Shock Wave Treatment in Patients With Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuadarrama Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
strengthening exercise
Other interventiona strengthening exercise program will be carried out for three weeks
shock wave
Other intervention3 sessions of shock wave therapy, frequency of one session per week
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: control groupActive comparator 1 intervention
Group B: intervention groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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
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.
Time frame
From inclusion in the study until three months after the last treatment sessionSecondary outcomes
1
To examine difference in knee functionality improvement between both treatment groups
To assess functionality, the Western Ontario and McMaster Universities Osteoarthritis 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. The scale will be used under license during the study.
Time frame
From inclusion in the study until three months after the last treatment session.2
To evaluate the difference in degree of disability
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. The scale will be used under license during the study.
Time frame
From inclusion in the study until three months after the last treatment session.3
Analyze the level of patient satisfaction with the outcomes obtained from each therapeutic modality.
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. The scale will be used under license during the study.
Time frame
From inclusion in the study until three months after the last treatment sessionSponsors and contacts
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Source ClinicalTrials.gov
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