Randomized Trial in knEe Osteoarthritis Using Low Intensity Ultrasound - Evaluating Feasibility (RELIEF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by McMaster University
Sponsor:
Collaborators:
Bioventus LLC
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01623804
First received: May 31, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Device: low intensity, pulsed ultrasound
Device: sham ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Very Low Intensity Ultrasound Therapy Improve Pain in People With Knee Osteoarthritis? A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Rate of recruitment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Ability to recruit 30 participants over a 6 month period

  • Adherence to study protocol [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent adherence to the protocols for randomization, recruitment, intervention, and assessment

  • Rate of retention [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Number of participants completing the trial

  • Rate of all adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Change from baseline in pain at 13 weeks

  • Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Physical Function at 26 weeks

  • 6 Minute Walk Test (6MWT) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change from baseline distance (metres) walked in 6 minutes at 26 weeks

  • SF-36 (RAND 36-item Health Survey 1.0) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Health Related Quality of Life at 26 weeks

  • Global Rating of Disease Severity [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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))

  • 11-point Verbal Numeric Rating Scale (VNRS) [ Time Frame: 0 and 13 weeks ] [ Designated as safety issue: No ]
    Change from baseline in pain intensity (average, minimum and maximum over the past 24 hours and following physical performance tests)

  • Lower Extremity Functional Scale (LEFS) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change from baseline in physical function at 26 weeks

  • Stair Climb test [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Time (seconds) to ascend and descend a staircase with 9 steps

  • Perceived change [ Time Frame: 13 and 26 weeks ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low intensity, pulsed ultrasound Device: low intensity, pulsed ultrasound
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.
Other Name: Exogen Express Ultrasound Bone Healing System
Sham Comparator: Sham ultrasound Device: sham ultrasound
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
Other Name: sham Exogen Express Ultrasound Bone Healing System

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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);
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623804

Contacts
Contact: Norma J MacIntyre, PT, PhD 905-525-9140 ext 21166 macint@mcmaster.ca
Contact: Mohit Bhandari, MD, PhD 905-527-4322 ext 44490 bhandam@mcmaster.ca

Locations
Canada, Ontario
Regional Joint Assessment Program - HHS/SJHH Recruiting
Hamilton, Ontario, Canada, L8S 1C7
Contact: Mitch Winemaker, MD    905-570-8884    mwinemaker@cogeco.ca   
Contact: Anthony Adili, MD    905-521-6062    adilia@mcmaster.ca   
Principal Investigator: Norma J MacIntyre, PT, PhD         
Sponsors and Collaborators
McMaster University
Bioventus LLC
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Norma J MacIntyre, PT, PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01623804     History of Changes
Other Study ID Numbers: EX-KOA-1206, EX-KOA-xxxxxx, MTP 108229/MTO 108232
Study First Received: May 31, 2012
Last Updated: May 15, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

Keywords provided by McMaster University:
Ultrasound therapy
Tibiofemoral joint, medial
Nonsurgical

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014