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

Physical Activity Clinical Trial

— ALBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517762
• Other study ID #: XC90-ALBP
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: August 10, 2015
• Start date: March 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2015
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Region Västra Götaland
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Low Back Pain
• Back Pain
• Low Back Pain
• Physical Activity

Intervention

Behavioral:
• Physical activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No