For Researchers

Data Types & Data Availability


Data Types

Surveys:

We will be assessing multiple self-reported putative biomarkers, either accessed remotely from an off-site computer (e.g. at home) or at the clinic visits if necessary.

Functional Testing:

Two measures of physical function will be assessed: the Five Times Sit-to-Stand Test (5TSTS) and the 6-meter Walk Test (6MWT) following standard protocols. In addition to functional capability, pain will be assessed prior to and immediately following each test to assess movement pain. With a brief rest between tests, these assessments should take no more than 15 min.

Sensory Testing:

To assess pain sensitivity, three forms of QST will be performed, requiring approximately 15 min with rest intervals between tests:

  • Pressure pain thresholds (PPTs): three repetitions at the index site (e.g. knee for TKA cohort) and a remote site (e.g. upper arm for the TKA cohort) will be performed to assess mechanical pain threshold.
  • Temporal summation of pain (TSP): using a mechanical probe, 10 repetitions will be applied at the index site ((e.g. knee for TKA cohort) and a remote site (e.g. arm for the TKA cohort). Pain ratings over time will be recorded. The change in pain over time at each site will be recorded to assess pain facilitation.
  • Conditioned pain modulation (CPM): PPTs at the remote site (see above) will be assessed immediately prior and following opposite hand immersion in painfully cold, circulating water. The difference in pain thresholds will be used to assess for pain inhibition (i.e., elevated PPTs indicates inhibition).

Omics:

  • exRNA, genetic variants, proteomics, lipodomics, metabolomics

Imaging:

Imaging data will be collected using a number of imaging modalities that are acquired using a magnetic resonance scanner. These include:

  • T1-weighted structural imaging;
  • diffusion weighted imaging (DWI);
  • resting-state functional magnetic resonance imaging (fMRI); and
  • task-fMRI using tonic cuff pain. The cuff pain will be applied to the calf at a subject-specific level designed to invoke a pain intensity rating of ∼50/100. When outside the scanner, the patient will be asked to rate the cuff pressure pain.

Timeline

What happens when during the study?

Timeline

2 - 6 weeks before surgery

Surgery

3 - 28 days after surgery

6 weeks after surgery

3 months after surgery

6 months after surgery

12 months after surgery

Location

Visit 1

Remote

Visit 2

Visit 3

Remote

Remote

Set of Surveys: Online after consent, prior to visit or at study visit

 
   

Brief Surveys - Remote

 
   

Functional Testing

   
   

Sensory Testing

   
   

Blood Draw

 
   

Brain Imaging

   
   

When will data be available?

Data will be made publicly available upon completion of the project.


What are the data sharing policies?

This study will be conducted in accordance with the following publication and data sharing policies and regulations:

National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information. A2CPS will submit human sample-derived data to both unrestricted and controlled access databases. All individual-level data will be coded with linked identifiers to controlled-access meta-data labels/tables that will facilitate coordinated identification across samples, individuals, and databases.

In addition, this study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.