Shock Waves in Knee Arthritis
ConditionArthritis of Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About this trial
Pathological arthritis is a degenerative disease affecting the joints, characterized by pain, limitation of movement up to ankylosis and disability. Treatment is aimed at reducing pain and slowing the loss of functionality of the district. Among conservative treatments, pharmacological options (NSAIDs, cortisone, contrasupplements, hyaluronic acid) and non-pharmacological options (therapeutic exercise, physical therapy, orthosis, etc.) are indicated. In cases not responding to conservative treatments, surgical treatment will be necessary with prosthetic replacement of the joint district.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
persistent knee pain for at least 3 months, measured with a VAS scale of 4 or higher,
clinical and radiological diagnosis confirming knee osteoarthritis grade 2 and 3 based on the Kellgren-Lawrence system,
no history of physical therapy in the last 3 months,
no infections, tumors in the treatment area of the knee,
Disqualifiers
inability to walk,
a history of clinically symptomatic spinal stenosis or lumbar radiculopathy,
evidence of a neurological disorder based on history or physical examination,
generalized pain or fibromyalgia,
Trial design
Design model
Parallel
Treatments tested in this trial
ESWT group
DeviceDuring each session, participants will receive 2000 pulses at a frequency of 4 Hz and an EDF between 0.02 and 0.2 mJ/mm2.
exercise group
Other interventiondaily exercise program
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Exercise GroupActive comparator 1 intervention
Group B: ESWT groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time frame
From enrollment to 1, 3 and 6 months2
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
questionnaire consisting of 24 questions addressing pain, stiffness and physical function. Score from 0 to 96, higher scores correspond to worse clinical condition.
Time frame
From enrollment to 1, 3 and 6 monthsSecondary outcomes
1
Roles and Maudsley Score
rating of the perception of one's own clinical improvement, from 1 (excellent) to 4 (poor).
Time frame
At 1, 3 and 6 months2
MR image
weighted in t2 according to the ICRS classification
Time frame
From enrollment to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov