The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

Phase 2

Suspended

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Sham rESWT; Device: Active rESWT

• Registration Number: NCT03344770
• Lead Sponsor: Marta Imamura

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-20
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rESWT	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.
Active rESWT	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.

Primary Outcome Measures

Name	Time	Method
Functional Change	At baseline and three months after the end of the treatment.	Functional change from baseline, measured by KOOS.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Medicina Fisica e Reabilitacao HCFMUSP; 🇧🇷 Sao Paulo, Brazil