Trial Outcomes & Findings for NEPAL (Neuromodulatory Examination of Pain and Mobility Across the Lifespan) (NCT NCT02488863)
NCT ID: NCT02488863
Last Updated: 2025-03-18
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
105 participants
Primary outcome timeframe
At baseline-physical function visit
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
22
|
30
|
|
Overall Study
COMPLETED
|
44
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NEPAL (Neuromodulatory Examination of Pain and Mobility Across the Lifespan)
Baseline characteristics by cohort
| Measure |
Older Adults With Musculoskeletal Pain
n=53 Participants
Older adults (60+ years old) experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.
|
Older Adults Without Musculoskeletal Pain
n=22 Participants
Older adults (60+ years old) not experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.
|
Young Controls
n=30 Participants
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.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
53 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
46 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
22 participants
n=7 Participants
|
30 participants
n=5 Participants
|
105 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline-physical function visitThe 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.
Outcome measures
| Measure |
Older Adults With Musculoskeletal Pain
n=44 Participants
Older adults (60+ years old) experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.
|
Older Adults Without Musculoskeletal Pain
n=22 Participants
Older adults (60+ years old) not experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.
|
Young Controls
n=20 Participants
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.
|
|---|---|---|---|
|
Short Physical Performance Battery (SPPB)
|
10.95 score on a scale
Standard Deviation 1.10
|
10.82 score on a scale
Standard Deviation 1.87
|
11.75 score on a scale
Standard Deviation 0.64
|
Adverse Events
Older Adults With Musculoskeletal Pain
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Older Adults Without Musculoskeletal Pain
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Young Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Older Adults With Musculoskeletal Pain
n=53 participants at risk
Older adults (60+ years old) experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.
|
Older Adults Without Musculoskeletal Pain
n=22 participants at risk
Older adults (60+ years old) not experiencing musculoskeletal pain will undergo: MRI Neuroimaging, Quantitative Sensory Testing, Physical and Cognitive Function Testing, and questionnaire batteries.
|
Young Controls
n=30 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.8%
2/53 • Number of events 2 • Each participant was assessed over their time in the study, about 2 weeks
|
0.00%
0/22 • Each participant was assessed over their time in the study, about 2 weeks
|
0.00%
0/30 • Each participant was assessed over their time in the study, about 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place