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

NCT ID: NCT02517762

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-12-31

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.

Conditions

Acute Low Back Pain; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stay active

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

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

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

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Interventions

Physical activity

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tommy Hansson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, Sahlgrenska Academy at the University of Gothenburg

References

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.

Reference Type: DERIVED

PMID: 26322232 (View on PubMed)

Other Identifiers

XC90-ALBP

Identifier Type: -

Identifier Source: org_study_id