The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03344770
• Other study ID #: 72067817.8.0000.0068
• Status: Suspended
• Phase: Phase 2
• Start date: October 20, 2017
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 44
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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 rESWT
5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Fisica e Reabilitacao HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Marta Imamura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Change	Functional change from baseline, measured by KOOS.	At baseline and three months after the end of the treatment.
Secondary	Short Term Functional Changes	Functional change from baseline, measured by KOOS	At baseline and one week after the end of the treatment.
Secondary	Knee pain reduction	Knee pain changes from baseline, measured by KOOS	At baseline, one week and three months after the end of the treatment
Secondary	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
Secondary	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
Secondary	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