Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 94 of 45962 for:    intensity

The Effect of Low Intensity Ultrasound Therapy on Chronic Pain Due to Osteoarthritis of the Knee.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679507
Recruitment Status : Enrolling by invitation
First Posted : September 20, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Kevin Rod, Toronto Poly Clinic

Brief Summary:

To evaluate a new, low intensity ultrasound device in the treatment of chronic pain due to osteoarthritis in the knee.

Enhancing CBD oil penetration into joints by sonophoresis.


Condition or disease Intervention/treatment Phase
Osteoarthritis in the Knee Procedure: Low Intensity Ultrasound Therapy Other: Enhancing CBD oil penetration into joints by sonophresis Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This clinical trial will investigate the safety and efficacy of a new hand-held, low-intensity therapeutic ultrasound (LIPUS) device to treat chronic knee pain in osteoarthritis patients. Osteoarthritis of the knee is painful condition, and a leading cause of disability [11]. Two meta-analyses of this application indicate its efficacy in controlling pain [7,10]; one in improving function [10]. Three randomized, double blind, placebo-controlled studies have been published recently. Two demonstrate the ameliorative effects of low-intensity ultrasound therapy on pain, function and quality of life in patients with knee osteoarthritis [12,13]; one showed no significant difference from placebo [9]. Significantly, no adverse event was reported in any of these clinical trials. However subjects will have 24 hours phone access and email access to study administrator and study investigator for reporting any type of adverse event and seeking guidance if needed.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: A Study Administrator will assign subjects to a treatment group randomly, and keep this information strictly confidential. Subjects and investigators will be blinded. The Study Administrator will assign each participant a randomly generated Patient ID number to be used in the collection of data.
Primary Purpose: Treatment
Official Title: The Effect of Low Intensity Ultrasound Therapy on Chronic Pain Due to Osteoarthritis of the Knee.
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
The first patient group will receive Low Intensity Ultrasound Therapy on the affected knee joint, using the CPI-LIPUS Device
Procedure: Low Intensity Ultrasound Therapy
Subjects suffering from chronic pain due to osteoarthritis of the knee will be recruited for this study, and randomly assigned to two groups. One-half of these Subjects (Group A) will receive ultrasound therapy as detailed below on the affected joint; the other half (Group B) is a placebo group.

Placebo Comparator: Group B
Will be "treated" with an identical device whose ultrasound emitting capabilities has been nullified. This device appears to operate, including illumination of the operating light.
Procedure: Low Intensity Ultrasound Therapy
Subjects suffering from chronic pain due to osteoarthritis of the knee will be recruited for this study, and randomly assigned to two groups. One-half of these Subjects (Group A) will receive ultrasound therapy as detailed below on the affected joint; the other half (Group B) is a placebo group.

Active Comparator: Group B1
The first patient group will receive high CBD oil applied topically to the affected knee joint.
Other: Enhancing CBD oil penetration into joints by sonophresis
High CBD oil will be applied to the affected knee of one-half of the recruited subjects.

No Intervention: Group B2
This group of patients will not receive high CBD oil to the affected joint.



Primary Outcome Measures :
  1. Pain Intensity Measure [ Time Frame: The outcome will be measured over a period of 6 weeks. ]
    Participants who receive treatment using the CPI-LIPUS , a low intensity pulsed ultrasonic device will document any changes to their pain severity on a Brief Pain Inventory numeric scale from 1 to 10, with 1 being no pain, and 10 being the worst pain at each appointment.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Osteo-arthritis of knee joint diagnosed through X-Ray evaluation
  2. Moderate or sever level of pain due to knee osteoarthritis and no other known reason
  3. Male of Female patients of 18 to 85 years old
  4. Pain interfering with activities of daily life

Exclusion Criteria:

  1. Cancer pain or any other concurrent cancerous condition
  2. History of Knee replacement surgery in the study joint
  3. Local infection or any kind of inflammatory or allergic skin lesion
  4. Rheumatoid arthritis
  5. Mobility disorders or not being able to walk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679507


Locations
Layout table for location information
Canada, Ontario
Toronto Poly Clinic
Toronto, Ontario, Canada, M2N 6K7
Sponsors and Collaborators
Dr. Kevin Rod

Layout table for additonal information
Responsible Party: Dr. Kevin Rod, Director, Toronto Poly Clinic
ClinicalTrials.gov Identifier: NCT03679507     History of Changes
Other Study ID Numbers: TPC-5460-204-0918
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Chronic Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms