Knee OsteoarthritisRELIEFNCT01623804
Randomized Trial in knEe Osteoarthritis Using Low Intensity Ultrasound - Evaluating Feasibility (RELIEF)
A study testing low intensity, pulsed ultrasound in people with Knee Osteoarthritis, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this pilot study is to determine the feasibility of conducting a high quality clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee osteoarthritis pain and physical function. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- low intensity, pulsed ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 40 years of age;
- have medial tibiofemoral compartment knee OA;
- have mild to moderate medial compartment radiographic OA severity (determined by the attending surgeon and/or Advanced Practice Physiotherapist on the basis of a standing x-ray or MRI scan depending upon which is available at initial consult);
- have stable ('not getting worse or better overall despite short-term fluctuations during the past three months') pain having an average intensity ≥ 3 and ≤ 8 on an 11-point verbal numeric rating scale, VNRS) in one knee which is aggravated by activity and eased with rest;
- limited pain from other lower extremity joints; and
- no change in first line pain medication in the past 2 months and willingness to forego alterations in pain medication for the duration of the study unless deemed medically necessary.
Who cannot join
- history of traumatic OA or previous surgical intervention in the knee or knee effusion;
- intra-articular injection of the knee in the previous 6 months;
- received ultrasound treatment for knee OA within the past 6 months;
- body weight changed ≥ 5% in the past 2 months;
- level of physical function insufficient to perform the required assessments or administer the intervention (e.g. intermittent claudication, severe peripheral neuropathy, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, chronic pain, arthritis in joints other than the study knee, bone fracture in the past 3 months);
- conditions listed as precautions or unknown safety risks for using the EXOGEN EXPRESS ultrasound device (pregnant or nursing women, individuals with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, open wound at the medial joint line of the knee, taking steroids/anti-coagulants, prescription non-steroidal anti-inflammatory, calcium channel blocker or applying the EXOGEN EXPRESS in close proximity to someone wearing a cardiac pacemaker);
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- unable to read, write and/or understand English;
- other illness or reasons judged by the participant, clinicians or researchers to make participation inadvisable (e.g. plans to move or travel, cognitive deficit resulting in difficulty comprehending and complying with instructions, caregiving demands/lack of social support for participation);
- unwillingness to sign informed consent; or
- participation in a competing study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Regional Joint Assessment Program - HHS/SJHH
Hamilton, Ontario, L8S 1C7
About this study
Official title: Can Very Low Intensity Ultrasound Therapy Improve Pain in People With Knee Osteoarthritis? A Pilot Randomized Controlled Trial
The purpose of this pilot study is to determine the feasibility of conducting a high quality clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee osteoarthritis pain and physical function.
- Conditions
- Knee Osteoarthritis
- Being tested
- low intensity, pulsed ultrasound, sham ultrasound
- Keywords
- Ultrasound therapy, Tibiofemoral joint, medial, Nonsurgical
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity, pulsed ultrasoundDevice
Also called Exogen Express Ultrasound Bone Healing System
1.5MHz, spatial average-temporal average intensity = 0.03W/cm2, pulsed (burst frequency 1kHz, burst duration 200µm, duty cycle 20%); self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months.
sham ultrasoundDevice
Also called sham Exogen Express Ultrasound Bone Healing System
no ultrasonic energy emitted; self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Low intensity, pulsed ultrasound | Active comparator | Not described Receives: Device: low intensity, pulsed ultrasound |
| Sham ultrasound | Sham comparator | Not described Receives: Device: sham ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Ability to recruit 30 participants over a 6 month period
Measured: 6 months
Adherence to study protocol
Percent adherence to the protocols for randomization, recruitment, intervention, and assessment
Measured: 26 weeks
Rate of retention
Number of participants completing the trial
Measured: 26 weeks
Rate of all adverse events
Participants will be asked about serious and non-serious adverse events weekly during the 13 week intervention phase and monthly during the 13 week follow up phase. All adverse events will be recorded and addressed as indicated.
Measured: 26 weeks
Secondary outcomes (9)
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale
Change from baseline in pain at 13 weeks
Measured: 13 weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale
Change from baseline in Physical Function at 26 weeks
Measured: 26 weeks
6 Minute Walk Test (6MWT)
Change from baseline distance (metres) walked in 6 minutes at 26 weeks
Measured: 26 weeks
SF-36 (RAND 36-item Health Survey 1.0)
Change from baseline in Health Related Quality of Life at 26 weeks
Measured: 26 weeks
Global Rating of Disease Severity
Change from baseline in Global Rating of Disease Severity at 13 and 26 weeks will be assessed using an 11-point scale ('Considering all the ways that your knee arthritis affects you, please rate how you are doing on a scale from 0 (very well) to 10 (very poor))
Measured: 26 weeks
11-point Verbal Numeric Rating Scale (VNRS)
Change from baseline in pain intensity (average, minimum and maximum over the past 24 hours and following physical performance tests)
Measured: 0 and 13 weeks
Lower Extremity Functional Scale (LEFS)
Change from baseline in physical function at 26 weeks
Measured: 26 weeks
Stair Climb test
Time (seconds) to ascend and descend a staircase with 9 steps
Measured: 26 weeks
Perceived change
Perceived change from baseline will be assessed at 13 and 26 weeks using an 11-point scale ('With respect to your OA knee treated with ultrasound, how would you describe yourself now compared to baseline assessment?' -5 = a very great deal worse, 0 = about the same, +5 = a very great deal better)
Measured: 13 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: funding to support alternate feasible recruitment strategy was not acquired
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.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Bioventus LLC, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Norma J MacIntyre, PT, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623804
- Sponsor's protocol ID
- EX-KOA-1206
- Other IDs
- EX-KOA-xxxxxx, MTP 108229/MTO 108232
- Acronym
- RELIEF
- Status last verified
- Apr 2015
- First submitted
- 31 May 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Very Low Intensity Ultrasound Therapy Improve Pain in People With Knee Osteoarthritis? A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01623804
- Acronym / sponsor ID
- RELIEF / EX-KOA-1206
- Conditions
- Knee Osteoarthritis
- Keywords
- Ultrasound therapy, Tibiofemoral joint, medial, Nonsurgical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding to support alternate feasible recruitment strategy was not acquired
- Enrolment
- 1 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Bioventus LLC, Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Jun 2012 (estimated)
- 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 pilot study is to determine the feasibility of conducting a high quality clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee osteoarthritis pain and physical function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity, pulsed ultrasound | Active comparator | Device: low intensity, pulsed ultrasound |
| Sham ultrasound | Sham comparator | Device: sham ultrasound |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- over 40 years of age;
- have medial tibiofemoral compartment knee OA;
- have mild to moderate medial compartment radiographic OA severity (determined by the attending surgeon and/or Advanced Practice Physiotherapist on the basis of a standing x-ray or MRI scan depending upon which is available at initial consult);
- have stable ('not getting worse or better overall despite short-term fluctuations during the past three months') pain having an average intensity ≥ 3 and ≤ 8 on an 11-point verbal numeric rating scale, VNRS) in one knee which is aggravated by activity and eased with rest;
- limited pain from other lower extremity joints; and
Key exclusion criteria (10 listed)
- history of traumatic OA or previous surgical intervention in the knee or knee effusion;
- intra-articular injection of the knee in the previous 6 months;
- received ultrasound treatment for knee OA within the past 6 months;
- body weight changed ≥ 5% in the past 2 months;
- level of physical function insufficient to perform the required assessments or administer the intervention (e.g. intermittent claudication, severe peripheral neuropathy, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, chronic pain, arthritis in joints other than the study knee, bone fracture in the past 3 months);
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 |
|---|---|---|
| low intensity, pulsed ultrasoundAlso: Exogen Express Ultrasound Bone Healing System1.5MHz, spatial average-temporal average intensity = 0.03W/cm2, pulsed (burst frequency 1kHz, burst duration 200µm, duty cycle 20%); self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months. | Device | Low intensity, pulsed ultrasound |
| sham ultrasoundAlso: sham Exogen Express Ultrasound Bone Healing Systemno ultrasonic energy emitted; self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months | Device | Sham ultrasound |
Primary outcome
Rate of recruitment
Time frame: 6 months
Ability to recruit 30 participants over a 6 month period
Adherence to study protocol
Time frame: 26 weeks
Percent adherence to the protocols for randomization, recruitment, intervention, and assessment
Rate of retention
Time frame: 26 weeks
Number of participants completing the trial
Rate of all adverse events
Time frame: 26 weeks
Participants will be asked about serious and non-serious adverse events weekly during the 13 week intervention phase and monthly during the 13 week follow up phase. All adverse events will be recorded and addressed as indicated.
9 secondary outcomes
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale
Time frame: 13 weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale
Time frame: 26 weeks
6 Minute Walk Test (6MWT)
Time frame: 26 weeks
SF-36 (RAND 36-item Health Survey 1.0)
Time frame: 26 weeks
Global Rating of Disease Severity
Time frame: 26 weeks
11-point Verbal Numeric Rating Scale (VNRS)
Time frame: 0 and 13 weeks
Lower Extremity Functional Scale (LEFS)
Time frame: 26 weeks
Stair Climb test
Time frame: 26 weeks
Perceived change
Time frame: 13 and 26 weeks
Results and safety
The study was stopped early (reason given: funding to support alternate feasible recruitment strategy was not acquired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Norma J MacIntyre, PT, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity, pulsed ultrasound in people with Knee Osteoarthritis, run by McMaster University 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 8 Apr 2015. 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?
The study was stopped early (reason given: funding to support alternate feasible recruitment strategy was not acquired). Results are not available in the source record.
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?
Rate of recruitment (time frame: 6 months). The study lists 4 primary outcomes in all. 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 8 Apr 2015.