Clinical Trial Finder

Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

Study Purpose

The primary aim of this study is to investigate whether low-dose radiotherapy is an effective treatment to reduce the pain of knee osteoarthritis. A secondary aim is to determine whether patients experience any more measurable side effects than those receiving sham treatments.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 50 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - age 50-85 years.
  • - ICOAP pain scale A1 at least moderate intensity or B6 at least moderate intensity.
  • - diagnosed with primary knee OA ICD-10 codes M17.
x.
  • - history of morning stiffness in knees that lasts less than 30 minutes.
  • - history of crepitus without a history of warmth, redness or sudden onset of swelling.
  • - physical exam findings of medial or lateral joint line tenderness on palpation that is in the same location as the knee pain for which their primary care provider has ordered an intraarticular steroid injection into the same knee.
  • - absence of primary knee pain in the pes anserine or hamstring or gastrocnemius tendons.
  • - radiographic Kellgren-Lawrence grade 2-3 on 4-view knee x-rays taken within the last year.
  • - ability to complete surveys in English.

Exclusion Criteria:

  • - Kellgren-Lawrence grade 1 or 4.
  • - history of ipsilateral intraarticular knee surgery.
  • - use of injected corticosteroids within 3 months or hyaluronans within 6 months or within 1 month if there was no sustained improvement post-injection of either corticosteroid or hyaluronan.
  • - history of trauma to this knee in the last year that clearly caused the pain now present.
  • - history of RA, gout, pseudogout, hemarthroses (eg, hemophilic arthropathy) or other inflammatory arthritis involving this knee.
  • - history of symptomatic hip OA.
  • - history of psychosis, personality disorder, uncontrolled affective disorder.
  • - history of fibromyalgia.
  • - malignancy requiring active treatment.
  • - current regular use of opiate analgesics, PRP, or acupuncture for the knees (may use during trial up to x doses per week and y days per week).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06887829
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Stephen P. Merry, M.D.Paul D. Brown, M.D.
Principal Investigator Affiliation Mayo ClinicMayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Additional Details

This single center, single-blinded, sham-controlled randomized controlled trial will compare low dose radiation therapy and sham radiation therapy for knee osteoarthritis. Participants with symptomatic knee OA based on clinical and radiographic criteria will be randomized 1:1 to receive 0.5 Gy LDRT over 2 weeks ideally on a Monday-Wednesday-Friday three times each week for two weeks treatment course for a total of 3 Gray or identical sham treatment (an identical procedure without the radiation). Non-responders to the initial Low-Dose Radiotherapy (LDRT)/sham treatment will receive a second treatment course of 0.5 Gy Low-Dose Radiotherapy (LDRT) or sham repeat treatment course over 2 weeks x 6 depending on their randomization (treatment arm participants receiving a second treatment course and sham arm participants receiving a second course of identical sham treatments without radiation). Intermittent and Constant Osteoarthritis Pain (ICOAP) outcome scales will be emailed to all participants for completion at baseline and weekly for six months. The study will thus terminate after all participants have completed 6 months of time in the study.

Arms & Interventions

Arms

Active Comparator: Low dose radiotherapy

Low dose radiation therapy for knee osteoarthritis

Sham Comparator: Placebo

No radiation therapy

Interventions

Radiation: - Low dose radiotherapy

Participants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device.

Other: - Sham comparator

Participants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

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