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Recruiting NCT07003113

Ischemic Preconditioning in Osteoarthritis and Back Pain

No phase Interventional Low Back Pain Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ischemic Preconditioning, Sham Intervention.
Who it may be relevant to
Registry conditions: Low Back Pain, Knee Osteoarthritis. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Preferred walking speed [Time frame: At baseline (from enrollment) until end of intervention (3 weeks).]
  • Muscle strength [Time frame: From baseline (enrollment) until end of intervention (3 weeks)]
  • Patient Reported Outcomes [Time frame: At baseline (enrollment) through the intervention (3 weeks)]
  • Gait Kinematics [Time frame: At baseline (from enrollment) until end of intervention (3 weeks).]
  • Gait Kinetics/Moments [Time frame: At baseline (from enrollment) until end of intervention (3 weeks).]
Secondary outcome measures (1)
  • Cartilage Health [Time frame: From baseline (enrollment) until completion of intervention (3 weeks)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Human and Sport Performance Lab — Chicago

Identifiers

NCT: NCT07003113 · 2024-0021 · 90SFE0071

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗