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

About this trial
This is an interventional treatment trial for Acute Low Back Pain
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
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
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
Learn more about this trial
Acute Low Back Pain: Causes, Mechanisms, Treatment and Followup
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