Trial Outcomes & Findings for Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study (NCT NCT02624687)

NCT ID: NCT02624687

Last Updated: 2019-03-13

Results Overview

Oswestry Disability Index. This measurements is reported as a % (range 1-100%) where a higher score indicates worse low back pain disability.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-03-13

Participant Flow

Participant milestones

Measure	Intervention These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control These subjects will receive no intervention. No intervention
Overall Study STARTED	13	14
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Intervention These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control These subjects will receive no intervention. No intervention
Overall Study Withdrawal by Subject	1	1
Overall Study medical leave from work	0	1

Baseline Characteristics

Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study

Baseline characteristics by cohort

Measure	Intervention n=13 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=14 Participants These subjects will receive no intervention. No intervention	Total n=27 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 9 • n=5 Participants	51 years STANDARD_DEVIATION 13 • n=7 Participants	52 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Oswestry Disability Index, %	23.6 % STANDARD_DEVIATION 10.9 • n=5 Participants	24.6 % STANDARD_DEVIATION 10.3 • n=7 Participants	24.1 % STANDARD_DEVIATION 10.5 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: ITT LOCF

Oswestry Disability Index. This measurements is reported as a % (range 1-100%) where a higher score indicates worse low back pain disability.

Outcome measures

Measure	Intervention n=13 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=14 Participants These subjects will receive no intervention. No intervention
Low Back Pain Disability	12.1 Oswestry Disability % Standard Error 2.3	19.6 Oswestry Disability % Standard Error 2.2

PRIMARY outcome

Timeframe: 6 months

Population: ITT LOCF

Pain rated by Visual Analog Scale (Usual Back Pain). This score ranges from 1-10 where a higher score indicates worse pain.

Outcome measures

Measure	Intervention n=13 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=14 Participants These subjects will receive no intervention. No intervention
Usual Low Back Pain	2.87 points (out of 10) Standard Error 0.33	3.02 points (out of 10) Standard Error 0.32

SECONDARY outcome

Timeframe: 6 months

36-item Short Form Survey (SF-36). This validated survey collects information on quality of life, with scores ranging from 0-100, and where higher scores indicate higher quality of life.The General Health Score is reported.

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
Quality of Life (Self-reported)	73.33 points Standard Deviation 11.55	62.08 points Standard Deviation 21.05

SECONDARY outcome

Timeframe: 6 months

Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points).

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
Mood	87.25 points Standard Deviation 11.76	102.67 points Standard Deviation 31.58

SECONDARY outcome

Timeframe: 6 months

Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
50-ft Walk Test	10.67 seconds Standard Deviation 1.38	11.09 seconds Standard Deviation 2.31

SECONDARY outcome

Timeframe: 6 months

Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
Chair Stand Test	10.05 seconds Standard Deviation 1.96	10.42 seconds Standard Deviation 2.69

SECONDARY outcome

Timeframe: 6 months

Timed up and go test (seconds). A lower time indicates better function.

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
Timed up and go Test	7.49 seconds Standard Deviation 1.11	8.20 seconds Standard Deviation 1.43

SECONDARY outcome

Timeframe: 6 months

Distance on an unloaded reach test (cm). Greater distance indicates better function.

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
Unloaded Reach Test	36.2 cm Standard Deviation 7.5	34.0 cm Standard Deviation 4.9

SECONDARY outcome

Timeframe: 6 months

Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
Presenteeism	27.83 points Standard Deviation 3.49	25.08 points Standard Deviation 5.78

SECONDARY outcome

Timeframe: 6 months

Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).

Outcome measures

Measure	Intervention n=12 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=12 Participants These subjects will receive no intervention. No intervention
Work Productivity	6.57 points Standard Deviation 0.72	6.61 points Standard Deviation 0.88

SECONDARY outcome

Timeframe: 6 months

Population: ITT LOCF

Minutes per week of moderate-to-vigorous physical activity by self-report

Outcome measures

Measure	Intervention n=13 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=14 Participants These subjects will receive no intervention. No intervention
Physical Activity	300 minutes/week Standard Error 53	195 minutes/week Standard Error 52

SECONDARY outcome

Timeframe: 6 months

Population: ITT LOCF

Self-reported hours per day

Outcome measures

Measure	Intervention n=13 Participants These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=14 Participants These subjects will receive no intervention. No intervention
Sedentary Behavior	7.3 hours/day Standard Error 0.4	9.0 hours/day Standard Error 0.4

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=13 participants at risk These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction. Decreasing Sedentary Behavior	Control n=14 participants at risk These subjects will receive no intervention. No intervention
Musculoskeletal and connective tissue disorders Worsening of Low Back Pain by >50%	7.7% 1/13 • Number of events 1 • Monthly during the 6 month study	21.4% 3/14 • Number of events 3 • Monthly during the 6 month study
Musculoskeletal and connective tissue disorders New weakness, numbness, tingling in lower legs	0.00% 0/13 • Monthly during the 6 month study	7.1% 1/14 • Number of events 1 • Monthly during the 6 month study
Musculoskeletal and connective tissue disorders Medical procedure	0.00% 0/13 • Monthly during the 6 month study	7.1% 1/14 • Number of events 1 • Monthly during the 6 month study

Additional Information

Bethany Barone Gibbs

University of Pittsburgh

Phone: 4123834002

Email: bbarone@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place