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

NCT ID: NCT01623804

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-08-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low intensity, pulsed ultrasound

Group Type: ACTIVE_COMPARATOR

low intensity, pulsed ultrasound

Intervention Type: DEVICE

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 ultrasound

Group Type: SHAM_COMPARATOR

sham ultrasound

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Exogen Express Ultrasound Bone Healing System; sham Exogen Express Ultrasound Bone Healing System

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioventus LLC

INDUSTRY

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norma J MacIntyre, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Regional Joint Assessment Program - HHS/SJHH

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

EX-KOA-xxxxxx

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MTP 108229/MTO 108232

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EX-KOA-1206

Identifier Type: -

Identifier Source: org_study_id