Can Very Low Intensity Ultrasound Therapy Improve Pain in People With Knee Osteoarthritis? A Pilot Randomized Controlled Trial

McMaster University1 site in 1 country1 target enrollmentJuly 2012

ConditionsKnee Osteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: McMaster University
Enrollment: 1
Locations: 1
Primary Endpoint: Rate of recruitment
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

McMaster University

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Lower Extremity Functional Scale (LEFS)(26 weeks)
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale(13 weeks)
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale(26 weeks)
6 Minute Walk Test (6MWT)(26 weeks)
SF-36 (RAND 36-item Health Survey 1.0)(26 weeks)
Global Rating of Disease Severity(26 weeks)
11-point Verbal Numeric Rating Scale (VNRS)(0 and 13 weeks)
Stair Climb test(26 weeks)
Perceived change(13 and 26 weeks)