Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis

February 26, 2024 updated by: Birkan Sonel Tur, Ankara University

Effectiveness of the Effect of Radial Extracorporeal Shock Wave Therapy in Addition to Exercise on Pain, Functionality and Walking Distance in Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.

Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study was planned as a randomized controlled trial. Eligible patients who meet the inclusion criteria, will be invited to the study.

Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise. Computer-aided software will be used to assign patients to treatment groups.

The following evaluations will be made: visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 6-minute walking test.

VAS is widely used in the assessment of pain. WOMAC is widely used to evaluate the functional status of patients with knee osteoarthritis. High WOMAC values indicate increased pain and stiffness/stiffness, and impaired physical function.

6 minutes walking test will be done by the physician in the marked corridor of 30 meters in our clinic. At the end of 6 minutes, the total distance they walked will be determined and recorded in meters.

The exercises to be applied to each group are knee range of motion and strengthening exercises for the knee. It will be checked by phone on a weekly basis.

The first group will receive ESWT and exercise therapy. ESWT application will be given to the medial part of the knee region on the side where the pain is described, on the patellofemoral and tibiofemoral joint lines and once a week in a total of four sessions.

The second group will receive sham ESWT and exercise therapy. Sham ESWT application will be given to the medial part of the knee region on the side where the pain is described, on the patellofemoral and tibiofemoral joint lines and once a week in a total of four sessions.

Before starting the 4-session treatment program, at the end of the treatment program and at the third, sixth and twelfth months from the beginning of the treatment, the scales and tests under the heading of evaluations will be administered.

The sample calculation was made on the effect size. When the effect size of the difference between the two treatment groups in terms of change in VAS is taken as 0.8, when the sample is calculated using the Mann-Whitney U test with a significance level of 0.05 and a power of 0.90, the sample study is 36 patients per group and a total of 72 patients in total was found to be sufficient.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06230
        • Recruiting
        • Ankara University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Birkan Sonel Tur, Prof. Dr.
        • Sub-Investigator:
          • Taha Can Başar, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being over 50-85 years old.
  • Diagnosis of knee osteoarthritis according to ACR clinical/radiological diagnostic criteria
  • Stage 2 and above according to Kellgren Lawrence (K-L)
  • Completion of Informed Signed Consent Form

Exclusion Criteria:

  • Gait disorders due to orthopedic or neuromuscular disease
  • Participation in a structured physical rehabilitation program in the last 12 months before the study
  • Those who have had an intra-articular injection of the knee in the last 6 months
  • History of lower extremity surgery
  • Those with mechanical instability in the knee, a history of infection, malignancy
  • Inflammatory rheumatic diseases (rheumatoid arthritis, spondyloarthritis etc.)
  • A medical diagnosis or self-reported cognitive impairment
  • Presence of progressive cancer AND/OR other diseases that impair general condition
  • Situations where ESWT application is contraindicated
  • Patients with hip and/or ankle pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESWT group
The participants in this group will be applied with ESWT plus a home-based exercise program.
Device: ESWT

All patients in both groups will be applied with a home-based exercise program around for 30-minutes per day for four weeks. The exercises that mentioned in the research content are knee range of motion and strengthening exercises for the knee. It will be checked by phone on a weekly basis. Also, each patient in group 1 will receive shockwaves of continuous frequency and intensity (1000 shocks, 2.0 to 3.0 bar,10 Hz and 0.08-0.25mJ/mm2 energy range), while the second group of patients will receive sham-ESWT.

ESWT application will be applied to the medial part of the knee area on the side where the pain is described, or at the patellofemoral and tibiofemoral borders of the affected knee, and will be given in four sessions in total once a week.
Sham Comparator: Sham-ESWT group
The participants in this group will be applied with sham-ESWT plus a home-based exercise program.
Device: Sham-ESWT
Sham ESWT application will be set to 1000 pulses, 2-3 bar pressure, 10 Hz frequency and 0 mJ/mm2 energy to be sham.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain [by using the Visual Analogue Scale(VAS)]
Time Frame: Up to 24 weeks

It was defined as the change in pain (VAS) felt after 4 sessions of ESWT treatment from baseline.

Visual Analog Scale (VAS): Vas is widely used in pain assessment. The numbers 0 and 10 are written at both ends of a 10 cm line. 0 = I have no pain 10 = means I have unbearable pain. The pain level increases from 0 to 10. The patient is asked to indicate which point on this chart is most appropriate for his/her situation. The location marked by the patient will be evaluated by measuring its distance from point 0.
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in functionality and walking distance
Time Frame: Up to 24 weeks

Change from baseline in functionality (WOMAC) and walking distance (6-minute walk test)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): WOMAC is widely used to evaluate the functionality status in patients with knee osteoarthritis.

High WOMAC values indicate increased pain and stiffness and deterioration in physical function.

The form consists of three subheadings (pain, stiffness, physical function) and 24 questions.

The pain subheading is questioned with 5 questions, and the stiffness subheading is questioned with 2 questions. In the physical function evaluation, 17 activities are questioned.

Scoring of the items is done according to the Likert scale. The degree of pain and strain is indicated by giving points from 0 to 4 on the Likert scale.
Up to 24 weeks
Change from baseline in walking distance
Time Frame: Up to 24 weeks

Change from baseline in walking distance (6-minute walk test)

6-minute walk test: It will be performed by the physician in the 30-meter marked corridor in our clinic. Patients will be asked to rest for at least 10 minutes before starting the test.

Patients will be asked to walk as far as they can in the corridor for 6 minutes at their own pace.

At the end of 6 minutes, the total distance walked will be determined and recorded in meters.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Birkan Sonel Tur, Prof, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Estimated)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • i07-453-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on ESWT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe