N/A
N=105
NEPAL (Neuromodulatory Examination of Pain and Mobility Across the Lifespan)
Musculoskeletal Pain · Pain, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02488863 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Short Physical Performance Battery (SPPB) — 10.95; 10.82; 11.75 score on a scale — p=0.0561
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MRI Neuroimaging (Other); Quantitative Sensory Testing (Other); Questionnaires (Other); Physical and Cognitive Function Testing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Physical Performance Battery (SPPB) |
10.95; 10.82; 11.75 | 0.0561 |
Summary
Musculoskeletal pain represents the leading cause of disability worldwide. It has been traditionally attributed to peripheral mechanisms, but peripheral damage, inflammation, and psychological factors have failed to significantly account for the presence, absence, or severity of chronic musculoskeletal pain (CMP). Recent studies show that individuals with CMP exhibit dysfunctional pain modulation supporting a significant central nervous system (CNS) contribution. However, the CNS mechanisms underlying these changes in pain modulation are not currently known, nor is their relation to clinical pain progression. The proposed pilot examines brain circuits recently described in predicting the transition from acute to chronic pain, in predicting clinical and experimental pain changes as well as physical performance and mobility changes in older persons with musculoskeletal pain over a one year period. The findings will provide novel and important information regarding the mechanisms underlying aberrant pain processing and its functional consequences in older adults with musculoskeletal pain. The information learned can be subsequently used to target treatment and prevention strategies in future studies of older adults. The central hypothesis is that increased functional and structural connectivity of cortico-striatal regions will be significantly associated with baseline clinical and experimental pain and decreased physical function in persons with CMP and will account for more rapid clinical pain and disability progression over time.
Eligibility Criteria
Inclusion Criteria
- older adults over 60 years of age with and without musculoskeletal pain
- healthy young adults between the ages of 18-25
Exclusion Criteria
- pregnant women
- history of alcohol/drug abuse in the past
- known intra-cerebral pathology or epilepsy
- significant cognitive impairment as evidenced by the 3MS
- hospitalizations for mental health reasons in the past year
- not meeting MRI screening requirements (implants, prosthesis, artificial limb/joint, shunt, metal rods, hearing aid, claustrophobia or anxiety)
- chronic/current use of narcotic medications
- serious systemic (uncontrolled diabetes; self reported A1C>7), neurological , or cardiovascular disease (uncontrolled hypertension >155/90)
- liver or kidney disease
- inability to consent for study participation
Data sourced from ClinicalTrials.gov (NCT02488863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.