Showmotion for Osteoarthritis

Overseen By CLAIRE COFER, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Active infections, Surgery, BMI >30, Pregnancy

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called Showmotion to study joint and muscle movement in healthy individuals. It focuses on understanding normal movement in the shoulders, hips, knees, and spine. This information can help identify issues related to injuries in these areas. Healthy individuals with no joint problems who can follow instructions might be suitable participants. As an unphased study, this trial offers the chance to contribute to foundational research that could enhance future injury prevention and treatment.

Do I need to stop my current medications for the trial?

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

What prior data suggests that the Showmotion platform is safe for analyzing joint and muscle activity?

Research has shown that Showmotion is a non-invasive tool, meaning it doesn't enter the body, which generally increases safety. One study found that Showmotion uses sensors placed on the skin to gather information about body movement without causing harm.

Since the trial uses skin sensors instead of drugs or surgeries, the risks are likely very low. No reports of serious side effects or problems have emerged from this type of testing. It's similar to wearing a fitness tracker that measures movements.

Because this trial does not test a new drug or medical device, safety concerns are reduced. Overall, Showmotion appears safe for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Showmotion for osteoarthritis because it introduces a unique approach to understanding joint movement and function. Unlike traditional treatments like NSAIDs or physical therapy, which focus on symptom relief, Showmotion employs advanced sensors to gather precise biomechanical data. These sensors, placed on the skin, wirelessly transmit information to a computer that processes it using a proprietary algorithm. This setup offers an unprecedented level of detail in assessing joint health, potentially allowing for more personalized treatment plans and better long-term management of osteoarthritis.

What evidence suggests that the Showmotion platform is effective for analyzing joint and muscle activity?

Research has shown that Showmotion is a new tool designed to effectively study joint and muscle movement. It uses small sensors placed on the skin to collect data on the movement of the shoulder, hip, knee, and spine. These sensors transmit the information to a computer, enhancing the understanding of body movements. In this trial, participants will use the Showmotion platform to analyze joint movements. While primarily used to establish a baseline for healthy volunteers, the technology could help identify osteoarthritis-related problems by providing detailed insights into joint function. Although more research is needed specifically for osteoarthritis, the technology's precise measurement capabilities suggest it could be useful for understanding and managing joint issues. ^{2 4 6 7 8}

Who Is on the Research Team?

Vikas Patel, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged between 18 and 65 who can follow instructions and have given written consent. They should not be overweight (BMI over 30), pregnant, have had surgery on the joint of interest, or suffer from active infections.

Inclusion Criteria

Age > 18, <65

Volunteers given written informed consent

Ability to understand and execute instructions at all stages of the procedure

Exclusion Criteria

You have a body mass index (BMI) higher than 30, which means you are considered overweight.

You recently had surgery on the joint that is being studied.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Establish baseline of shoulder, hip, knee, and spine kinematics and muscle activity using Showmotion

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or data validation post-assessment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Showmotion

Trial Overview

The study is testing Showmotion, an innovative platform to measure how joints and muscles in the shoulder, hip, knee, and spine move and work in healthy volunteers to establish a baseline for future clinical use.

How Is the Trial Designed?

Group I: Showmotion Experimental Treatment 1 Intervention

Performing an analysis requires the positioning of sensors on the patient's skin in predetermined positions, according to the related protocols. Each sensor positioned on patient's skin provides both raw data (accelerometer, magnetometer, gyroscope) and the orientation matrix, representing the orientation of the local System of Reference (SoR) with respect to a fixed SoR. A proprietary sensor-fusion algorithm allows provides an accurate estimate of the orientation, as assessed by stereo-photogrammetric system-based testing. Data from each sensor are sampled at 50 Hz and transferred wirelessly to a laptop with a proprietary software that processes the data according to the biomechanical model chosen for the analysis.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

MyArthritisRx.com (MARx) is an effective online platform for managing osteoarthritis, utilizing data from 150,000 arthritis patients to provide personalized self-evaluation and staging assessments for disease severity.

In a pilot study with 100 patients over 6 weeks, 92% reported improvements in their condition, suggesting that MARx not only enhances patient care but also holds potential for cost savings in arthritis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Digital Platform for the Self-Management of Knee Arthritis: MyArthritisRx.com. Iorio, R., Biadasz, N., Giunta, N., et al.[2022]

Osteoarthritis (OA) is the most common musculoskeletal disease in developed countries, leading to significant physical disability and reduced quality of life, especially as the population ages.

The article evaluates various imaging techniques for diagnosing OA, focusing on the hand, hip, and knee, to improve the understanding and management of this complex condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiological aspects of osteoarthritis. Sautner, J., Schueller-Weidekamm, C.[2021]

The Join2move intervention, a 9-week web-based program, significantly improved physical function and self-perceived effects in patients with knee and/or hip osteoarthritis after 3 months compared to a control group, with 94% of participants starting the program.

After 12 months, participants in the Join2move group reported higher levels of both subjective and objective physical activity, indicating the program's effectiveness in promoting long-term activity levels, although no significant effects on physical function were observed at that time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based physical activity intervention in patients with knee and/or hip osteoarthritis: randomized controlled trial. Bossen, D., Veenhof, C., Van Beek, KE., et al.[2022]

The adoption of the OMERACT-OARSI core outcome set (COS) in hip and knee osteoarthritis trials decreased significantly from 61% in 1997-2001 to 38% in 2012-2016, highlighting a concerning trend in trial reporting.

While pain and physical function were the most commonly included domains in these trials, the patient's global assessment was notably underrepresented, being included in only 48% of studies, indicating a need for improved adherence to COS guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017. Smith, TO., Mansfield, M., Hawker, GA., et al.[2023]

Osteoarthritis (OA) currently has no known cause or cure, and there are no effective disease-modifying drugs available, making it a challenging condition for both patients and doctors.

Recent insights suggest that OA may be an epigenetic disease, which could explain the limited success of existing therapies and guide future drug development aimed at preventing or slowing disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential directions for drug development for osteoarthritis. Roach, HI.[2014]

Osteoarthritis (OA) is the most prevalent form of arthritis, primarily affecting joints like the knees and hips, and is a leading cause for total joint replacements.

The economic burden of OA is significant, costing over 2% of the gross national product in developed countries, and it leads to more functional limitations and disabilities in adults than any other chronic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Osteoarthritis--epidemiology, economics and quality of life]. Grazio, S.[2009]

A systematic review of 20 randomized controlled trials involving 2570 patients found that glucosamine, particularly the Rotta preparation, showed significant benefits in reducing pain and improving function in osteoarthritis compared to placebo.

However, when analyzing studies with adequate allocation concealment or non-Rotta preparations, glucosamine did not demonstrate significant improvements in pain or function, indicating that its efficacy may vary based on the formulation used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucosamine therapy for treating osteoarthritis. Towheed, TE., Maxwell, L., Anastassiades, TP., et al.[2022]

The study aims to create a composite measure that combines pain, physical function, and structural changes in osteoarthritis (OA) to better define the severity of the disease and the need for joint replacement surgery.

Preliminary findings indicate that understanding the distressing features of pain and refining functional assessment tools are crucial steps toward developing this composite index, which could enhance the evaluation of treatment responses in OA clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OMERACT/OARSI initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis. Gossec, L., Hawker, G., Davis, AM., et al.[2022]

A comprehensive update to the core domain set for clinical trials in hip and/or knee osteoarthritis (OA) was achieved through a systematic review and an international Delphi survey involving 426 participants from 25 countries.

The final consensus identified six mandatory domains to be measured in all OA clinical trials: pain, physical function, quality of life, patient's global assessment of the target joint, adverse events (including mortality), and joint structure under specific circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis. Smith, TO., Hawker, GA., Hunter, DJ., et al.[2023]

A digital management program for hip and knee osteoarthritis, which included education, exercises, and access to a physical therapist, was positively received by 19 participants, highlighting its flexibility and ease of access compared to traditional care.

Key benefits of the program included no waiting lists, the ability to participate from various locations at convenient times, and daily support from a physical therapist, making it a valid alternative for managing osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'I would never have done it if it hadn't been digital': a qualitative study on patients' experiences of a digital management programme for hip and knee osteoarthritis in Sweden. Cronström, A., Dahlberg, LE., Nero, H., et al.[2020]

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