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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Physical Activity, Acute Low Back Pain

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stay active<br>Receive the advice by the physician to stay as active as possible in spite of the pain experienced | Behavioral: Physical activity<br> <br> |
| Experimental: Adjust activity<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days |