Back to resultsThe Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Suspended
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Active rESWT
Sham rESWT
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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.
Sites / Locations
- Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active rESWT
Sham rESWT
Arm 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.
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.
Outcomes
Primary Outcome Measures
Functional Change
Functional change from baseline, measured by KOOS.
Secondary Outcome Measures
Short Term Functional Changes
Functional change from baseline, measured by KOOS
Knee pain reduction
Knee pain changes from baseline, measured by KOOS
Pain pressure threshold tolerance changes
Changes in pain pressure threshold tolerance over time, measured by algometer
Diffuse noxious inhibitory control alterations
Changes in diffuse noxious inhibitory control over time, measured by algometer
Thermography evaluation
Changes thermographic characteristics of lower limbs and knee over time, measured by Infrared Thermography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03344770
Brief Title
The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis
Official Title
The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Study suspended due to Covid-19 pandemic.
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marta Imamura
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active rESWT
Arm Type
Experimental
Arm 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.
Arm Title
Sham rESWT
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Active rESWT
Intervention Description
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
Intervention Name(s)
Sham rESWT
Intervention Description
5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
Primary Outcome Measure Information:
Title
Functional Change
Description
Functional change from baseline, measured by KOOS.
Time Frame
At baseline and three months after the end of the treatment.
Secondary Outcome Measure Information:
Title
Short Term Functional Changes
Description
Functional change from baseline, measured by KOOS
Time Frame
At baseline and one week after the end of the treatment.
Title
Knee pain reduction
Description
Knee pain changes from baseline, measured by KOOS
Time Frame
At baseline, one week and three months after the end of the treatment
Title
Pain pressure threshold tolerance changes
Description
Changes in pain pressure threshold tolerance over time, measured by algometer
Time Frame
At baseline, one week and three months after the end of the treatment
Title
Diffuse noxious inhibitory control alterations
Description
Changes in diffuse noxious inhibitory control over time, measured by algometer
Time Frame
At baseline, one week and three months after the end of the treatment
Title
Thermography evaluation
Description
Changes thermographic characteristics of lower limbs and knee over time, measured by Infrared Thermography
Time Frame
At baseline, one week and three months after the end of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Imamura, MD
Organizational Affiliation
Instituto de Medicina Física e Reabilitação HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
City
Sao Paulo
ZIP/Postal Code
05716-150
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis
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