Post-Operative Pain Following Total Knee Arthroplasty Clinical Trial
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
| Verified date | September 2017 |
| Source | Regenesis Biomedical, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Subject age is greater or equal to 18 years. 2. 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 < 36 months following surgery. 3. Subject has been receiving medication for persistent post-operative knee pain, including opioid or non-opioid analgesic medication that is administered on an "as needed" (prn) basis, and is on a stable analgesic dosing regimen (i.e. the same medications and dosages) for > 30 days prior to the screening visit. 4. Mean Pain Intensity (calculated as the mean of the daily average pain intensity scores) is =3 and < 9 as measured on Numeric Pain Rating Scale (NPRS) during the run-in phase. 5. Subject has completed a minimum of 80% (8 of 10 possible) of the pain intensity assessments during the run-in phase. 6. Subject is willing and able to wear an activity meter from the screening visit through Day 75. 7. Subject is able to access an internet browser in the home environment. 8. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol. 9. Female Subjects must be post menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization). Exclusion Criteria: 1. Subject has undergone simultaneous bilateral knee arthroplasty or revision arthroplasty on the index knee. 2. Subject requires revision surgery prior to Day 75. 3. Subject has undergone manipulation under anesthesia of the index knee or any local injection into the index knee within 30 days prior to the Screening Visit, or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products. 4. Subject has received any investigational drug or device within 30 days prior to the Screening Visit or is enrolled in another clinical trial. 5. Subjects consuming an average of > 100 mg oral Morphine Sulfate equivalents per day during the run-in phase. 6. Subject has evidence on physical or radiological exam of joint instability or infection involving the index knee. 7. Passive range of motion demonstrates maximal flexion of the index knee < 90 degrees or maximal extension of the index knee < -10 degrees. 8. Body Mass Index (BMI) < 19 kg/m2, or > 38 kg/m2. 9. 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. 10. 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. 11. Use of systemic corticosteroids within 2 months of the Screening visit. 12. Subject anticipates the need for surgery of any type through the Day 75 visit. 13. Subjects whom, in the judgment of the Investigator, have serious psychosocial co-morbidities. 14. History of drug or alcohol abuse within one year prior to screening. 15. 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. 16. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s). 17. Existing or planned pregnancy. 18. Subject has been previously treated with study device. 19. Subject is in current litigation related to the index knee or is receiving Worker's Compensation for an injury related to the index knee. 20. Subject is unwilling or unable to follow study instructions, comply with the treatment regimen, study visits, and ePRO assessments. 21. Standard deviation around the mean of the average pain intensity scores during the run-in period is >2.0. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Regenesis Biomedical, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Pain Intensity | 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". | Assessed at Day 60 as compared to Baseline | |
| Secondary | Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | Mean change from Day 0 to Day 75 | |
| Secondary | Beck Depression Inventory (BDI) | 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. |
Responders at Day 75 (compared to baseline) | |
| Secondary | Patient Global Impression of Change (PGIC) | 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. | Day 75 | |
| Secondary | Analgesic Consumption | 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. | Day 56 to Day 60 (compared to baseline) | |
| Secondary | Change From Baseline in Range of Motion (ROM) | 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. | Days 0 (Baseline) and Day 75 | |
| Secondary | Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm) | 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. | Day 75 | |
| Secondary | Change in Pain Intensity - Average Pain Intensity | 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). | At Days 75, 90, 150 and 240, as compared to Baseline |