The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

Marta Imamura

Status and phase: Suspended; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Device: Active rESWT; Device: Sham rESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT03344770

72067817.8.0000.0068

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Active rESWT

Experimental group

Description:

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.

Treatment:

Device: Active rESWT

Sham rESWT

Sham Comparator group

Description:

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.

Treatment:

Device: Sham rESWT