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Recruiting

NCT Number: 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 other day for 2 weeks to improve function in individuals with knee osteoarthritis and low back pain.

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Key information

Conditions

Low Back Pain Arthritis Back Pain Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human and Sport Performance Lab

Chicago, Illinois, 60608, United States

Location status: Recruiting

Location contact

Shraddha Sudhir

CONTACT

[email protected]

312-413-5118

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischemic Preconditioning

Device

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.

Sham intervention

Device

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

Primary outcomes

  1. Preferred walking speed

    Time frame: At baseline (from enrollment) until end of intervention (3 weeks).

    Changes in preferred walking speed (m/s) from intervention

  2. Muscle strength

    Time frame: From baseline (enrollment) until end of intervention (3 weeks)

    Change in quadriceps, hamstring, and hip strength

  3. Patient Reported Outcomes

    Time frame: At baseline (enrollment) through the intervention (3 weeks)

    Change in subjective function and reporting based on questionnaires

  4. Gait Kinematics

    Time frame: At baseline (from enrollment) until end of intervention (3 weeks).

    Changes in gait kinematics (in degrees) from intervention

  5. Gait Kinetics/Moments

    Time frame: At baseline (from enrollment) until end of intervention (3 weeks).

    Changes in gait kinetics (joint moments) (in N/m) from intervention

Secondary outcomes

  1. Cartilage Health

    Time frame: From baseline (enrollment) until completion of intervention (3 weeks)

    Change in knee cartilage thickness using ultrasound methods

Study contacts

Contact information is provided by the study sponsor or research team.

Shraddha Sudhir

CONTACT

[email protected]

312-413-5118

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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