Clinical trial NCT06281444: Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Extracorporeal shock wave therapy(ESWT)
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain [by using the Visual Analogue Scale(VAS)]
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change from baseline in functionality and walking distance
timeFrame: Up to 24 weeks
measure: Change from baseline in walking distance
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
state: Altındağ
Study officials:
affiliation: Ankara University
name: Birkan Sonel Tur, Prof
role: PRINCIPAL_INVESTIGATOR
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