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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Montreal General Hospital

    Montreal, Quebec, H3A 1A1

    JF Asenjo, MD, 514) 934-1934 ext. 43261, jfasenjog@yahoo.com

    JF Asenjo, MD

    Recruiting

Other trials in Canada

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.

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 groups in NCT03758300
Study groupRoleWhat they receive
Radiofrequency groupExperimentalIn 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) groupSham comparatorIn 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.

  1. 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)
  1. Change in WOMAC score

    Change in score of WOMAC questionnaire

    Measured: Baseline and 18 weeks

  2. Change in knee pain levels assessed by VAS (Dynamic/Static)

    Measured: Baseline and 18 weeks

  3. Change in amount of daily pain relief medication consumption

    Measured: Baseline and 18 weeks

  4. 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.

  1. First posted29 Nov 2018
  2. Study start1 Dec 2017
  3. Primary completion31 Dec 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

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)
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

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.

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