Trial Outcomes & Findings for Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics (NCT NCT02906358)

Last Updated: 2018-11-05

Results Overview

Participants are instructed to sit and stand up five times as fast as they can from a standard armless chair while the researcher times how many seconds it takes them to complete the task. After a brief rest, they repeat the test a second time and the average of two tests is calculated.

Recruitment status

COMPLETED

Study phase

Target enrollment

111 participants

Primary outcome timeframe

Change from Baseline sit-to-stand at 3 and 6 months

Results posted on

2018-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Community-based Pain Self-management Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Overall Study STARTED	58	53
Overall Study Completed 3 Month Measures	36	33
Overall Study COMPLETED	36	31
Overall Study NOT COMPLETED	22	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Community-based Pain Self-management Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Overall Study Withdrawal by Subject	10	7
Overall Study Lost to Follow-up	12	15

Baseline Characteristics

Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Community-based Pain Self-management n=58 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=53 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management	Total n=111 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 8.7 • n=5 Participants	56.2 years STANDARD_DEVIATION 9.4 • n=7 Participants	56.5 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	24 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Primary Language English	45 Participants n=5 Participants	36 Participants n=7 Participants	81 Participants n=5 Participants
Primary Language Spanish	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Marital Status Married	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Marital Status Other (single, divorced, separated, widowed)	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Employment Status Employed	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Employment Status Unemployed (retired, disabled, unemployed)	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Insurance Type Private Insurance	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Insurance Type Medicare	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Insurance Type Medicaid	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Insurance Type Unisured	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
BMI	35.5 kg/m^2 STANDARD_DEVIATION 8.0 • n=5 Participants	33.3 kg/m^2 STANDARD_DEVIATION 8.8 • n=7 Participants	34.5 kg/m^2 STANDARD_DEVIATION 8.4 • n=5 Participants
Pain Location Neck	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Pain Location Upper Extremity	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Pain Location Back	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Pain Location Abdomen	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Pain Location Lower Extremity	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Pain Location Multiple areas	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline sit-to-stand at 3 and 6 months

Population: We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=33 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Five Times Sit-to-stand (5XSTS) Change from Baseline Score at 3 Months	-4.53 seconds Standard Deviation 6.78	-5.20 seconds Standard Deviation 17.53
Five Times Sit-to-stand (5XSTS) Change from Baseline Score at 6 Months	-4.18 seconds Standard Deviation 6.45	-6.43 seconds Standard Deviation 14.11

SECONDARY outcome

Timeframe: Change from Baseline 50-foot speed walk at 3 and 6 months

This test requires participants to walk along a 25-foot walkway turn around and return to the starting point. They are instructed to safely walk as fast as they can and the time taken to complete the test is recorded in seconds.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=33 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
50-foot Speed Walk (50FtSW) Change from Baseline Score at 3 Months	-1.58 seconds Standard Deviation 5.55	-1.22 seconds Standard Deviation 4.29
50-foot Speed Walk (50FtSW) Change from Baseline Score at 6 Month	-1.32 seconds Standard Deviation 7.16	-1.42 seconds Standard Deviation 4.85

SECONDARY outcome

Timeframe: Change from Baseline PSFS at 3 and 6 months

This is a brief, one-page document that prompts subjects to identify limitations to three activities, rank the importance of these activities, and track progress over time. The activities are scored on a scale of 0 to 10, where 0 indicates that the subject is unable to perform the activity and 10 indicates ability to perform the activity at the same level as before the injury or problem. The total summed score is divided by the number of activities, where a lower score would indicate less ability to perform the task, and the higher score would indicate easier performance of the task.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=33 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Patient Specific Functional Scale (PSFS) Change from Baseline Score at 3 Months	1.07 units on a scale Standard Deviation 1.95	1.04 units on a scale Standard Deviation 1.66
Patient Specific Functional Scale (PSFS) Change from Baseline Score at 6 Months	1.64 units on a scale Standard Deviation 2.28	1.65 units on a scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: Change from Baseline SDMT at 3 and 6 months

Participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes (written and oral versions) with the correct digit assigned to a particular symbol. Total correct responses within 90 seconds were measured. The score of the test is the number of correct substitutions completed within the time limit, with a maximum score of 110. A score under 33 is generally considered to be a clear indicator of the existence of some type of cognitive disorder. The higher the score, the better the cognitive function.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=33 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Symbol-Digit Modalities Test (SDMT) Change from Baseline Score at 3 Months	4.19 units on a scale Standard Deviation 6.61	6.84 units on a scale Standard Deviation 10.0
Symbol-Digit Modalities Test (SDMT) Change from Baseline Score at 6 Month	4.61 units on a scale Standard Deviation 8.67	7.37 units on a scale Standard Deviation 8.94

SECONDARY outcome

Timeframe: Change from Baseline BPI at 3 and 6 months

The BPI is brief and uses simple 0-10 rating scales to measure pain intensity, where zero is no pain and ten is most intense pain imaginable.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=33 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
The Brief Pain Inventory (BPI): Severity Change from Baseline Score at 3 Months	-0.90 units on a scale Standard Deviation 1.59	-1.17 units on a scale Standard Deviation 2.00
The Brief Pain Inventory (BPI): Severity Change from Baseline Score at 6 Month	-0.95 units on a scale Standard Deviation 1.84	-1.08 units on a scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: Change from Baseline BPI at 3 and 6 months

The BPI is brief and uses simple 0-10 rating scales to measure the degree to which pain interferes with common dimensions of feeling and function, where zero is does not interfere and ten is completely interferes.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=33 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
The Brief Pain Inventory (BPI): Interference Change from Baseline Score at 3 Months	-0.31 units on a scale Standard Deviation 1.84	-1.15 units on a scale Standard Deviation 4.10
The Brief Pain Inventory (BPI): Interference Change from Baseline Score at 6 Months	-1.09 units on a scale Standard Deviation 2.46	-1.37 units on a scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: Change from Baseline 6-minute distance walk at 6 months

For this test, participants walk as far as they can for six minutes, and the total distance in feet is measured with a surveyor's wheel pushed by a research assistant walking behind the subject. Participants can pause or stop as necessary.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=34 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=31 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
6-minute Distance Walk (6MW)	20.0 feet Standard Deviation 291.9	193.9 feet Standard Deviation 429.0

SECONDARY outcome

Timeframe: Change from Baseline perceived effort at 6 months

Completed in conjunction with the 6-minute walk, this measures intensity and perceived effort after the test using a 0-10 Likert-type scale. Anchor words for the effort scales are "no effort" and "most intense effort imaginable."

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=34 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=29 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Borg Perceived Effort (Borg)	-0.21 units on a scale Standard Deviation 3.60	-1.76 units on a scale Standard Deviation 4.19

SECONDARY outcome

Timeframe: Change from Baseline SF-12 PCS at 6 months

The 12-item Short Form Health Survey created for Medical Outcomes Study measures physical summary scores through a brief survey with limited respondent burden while retaining precision. Physical Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of health, and 100 indicates the highest level of health.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=35 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=30 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS)	2.20 units on a scale Standard Deviation 8.56	6.76 units on a scale Standard Deviation 9.99

SECONDARY outcome

Timeframe: Change from baseline SF-12 MCS at 6 months

The 12-item Short Form Health Survey created for Medical Outcomes Study measures mental summary scores through a brief survey with limited respondent burden while retaining precision. Mental Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of mental health, and 100 indicates the highest level of mental health.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=35 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=30 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS)	41.44 units on a scale Standard Deviation 12.58	39.39 units on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: Change from Baseline PHQ-9 at 6 months

The PHQ-9 is a brief, self-administered questionnaire that assesses somatic symptom severity. Participants rate the severity of 15 somatic symptoms as 0 (not bothered at all), 1 (bothered a little) or 2 (bothered a lot). The scores are totaled, with a possible total of 30, which would mean the most severe somatic symptoms, and 0 meaning the least somatic symptoms.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=31 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Patient Health Questionnaire -9 (PHQ-9)	-2.08 units on a scale Standard Deviation 6.42	-3.45 units on a scale Standard Deviation 6.81

SECONDARY outcome

Timeframe: Change from Baseline TSK at 6 months

This is a 11-item questionnaire, where individuals score items on a scale of 1 to 4 (1=strongly disagree, 4=strongly agree) to measures fear of completing physical activities. The scores are totaled for all items, to give a possible score of 44, which would indicate a greater fear of injuring oneself. A lower score would indicate less fear of injury to oneself.

Outcome measures

Outcome measures
Measure	Community-based Pain Self-management n=36 Participants Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=31 Participants Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Tampa Scale for Kinesiophobia (TSK)	-2.64 units on a scale Standard Deviation 6.32	-2.77 units on a scale Standard Deviation 7.10

Adverse Events

Community-based Pain Self-management

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Clinic-based Pain Self-management

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Community-based Pain Self-management n=58 participants at risk Community-based pain self-management: two, one-hour monthly meetings for first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=53 participants at risk Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Musculoskeletal and connective tissue disorders Fractured leg	1.7% 1/58 • Number of events 1 • Adverse event data was collected for 11 months, the duration of the program.	0.00% 0/53 • Adverse event data was collected for 11 months, the duration of the program.
Musculoskeletal and connective tissue disorders Gout attack	1.7% 1/58 • Number of events 1 • Adverse event data was collected for 11 months, the duration of the program.	0.00% 0/53 • Adverse event data was collected for 11 months, the duration of the program.
Musculoskeletal and connective tissue disorders Diabetic foot infection leading to leg amputation	1.7% 1/58 • Number of events 1 • Adverse event data was collected for 11 months, the duration of the program.	0.00% 0/53 • Adverse event data was collected for 11 months, the duration of the program.

Other adverse events

Other adverse events
Measure	Community-based Pain Self-management n=58 participants at risk Community-based pain self-management: two, one-hour monthly meetings for first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management	Clinic-based Pain Self-management n=53 participants at risk Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management
Musculoskeletal and connective tissue disorders Sprained wrist	0.00% 0/58 • Adverse event data was collected for 11 months, the duration of the program.	1.9% 1/53 • Number of events 1 • Adverse event data was collected for 11 months, the duration of the program.
Musculoskeletal and connective tissue disorders Fall	0.00% 0/58 • Adverse event data was collected for 11 months, the duration of the program.	1.9% 1/53 • Number of events 1 • Adverse event data was collected for 11 months, the duration of the program.

Additional Information

Barbara J Turner

The University of Texas Health Science Center at San Antonio

Phone: 210-562-5551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place