Low Back PainNCT07003113
Ischemic Preconditioning in Osteoarthritis and Back Pain
A study testing Ischemic Preconditioning in people with Low Back Pain and Knee Osteoarthritis, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Low Back Pain, Knee Osteoarthritis
- What is being tested?
- Ischemic Preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Allergic to ultrasound gel
- History of spine surgery
- Non-English speaker
- Currently pregnant or intends to become pregnant during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Human and Sport Performance Lab
Chicago, Illinois, 60608
Shraddha Sudhir, 312-413-5118, ssudhi5@uic.edu
About this study
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
- Being tested
- Ischemic Preconditioning, Sham Intervention
- Keywords
- ischemic preconditioning, restricted blood flow, knee pain, back pain
- Medical subject headings
- Low Back Pain, Osteoarthritis, Knee, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic PreconditioningDevice
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 InterventionDevice
This intervention includes 25mmHg of pressure, which is not sufficient for blodo flow occlusion.
| Study group | Role | What they receive |
|---|---|---|
| IC Arm | Experimental | Not described Receives: Device: Ischemic Preconditioning |
| Sham Arm | Sham comparator | Not described Receives: Device: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred walking speed
Changes in preferred walking speed (m/s) from intervention
Measured: At baseline (from enrollment) until end of intervention (3 weeks).
Muscle strength
Change in quadriceps, hamstring, and hip strength
Measured: From baseline (enrollment) until end of intervention (3 weeks)
Patient Reported Outcomes
Change in subjective function and reporting based on questionnaires
Measured: At baseline (enrollment) through the intervention (3 weeks)
Gait Kinematics
Changes in gait kinematics (in degrees) from intervention
Measured: At baseline (from enrollment) until end of intervention (3 weeks).
Gait Kinetics/Moments
Changes in gait kinetics (joint moments) (in N/m) from intervention
Measured: At baseline (from enrollment) until end of intervention (3 weeks).
Secondary outcomes (1)
Cartilage Health
Change in knee cartilage thickness using ultrasound methods
Measured: From baseline (enrollment) until completion of intervention (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start12 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Lindsay Hannigan, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003113
- Sponsor's protocol ID
- 2024-0021
- Other IDs
- 90SFE0071
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Preconditioning in Osteoarthritis and Back Pain
- ClinicalTrials.gov ID
- NCT07003113
- Acronym / sponsor ID
- 2024-0021
- Conditions
- Low Back Pain, Knee Osteoarthritis
- Keywords
- ischemic preconditioning, restricted blood flow, knee pain, back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IC Arm | Experimental | Device: Ischemic Preconditioning |
| Sham Arm | Sham comparator | Device: Sham Intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic PreconditioningThe 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 | IC Arm |
| Sham InterventionThis intervention includes 25mmHg of pressure, which is not sufficient for blodo flow occlusion. | Device | Sham Arm |
Primary outcome
Preferred walking speed
Time frame: At baseline (from enrollment) until end of intervention (3 weeks).
Changes in preferred walking speed (m/s) from intervention
Muscle strength
Time frame: From baseline (enrollment) until end of intervention (3 weeks)
Change in quadriceps, hamstring, and hip strength
Patient Reported Outcomes
Time frame: At baseline (enrollment) through the intervention (3 weeks)
Change in subjective function and reporting based on questionnaires
Gait Kinematics
Time frame: At baseline (from enrollment) until end of intervention (3 weeks).
Changes in gait kinematics (in degrees) from intervention
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
1 secondary outcome
Cartilage Health
Time frame: From baseline (enrollment) until completion of intervention (3 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay Hannigan principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Preconditioning in people with Low Back Pain and Knee Osteoarthritis, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shraddha Sudhir (312-413-5118, ssudhi5@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferred walking speed (time frame: At baseline (from enrollment) until end of intervention (3 weeks).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.