Post-Operative Pain Following Total Knee ArthroplastyNCT02211534
Pilot Study of PEMF Therapy in Treatment of Post-operative Pain Following Total Knee Arthroplasty
A study testing Pulsed Electromagnetic Field Device (Provant) in people with Post-Operative Pain Following Total Knee Arthroplasty, run by Regenesis Biomedical, Inc. at 14 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Pain Following Total Knee Arthroplasty
- What is being tested?
- Pulsed Electromagnetic Field Device (Provant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 < 36 months following surgery.
- 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.
- 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.
- Subject has completed a minimum of 80% (8 of 10 possible) of the pain intensity assessments during the run-in phase.
- Subject is willing and able to wear an activity meter from the screening visit through Day 75.
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- Subject is able to access an internet browser in the home environment.
- Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
- 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).
Who cannot join
- Subject has undergone simultaneous bilateral knee arthroplasty or revision arthroplasty on the index knee.
- Subject requires revision surgery prior to Day 75.
- 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.
- Subject has received any investigational drug or device within 30 days prior to the Screening Visit or is enrolled in another clinical trial.
- Subjects consuming an average of > 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.
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- Passive range of motion demonstrates maximal flexion of the index knee < 90 degrees or maximal extension of the index knee < -10 degrees.
- Body Mass Index (BMI) < 19 kg/m2, or > 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Birmingham, Alabama
Study site
Bradenton, Florida
Study site
Danville, Virginia
Study site
El Cajon, California, 92020
Study site
Fort Lauderdale, Florida
Study site
Las Vegas, Nevada, 89128
Study site
Lone Tree, Colorado, 80124
Study site
New York, New York, 10022
Study site
Phoenix, Arizona, 85018
Study site
Phoenix, Arizona, 85023
Study site
Raleigh, North Carolina
Study site
Spartanburg, South Carolina, 29303
Study site
Spokane, Washington, 99218
Study site
St. George, Utah, 84790
About this study
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
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)
Read the detailed description
This is a multi-site randomized, double-blinded, parallel-group prospective pilot study of the analgesic effectiveness of twice-daily PEMF therapy in the treatment of persistent post-operative pain following Total Knee Arthroplasty (TKA). Following a run-in period of 10 days to collect their baseline pain intensity scores, activity levels and opioid consumption, eligible subjects will be randomized in a 2:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device. Subjects will self-treat twice daily for 60 days while at home. Subjects will collect electronic patient-reported outcome (ePRO) data each morning through Day 75. Subjects will be evaluated at the research center for Interim Visits at Day 21, Day 41, Day 61 and Day 75 for assessment of safety, concomitant medications, range of motion, weight, peripheral edema, and quality of life outcomes. At Day 90, Day 150, and Day 240 assessment of pain intensity, opioid consumption, safety, review of concomitant medications and interval history will be performed, with data collected via telephone contact.
- Being tested
- Pulsed Electromagnetic Field Device (Provant), Sham Pulsed Electromagnetic Field Device
- Keywords
- Pulsed Electromagnetic Energy Fields, Total Knee Arthroplasty, Pain Intensity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field Device (Provant)Device
Also called Provant Therapy System
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.
Sham Pulsed Electromagnetic Field DeviceDevice
Also called Sham Provant Therapy System
The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electromagnetic Field Device | Active comparator | Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Receives: Device: Pulsed Electromagnetic Field Device (Provant) |
| Sham Pulsed Electromagnetic Field Device | Sham comparator | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Receives: Device: Sham Pulsed Electromagnetic Field Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Assessed at Day 60 as compared to Baseline
Secondary outcomes (7)
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.
Measured: Mean change from Day 0 to Day 75
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.
Measured: Responders at Day 75 (compared to baseline)
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.
Measured: Day 75
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.
Measured: Day 56 to Day 60 (compared to baseline)
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.
Measured: Days 0 (Baseline) and Day 75
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.
Measured: Day 75
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).
Measured: At Days 75, 90, 150 and 240, as compared to Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Operative Pain Following Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenesis Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211534
- Sponsor's protocol ID
- RBI.2014.002
- Status last verified
- Sep 2017
- First submitted
- 1 Aug 2014
- Last updated
- 27 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02211534
- Acronym / sponsor ID
- RBI.2014.002
- Keywords
- Pulsed Electromagnetic Energy Fields, Total Knee Arthroplasty, Pain Intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Posted 27 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This is a multi-site randomized, double-blinded, parallel-group prospective pilot study of the analgesic effectiveness of twice-daily PEMF therapy in the treatment of persistent post-operative pain following Total Knee Arthroplasty (TKA). Following a run-in period of 10 days to collect their baseline pain intensity scores, activity levels and opioid consumption, eligible subjects will be randomized in a 2:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device. Subjects will self-treat twice daily for 60 days while at home. Subjects will collect electronic patient-reported outcome (ePRO) data each morning through Day 75. Subjects will be evaluated at the research center for Interim Visits at Day 21, Day 41, Day 61 and Day 75 for assessment of safety, concomitant medications, range of motion, weight, peripheral edema, and quality of life outcomes. At Day 90, Day 150, and Day 240 assessment of pain intensity, opioid consumption, safety, review of concomitant medications and interval history will be performed, with data collected via telephone contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electromagnetic Field Device | Active comparator | Device: Pulsed Electromagnetic Field Device (Provant)Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. |
| Sham Pulsed Electromagnetic Field Device | Sham comparator | Device: Sham Pulsed Electromagnetic Field DeviceInactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 < 36 months following surgery.
- 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.
- 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.
- Subject has completed a minimum of 80% (8 of 10 possible) of the pain intensity assessments during the run-in phase.
Key exclusion criteria (21 listed)
- Subject has undergone simultaneous bilateral knee arthroplasty or revision arthroplasty on the index knee.
- Subject requires revision surgery prior to Day 75.
- 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.
- Subject has received any investigational drug or device within 30 days prior to the Screening Visit or is enrolled in another clinical trial.
- Subjects consuming an average of > 100 mg oral Morphine Sulfate equivalents per day during the run-in phase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Field Device (Provant)Also: Provant Therapy SystemThe 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. | Device | Pulsed Electromagnetic Field Device |
| Sham Pulsed Electromagnetic Field DeviceAlso: Sham Provant Therapy SystemThe Sham device will be identical in appearance, physical characteristics and operation to the Active device. | Device | Sham Pulsed Electromagnetic Field Device |
Primary outcome
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".
7 secondary outcomes
Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Mean change from Day 0 to Day 75
Beck Depression Inventory (BDI)
Time frame: Responders at Day 75 (compared to baseline)
Patient Global Impression of Change (PGIC)
Time frame: Day 75
Analgesic Consumption
Time frame: Day 56 to Day 60 (compared to baseline)
Change From Baseline in Range of Motion (ROM)
Time frame: Days 0 (Baseline) and Day 75
Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm)
Time frame: Day 75
Change in Pain Intensity - Average Pain Intensity
Time frame: At Days 75, 90, 150 and 240, as compared to Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field Device (Provant) in people with Post-Operative Pain Following Total Knee Arthroplasty, run by Regenesis Biomedical, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Assessed at Day 60 as compared to Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.