Ischemic Preconditioning in Osteoarthritis and Back Pain

NCT07003113 | Recruiting

• 2 other identifiers: 2024-002190SFE0071
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Knee Osteoarthritis

Keywords

ischemic preconditioning; restricted blood flow; knee pain; back pain

Outcome Measures

Primary Outcomes (5)

• Preferred walking speed

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

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

• Muscle strength

  Change in quadriceps, hamstring, and hip strength

  From baseline (enrollment) until end of intervention (3 weeks)

• Patient Reported Outcomes

  Change in subjective function and reporting based on questionnaires

  At baseline (enrollment) through the intervention (3 weeks)

• Gait Kinematics

  Changes in gait kinematics (in degrees) from intervention

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

• Gait Kinetics/Moments

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

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

Secondary Outcomes (1)

• Cartilage Health

  From baseline (enrollment) until completion of intervention (3 weeks)

Study Arms (2)

IC Arm

EXPERIMENTAL

Device: Ischemic Preconditioning

Sham Arm

SHAM COMPARATOR

Device: Sham Intervention

Interventions

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.

IC Arm

Sham Intervention DEVICE

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

Sham Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Human and Sport Performance Lab

Chicago, Illinois, 60608, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Osteoarthritis, Knee; Back Pain

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Lindsay Hannigan

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shraddha Sudhir

CONTACT

312-413-5118; ssudhi5@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 4, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)