Shock Waves in Knee Arthritis (SWinKA)

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Not yet enrolling

Conditions: Arthritis of Knee

Treatments: Other: exercise group; Device: ESWT group

Study type: Interventional

Funder types: Other

Identifiers

NCT06833372

SWinKA

Details and patient eligibility

About

Pathological arthritis is a degenerative disease affecting the joints, characterized by pain, limitation of movement up to ankylosis and disability. Treatment is aimed at reducing pain and slowing the loss of functionality of the district. Among conservative treatments, pharmacological options (NSAIDs, cortisone, contrasupplements, hyaluronic acid) and non-pharmacological options (therapeutic exercise, physical therapy, orthosis, etc.) are indicated. In cases not responding to conservative treatments, surgical treatment will be necessary with prosthetic replacement of the joint district.

Full description

In recent years, shock wave therapy has received a lot of interest in the treatment of numerous musculoskeletal pathologies. This physical therapy exploits the cavitational effect induced on the tissues which translates into neo-angiogenic, anti-inflammatory, regenerative and analgesic action. Until now, the indication has been reserved for the treatment of tendinopathies and delayed consolidation of fractures. Pre-clinical research is also paving the way for the treatment of cartilage pathologies; in fact, after the stimulation of the chondrocyte, a modulation of the phlogogenic cytokines has been found, supporting a slowing down of the progression of the arthritic pathology. The first clinical experiences on arthritic models, such as rhizarthrosis, allow to support the indication also on the pathological model of gonarthrosis. The aim of this study is to verify the effects of shock wave therapy in the patient affected by gonarthrosis, monitoring the action on pain, functionality and tissue district changes.

Enrollment: 72 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• persistent knee pain for at least 3 months, measured with a VAS scale of 4 or higher,
• clinical and radiological diagnosis confirming knee osteoarthritis grade 2 and 3 based on the Kellgren-Lawrence system,
• no history of physical therapy in the last 3 months,
• no infections, tumors in the treatment area of the knee,
• no pathology other than osteoarthritis that could cause knee pain,
• no pathology of the lumbar spine or hip that could refer knee pain,
• free from any condition that prevents participation in exercise or physical therapy willing to participate regularly in the treatment programs were included in the study.

Exclusion criteria

• inability to walk,
• a history of clinically symptomatic spinal stenosis or lumbar radiculopathy,
• evidence of a neurological disorder based on history or physical examination,
• generalized pain or fibromyalgia,
• secondary osteoarthritis (to metabolic or rheumatologic disease),
• administration of intra-articular injections (anesthetic, hyaluronic acid, cortisone) of the knee in the last 6 months,
• use of NSAIDs, paracetamol or topical agents in the previous week,
• a previous history of surgery involving the knee joint,
• contraindications to physical therapy (PM, epilepsy, neoplasia, coagulopathy, pregnancy).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Exercise Group

Active Comparator group

Description:

only a daily exercise program for 4 weeks: passive and active assisted movement of the knee joint, hamstring stretching, and quadriceps strengthening exercises

Treatment:

Other: exercise group

ESWT group

Experimental group

Description:

Shockwave therapy will be administered using an ESWT device (Minilith SL1, Storz) once a week for three consecutive weeks, for a total of three sessions. A focused shockwave modality with an electromagnetic device was chosen for the therapy.

Treatment:

Device: ESWT group