsed Electromagnetic Field Device (Provant)
The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment.
Other Name: Provant Therapy System
Sham Comparator: Sham Pulsed Electromagnetic Field Device
Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.
Device: Sham Pulsed Electromagnetic Field Device
The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Other Name: Sham Provant Therapy System
- Change in Pain Intensity [ Time Frame: Assessed at Day 60 as compared to Baseline ]Percent change from Baseline in Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). A score of 0 represents 'No Pain' while a score of 10 represents "Worst Pain Imaginable".
- Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Mean change from Day 0 to Day 75 ]Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 categories: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Patients are asked to answer questions relating to these categories and respond with Never/None/Not at all, Rarely/Monthly/Mild, Sometimes/Moderate/Weekly, Often/Severe/Daily or Always/Extreme/Totally/Constantly. Each response gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The mean change in score from baseline to Day 75 is displayed below.
- Beck Depression Inventory (BDI) [ Time Frame: Responders at Day 75 (compared to baseline) ]
Responders: Defined as subjects with a 5-point decrease in Beck Depression Inventory (BDI) score.
BDI is a validated self-reported assessment of current symptoms of depressive disorders, with total scores ranging from 0 to 63. The BDI scale consists of 21 groups of statements with each score/response ranging from 0 to 3. Higher scores represent greater depression. The BDI was conducted at baseline prior to study device treatments and again at Day 61.
- Patient Global Impression of Change (PGIC) [ Time Frame: Day 75 ]Responder Analysis at Day 75 (patents stating they are "Improved" to "Much Improved") using the Patient Global Impression of Change (PGIC). PGIC is a 7-point validated categorical scale of overall change in status since initiation of treatment with the study device. PGIC allows subjects to integrate into one overall evaluation the different aspects of their response to treatment, including pain reduction, improvement in functioning and side effects. Subjects select one of the following response at the end of treatment: Very Much Worse, Much Worse, Minimally Worse, No Change, Minimally Improved, Improved, or Much Improved.
- Analgesic Consumption [ Time Frame: Day 56 to Day 60 (compared to baseline) ]Consumption of opioid analgesics in the preceding 24 hours will be self-reported by the subject in the ePRO diary on a daily basis during the 10-day run-in period, treatment period and through Day 75. The results below display the difference in opioid analgesic consumption from baseline to Day 56-60. Subject recorded the number of tablets consumed.
- Change From Baseline in Range of Motion (ROM) [ Time Frame: Days 0 (Baseline) and Day 75 ]The degree of passive (movement of the knee with the aid of study personnel) and active (subject moving the knee) knee flexion and extension tolerated by the subject will be recorded. ROM will be assessed in the sitting position using a goniometer.
- Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm) [ Time Frame: Day 75 ]The maximal circumference of the calf and circumference of the thigh at 10 cm and 15 cm cranial to the superior pole of the patella of the index knee will be measured using a tape measure.
- Change in Pain Intensity - Average Pain Intensity [ Time Frame: At Days 75, 90, 150 and 240, as compared to Baseline ]Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211534
|United States, Alabama|
|Birmingham, Alabama, United States|
|United States, Arizona|
|Phoenix, Arizona, United States, 85018|
|Phoenix, Arizona, United States, 85023|
|United States, California|
|El Cajon, California, United States, 92020|
|United States, Colorado|
|Lone Tree, Colorado, United States, 80124|
|United States, Florida|
|Bradenton, Florida, United States|
|Fort Lauderdale, Florida, United States|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89128|
|United States, New York|
|New York, New York, United States, 10022|
|United States, North Carolina|
|Raleigh, North Carolina, United States|
|United States, South Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Utah|
|Saint George, Utah, United States, 84790|
|United States, Virginia|
|Danville, Virginia, United States|
|United States, Washington|
|Spokane, Washington, United States, 99218|