Focused Extracorporeal Shockwave Therapy for Knee Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorKessler Foundation
About this trial
Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of knee OA patients. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs. This is an exploratory, randomized-controlled, pilot study to determine the efficacy and safety of f-ESWT compared to the standard-of-care (analgesics and protected weight bearing) for the treatment of BMLs in patients with knee OA. Thirty subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study. Subjects will receive a total of 4 sessions (at high energy level) over 4 consecutive weeks. Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score, respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be performed prior to treatment (baseline) and 3 months and 6 months after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females 30-80 years old, inclusive.
Kellgren-Lawrence (KL) score grade 2-4 as diagnosed on X-Ray.
Presence of BML(s) on MRI in a weight-bearing region of the knee (medial/lateral femoral condyle or tibial plateau).
Knee pain for more than 2 months.
Disqualifiers
Traumatic BMLs.
Primary cause of patient pain and loss of function is due to pathology other than BML(s), according to patient history and clinical evaluation.
Presence of bilateral BML(s).
Systemic autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis.
Trial design
Design model
Single group
Treatments tested in this trial
Focused extracorporeal shockwave therapy
DeviceHigh energy level shockwaves (between 0.28-0.60 mJ/mm\^2) will be focused over the subchondral bone with the bone marrow lesion, previously localized on MRI.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in knee pain numerical rating scale scores
Twelve-week knee pain intensity will be assessed using NRS. Subjects will be asked to rate their average pain, most severe pain, and least severe pain using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." NRS allows comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
Time frame
12 weeksSecondary outcomes
1
Change in knee pain numerical rating scale scores
Eight-week knee pain intensity will be assessed using NRS. Subjects will be asked to rate their average pain, most severe pain, and least severe pain using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." NRS allows comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
Time frame
8 weeks2
Change in knee pain numerical rating scale scores
Twenty-four-week knee pain intensity will be assessed using NRS. Subjects will be asked to rate their average pain, most severe pain, and least severe pain using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." NRS allows comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
Time frame
24 weeks3
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a comprehensive instrument widely used in research and clinical practice, including in large-scale databases and registries in the setting of knee injury and knee OA. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame
8 weeks4
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a comprehensive instrument widely used in research and clinical practice, including in large-scale databases and registries in the setting of knee injury and knee OA. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kessler Foundation
Lead sponsor
New Jersey Regenerative Institute, LLC
Collaborator
Source ClinicalTrials.gov