NCT02517762

Brief Summary

The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. Thereafter, the included patients are allocated either to the advice to stay as active as possible in spite of the pain or to adjust their activity to the pain. Pain intensity and physical activity are followed prospectively over seven days using a diary and a pedometer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

3.8 years

First QC Date

August 5, 2015

Last Update Submit

August 10, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Acute low back pain

    Pain intensity is assessed from a numerical graphic scale, ranging from 0 (no pain) to 10 (pain as bad as it can be); the patients complete the scale each day in a diary

    7 days

  • Physical activity

    The patients wear a pedometer attached to the hip and annotate the number of daily steps each day in a diary

    7 days

Secondary Outcomes (1)

  • Work absenteeism and sick leave

    7 days

Study Arms (2)

Stay active

EXPERIMENTAL

Receive the advice by the physician to stay as active as possible in spite of the pain experienced

Behavioral: Physical activity

Adjust activity

EXPERIMENTAL

Receive the advice by the physician to adjust the activity according to the pain, i.e. to avoid activities, movements or positions that cause or worsen the pain

Behavioral: Physical activity

Interventions

Adjust activityStay active

Eligibility Criteria

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

You may qualify if:

  • Severe acute low back pain, duration within 24h after onset, pain exceeds 50mm on the visual analog scale (VAS)

You may not qualify if:

  • Sick-leave because of low back pain or in spine in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Olaya-Contreras P, Styf J, Arvidsson D, Frennered K, Hansson T. The effect of the stay active advice on physical activity and on the course of acute severe low back pain. BMC Sports Sci Med Rehabil. 2015 Aug 27;7:19. doi: 10.1186/s13102-015-0013-x. eCollection 2015.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tommy Hansson, MD, PhD

    Department of Orthopedics, Sahlgrenska Academy at the University of Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

March 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 11, 2015

Record last verified: 2015-08