Cold and Compression for Osteoarthritis

Overseen By Ken Bode

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ochsner Health System

Must not be taking: Opioids

Disqualifiers: Chronic opioid use, Inflammatory diseases, Uncontrolled hypertension, Diabetes, Others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how cold and compression therapy might reduce pain after knee replacement surgery. Researchers aim to determine if this method offers benefits over the usual treatment of ice packs and pain medication. Individuals with osteoarthritis, a condition causing joint pain and stiffness, who are scheduled for knee replacement surgery with specific doctors, may find this trial relevant. The goal is to discover more effective ways to manage post-surgery pain and improve recovery. As an unphased trial, participants have the opportunity to contribute to innovative pain management strategies that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used opioids in the last 3 months or have chronic opioid use.

What prior data suggests that this cold and compression method is safe for osteoarthritis patients?

Research has shown that cold and compression therapy is generally safe and easy to use. Studies have found this treatment to be a straightforward and non-invasive method for managing arthritis. It avoids complex medical procedures or medications, which often have more side effects. Reports indicate that cold and compression can reduce pain and swelling after surgery without causing harm. Therefore, this treatment is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cold and compression therapy for osteoarthritis because it introduces a novel way to manage pain and inflammation post-surgery. Unlike the standard care that typically involves medication like hydrocodone/APAP along with basic cold therapy, this treatment integrates a specialized cold and compression device. This device aims to enhance pain relief and reduce the reliance on opioids, offering a potentially safer and more effective recovery process for patients. By combining targeted cold therapy with compression, it might improve circulation and reduce swelling more efficiently than traditional methods.

What evidence suggests that cold and compression therapy is effective for osteoarthritis?

Research has shown that cold and compression therapy, which participants in this trial may receive, can reduce pain and speed recovery for people with osteoarthritis. Studies have found that ice packs decrease inflammation, which is linked to pain. One study found that cold therapy reduced swelling and improved joint function. Adding compression to cold treatment can enhance these benefits, aiding joint movement and comfort. Overall, these methods can help manage pain and improve the quality of life for those with osteoarthritis. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with osteoarthritis who are undergoing total knee arthroplasty (TKA). Participants should be able to follow the study procedures and report pain scores. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

English speaking

I have been diagnosed with primary osteoarthritis.

I am a patient of Dr. Hirsch or Dr. Dasa and scheduled for knee replacement at Ochsner Kenner.

Exclusion Criteria

PCS score ≥ 30

I have been diagnosed with an inflammatory disease like gout or lupus.

I have issues with my blood flow regulation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical

Participants are assessed pre-surgically for baseline pain scores

1 week

1 visit (in-person)

Post-surgical Treatment

Participants receive either standard care or cold/compression therapy post-surgery

14 days

Daily monitoring (virtual or in-person)

Extended Monitoring

Weekly monitoring of pain scores for 3 months post-surgery

3 months

Weekly visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness at 6 months post-surgery

1 visit

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cold and Compression

Trial Overview The study compares standard post-surgery care with an added cold and compression treatment after TKA. Pain levels will be measured using PROMIS NRS Pain Subscale before surgery, daily for two weeks, weekly for three months, and at six months post-surgery.

How Is the Trial Designed?

Group I: Cold and Compression Experimental Treatment 1 Intervention

Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold \& compression therapy device provided by Sponsor)

Group II: Standard of Care Arm Active Control 1 Intervention

Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)

Who Is Running the Clinical Trial?

Ochsner Health System

Lead Sponsor

Trials

97

Recruited

91,900+

BREG, Inc

Industry Sponsor

Trials

4

Recruited

370+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12168428/

Cryotherapy in Knee Osteoarthritis: A Systematic Review ... The meta‐analysis included all five studies in the pain intensity outcome, resulting in a standardized mean difference (SMD) of −0.57 (95% CI: [ ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667325824003054

Cryotherapy and thermotherapy in the management of ... The results showed that local ice packs (twice daily for 30 min, at 8-hour intervals, for 1 day) significantly lowered the levels of IL-6, IL-1β ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6669258/

Thermotherapy for treatment of osteoarthritis - PMC Ice massage compared to control had a statistically beneficial effect on ROM, function and knee strength. Cold packs decreased swelling.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07021287

Effect of Different Cold Therapy Programs in Patients ... Additionally, cold therapy mitigates local inflammatory responses and blood loss, effectively improving pain and patient comfort . Existing ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-07310-7

Randomized controlled trial of compressive cryotherapy ... Both cryotherapy methods improved joint ROM, trophic changes, pain and function. Adding dynamic compression to a cryotherapy protocol provided further benefits.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2920200/

Preferences for heat, cold, or contrast in patients with knee ... Near equal preferences were observed for cold (24%) and contrast (24%). Pain reduction and improvements in KOOS subscale measures were demonstrated for each ...

7. worksafebc.com worksafebc.com/resources/health-care-providers/guides/efficacy-effectiveness-of-cold-compression-therapies-post-joint-surgery?lang=en&direct

Efficacy and Effectiveness of Cold-Compression Therapies ... The continuous outcomes without sufficient data for meta-analysis were the length of hospital stay, use of analgesic medication, edema, ROM, knee function, ...

8. muhclibraries.ca muhclibraries.ca/Documents/RR_Final-Report_Cryotherapy-TKA_JAN2018.pdf

Rapid Review Evidence Summary: Cryotherapy for TKA What evidence exists that describes whether the use of cryotherapy (cold therapy) is effective for improving adult patient outcomes following total knee ...