Ischemic Preconditioning for Osteoarthritis and Lower Back Pain

Overseen By Shraddha Sudhir

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Knee/hip replacements, Blood clots, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with knee osteoarthritis and lower back pain. It uses a technique called ischemic preconditioning, which restricts blood flow to one thigh for short periods over two weeks, to assess improvements in movement and pain reduction. Participants will be divided into two groups: one receiving the actual treatment and the other a sham (inactive) version for comparison. Individuals who frequently experience knee or back pain and can walk for at least three minutes without assistance may be suitable for this trial. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could lead to new pain relief methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for individuals with knee osteoarthritis and low back pain?

Research shows that ischemic preconditioning (IPC) is generally safe. IPC involves briefly stopping and then restarting blood flow, which can help the body protect itself. Studies have found that this technique can reduce pain and improve movement in conditions like osteoarthritis and back pain.

Previous research has not identified any major side effects from IPC. The method usually involves cycles of 5 minutes on and 5 minutes off, which appears safe based on current data. Although the FDA has not yet approved this treatment for osteoarthritis or back pain, its use in other conditions suggests it is safe.

Overall, safety data from earlier studies suggest that IPC is well-tolerated with few side effects. However, prospective trial participants should discuss any concerns with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ischemic preconditioning for osteoarthritis and lower back pain because it offers a new way to potentially reduce pain without the need for drugs or surgery. Unlike standard treatments like NSAIDs, opioids, or physical therapy, ischemic preconditioning involves temporarily restricting blood flow to a limb, which is believed to trigger the body’s natural protective mechanisms to reduce pain and inflammation. This non-invasive approach could provide relief with fewer side effects and risks compared to conventional medications and invasive procedures. By harnessing the body's own defenses, it could offer a safer and more sustainable option for individuals suffering from chronic pain.

What evidence suggests that ischemic preconditioning is effective for knee osteoarthritis and low back pain?

Research has shown that ischemic preconditioning (IPC) can reduce pain and improve movement in conditions like osteoarthritis and lower back pain. Studies have found that IPC, which involves briefly stopping blood flow, helps the body manage pain better and increases strength. This trial will compare the effects of IPC with a sham procedure. Some research also suggests that IPC could enhance athletic performance by boosting muscle function. While results are promising, they can vary, but this treatment holds potential for improving pain and movement in the targeted conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Lindsay Hannigan

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for people with knee pain from osteoarthritis and low back pain who can walk unaided for at least 3 minutes. Participants must meet specific criteria for knee pain (ACR Criteria) and have a certain level of back pain (ODI > 12). They also need to be able to give written consent.

Inclusion Criteria

Ability to provide written informed consent

I can walk for 3 minutes without help.

Reported Knee Pain using ACR Criteria

Exclusion Criteria

Non-English speaker

Currently pregnant or intends to become pregnant during the study

I have had blood clots in my leg or a condition that prevents pressure on my thigh.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo restricted blood flow intervention on a single thigh for 50 minutes every other day for 2 weeks

2 weeks

Follow-up

Participants are monitored for changes in gait kinematics, walking speed, muscle strength, and patient-reported outcomes

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ischemic Preconditioning

Trial Overview The study tests if restricting blood flow in the thigh using full occlusion improves function in those with knee osteoarthritis and low back pain. The procedure lasts for 50 minutes, alternating between on and off every 5 minutes, done every other day over two weeks.

How Is the Trial Designed?

Group I: IC Arm Experimental Treatment 1 Intervention

Group II: Sham Arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07003113

Ischemic Preconditioning in Osteoarthritis and Back Pain 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10405415/

Effects of remote ischemic conditioning on conditioned pain ... This study aims to analyze the acute effect of remote ischemic conditioning on local pain, conditioned pain modulation, and cardiac autonomic control in women ...

3. journals.physiology.org journals.physiology.org/doi/full/10.1152/jn.00227.2024

Ischemic preconditioning: what else can it do…? Ischemic preconditioning (IPC) can enhance maximal strength likely due to neural priming. Cruz et al. (Cruz R, Tramontin AF, Oliveira AS, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2095254624001686

Review Does ischemic preconditioning enhance sports ... Ischemic preconditioning (IPC) is purported to have beneficial effects on athletic performance, although findings are inconsistent, with some studies ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12296812/

Potential Short- and Long-Term Physiological Effects of ... Abstract. Ischemic preconditioning (IPC) has emerged as a promising intervention for enhancing health- and exercise-related outcomes.

6. withpower.com withpower.com/trial/phase-back-pain-6-2025-c506b

Ischemic Preconditioning for Osteoarthritis and Lower Back ... Trial Overview The study tests if restricting blood flow in the thigh using full occlusion improves function in those with knee osteoarthritis and low back pain ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022522320307935

Protective effects of remote ischemic preconditioning ... Our results showed that remote ischemic preconditioning prevented spinal cord ischemia–induced extracellular glutamate increase in ventral horn.

8. intechopen.com intechopen.com/online-first/1227713

Methodological Issues and Safety Considerations in ... Ischemic preconditioning IPC involves short-duration, high-frequency cycles of limb blood flow occlusion and reperfusion, eliciting physiological responses that ...