The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial

This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis.

For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week.

Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy.

Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.

Study Overview

• Status: Suspended
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Active rESWT; Device: Sham rESWT

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05716-150
    • Instituto de Medicina Fisica e Reabilitacao HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of knee osteoarthritis;
• Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) > 4;
• Onset knee pain over 3 months prior to the inclusion;

Exclusion Criteria:

• Presence of psychiatric disease;
• Presence of fibromyalgia;
• Presence of systemic inflammatory rheumatic diseases;
• History of neoplasia;
• Presence of clinical diseases in other joints;
• Ongoing use of anticoagulant drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active rESWT; Application of 5,000 pulses of rESWT by a pneumatic generator, with 0.16mJ/mm2 (millijoule per squared millimeter) of energy at a frequency of 20Hz on the most painful spot of the knee. The applications will be given once a week for three weeks.	Device: Active rESWT; 5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
Sham Comparator: Sham rESWT; Application of 5,000 pulses of rESWT by a pneumatic generator, at a frequency of 20Hz on the most painful spot of the knee with 0 mJ/mm2 energy. The applications will also be given once a week for three weeks.	Device: Sham rESWT; 5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Change	Functional change from baseline, measured by KOOS.	At baseline and three months after the end of the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Term Functional Changes	Functional change from baseline, measured by KOOS	At baseline and one week after the end of the treatment.
Knee pain reduction	Knee pain changes from baseline, measured by KOOS	At baseline, one week and three months after the end of the treatment
Pain pressure threshold tolerance changes	Changes in pain pressure threshold tolerance over time, measured by algometer	At baseline, one week and three months after the end of the treatment
Diffuse noxious inhibitory control alterations	Changes in diffuse noxious inhibitory control over time, measured by algometer	At baseline, one week and three months after the end of the treatment
Thermography evaluation	Changes thermographic characteristics of lower limbs and knee over time, measured by Infrared Thermography	At baseline, one week and three months after the end of the treatment

Collaborators and Investigators

• Sponsor: Marta Imamura
• Investigators: Principal Investigator: Marta Imamura, MD, Instituto de Medicina Fisica e Reabilitacao HCFMUSP

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 72067817.8.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No