Bioactive Sleeve for Recovery

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

13 Participants Needed

Trial Summary

What is the purpose of this trial?

In-season pitch volume have been shown to relate to arm soreness in collegiate baseball players. Arm soreness is a common ailment following a pitching appearance due to the adaptation to soft tissue in response to a repetitive load to the throwing arm. Specifically, ongoing and accumulated fatigue and soreness to the flexor pronator mass region of the arm may be a predecessor for UCL injury. Different recovery modalities such as a bioactive fabric sleeve may give pitchers a recovery advantage throughout a baseball season. The primary purpose of this study is to determine if there is a difference in subjective soreness of the flexor pronator mass the day following a game pitching appearance using a sleeve with bioactive fabric which potentially improves cellular function versus a control sleeve.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Bioactive Sleeve treatment?

The research on a heat-retaining knee sleeve for knee osteoarthritis suggests that similar sleeve treatments can help reduce joint pain and improve function by retaining body heat. Additionally, compression sleeves have been shown to reduce swelling in other conditions, like breast cancer-related lymphedema, which may indicate potential benefits for the Bioactive Sleeve. ^{1 2 3 4 5}

Is the Bioactive Sleeve generally safe for use in humans?

The studies on bioactive stents, which are similar to the Bioactive Sleeve, show that they are generally safe for use in patients with acute coronary syndrome, with outcomes comparable to other stents. However, there is a higher risk of complications in patients with preexisting vascular disease. ^{6 7 8 9 10}

How does the Bioactive Sleeve for Recovery treatment differ from other treatments for this condition?

The Bioactive Sleeve for Recovery is unique because it likely incorporates bioactive materials, such as bioactive glasses, which are known for their antibacterial properties and ability to stimulate tissue healing. This approach may differ from standard treatments by promoting faster recovery and reducing infection risk, although specific details about its application in this trial are not provided. ^{11 12 13 14 15}

Research Team

Michael Freehill, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for collegiate baseball players who experience arm soreness after pitching. It aims to see if wearing a special sleeve can help with recovery. Players must be actively participating in the season to join.

Inclusion Criteria

Stanford Baseball Player

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a bioactive fabric sleeve or control sleeve on the throwing arm after each game they pitch

6 months

Regular assessments throughout the baseball season

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bioactive Sleeve
• Control Sleeve

Trial Overview The study is testing two types of sleeves: one is a regular control sleeve, and the other is a bioactive fabric sleeve that may improve muscle recovery. The goal is to compare how each affects arm soreness after games.

Participant Groups

Group I: Control Sleeve then Bioactive Sleeve Experimental Treatment 2 Interventions

Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches

Group II: Bioactive Sleeve then Control Sleeve Experimental Treatment 2 Interventions

Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Challenger Health, LLC

Collaborator

Trials

1

Recruited

10+

Findings from Research

A large randomized controlled trial (RCT) involving 2600 adult patients will assess the efficacy of short-stretch compression bandages compared to standard bandaging after total knee arthroplasty, aiming to detect a significant improvement in patient-reported outcomes at 52 weeks.

The study will evaluate multiple outcomes, including knee pain and function (measured by the Oxford Knee Score), quality of life (EQ-5D scores), and complications, contributing valuable data to guide clinical practices in post-surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial. Cook, L., Northgraves, MJ., Fairhurst, C., et al.[2020]

This feasibility study involves 50 patients undergoing total knee arthroplasty to assess the impact of a short-stretch compression bandage on post-operative knee swelling, pain, and function compared to a standard bandage.

The study aims to gather preliminary data on the effectiveness of compression bandages, which could inform a larger trial, as current clinical data on their efficacy in knee surgery is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study. Brock, TM., Sprowson, AP., Muller, S., et al.[2018]

References

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

Pilot study of the effects of a heat-retaining knee sleeve on joint pain, stiffness, and function in patients with knee osteoarthritis. [2022]

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

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study. [2018]

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

Novel approach for peripheral subcutaneous field stimulation for the treatment of severe, chronic knee joint pain after total knee arthroplasty. [2022]

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

Prophylactic Use of Compression Sleeves Reduces the Incidence of Arm Swelling in Women at High Risk of Breast Cancer-Related Lymphedema: A Randomized Controlled Trial. [2022]

6. France pubmed.ncbi.nlm.nih.gov

A prospective randomised comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome: the BASE-ACS trial. [2015]

7. China pubmed.ncbi.nlm.nih.gov

Are acute coronary syndromes an ideal scenario for bioresorbable vascular scaffold implantation? [2020]

8. England pubmed.ncbi.nlm.nih.gov

4-Year outcome of bioactive stents versus everolimus-eluting stents in acute coronary syndrome. [2017]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term clinical outcome of elderly patients with acute coronary syndrome treated with early percutaneous coronary intervention: Insights from the BASE ACS randomized controlled trial: Bioactive versus everolimus-eluting stents in elderly patients. [2018]

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

Impact of Preexisting Vascular Disease on the Outcome of Patients With Acute Coronary Syndrome: Insights From the Comparison of Bioactive Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome Trial. [2018]

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

Controlling acute inflammation with fast releasing dexamethasone-PLGA microsphere/pva hydrogel composites for implantable devices. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Intra-articular injection of triamcinolone acetonide releasing biomaterial microspheres inhibits pain and inflammation in an acute arthritis model. [2023]

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

Reconstruction of orbital wall defects with bioactive glass plates. [2008]

14. England pubmed.ncbi.nlm.nih.gov

Sustained release of bupivacaine for post-surgical pain relief using core-shell microspheres. [2020]

15. Germany pubmed.ncbi.nlm.nih.gov

Design, in vitro bioactivity and in vivo influence on oxidative stress and matrix metalloproteinases of bioglasses in experimental skin wound. [2022]