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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group | Active Comparator | only a daily exercise program for 4 weeks: passive and active assisted movement of the knee joint, hamstring stretching, and quadriceps strengthening exercises |
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| ESWT group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESWT group | 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Notarnicola, M.D.Ph.D. | Contact | +39 0805592938 | angelanotarnicola@yahoo.it | |
| Ilaria Covelli, M.D.Ph.D. | Contact | + 39 0805592938 | ilariacovelli@yahoo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico di Bari | Recruiting | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22825641 | Background | 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. | |
| 17466542 | Background |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Prospective randomized clinical study
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| exercise group | Other | daily exercise program |
|
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| From enrollment to 6 months |
| 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. |
| 34986012 | Background | 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. |