Knee OsteoarthritisNCT03758300
RF TKA Prehabilitation
A study testing Radiofrequency in people with Knee Osteoarthritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to compare the effects of the radiofrequency applied to the sensory innervation of the knee, with respect to a control group (standard therapy), in a prehabilitation program aiming to improve the functional recovery of patients undergoing TKA. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Radiofrequency
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic knee pain, with Dynamic VAS ≥ 5
- Scheduled for elective total knee arthroplasty
- Functional impairment due to pain because of knee osteoarthritis
- Taking medications to control the pain.
- Ability to perform the 6 MWT.
Who cannot join
- ASA physical status > 3
- Morbid obesity (BMI >40)
- Revision of total knee arthroplasty
- Mayor neuropsychiatric disease
- Mayor cardiac, renal or hepatic failure
- Anemia (hematocrit <30%)
Show all 22Show fewer
- Immunosuppression
- Rheumatoid arthritis
- Allergy to opioids, to local anesthetics or other medications used in the study,
- Chronic regular use of large doses of opioids (>20mg equivalent of morphine/day) or sedatives
- Unwillingness to have spinal anesthesia
- History of recent drug abuse
- Contraindication to receive regional anesthesia (e.g. coagulation defect)
- Inability to walk before the surgery
- Inability to perform physical tasks
- Contraindications to physical exercise and training
- Prior mayor knee surgery
- Connective tissue diseases affecting the knee
- Serious neurologic disorders
- Injection with steroids or hyaluronic acids during the previous 3 months
- Active sciatic pain
- Anticoagulant medications
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3A 1A1
JF Asenjo, MD, 514) 934-1934 ext. 43261, jfasenjog@yahoo.com
JF Asenjo, MD
About this study
Official title: Radiofrequency Facilitates the Prehabilitation Process in Patients Undergoing Total Knee Arthroplasty: Effects on Preoperative and Postoperative Functional Capacity. A Double Blind Randomized Controlled Trial
The purpose of this study is to compare the effects of the radiofrequency applied to the sensory innervation of the knee, with respect to a control group (standard therapy), in a prehabilitation program aiming to improve the functional recovery of patients undergoing TKA.
In the present study, the investigators hypothesize that participants treated with radiofrequency 4-6 weeks before the surgery, should be able to effectively accomplish the prehabilitation program and, therefore, have a faster recovery of their functional status in the post operative period , compared with the control group (That use the present state of the art approach)
Read the detailed description
Postoperative functional capacity following TKA surgery has been strongly associated with preoperative functional status. Presence of pain, poor strength and flexibility, and limited ability to complete physiological tasks have been shown to be consistent predictors of poor recovery from knee surgery.
The postoperative period is associated with 30-40% decrease in functional capacity, and efforts have been made to facilitate the recovery by implementing rehabilitative measures over the period of weeks and months. However, the postoperative period might not be the best time to engage patients in intensive physiotherapy as they are easily tired and in pain. Preparing patients for the stress of surgery, called also prehabilitation, is emerging as a mean to optimize pre-operative status and increase functional reserve thus, increasing surgical stress tolerance. Observational and randomized controlled studies in patients scheduled for colorectal, thoracic, and spinal surgeries have suggested that a 4-6 weeks of moderate preoperative physical activity can lead to significant postoperative improvements in cardiorespiratory reserve and functional capacity. However, preliminary trials on the effect of a 6-8 weeks prehabilitation program with structured exercises prior to knee arthroplasty have reported contrasting results, and one of the reasons might be the high levels of pain encountered by these patients while exercising, therefore making it difficult to engage them in achieving effective prehabilitation. It would therefore, make sense if efforts were directed towards relieving pain thus, facilitating broader fitness enhancement strategies and improving the surgical experience and the recovery process.
Common pharmacological methods to relieve osteoarthritic pain while waiting for surgery, include acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDS and Cox-2 inhibitors) and occasionally opioids. Non-surgical interventions, such as intra-articular injection with steroids or hyaluronic acids, acupuncture and periosteal stimulation therapy, are often used as complementary therapies of limited benefit. The use of pulsed and Continuous radiofrequency (PRF and CRF) to the saphenous nerve and the genicular nerves branches of the knee, have been shown to decrease significantly pain scores in 44% of patients with chronic OA of the knee for up to one year after the treatment. Akbasa et al. using the Western Ontario and McMaster Osteoarthritis Index (WOMAC), reported significant reduction of pain at rest, movement and flexion of the knee and increase in patient's satisfaction 6 months after the PRF treatment. Our group has recently demonstrated the benefits of radiofrequency treatment in patients waiting for total knee replacement TKA 9. More so, the investigators recent results reported to the American Society of Regional Anesthesia and Pain, showed in a randomized controlled trial promising results in terms of faster recovery of patients undergoing TKA, when they received RF instead of the standard postoperative analgesia technique 10.
The present study is, as mentioned above, related to an already approved and finished study in this institution: 15-209-MUHC "Functional outcome and postoperative analgesia following total knee arthroplasty: a prospective, randomized, double blind comparison between continuous adductor canal block and pulsed radiofrequency of saphenous and genicular nerves of the knee". In that study, our research group was investigating the effects of the Radiofrequency treatment preoperatively on the postoperative pain and functional recovery, in patients who did not participate in a prehabilitation program.
- Conditions
- Knee Osteoarthritis
- Being tested
- Radiofrequency
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyOther
See previous page
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency group | Experimental | In this group patients will receive in a sterile fashion continuous radiofrequency for 4 minutes to the 3 genicular nerves in the operative knee as well as Pulsed Radiofrequency at 42 degrees celsius, for 4 minutes (60-70 volts) to the saphenous nerve and the nerve to the Vastus Medialis, at the level of the adductor canal. The procedure is done under local anesthesia on an ambulatory basis. After the radiofrequency, Ropivacaine 0.5% 5 ml is injected to each one of the nerves, along with 5 milligrams of Methylprednisolone to each nerve. Once the procedure is completed (takes about 20 minutes), patients will be observed in the preoperative program facility for 30 minutes and then discharged home. Receives: Other: Radiofrequency |
| Control (Sham Radiofrequency) group | Sham comparator | In this group patients will receive injections of the local anesthetic and steroids in the same anatomical locations, without activating the radiofrequency generator. Receives: Other: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of 15% of the total distance walked during a 6MWT
change of 15% or more in total distance in six minute walk test from baseline
Measured: 18 weeks
Secondary outcomes (4)
Change in WOMAC score
Change in score of WOMAC questionnaire
Measured: Baseline and 18 weeks
Change in knee pain levels assessed by VAS (Dynamic/Static)
Measured: Baseline and 18 weeks
Change in amount of daily pain relief medication consumption
Measured: Baseline and 18 weeks
Change in total time of the time up and go (TUG) test
Measured: Baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JF Asenjo, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758300
- Sponsor's protocol ID
- 2018-3664
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Facilitates the Prehabilitation Process in Patients Undergoing Total Knee Arthroplasty: Effects on Preoperative and Postoperative Functional Capacity. A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03758300
- Acronym / sponsor ID
- 2018-3664
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
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 compare the effects of the radiofrequency applied to the sensory innervation of the knee, with respect to a control group (standard therapy), in a prehabilitation program aiming to improve the functional recovery of patients undergoing TKA.
In the present study, the investigators hypothesize that participants treated with radiofrequency 4-6 weeks before the surgery, should be able to effectively accomplish the prehabilitation program and, therefore, have a faster recovery of their functional status in the post operative period , compared with the control group (That use the present state of the art approach)
Detailed description
Postoperative functional capacity following TKA surgery has been strongly associated with preoperative functional status. Presence of pain, poor strength and flexibility, and limited ability to complete physiological tasks have been shown to be consistent predictors of poor recovery from knee surgery.
The postoperative period is associated with 30-40% decrease in functional capacity, and efforts have been made to facilitate the recovery by implementing rehabilitative measures over the period of weeks and months. However, the postoperative period might not be the best time to engage patients in intensive physiotherapy as they are easily tired and in pain. Preparing patients for the stress of surgery, called also prehabilitation, is emerging as a mean to optimize pre-operative status and increase functional reserve thus, increasing surgical stress tolerance. Observational and randomized controlled studies in patients scheduled for colorectal, thoracic, and spinal surgeries have suggested that a 4-6 weeks of moderate preoperative physical activity can lead to significant postoperative improvements in cardiorespiratory reserve and functional capacity. However, preliminary trials on the effect of a 6-8 weeks prehabilitation program with structured exercises prior to knee arthroplasty have reported contrasting results, and one of the reasons might be the high levels of pain encountered by these patients while exercising, therefore making it difficult to engage them in achieving effective prehabilitation. It would therefore, make sense if efforts were directed towards relieving pain thus, facilitating broader fitness enhancement strategies and improving the surgical experience and the recovery process.
Common pharmacological methods to relieve osteoarthritic pain while waiting for surgery, include acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDS and Cox-2 inhibitors) and occasionally opioids. Non-surgical interventions, such as intra-articular injection with steroids or hyaluronic acids, acupuncture and periosteal stimulation therapy, are often used as complementary therapies of limited benefit. The use of pulsed and Continuous radiofrequency (PRF and CRF) to the saphenous nerve and the genicular nerves branches of the knee, have been shown to decrease significantly pain scores in 44% of patients with chronic OA of the knee for up to one year after the treatment. Akbasa et al. using the Western Ontario and McMaster Osteoarthritis Index (WOMAC), reported significant reduction of pain at rest, movement and flexion of the knee and increase in patient's satisfaction 6 months after the PRF treatment. Our group has recently demonstrated the benefits of radiofrequency treatment in patients waiting for total knee replacement TKA 9. More so, the investigators recent results reported to the American Society of Regional Anesthesia and Pain, showed in a randomized controlled trial promising results in terms of faster recovery of patients undergoing TKA, when they received RF instead of the standard postoperative analgesia technique 10.
The present study is, as mentioned above, related to an already approved and finished study in this institution: 15-209-MUHC "Functional outcome and postoperative analgesia following total knee arthroplasty: a prospective, randomized, double blind comparison between continuous adductor canal block and pulsed radiofrequency of saphenous and genicular nerves of the knee". In that study, our research group was investigating the effects of the Radiofrequency treatment preoperatively on the postoperative pain and functional recovery, in patients who did not participate in a prehabilitation program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency group | Experimental | Other: RadiofrequencyIn this group patients will receive in a sterile fashion continuous radiofrequency for 4 minutes to the 3 genicular nerves in the operative knee as well as Pulsed Radiofrequency at 42 degrees celsius, for 4 minutes (60-70 volts) to the saphenous nerve and the nerve to the Vastus Medialis, at the level of the adductor canal. The procedure is done under local anesthesia on an ambulatory basis. After the radiofrequency, Ropivacaine 0.5% 5 ml is injected to each one of the nerves, along with 5 milligrams of Methylprednisolone to each nerve. Once the procedure is completed (takes about 20 minutes), patients will be observed in the preoperative program facility for 30 minutes and then discharged home. |
| Control (Sham Radiofrequency) group | Sham comparator | Other: RadiofrequencyIn this group patients will receive injections of the local anesthetic and steroids in the same anatomical locations, without activating the radiofrequency generator. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic knee pain, with Dynamic VAS ≥ 5
- Scheduled for elective total knee arthroplasty
- Functional impairment due to pain because of knee osteoarthritis
- Taking medications to control the pain.
- Ability to perform the 6 MWT.
Key exclusion criteria (22 listed)
- ASA physical status > 3
- Morbid obesity (BMI >40)
- Revision of total knee arthroplasty
- Mayor neuropsychiatric disease
- Mayor cardiac, renal or hepatic failure
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 |
|---|---|---|
| RadiofrequencySee previous page | Other | Control (Sham Radiofrequency) group, Radiofrequency group |
Primary outcome
change of 15% of the total distance walked during a 6MWT
Time frame: 18 weeks
change of 15% or more in total distance in six minute walk test from baseline
4 secondary outcomes
Change in WOMAC score
Time frame: Baseline and 18 weeks
Change in knee pain levels assessed by VAS (Dynamic/Static)
Time frame: Baseline and 18 weeks
Change in amount of daily pain relief medication consumption
Time frame: Baseline and 18 weeks
Change in total time of the time up and go (TUG) test
Time frame: Baseline and 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
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Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency in people with Knee Osteoarthritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of 15% of the total distance walked during a 6MWT (time frame: 18 weeks). 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 29 Nov 2018.