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Acute Low Back Pain: Causes, Mechanisms, Treatment and Followup (ALBP)

Primary Purpose

Acute Low Back Pain, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Stay active

    Adjust activity

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Work absenteeism and sick leave
    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

    Full Information

    First Posted
    August 5, 2015
    Last Updated
    August 10, 2015
    Sponsor
    Göteborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02517762
    Brief Title
    Acute Low Back Pain: Causes, Mechanisms, Treatment and Followup
    Acronym
    ALBP
    Official Title
    Labour Triggered Acute Low Back Pain: Origin, Mechanisms, Causes of Pain, Evaluation of Treatment and Followup
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Göteborg University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Low Back Pain, Physical Activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stay active
    Arm Type
    Experimental
    Arm Description
    Receive the advice by the physician to stay as active as possible in spite of the pain experienced
    Arm Title
    Adjust activity
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical activity
    Primary Outcome Measure Information:
    Title
    Acute low back pain
    Description
    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
    Time Frame
    7 days
    Title
    Physical activity
    Description
    The patients wear a pedometer attached to the hip and annotate the number of daily steps each day in a diary
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Work absenteeism and sick leave
    Description
    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
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tommy Hansson, MD, PhD
    Organizational Affiliation
    Department of Orthopedics, Sahlgrenska Academy at the University of Gothenburg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26322232
    Citation
    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.
    Results Reference
    derived

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

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