Shock Waves in Knee Arthritis

NCT ID: NCT06833372

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-09-01

Brief 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.

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.

Conditions

Arthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

exercise group

Intervention Type: OTHER

daily exercise program

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.

Group Type: EXPERIMENTAL

ESWT group

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

exercise group

daily exercise program

Intervention Type: OTHER

Other Intervention Names

shock waves therapy; exercise

Eligibility Criteria

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Policlinico di Bari

Bari, , Italy

Countries

Italy

Central Contacts

Angela Notarnicola, M.D.Ph.D.

Role: CONTACT

angelanotarnicola@yahoo.it

+39 0805592938

Ilaria Covelli, M.D.Ph.D.

Role: CONTACT

ilariacovelli@yahoo.it

+ 39 0805592938

Facility Contacts

Angela Notarnicola

Role: primary

angelanotarnicola@yahoo.it

0805592938

References

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.

Reference Type: BACKGROUND

PMID: 22825641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17466542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34986012 (View on PubMed)

Other Identifiers

SWinKA

Identifier Type: -

Identifier Source: org_study_id