Shock Waves in Knee Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ESWT group, exercise group.
- Who it may be relevant to
- Registry conditions: Arthritis of Knee. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Extracorporeal Shock Wave Therapy in Patients With Knee Arthritis
Overview
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.
Interventions
- 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 exercise group
daily exercise program
Primary outcome measures
- recovery of pain [Time frame: From enrollment to 1, 3 and 6 months]
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: From enrollment to 1, 3 and 6 months]
Secondary outcome measures (2)
- Roles and Maudsley Score [Time frame: At 1, 3 and 6 months]
- MR image [Time frame: From enrollment to 6 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Policlinico di Bari — Bari
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. PMID 22825641
- 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. PMID 17466542
- 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. PMID 34986012
Identifiers
NCT: NCT06833372 · SWinKA