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

NCT03679507 | Unknown

• 1 other identifier: TPC-5460-204-0918
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis in the Knee

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measure

  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.

  The outcome will be measured over a period of 6 weeks.

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Group B

PLACEBO COMPARATOR

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

Group B1

ACTIVE COMPARATOR

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

Group B2

NO INTERVENTION

This group of patients will not receive high CBD oil to the affected joint.

Interventions

Low Intensity Ultrasound Therapy PROCEDURE

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.

Group A; Group B

Enhancing CBD oil penetration into joints by sonophresis OTHER

High CBD oil will be applied to the affected knee of one-half of the recruited subjects.

Group B1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Kevin Rod: lead

Study Sites (1)

Toronto Poly Clinic

Toronto, Ontario, M2N 6K7, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 20, 2018
• Study Start: June 15, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)