NEPAL (Neuromodulatory Examination of Pain and Mobility Across the Lifespan)

NCT02488863 | Completed Results

• 4 other identifiers: IRB201401056-NK01AG048259P30AG059297Pepper Grant
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Musculoskeletal Pain; Pain, Chronic

Keywords

Older adults; Chronic Pain; Musculoskeletal

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB)

  The Short Physical Performance Battery (SPPB) Total Score is a measure of physical function. It is calculated by summing three measures of lower-extremity function: standing balance (side-by-side, semi-tandem, and tandem stance), 4-meter walking speed, and ability to rise from a chair. Each task is rated on a 0-4 scale, with increasing scores indicating better physical performance. The SPPB Total scores range from 0-12.

  At baseline-physical function visit

Study Arms (3)

Older Adults with Musculoskeletal Pain

Older adults (60+ years old) experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.

Other: MRI Neuroimaging; Other: Quantitative Sensory Testing; Other: Questionnaires; Other: Physical and Cognitive Function Testing

Older Adults without Musculoskeletal Pain

Older adults (60+ years old) not experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.

Other: MRI Neuroimaging; Other: Quantitative Sensory Testing; Other: Questionnaires; Other: Physical and Cognitive Function Testing

Young Controls

Healthy young adults (18-25 years old) not experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.

Other: MRI Neuroimaging; Other: Quantitative Sensory Testing; Other: Questionnaires; Other: Physical and Cognitive Function Testing

Interventions

MRI Neuroimaging OTHER

MRI scans utilized to measure the structural and functional integrity of the brain.

Also known as: Functional Magnetic Resonance Imaging (fMRI)

Older Adults with Musculoskeletal Pain; Older Adults without Musculoskeletal Pain; Young Controls

Quantitative Sensory Testing OTHER

Vibratory Detection Thresholds; Tactile Detection Thresholds; Thermal Detection Thresholds, Pain Thresholds, and Temporal Summation; Allodynia and Temporal Summation; Punctate Pain Testing and Temporal Summation; and Pressure Pain Thresholds.

Also known as: QST

Older Adults with Musculoskeletal Pain; Older Adults without Musculoskeletal Pain; Young Controls

Questionnaires OTHER

The Modified Mini-Mental State Examination (3MS), the Montreal Cognitive Assessment (MoCA), the Center for Epidemiologic Studies Depression Scale (CES-D), the Geriatric Depression Scale (GDS), the Edinburg Handedness Inventory, the Ten-Item Personality Inventory (TIPI), the Pittsburgh Sleep Quality Index (PSQI), the state and trait versions of the State-Trait Anxiety Inventory (STAI), the state and trait versions of the Positive and Negative Affect Schedule (PANAS), pain questionnaires (the Graded Chronic Pain Scale (GCPS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Pain-Detect, the short-form McGill Pain Questionnaire (SF-MPQ-2), and the Coping Strategies Questionnaire-Revised (CSQ-R)), a standardized paper and pencil cognitive battery (Hopkins Verbal Learning Test (HVLT), Trail Making A\&B, Boston Naming Test, Controlled Oral Word Association Test (COWAT), Stroop Interference Test, Ruff Figural Fluency Test, and Raven's Progressive Matrices Test).

Older Adults with Musculoskeletal Pain; Older Adults without Musculoskeletal Pain; Young Controls

Physical and Cognitive Function Testing OTHER

Upper Limb Isometric Strength, Short Physical Performance Battery (SPPB), GAITRite Instrumented Walking, Galvanic Skin Response, Knee Extension Isokinetic Strength, the Pepper Assessment Tool for Disability (PAT-D), and an electronic NIH Toolbox Cognitive Battery.

Older Adults with Musculoskeletal Pain; Older Adults without Musculoskeletal Pain; Young Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults (60+ years old) who experience musculoskeletal pain as well as those who do not experience musculoskeletal pain; healthy young adults (18-25 years old).

You may qualify if:

• older adults over 60 years of age with and without musculoskeletal pain
• healthy young adults between the ages of 18-25

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (4)

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

UF Health Science Center

Gainesville, Florida, 32608, United States

Location

Clinical Translational Research Building

Gainesville, Florida, 32611, United States

Location

McKnight Brain Institute of the University of Florida

Gainesville, Florida, 32611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Results Point of Contact

• Title: Eric Weber
• Organization: University o fFlorida

ebweber@ufl.edu

352-273-7802

Study Officials

• Yenisel Cruz-Almeida, MSPH, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: February 4, 2024
• Study Completion: February 4, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Locations

US (4)