The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

NCT03344770 | Suspended Phase 2 DMC

• 1 other identifier: 72067817.8.0000.0068
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Functional Change

  Functional change from baseline, measured by KOOS.

  At baseline and three months after the end of the treatment.

Secondary Outcomes (5)

• Short Term Functional Changes

  At baseline and one week after the end of the treatment.

• Knee pain reduction

  At baseline, one week and three months after the end of the treatment

• Pain pressure threshold tolerance changes

  At baseline, one week and three months after the end of the treatment

• Diffuse noxious inhibitory control alterations

  At baseline, one week and three months after the end of the treatment

• Thermography evaluation

  At baseline, one week and three months after the end of the treatment

Study Arms (2)

Active rESWT

EXPERIMENTAL

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

Sham rESWT

SHAM COMPARATOR

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

Interventions

Active rESWT DEVICE

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

Active rESWT

Sham rESWT DEVICE

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

Sham rESWT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of knee osteoarthritis;
• Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) \> 4;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marta Imamura: lead

Study Sites (1)

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, 05716-150, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marta Imamura, MD

  Instituto de Medicina Física e Reabilitação HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: October 20, 2017
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

BR (1)