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

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.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: low intensity, pulsed ultrasound; Device: sham ultrasound

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • Regional Joint Assessment Program - HHS/SJHH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: sham Exogen Express Ultrasound Bone Healing System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recruitment	Ability to recruit 30 participants over a 6 month period	6 months
Adherence to study protocol	Percent adherence to the protocols for randomization, recruitment, intervention, and assessment	26 weeks
Rate of retention	Number of participants completing the trial	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.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale	Change from baseline in pain at 13 weeks	13 weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale	Change from baseline in Physical Function at 26 weeks	26 weeks
6 Minute Walk Test (6MWT)	Change from baseline distance (metres) walked in 6 minutes at 26 weeks	26 weeks
SF-36 (RAND 36-item Health Survey 1.0)	Change from baseline in Health Related Quality of Life at 26 weeks	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))	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)	0 and 13 weeks
Lower Extremity Functional Scale (LEFS)	Change from baseline in physical function at 26 weeks	26 weeks
Stair Climb test	Time (seconds) to ascend and descend a staircase with 9 steps	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)	13 and 26 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); Bioventus LLC
• Investigators: Principal Investigator: Norma J MacIntyre, PT, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Ultrasound therapy; Tibiofemoral joint, medial; Nonsurgical
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: EX-KOA-1206; EX-KOA-xxxxxx (Other Grant/Funding Number: Smith & Nephew, Inc); MTP 108229/MTO 108232 (Other Grant/Funding Number: Canadian Institutes of Health Research)