# Development and Validation of a Novel Rat Model of Fibromyalgia

> **NIH NIH R61** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2022 · $411,053

## Abstract

PROJECT SUMMARY
Millions of Americans suffer from Fibromyalgia syndrome (FMS) and experience severe disability and diminished
quality of life. This chronic widespread pain syndrome is accompanied by a range of symptoms including chronic
fatigue, non-restorative sleep, functional disability, and cognitive and mood disturbances. Currently used animal
models of FMS suffer from deficits in face, construct, and predictive validities, which has resulted in a translation
gap; new therapies that appear to be promising in animal models have failed in human clinical trials. One strategy
to improve the evaluation of face and construct validities of FMS animal models would be to measure several
symptoms that correlate with the human disease in the same animal. We will therefore develop a Fibromyalgia
Analog Model (FAM) that will serve as a diagnostic index similar to those used clinically. We hypothesize that
this index will improve the evaluation of face and predictive validities of animal FMS models, and will provide a
defined method to compare them. A secondary endpoint is a comparison between the established reserpine
model of FMS and an innovative model: the Dahl salt-sensitive (SS) rat. Our preliminary studies show that SS
rats are a model of spontaneous allodynia, as they exhibit mechanical pressure sensitivity without an external
precipitating intervention. Accompanying the decrease in mechanical thresholds, these rats also fail to mount a
diffuse noxious inhibitory control response to painful stimuli. This strain demonstrates additional phenotypes
consistent with FMS such as anxiety, systemic and neural inflammation and dysfunction in stress response
systems (construct validity). These rats also demonstrate predictive validity as gabapentin, but not indomethacin
or dexamethasone provides >30% improvement in hyperalgesia. We hypothesize that the FAM index will allow
us to determine the suitability of the SS strain as an FMS model. The R61 phase will comprise three experiments.
(1) Six behavioral endpoints will test for FMS traits in the same individual female reserpine treated Sprague
Dawley rat; behavioral aspects of fatigue, muscle tenderness, disrupted sleep, widespread pain, anxiety, and
depression. The results will then be analyzed using regression modelling within a rigorous multivariate framework
to define relationships in observable clinical phenotypes to develop the FAM index. The data will also be used
to maximize the internal validity of the measurements. (2) We will certify the external validity of the FAM index
using two additional strains, female SS and Brown Norway (BN) rats. (3) We will repeat the studies in males of
all three strains. Five statistical milestones will determine whether to move forward with further experiments. In
the R33 phase, we will externally validate the SS model and FAM index and examine its predictive validity via
three sets of experiments: (1) externally validate the FAM index in additional rat strains; (2) es...

## Key facts

- **NIH application ID:** 10434397
- **Project number:** 1R61NS123758-01A1
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Norman Taylor
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $411,053
- **Award type:** 1
- **Project period:** 2022-04-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10434397

## Citation

> US National Institutes of Health, RePORTER application 10434397, Development and Validation of a Novel Rat Model of Fibromyalgia (1R61NS123758-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10434397. Licensed CC0.

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