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Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients with Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Rehab Group | Active Comparator | Participants in this arm will receive physical rehab only for at the same frequency and duration as the comparator group. |
|
| Focused Shockwave Therapy Group | Active Comparator | This arm will receive focused shockwave therapy at the same frequency and duration as the comparator group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Rehab | Other | Physical rehab through the use of body weight exercises, resistance bands, weights, movement, repetitive movement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC Pain Subscale score from baseline to the primary endpoint - likely 8 or 12 weeks after treatment begins. | The primary outcome measure will be the between-group difference in change from baseline in WOMAC Pain Subscale score at 12 weeks. | 8 to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cameron A Hall, DC, PhD | Contact | 720-518-8005 | drhall@pulse-wave.us |
| Name | Affiliation | Role |
|---|---|---|
| Cameron A Hall, DC, PhD | Pulse Wave USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westminster Spine & Injury Center | Westminster | Colorado | 80021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32798759 | Background | Avendano-Coy J, Comino-Suarez N, Grande-Munoz J, Avendano-Lopez C, Gomez-Soriano J. Extracorporeal shockwave therapy improves pain and function in subjects with knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials. Int J Surg. 2020 Oct;82:64-75. doi: 10.1016/j.ijsu.2020.07.055. Epub 2020 Aug 13. | |
| 39598251 |
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Patient privacy and HIPAA.
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| Focused Shockwave Therapy | Device | Applying focused shockwave therapy using a focused shockwave therapy device to the treatment area. |
|
| Covelli I, De Giorgi S, Di Lorenzo A, Pavone A, Salvato F, Rifino F, Moretti B, Solarino G, Notarnicola A. Extracorporeal Shock Wave Therapy (ESWT) vs. Exercise in Thumb Osteoarthritis (SWEX-TO): Prospective Clinical Trial at 6 Months. Life (Basel). 2024 Nov 8;14(11):1453. doi: 10.3390/life14111453. |
| 38765896 | Background | Liao PC, Chou SH, Shih CL. A systematic review of the use of shockwave therapy for knee osteoarthritis. J Orthop. 2024 May 1;56:18-25. doi: 10.1016/j.jor.2024.04.020. eCollection 2024 Oct. |
| 32215674 | Background | Uysal A, Yildizgoren MT, Guler H, Turhanoglu AD. Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial. Int Orthop. 2020 Jul;44(7):1311-1319. doi: 10.1007/s00264-020-04541-w. Epub 2020 Mar 26. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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