Shock Waves in Knee Arthritis (SWinKA)

Extracorporeal Shock Wave Therapy in Patients With 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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis of Knee
• Intervention / Treatment: Device: ESWT group; Other: exercise group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Notarnicola, M.D.Ph.D.; Phone Number: +39 0805592938; Email: angelanotarnicola@yahoo.it
• Study Contact Backup: Name: Ilaria Covelli, M.D.Ph.D.; Phone Number: + 39 0805592938; Email: ilariacovelli@yahoo.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Policlinico di Bari
    • Contact: Angela Notarnicola; Phone Number: 0805592938; Email: angelanotarnicola@yahoo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESWT group; 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.	Device: 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.; Other Names: shock waves therapy
Active Comparator: Exercise Group; only a daily exercise program for 4 weeks: passive and active assisted movement of the knee joint, hamstring stretching, and quadriceps strengthening exercises	Other: exercise group; daily exercise program; Other Names: exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery of pain	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."	From enrollment to 1, 3 and 6 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	questionnaire consisting of 24 questions addressing pain, stiffness and physical function. Score from 0 to 96, higher scores correspond to worse clinical condition.	From enrollment to 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roles and Maudsley Score	rating of the perception of one's own clinical improvement, from 1 (excellent) to 4 (poor).	At 1, 3 and 6 months
MR image	weighted in t2 according to the ICRS classification	From enrollment to 6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Publications and helpful links

General Publications

• Zhao Z, Ji H, Jing R, Liu C, Wang M, Zhai L, Bai X, Xing G. Extracorporeal shock-wave therapy reduces progression of knee osteoarthritis in rabbits by reducing nitric oxide level and chondrocyte apoptosis. Arch Orthop Trauma Surg. 2012 Nov;132(11):1547-53. doi: 10.1007/s00402-012-1586-4. Epub 2012 Jul 24.
• Ochiai N, Ohtori S, Sasho T, Nakagawa K, Takahashi K, Takahashi N, Murata R, Takahashi K, Moriya H, Wada Y, Saisu T. Extracorporeal shock wave therapy improves motor dysfunction and pain originating from knee osteoarthritis in rats. Osteoarthritis Cartilage. 2007 Sep;15(9):1093-6. doi: 10.1016/j.joca.2007.03.011. Epub 2007 Apr 26.
• Mostafa MSEM, Hamada HA, Kadry AM, Zahran SS, Helmy NA. Effect of High-Power Laser Therapy Versus Shock Wave Therapy on Pain and Function in Knee Osteoarthritis Patients: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Mar;40(3):198-204. doi: 10.1089/photob.2021.0136. Epub 2022 Jan 5.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: conservative treatment; shock waves
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: SWinKA

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