Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis

NCT02197962 | Completed Phase 2 DMC

• 1 other identifier: Radial Shockwave
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to compare the results of 2000 impulses of radius shockwaves per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of patients with severe primary knee osteoarthritis, who did not satisfactory respond to previous conventional treatments.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Radial shockwaves

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.

  Before intervention and after 3 months of the end of intervention

Secondary Outcomes (1)

• Level of tolerance of pain

  Immediately before the intervention, immediately after the intervention and 3 months after the intervention.

Other Outcomes (1)

• The influence of pain over the functional capacity of patients based on the WOMAC questionnaire

  Immediately before the intervention and 3 months after the intervention.

Study Arms (2)

Extracorporeal radial shockwaves

EXPERIMENTAL

Patients will receive 2,000 impulses of extracorporeal radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.

Device: Extracorporeal Radial shockwaves

Placebo Radial Shockwaves

PLACEBO COMPARATOR

Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.

Device: Placebo Radial Shockwaves

Interventions

Extracorporeal Radial shockwaves DEVICE

Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.

Extracorporeal radial shockwaves

Placebo Radial Shockwaves DEVICE

Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.

Placebo Radial Shockwaves

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiological diagnosis of primary knee diagnosis.
• Pain intensity: Visual Analog Scale (VAS) ≥ 6;
• One of more failures with conventional treatment (drugs, Non-Steroidal Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and others);
• Age over 60 years;
• No use of corticosteroids in the prior 48 hours;
• No major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
• No clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
• Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
• Absence of infection or cancer at the application site;
• Absence of related endocrine and metabolic diseases;
• Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
• Absence of severe blood dyscrasias;
• Absence of severe psychiatric disturbances that requires psychiatric assessment;
• Availability to comply with the clinic visits and follow up evaluations along the treatment

You may not qualify if:

• Patients who withdraw the informed consent form at any time

Sponsors & Collaborators

• Marta Imamura: lead
• University of Sao Paulo: collaborator

Study Sites (2)

Instituto de Ortopedia e Traumatologia HCFMUSP

São Paulo, São Paulo, 05403-010, Brazil

Location

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, São Paulo, 05716-150, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marta Imamura, MD

  Instituto de Medicina Fisica e Reabilitacao HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 23, 2014
• Study Start: May 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)