Shock Waves in Knee Arthritis

NCT06833372 · tracked via the Priya Life Science Italy tracker

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Phase

Not applicable

Started

2025-10-01

Last updated

2026-05-15

Condition(s) studied

Arthritis of Knee

Investigational drug(s) / intervention(s)

ESWT groupexercise group

ESWT group: 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.

exercise group: daily exercise program

Study summary

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.

Eligibility

Sex

ALL

Min age

45 Years

Max age

80 Years

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).

Primary outcome measure(s)

recovery of pain — 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."
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — 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.

Trial sites (1)

Facility	City	Region	Status
Policlinico di Bari	Bari	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833372 on ClinicalTrials.gov ↗ ← All trials in Italy