The primary goal of this study is to provide an estimate of treatment effects and patient inclusion rate to assess the feasibility of conducting a future randomised controlled non-inferiority trial to assess whether the effect of conventional RF…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome parameter is the proportion of patients with a pain
intensity reduction of at least 50% at 3 months post intervention compared to
baseline. Pain intensity is measured by a Numeric Rating Scale.
Secondary outcome
Secondary parameters include physical functioning, health-related quality of
life, emotional outcome, patient satisfaction, side effects, duration effect,
medication use, costs and cost effectiveness. Inclusion rates per patient
subgroup (osteoarthritis and post total knee arthroplasty) and per hospital
will be monitored as well.
Background summary
Knee osteoarthritis is a progressive degenerative process that affects joint
cartilage and the subchondral bone. Approximately 10% to 30% of all
osteoarthritis patients suffer from disabling symptoms such as pain, stiffness
and loss of function leading to psychological and sleeping disorders and a
diminished quality of life. When conservative treatment fails to treat the
symptoms, a total knee arthroplasty can be performed. Due to comorbidities or
young age due to the limited lifetime of the prostheses used, the total knee
arthroplasty procedure is not suitable for all patients. Also, persistent pain
after tot knee arthroplasty is also possible. For these specific groups of
patients a radiofrequent treatment of the genicular nerves (superolateral,
superomedial and inferomedial) might be an alternative treatment option.
Multiple researchers investigated the effect of conventional and later also,
cooled radiofrequent treatment of the genicular nerves, with promising results
for both techniques. However, the techniques have never been compared in a
randomised controlled trial.
Study objective
The primary goal of this study is to provide an estimate of treatment effects
and patient inclusion rate to assess the feasibility of conducting a future
randomised controlled non-inferiority trial to assess whether the effect of
conventional RF treatment of the genicular nerves (superomedial, superolateral
and inferomedial) of the index knee on knee pain relief is not inferior to the
more expensive cooled RF treatment of the genicular nerves. A secondary goal is
to estimate the initial costs and cost-effectiveness of conventional treatment
compared to cooled radiofrequent treatment so as to determine the need, focus
and scope of an economic evaluation alongside the RCT.
Study design
This study is a prospective, multicentre, double blind, randomised controlled,
non-inferiority study.
Intervention
One group is treated with a conventional radiofrequent treatment of the
genicular nerves (SL, SM, IM) of the index knee. The other group is treated
with a cooled radiofrequent treatment.
Study burden and risks
After study enrolment and baseline intake, patients are treated and followed
at 1, 3 , 6 and 12 months after the initial intervention (total of 4 site
visits). Primary endpoint is 3 months post intervention. During the intake a
physical examination is done. The treatment itself is performed without
sedation and is generally well tolerated without side effects of complications.
This study compares two active treatment therapies. Therefore, it is expected
that patients from both treatment groups experience similar positive effects
regarding pain relief and improved knee function.
P. Debyelaan 25
Maastricht 6229
NL
P. Debyelaan 25
Maastricht 6229
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Able to understand the informed consent form and provide written informed
consent and able to complete outcome measures.
- Chronic anterior knee pain (> 12 months) with an NRS > 4 on most or all days
for the index knee either constantly or with motion.
- Unresponsive to conventional treatments continued during 12 months including
physiotherapy, oral analgesics or intra-articular infiltrations.
- Radiologic confirmation of arthritis of OA grade of 2 (mild), 3 (moderate)
or 4 (severe) noted within 6 months for the index knee according the Kellgren
Lawrence criteria (27) diagnosed by an independent radiologist with experience
in musculoskeletal imaging on Rx or MRI or patients with total knee
arthroplasty of the index knee with a negative orthopaedic workout.
- Other therapies (including surgical interventions) for pain in the index
knee are allowed for the period of the study follow up as long as they are
documented. This is necessary to correctly estimate the costs in the cost
effectiveness analyses. Allowing patients to receive additional treatments will
also improve the protocol compliance.
- Agree to provide informed consent and to comply with the requirements of
this protocol for the full duration of the study
Exclusion criteria
- Patient refusal to comply to protocol procedures or schedule
- Local or systemic infection (bacteraemia)
- Evidence of inflammatory arthritis or an inflammatory systemic disease
responsible for knee pain
- Intra-articular injections (steroids, hyaluronic acid, platelet enriched
plasma, *) in the index knee during the 3 months prior to procedure
- Body mass index (BMI) > 40 kg/m2
- Pregnant, nursing or planning to become pregnant
- Chronic widespread pain
- Patients with psychosocial dysfunction will be referred for further
psychological follow up prior to possible inclusion
- Allergies to products used during the procedure
- Uncontrolled coagulopathy defined as supratherapeutic dose of
anticoagulation medication.
- Uncontrolled immune suppression
- Participating in another clinical trial/investigation within 30 days prior
to signing informed consent
- Patient is currently implanted with a defibrillator, neuromodulator or other
electrical devices
- Radicular pain in index leg
- Patient received previous conventional or cooled radiofrequency of the index
knee
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03865849 |
| CCMO | NL69877.068.19 |