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

NCT01623804 | Terminated DMC

• 3 other identifiers: EX-KOA-1206EX-KOA-xxxxxxMTP 108229/MTO 108232
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrasound therapy; Tibiofemoral joint, medial; Nonsurgical

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

Study Arms (2)

Low intensity, pulsed ultrasound

ACTIVE COMPARATOR

Device: low intensity, pulsed ultrasound

Sham ultrasound

SHAM COMPARATOR

Device: sham ultrasound

Interventions

low intensity, pulsed ultrasound 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.

Also known as: Exogen Express Ultrasound Bone Healing System

Low intensity, pulsed ultrasound

sham ultrasound 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

Also known as: sham Exogen Express Ultrasound Bone Healing System

Sham ultrasound

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Bioventus LLC: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Regional Joint Assessment Program - HHS/SJHH

Hamilton, Ontario, L8S 1C7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Norma J MacIntyre, PT, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (1)