Shock Wave Treatment in Patients With Knee Osteoarthritis

Official title

Efficacy of Shock Wave Treatment to Reduce Pain and Improve Functionality in Patients With Knee Osteoarthritis: Randomized Clinical Trial.

Overview

Introduction: Knee osteoarthritis represents a significant health problem due to its impact on the functionality and quality of life of patients. Its treatment can be pharmacological, non-pharmacological, or surgical. Recently, the chondroprotective potential of shockwave therapy has been evidenced. Objective: To determine whether shockwave treatment combined with knee strengthening exercises is superior to knee strengthening exercises alone in reducing pain and improving function in patients with knee osteoarthritis. Method: A randomized controlled trial with allocation concealment is proposed. Patients with knee pain secondary to knee osteoarthritis will participate during their hospital admission. Two groups will be formed: both will follow an exercise program for three weeks, and the intervention group will add a weekly shockwave session during that same period. The main variable will be pain intensity; other variables include stiffness, functional capacity, degree of satisfaction, and data related to the application of therapy (frequency, intensity, number of pulses, side effects). Clinical data will also be collected such as reason for admission, age, sex, comorbidities, degree of dependency, walking ability, analgesia, use of assistive devices, and progress during treatment. Applicability: The results could lead to a change in clinical practice, serving as a basis for modifying treatment protocols for knee osteoarthritis in medium-stay hospitals. Furthermore, they would provide additional scientific evidence on the efficacy of shock wave therapy for this condition.

Detailed description

The research team will recruit participants who meet inclusion criteria and do not present exclusion criteria during their admission to the functional recovery unit. A team member will inform and invite the subject to participate in the study. The Patient Information Sheet will be provided to them. Patients who decide to participate will need to sign the Informed Consent. At that moment, they will be scheduled to begin rehabilitation according to the protocol proposed for the study. Before starting treatment, patients will be randomized into treatment groups: shockwave treatment combined with knee strengthening exercises (intervention group) and treatment with knee strengthening exercises (control group).

The Data Collection Notebook will be completed, which has been prepared by the research team. In order to ensure the confidentiality of clinical data, these will be coded by dissociating the identifying and personal data from those necessary for the configuration of variables. For this, the principal investigator will carry out a coding process of the units of analysis.

All study participants will be evaluated at four points in time: before starting rehabilitative treatment, at the end of the three weeks of treatment, one month after the last treatment session, and three months after the last treatment session. At these four points, pain will be assessed using the VAS scale and functionality will be assessed using the WOMAC questionnaire.

Interventions

• Other strengthening exercise
  a strengthening exercise program will be carried out for three weeks
• Other shock wave
  3 sessions of shock wave therapy, frequency of one session per week

Primary outcome measures

• Compare the magnitude of pain reduction between patients with knee osteoarthritis treated with shockwave therapy plus strengthening exercises and those treated only with strengthening exercises [Time frame: From inclusion in the study until three months after the last treatment session]

Secondary outcome measures (3)

• To examine difference in knee functionality improvement between both treatment groups [Time frame: From inclusion in the study until three months after the last treatment session.]
• To evaluate the difference in degree of disability [Time frame: From inclusion in the study until three months after the last treatment session.]
• Analyze the level of patient satisfaction with the outcomes obtained from each therapeutic modality. [Time frame: From inclusion in the study until three months after the last treatment session]

Eligibility criteria

Inclusion criteria

• Knee pain assessed according to the VAS scale, with a score equal to or greater than 4 in the last 3 months.
• Osteoarthritis grade 2 or 3 in the Kellgren-Lawrence classification.
• Informed consent signature

Exclusion criteria

• Stroke in the last 3 months, knee surgery in the last 3 months, intra-articular infiltration in the last 3 months, secondary knee osteoarthritis, chronic inflammatory disease

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

Spain · 2 centers

• Guadarrama Hospital — Guadarrama
• Hospital Guadarrama — Madrid

Publications

• Roles NC, Maudsley RH. Radial tunnel syndrome: resistant tennis elbow as a nerve entrapment. J Bone Joint Surg Br. 1972 Aug;54(3):499-508. No abstract available. PMID 4340924
• Lequesne MG, Mery C, Samson M, Gerard P. Indexes of severity for osteoarthritis of the hip and knee. Validation--value in comparison with other assessment tests. Scand J Rheumatol Suppl. 1987;65:85-9. doi: 10.3109/03009748709102182. PMID 3479839
• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40. PMID 3068365
• Liao CD, Huang YY, Chen HC, Liou TH, Lin CL, Huang SW. Relative Effect of Extracorporeal Shockwave Therapy Alone or in Combination with Noninjective Treatments on Pain and Physical Function in Knee Osteoarthritis: A Network Meta-Analysis of Randomized Controlled Trials. Biomedicines. 2022 Jan 28;10(2):306. doi: 10.3390/biomedicines10020306. PMID 35203516
• 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. PMID 32798759
• Wang CJ, Wang FS, Yang KD, Weng LH, Hsu CC, Huang CS, Yang LC. Shock wave therapy induces neovascularization at the tendon-bone junction. A study in rabbits. J Orthop Res. 2003 Nov;21(6):984-9. doi: 10.1016/S0736-0266(03)00104-9. PMID 14554209
• Chen YJ, Wang CJ, Yang KD, Kuo YR, Huang HC, Huang YT, Sun YC, Wang FS. Extracorporeal shock waves promote healing of collagenase-induced Achilles tendinitis and increase TGF-beta1 and IGF-I expression. J Orthop Res. 2004 Jul;22(4):854-61. doi: 10.1016/j.orthres.2003.10.013. PMID 15183445
• Berta L, Fazzari A, Ficco AM, Enrica PM, Catalano MG, Frairia R. Extracorporeal shock waves enhance normal fibroblast proliferation in vitro and activate mRNA expression for TGF-beta1 and for collagen types I and III. Acta Orthop. 2009 Oct;80(5):612-7. doi: 10.3109/17453670903316793. PMID 19916698

Identifiers

NCT: NCT07125430 · Código H.U.P.H.: PI 119/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗