Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06833372

Shock Waves in Knee Arthritis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico di Bari

Bari, 70124, Italy

Location status: Recruiting

Location contact

Angela Notarnicola

CONTACT

[email protected]

0805592938

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ESWT group

Device

During each session, participants will receive 2000 pulses at a frequency of 4 Hz and an EDF between 0.02 and 0.2 mJ/mm2.

Other names: shock waves therapy

Exercise group

Other

daily exercise program

Other names: exercise

Primary outcomes

  1. recovery of pain

    Time frame: From enrollment to 1, 3 and 6 months

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: From enrollment to 1, 3 and 6 months

    questionnaire consisting of 24 questions addressing pain, stiffness and physical function. Score from 0 to 96, higher scores correspond to worse clinical condition.

Secondary outcomes

  1. Roles and Maudsley Score

    Time frame: At 1, 3 and 6 months

    rating of the perception of one's own clinical improvement, from 1 (excellent) to 4 (poor).

  2. MR image

    Time frame: From enrollment to 6 months

    weighted in t2 according to the ICRS classification

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Notarnicola, M.D.Ph.D.

CONTACT

[email protected]

+39 0805592938

Ilaria Covelli, M.D.Ph.D.

CONTACT

[email protected]

+ 39 0805592938

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

Extracorporeal Shock Wave Therapy in Patients With Knee Arthritis

Acronym: SWinKA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.