N/A
Completed N=35
Pilot Study of PEMF Therapy in Treatment of Post-operative Pain Following Total Knee Arthroplasty
Post-Operative Pain Following Total Knee Arthroplasty
Source: ClinicalTrials.gov NCT02211534 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Change in Pain Intensity — -30.9; -29.7 Units on a scale
Summary
The purpose of this study is to investigate whether pulsed electromagnetic energy field (PEMF) therapy is effective in the treatment of persistent pain following total knee arthroplasty (TKA)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity |
-30.9; -29.7 | — |
| SECONDARY Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) |
9.2; 8.9 | — |
| SECONDARY Beck Depression Inventory (BDI) |
3; 2 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
5; 2 | — |
| SECONDARY Analgesic Consumption |
-20.6; -22.2 | — |
| SECONDARY Change From Baseline in Range of Motion (ROM) |
-.5; .4; 3.2; 3.6; 4.4; 4.2 | — |
| SECONDARY Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm) |
.1; -.1 | — |
| SECONDARY Change in Pain Intensity - Average Pain Intensity |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject age is greater or equal to 18 years.
- Subject has undergone a total knee replacement for the treatment of osteoarthritis, and has persistent post-operative pain in the index knee for > 3 months and 30 days prior to the screening visit.
- Mean Pain Intensity (calculated as the mean of the daily average pain intensity scores) is ≥3 and 100 mg oral Morphine Sulfate equivalents per day during the run-in phase.
- Subject has evidence on physical or radiological exam of joint instability or infection involving the index knee.
- Passive range of motion demonstrates maximal flexion of the index knee 38 kg/m2.
- Subject has a history of any uncontrolled medical illness that in the investigator's judgment places the subject at unacceptable risk for receipt of Provant therapy.
- Subject has an ongoing painful condition that in the opinion of the Investigator might have a confounding influence on the safety or effectiveness analysis for this study.
- Use of systemic corticosteroids within 2 months of the Screening visit.
- Subject anticipates the need for surgery of any type through the Day 75 visit.
- Subjects whom, in the judgment of the Investigator, have serious psychosocial co-morbidities.
- History of drug or alcohol abuse within one year prior to screening.
- Subject has a history of malignancy within the past five years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area and/or localized carcinoma in situ of the cervix.
- Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
- Existing or planned pregnancy.
- Subject has been previously treated with study device.
- Subject is in current litigation related to the index knee or is receiving Worker's Compensation for an injury related to the index knee.
- Subject is unwilling or unable to follow study instructions, comply with the treatment regimen, study visits, and ePRO assessments.
- Standard deviation around the mean of the average pain intensity scores during the run-in period is >2.0.
Data sourced from ClinicalTrials.gov (NCT02211534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.