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

Labour Triggered Acute Low Back Pain: Origin, Mechanisms, Causes of Pain, Evaluation of 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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Acute Low Back Pain
• Intervention / Treatment: Behavioral: Physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Tommy Hansson, MD, PhD, Department of Orthopedics, Sahlgrenska Academy at the University of Gothenburg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Estimate): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: XC90-ALBP