Clinical trial NCT06833372: Shock Waves in Knee Arthritis
Official title: Extracorporeal Shock Wave Therapy in Patients With Knee Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis of Knee
Keywords: shock waves
conservative treatment
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 72
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized clinical study
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: recovery of pain
timeFrame: From enrollment to 1, 3 and 6 months
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: From enrollment to 1, 3 and 6 months
Secondary outcomes:
measure: Roles and Maudsley Score
timeFrame: At 1, 3 and 6 months
measure: MR image
timeFrame: From enrollment to 6 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico di Bari
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.