NCT02624687

Brief Summary

This study will test the effects of a sedentary behavior intervention on low back pain in working adults. The behavioral intervention will include the use of a sit-stand desk and a wrist-worn activity prompter that will notify participants when they have been sedentary for too long.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 19, 2019

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

October 13, 2015

Results QC Date

January 22, 2018

Last Update Submit

February 20, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Low Back Pain Disability

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

    6 months

  • Usual Low Back Pain

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

    6 months

Secondary Outcomes (10)

  • Quality of Life (Self-reported)

    6 months

  • Mood

    6 months

  • 50-ft Walk Test

    6 months

  • Chair Stand Test

    6 months

  • Timed up and go Test

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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.

Behavioral: Intervention

Control

PLACEBO COMPARATOR

These subjects will receive no intervention.

Other: No intervention

Interventions

InterventionBEHAVIORAL

Participants participated in monthly, individual counselling with a trained interventionist to decrease sedentary behavior and improve pain self-management. Participants were provided with a sit-stand desk attachment and a wrist worn activity prompter..

Intervention

No contact control

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have chronic low back pain defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months
  • Oswestry low back pain index \>20% to ensure a moderate level of disability is present, thus minimizing a potential floor effect
  • Currently perform deskwork at least 20 hours per week at a desk compatible with the sit-stand attachment
  • Stable employment (at least 3 months at current job and plan to stay at current job for the next 6 months)
  • Ability to obtain approval to install sit-stand workstation (i.e., from supervisor)
  • Access to internet connection and email to complete assessment surveys

You may not qualify if:

  • Unable to provide informed consent
  • Cardiovascular event in the last 6 months (e.g. heart attack, stoke, heart failure, revascularization procedure)
  • Presence of a comorbid condition that would limit ability to reduce sedentary behavior (e.g. currently undergoing treatment for cancer)
  • Back surgery in the past 3 months or planned in the next year
  • Presence of a medical "red flag" for a serious spinal condition (cancer, compression fracture, signs or symptoms of root compression, infection)
  • Inability to tolerate standing for any reason
  • Currently using a sit-stand desk, standing desk, or wearable activity monitor
  • Currently pregnant or planned pregnancy in the next 6 months
  • Blood pressure \>159/100 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh, Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • Barone Gibbs B, Hergenroeder AL, Perdomo SJ, Kowalsky RJ, Delitto A, Jakicic JM. Reducing sedentary behaviour to decrease chronic low back pain: the stand back randomised trial. Occup Environ Med. 2018 May;75(5):321-327. doi: 10.1136/oemed-2017-104732. Epub 2018 Jan 12.

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Bethany Barone Gibbs
Organization
University of Pittsburgh

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2015

First Posted

December 8, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 13, 2019

Results First Posted

February 19, 2019

Record last verified: 2019-02

Locations