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Trial · NCT07887893

Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis

NCT07887893, Not applicable, Recruiting, Dokuz Eylul University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis. Trials, record NCT07887893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887893

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis
NCT number
NCT07887893
Status
Recruiting
Phases
Not applicable
Enrollment
24 participants, estimated
Lead sponsor
Dokuz Eylul University
Conditions
Knee Arthritis, Osteoarthritis, Bone Marrow Edema of the Knee, Bone Marrow Edema
Interventions
Radial Extracorporeal Shock Wave Therapy, Sham Radial Extracorporeal Shock Wave Therapy
First posted
2026-10-22
Last updated
2026-10-22

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMagnetic Resonance Imaging (MRI) Findings: Volumetric Assessment of Bone Marrow EdemaBaseline (before treatment initiation) and week 13 (8 weeks after completion of the 5-week treatment period).
The volume of the bone marrow edema (BME) lesion will be assessed using magnetic resonance imaging (MRI). MRI examinations will be performed using the same 1.5-tesla MRI scanner for all participants. Imaging parameters will be standardized, including a slice thickness of 3 mm and a coronal spectral attenuated inversion recovery (SPAIR) sequence with a matrix size of 432 × 432. The symptomatic knee will be evaluated, and the BME lesion will be localized to either the medial or lateral compartment of the knee. The medial compartment will include the medial femoral condyle, medial tibial plateau, or both, while the lateral compartment will include the lateral femoral condyle, lateral tibial plateau, or both. The BME lesion will be manually delineated on consecutive MRI slices using image analysis software. Lesion volume will be calculated by summing the volumes of the segmented voxels and expressed in cubic millimeters (mm³). MRI examinations will be performed at baseline and week 13.
PrimaryVisual Analog Scale (VAS)Baseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
Pain intensity will be assessed using the visual analog scale (VAS), which consists of a 10-cm horizontal line, with 0 indicating "no pain" and 10 indicating "the worst pain imaginable." Participants will mark the point on the scale that best represents their current pain intensity. The distance from the zero point to the participant's mark will be measured in centimeters, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain intensity.
SecondaryWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Baseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-administered questionnaire designed to assess symptoms and functional status in patients with knee and hip osteoarthritis. The WOMAC consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a 5-point Likert scale ranging from 0 ("none") to 4 ("extreme"). The scores of all 24 items will be summed to calculate a total WOMAC score ranging from 0 to 96. Higher total scores indicate greater symptom severity and functional impairment.
SecondaryPatient SatisfactionBaseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
Patient satisfaction with treatment will be assessed using a 5-point scale with the following response options: completely satisfied (5 points), almost satisfied (4 points), moderately satisfied (3 points), somewhat satisfied (2 points), and dissatisfied (1 point). The total score ranges from 1 to 5, with higher scores indicating greater patient satisfaction.
OtherParacetamol UseBaseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
The total number of 500 mg paracetamol tablets used as rescue medication for pain relief will be recorded for each participant throughout the 13-week study period. Paracetamol consumption will be assessed separately during three intervals: baseline to Week 5, Week 5 to Week 9, and Week 9 to Week 13. Participants who do not use paracetamol will be assigned a value of zero.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
26637992BACKGROUNDPubMed
27784022BACKGROUNDPubMed
29384878BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07887893

GET https://conductscience.org/api/trials/v1/NCT07887893/registered