Ischemic Preconditioning in Osteoarthritis and Back Pain

Study Purpose

We are examining the use of restricted blood flow, through full occlusion, on a single thigh for 50 minutes (5 minutes on, 5 minutes off), completed every other day for 2 weeks to improve function in individuals with knee osteoarthritis and low back pain.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Reported Knee Pain using ACR Criteria.
  • - Reported Back Pain using ODI Criteria > 12.
  • - Ability to walk for at least 3 minutes without the use of aids.
  • - Ability to provide written informed consent.

Exclusion Criteria:

  • - Younger than 50 years old.
  • - History of Knee or Hip Replacements.
  • - History of steroid injection within the previous 6 months.
  • - Presence of neuromuscular joint condition that affects lower extremity function.
  • - History of blood clots in the leg or any condition in which compression of the thigh is contraindicated.
  • - History of heart failure or thrombosis.
  • - Allergic to ultrasound gel.
  • - History of spine surgery.
  • - Non-English speaker.
- Currently pregnant or intends to become pregnant during the study

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.

NCT07003113
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.

University of Illinois at Chicago
Principal Investigator

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

Lindsay Hannigan
Principal Investigator Affiliation University of Illinois at Chicago
Agency Class

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

Other, U.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

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

Low Back Pain, Knee Osteoarthritis
Arms & Interventions

Arms

Experimental: IC Arm

Sham Comparator: Sham Arm

Interventions

Device: - Ischemic Preconditioning

The intervention arm will include full blood flow occlusion in one thigh for 5 minutes followed by 5 minutes of reperfusion for a cycle of 50 minutes.

Device: - Sham Intervention

This intervention includes 25mmHg of pressure, which is not sufficient for blodo flow occlusion.

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.

Human and Sport Performance Lab, Chicago, Illinois

Status

Address

Human and Sport Performance Lab

Chicago, Illinois, 60608

Site Contact

Shraddha Sudhir

[email protected]

312-413-5118