The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

NCT ID: NCT03344770

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2025-10-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active rESWT

Intervention Type: DEVICE

5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.

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.

Group Type: SHAM_COMPARATOR

Sham rESWT

Intervention Type: DEVICE

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

Interventions

Active rESWT

5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marta Imamura

OTHER

Sponsor Role: lead

Responsible Party

Marta Imamura

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Imamura, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Física e Reabilitação HCFMUSP

Locations

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

72067817.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id