Shock Wave Treatment in Patients With Knee Osteoarthritis (SWKO)

Guadarrama Hospital

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Other: shock wave; Other: strengthening exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07125430

Código H.U.P.H.: PI 119/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

control group

Active Comparator group

Description:

In the control group, a strengthening exercise program will be carried out for three weeks.

Treatment:

Other: strengthening exercise

intervention group

Active Comparator group

Description:

In the intervention group, in addition to the strengthening exercise program, 3 sessions of shock wave therapy (PiezoWave 2 Control Unit, classification 93/42/EEC class IIb) will be conducted, at a frequency of one session per week. The parameters for shock wave therapy will be: frequency 4-6 Hz, intensity 0.11-0.35 mJ/mm2, and number of pulses 2000 (applied to the femoral condyle and tibial plateau).

Treatment:

Other: strengthening exercise

Other: shock wave