Two Standardized Radial Pressure Wave Techniques Versus Pain-Site Guided Therapy in Patients With Knee Osteoarthritis.

NCT06622512 | Completed

• 1 other identifier: CEI 157/24
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate and compare the effectiveness of radial pressure wave therapy (RPWT) applied at different anatomical sites in patients with knee osteoarthritis (OA) over a follow-up of four months. The main questions it aims to answer are: How effective is the application of RPWT on the medial and lateral interarticular lines in patients with knee OA? Are standardized RPWT application techniques on interarticular lines superior to the traditional application technique on the points of greatest pain in patients with knee OA? Researchers will compare the effectiveness of two standardized application techniques on interarticular lines to decrease pain and improve function in patients with knee OA. Participants will receive three sessions of RPWT on the most painful knee as a result of knee OA.

Conditions

Osteoarthritis, Knee

Keywords

knee; osteoarthritis; extracorporeal shock wave therapy; radial pressure wave therapy

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity will be assessed using the Numeric Pain Rating Scale, a world-renowned instrument consisting of a linear scale with numbered intervals from zero (no pain) to ten (the worst pain) that patients use to quantify their current pain intensity.

  At baseline, at the end of the third session, two months after the first session, and four months after the first session.

• Self-reported disability

  Self-reported disability measured with the Western Ontario and McMaster Universities Osteoarthritis Index, a disease-specific, self-administered questionnaire developed for patients with knee osteoarthritis and takes approximately 5 minutes to complete. It has a multidimensional scale consisting of 24 items grouped into three dimensions: pain (five items), stiffness (two items), and physical function (17 items). We will use the Likert version with five response levels for each item, representing different levels of intensity (none, mild, moderate, severe or extreme) that are scored from 0 to 4. The final score for the questionnaire is determined by adding the aggregate scores for pain, stiffness and function. The higher the score, the worse the patient's condition; therefore, improvement is achieved by reducing the total score. The data were standardized to a range of 0 to 100, with 0 representing the best possible health status and 100 representing the worst possible status.

  At baseline, at the end of the third session, two months after the first session, and four months after the first session.

Study Arms (3)

Control group

ACTIVE COMPARATOR

The three groups will receive RPWT with the device BTL-6000 Radial Shockwave Therapy (BTL Industries, Ltd.). Each patient, in supine position and knee flexion of 30 to 60 degrees, will receive 3 sessions of RPW, once per week, 2,000 impulses per session, 2.0 bar and frequency of 10Hz. The air pressure and frequency will be adjusted in response to discomfort. The control group will receive 1,000 pulses at the two most painful sites of the treated knee, in accordance with the technique employed in the majority of previous studies in this field.

Device: Radial Pressure Wave Therapy

Medial group

EXPERIMENTAL

The three groups will receive RPWT with the device BTL-6000 Radial Shockwave Therapy (BTL Industries, Ltd.). Each patient, in supine position and knee flexion of 30 to 60 degrees, will receive 3 sessions of RPW, once per week, 2,000 impulses per session, 2.0 bar and frequency of 10Hz. The air pressure and frequency will be adjusted in response to discomfort. The medial group will receive 2,000 pulses at the medial interarticular line of the treated knee.

Device: Radial Pressure Wave Therapy

Medial and lateral group

EXPERIMENTAL

The three groups will receive RPWT with the device BTL-6000 Radial Shockwave Therapy (BTL Industries, Ltd.). Each patient, in supine position and knee flexion of 30 to 60 degrees, will receive 3 sessions of RPW, once per week, 2,000 impulses per session, 2.0 bar and frequency of 10Hz. The air pressure and frequency will be adjusted in response to discomfort. The medial and lateral group will receive 1,000 pulses at the medial interarticular line and 1,000 pulses at the lateral interarticular line of the treated knee.

Device: Radial Pressure Wave Therapy

Interventions

Radial Pressure Wave Therapy DEVICE

Radial pressure wave therapy (RPWT) is a non-invasive treatment used for musculoskeletal disorders, including knee OA. (Schroeder AN) It involves the application of mechanical energy to stimulate biological responses, RPWT differs fundamentally from focal shock wave therapy (FSWT) in several physical properties, in its point of maximum energy flux density (EFD), and in some clinical applications. RPWT activates cellular pathways involved in tissue regeneration and generates mechanical energy that spreads radially from the point of application, primarily affecting superficial tissues and leading to pain relief and improved function through a process known as mechano-transduction, by enhancing blood flow and stimulating cellular repair processes . (Simplicio CL, Wang CJ)

Control group; Medial and lateral group; Medial group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic and current knee pain.
• Clinical and radiographic diagnosis of knee OA.

You may not qualify if:

• History of knee surgery.
• Inflammatory arthropathy.
• Septic arthritis.
• Fibromyalgia.
• Cancer.
• Severe vascular insufficiency

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (13)

• O'Neill TW, Felson DT. Mechanisms of Osteoarthritis (OA) Pain. Curr Osteoporos Rep. 2018 Oct;16(5):611-616. doi: 10.1007/s11914-018-0477-1.

  PMID: 30155845 BACKGROUND

• Giorgino R, Albano D, Fusco S, Peretti GM, Mangiavini L, Messina C. Knee Osteoarthritis: Epidemiology, Pathogenesis, and Mesenchymal Stem Cells: What Else Is New? An Update. Int J Mol Sci. 2023 Mar 29;24(7):6405. doi: 10.3390/ijms24076405.

  PMID: 37047377 BACKGROUND

• Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.

  PMID: 32722615 BACKGROUND

• Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.

  PMID: 33560326 BACKGROUND

• Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.

  PMID: 29035179 BACKGROUND

• Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.

  PMID: 37745043 BACKGROUND

• Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.

  PMID: 31278997 BACKGROUND

• Allaeys C, Arnout N, Van Onsem S, Govaers K, Victor J. Conservative treatment of knee osteoarthritis. Acta Orthop Belg. 2020 Sep;86(3):412-421.

  PMID: 33581025 BACKGROUND

• De la Corte-Rodriguez H, Roman-Belmonte JM, Rodriguez-Damiani BA, Vazquez-Sasot A, Rodriguez-Merchan EC. Extracorporeal Shock Wave Therapy for the Treatment of Musculoskeletal Pain: A Narrative Review. Healthcare (Basel). 2023 Oct 26;11(21):2830. doi: 10.3390/healthcare11212830.

  PMID: 37957975 BACKGROUND

• Zhou Q, Chen J. A critical overview of systematic reviews and meta-analyses of extracorporeal shockwave therapy for knee osteoarthritis. Asian J Surg. 2024 Jul;47(7):2975-2984. doi: 10.1016/j.asjsur.2024.01.127. Epub 2024 Jan 30.

  PMID: 38290944 BACKGROUND

• Imamura M, Alamino S, Hsing WT, Alfieri FM, Schmitz C, Battistella LR. Radial extracorporeal shock wave therapy for disabling pain due to severe primary knee osteoarthritis. J Rehabil Med. 2017 Jan 19;49(1):54-62. doi: 10.2340/16501977-2148.

  PMID: 27904912 BACKGROUND

• Tornese D, Mattei E, Lucchesi G, Bandi M, Ricci G, Melegati G. Comparison of two extracorporeal shock wave therapy techniques for the treatment of painful subcalcaneal spur. A randomized controlled study. Clin Rehabil. 2008 Sep;22(9):780-7. doi: 10.1177/0269215508092819.

  PMID: 18728131 BACKGROUND

• Zhang YF, Liu Y, Chou SW, Weng H. Dose-related effects of radial extracorporeal shock wave therapy for knee osteoarthritis: A randomized controlled trial. J Rehabil Med. 2021 Jan 13;53(1):jrm00144. doi: 10.2340/16501977-2782.

  PMID: 33367924 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tonatiuh Avila, MD

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding This study will employ a double-blind design, in which both the participants and the clinical evaluator responsible for conducting clinical and radiographic assessments will be blinded to the group assignments. Participants will be informed that they may receive one of three possible treatment options but will not know which specific technique is being applied to them. The RPWT will be administered by a final-year resident physician in Physical Medicine and Rehabilitation, who will be aware of the group allocation but will have no involvement in the outcome assessments. To ensure further blinding, the data collection and analysis personnel will also be blinded to the intervention groups. All treatment sessions will be conducted under standardized conditions, with identical instructions, setup, and environment for all groups to reduce potential bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Department of Physical Medicine and Rehabilitation

Model Details: Randomization After having obtained written informed consent the patients will be randomly assigned to one of three treatment groups, RPWT at the two most painful points (control group), RPWT at the medial interarticular line (medial group) or RPWT at the medial and lateral interarticular lines (medial and lateral group). Randomization will be carried out using the paper envelope randomization method. For this purpose, we will prepare a series of opaque papers, each indication one of the three possible assignments. These papers will be placed in an opaque bag, and during the enrollment process, each patient will draw a paper from the bag at random. The patient´s group assignment will be determined by the designation on the drawn paper.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 2, 2024
• Study Start: August 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: May 16, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From February 2025 to February 2026.
• Access Criteria: 1. Qualified researchers who have received IRB approval. 2. Prior reasonable request by email. 3. Data will be made available by PDF files or other non-editable formats.

Locations

ME (1)