Injectable Cold Energy Therapy for Knee Arthritis

(ICE Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brixton Biosciences, Inc.

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Rheumatoid arthritis, Raynaud's, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effectiveness of Neural Ice in the treatment of knee osteoarthritis in adults aged 22-80 years. Participants will attend study visits and complete subject diaries. Participants will be followed for 6 months after study procedure.

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 does mention that you should not have had certain knee injections recently and should not be on high doses of opioids. It's best to discuss your specific medications with the study investigator.

What data supports the effectiveness of the treatment Injectable Cold Energy Therapy for Knee Arthritis?

Research shows that triamcinolone acetonide, a component of the treatment, is effective in reducing knee osteoarthritis pain and improving joint function. In a clinical trial, it significantly improved pain, stiffness, and physical function compared to a placebo. ^{1 2 3 4 5}

Is Injectable Cold Energy Therapy for Knee Arthritis safe for humans?

Injectable Cold Energy Therapy, also known as Triamcinolone acetonide, has been generally well tolerated in studies for knee osteoarthritis, with a safety profile similar to placebo. However, there have been rare cases of adverse reactions, such as granulomatous reactions and Cushingoid state (a condition with symptoms like moon face and buffalo hump) following injections. ^{2 3 6 7 8}

How is the Injectable Cold Energy Therapy for Knee Arthritis different from other treatments?

Injectable Cold Energy Therapy, using Neural Ice and Triamcinolone acetate, is unique because it combines cold energy with a corticosteroid to potentially provide longer-lasting relief for knee arthritis. The cold energy may help reduce inflammation and pain, while the extended-release formulation of Triamcinolone acetate allows for a prolonged effect in the joint, minimizing systemic side effects. ^{1 3 9 10 11}

Research Team

Eligibility Criteria

Adults aged 22-80 with chronic pain from knee osteoarthritis can join this trial. Specific details on who can or cannot participate are not provided, so interested individuals should contact the study organizers for full eligibility criteria.

Inclusion Criteria

I've tried pain relief methods like NSAIDs, physical therapy, or injections for over 3 months without success.

Willing/able to understand the informed consent form and provide written informed consent

I have long-term knee pain from arthritis, confirmed by an X-ray in the last year.

Exclusion Criteria

History of cold urticaria

I've had surgery on my limb that may have affected its nerves or blood vessels.

Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Neural Ice or corticosteroid injections for knee osteoarthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

Treatment Details

Interventions

• Neural Ice (Procedure)
• Triamcinolone acetate (Corticosteroid)

Trial Overview The trial is testing Neural Ice, a new treatment for managing chronic knee pain due to osteoarthritis, against Triamcinolone acetate, an established therapy. Participants will be monitored over six months and must keep diaries of their condition.

Participant Groups

Group I: Neural Ice injections Experimental Treatment 1 Intervention

This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.

Group II: Corticosteroid injection Active Control 1 Intervention

Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space.

Who Is Running the Clinical Trial?

Brixton Biosciences, Inc.

Lead Sponsor

Trials

1

Recruited

260+

Findings from Research

In a double-blind study involving 30 patients with rheumatoid arthritis, all three intra-articular steroid preparations (prednisolone t-butyl acetate, methyl prednisolone acetate, and triamcinolone hexacetonide) showed thermographic improvement in knee synovitis, with triamcinolone demonstrating the greatest and longest-lasting effect.

Despite the local improvements in knee symptoms, no significant overall systemic improvement was observed after a single injection of any steroid, although all three preparations suppressed the body's natural cortisol production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. Bird, HA., Ring, EF., Bacon, PA.[2022]

The use of CryoVIVE® cryoanesthesia significantly reduced pain during intralesional triamcinolone injections for nodulocystic acne, with mean pain scores dropping from 5.933 without anesthesia to 3.667 with it (p = 0.0001).

The procedure was found to be safe, with no reported side effects, discoloration, or scarring, indicating that CryoVIVE® is a practical option for enhancing patient comfort during dermatologic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold anesthesia for pain reduction during intralesional steroid injection for nodulocystic acne. Park, SJ., Shin, SH., Koh, YG., et al.[2023]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

In a study of 60 children under 10 with pauci-articular juvenile chronic arthritis, 77% of treated knees showed excellent or good outcomes one year after receiving local injections of triamcinolone hexacetonide.

The treatment was effective in controlling disease activity, with only minor complications reported, such as small areas of subcutaneous tissue atrophy in 2 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone into the knee joint in juvenile chronic arthritis. Earley, A., Cuttica, RJ., McCullough, C., et al.[2017]

Intra-articular injections of triamcinalone acetonide, a common glucocorticoid, can lead to cutaneous hypopigmentation, which is a rare but notable side effect.

This case highlights a unique pattern of hypopigmentation with a linear ray distribution, suggesting that the glucocorticoid may spread through lymphatic channels after injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linear rays of hypopigmentation following intra-articular corticosteroid injection for post-traumatic degenerative joint disease. Schwartz, C., Javvaji, S., Feinberg, JS.[2013]

Using a cryotip to provide fast-acting cryoanesthesia significantly reduced pain during intralesional steroid injections for hypertrophic scars and keloids, with pain scores dropping from 7.87 to 2.7 on the visual analogue scale (VAS).

The study involved 30 patients and demonstrated that applying the cryotip before steroid injection not only alleviated pain effectively but could also enhance the overall therapeutic outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical cryoanesthesia for the relief of pain caused by steroid injections used to treat hypertrophic scars and keloids. Wang, X., Wu, X., Liu, K., et al.[2021]

Intralesional Kenalog (triamcinolone) is an effective treatment for skin conditions like nodulocystic acne, demonstrating its therapeutic potential.

However, this case highlights a rare but significant side effect: a granulomatous reaction, indicating that while the treatment is beneficial, it can also lead to adverse histopathological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. Song, Y., Guo, Y.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cold anesthesia for pain reduction during intralesional steroid injection for nodulocystic acne. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Triamcinolone into the knee joint in juvenile chronic arthritis. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Linear rays of hypopigmentation following intra-articular corticosteroid injection for post-traumatic degenerative joint disease. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Topical cryoanesthesia for the relief of pain caused by steroid injections used to treat hypertrophic scars and keloids. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Four cases of a secondary Cushingoid state following local triamcinolone acetonide (Kenacort) injection. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The intra-articular administration of triamcinolone hexacetonide in the treatment of osteoarthritis. Its effects in a naturally occurring canine osteoarthritis model. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Local Effects Following Single and Repeat Intra-Articular Injections of Triamcinolone Acetonide Extended-Release: Results from Three Nonclinical Toxicity Studies in Dogs. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Intraarticular triamcinolone hexacetonide in the management of chronic arthritis in children. [2019]