Shock Wave Treatment in Patients With Knee Osteoarthritis

Not Applicable

Not yet recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT07125430
• Lead Sponsor: Guadarrama Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	From inclusion in the study until three months after the last treatment session	To assess pain, the validated Visual Analog Scale (VAS) will be used. This scale represents pain intensity on a 10 cm horizontal line, where 0 corresponds to "no pain" and 10 to "the worst pain imaginable." The scores will be interpreted as follows: a score below 4 indicates mild or mild-to-moderate pain; a score between 4 and 6 suggests moderate to severe pain; and a score above 6 reflects the presence of intense or very severe pain.

Secondary Outcome Measures

Name	Time	Method
To examine difference in knee functionality improvement between both treatment groups	From inclusion in the study until three months after the last treatment session.	To assess functionality, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire will be used. This instrument consists of 24 items grouped into three subscales: a pain subscale (5 items), a stiffness subscale (2 items), and a physical function subscale (17 items). Each item is rated using a 5-point Likert scale coded as follows: None = 0, Slight = 1, Moderate = 2, Severe = 3, and Extreme = 4. The scores for each subscale are summed separately, with a maximum of 20 points for pain, 8 for stiffness, and 68 for physical function. Higher scores indicate worse symptoms or greater disability, whereas lower scores reflect better condition or less impairment.
To evaluate the difference in degree of disability	From inclusion in the study until three months after the last treatment session.	To evalute the difference in degree of disability between patients with knee osteoarthritis treated with shock wave therapy plus strengthening exercises and those treated with strengthening exercises alone. Lequesne Algofunctional Index will be used to assess the degree of functional disability associated with osteoarthritis. This validated questionnaire consists of 11 items distributed across three domains: pain or discomfort, maximum walking distance, and activities of daily living. The total score ranges from 0 to 24, with higher scores indicating greater severity of disability.
Analyze the level of patient satisfaction with the outcomes obtained from each therapeutic modality.	From inclusion in the study until three months after the last treatment session	To evaluate the difference in degree of satisfaction (assessed using the Roles-Maudsley scale). Patient satisfaction will be assessed using the Roles and Maudsley scale, a four-point subjective rating system. Scores range from 1 (excellent) to 4 (poor), with lower scores indicating better outcomes. This scale reflects the patient's perception of pain relief and functional recovery after treatment

Trial Locations

Locations (1)

Guadarrama Hospital; 🇪🇸 Guadarrama, Madrid, Spain