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Completed

NCT Number: NCT02517762

Acute Low Back Pain: Causes, Mechanisms, Treatment and Followup

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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. The patients go through x-ray examinations, physical examinations, they complete a battery of questionnaires covering history of acute low back pain, lifestyle characteristics, work place factors, psychosocial factors, and indicate pain intensity and pain locations. Thereafter the patients are randomly allocated to one of two treatment advices: stay active as much as possible in spite of pain or adjust the activity to the pain. During seven days after the medical examination the patients wear a pedometer attached to the waist and annotate the number of steps and pain intensity, pain location and pain-related disability in a diary. A numeric graphic scale is used for pain intensity. Work absenteeism and sick leave due to the current acute back pain is collected from the company records. Immediate inclusion after pain onset is facilitated with continuous communication with the manufactory company. Physical activity and pain development over the seven days is investigated statistically using linear mixed models for repeated measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Physical activity

Behavioral

Primary outcomes

  1. Acute low back pain

    Time frame: 7 days

    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

  2. Physical activity

    Time frame: 7 days

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

Secondary outcomes

  1. Work absenteeism and sick leave

    Time frame: 7 days

    Work absenteeism and sick leave due to the current backpain is collected from the manufacturing company records up to one month after the onset of the acute low back pain

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Labour Triggered Acute Low Back Pain: Origin, Mechanisms, Causes of Pain, Evaluation of Treatment and Followup

Acronym: ALBP

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 7, 2015
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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