TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pai

Not Applicable

Recruiting

• Conditions: ow back pain recurrence; Low back pain recurrence; Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12615000939594
• Lead Sponsor: The George Institute for Global Health, Sydney Medical School, The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1482

Inclusion Criteria

Recovered from a previous episode of non-specific LBP within the last 3 months. Non-specific low back pain is defined as pain in the area of the back between the 12th rib and buttock crease not attributable to a specific diagnosis such as sciatica, or a serious spinal pathology such as ankylosing spondylitis, vertebral fracture, spinal tumour etc. The date of recovery is defined as the 7th consecutive day with pain no greater than 1 on a 0-10 pain scale.

Exclusion Criteria

-Previous spinal surgery.
-Any co-existing medical condition that would restrict or prevent safe participation in the exercise program using the Physical Activity Readiness Questionnaire Plus (PARQ+) as a guide.
-Inadequate English to complete outcome measures.
-Currently participating in an exercise program similar to the one to be evaluated in the current trial.
-Unable to collect valid data for all baseline measures.
-Currently pregnant
-Less than 18 years of age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days from randomisation to first self-reported recurrence of an episode of low back pain (defined as back pain lasting at least 24hrs with a pain intensity of 3 or more on a 0-10 numeric pain rating scale).[Collected fortnightly for a minimum of 1 year from randomisation up until completion of the study];Cost-effectiveness analysis using the cost of the intervention and cost of a recurrence (Secondary Outcome 4) to generate cost and Primary Outcome 1 as the measure of effectiveness.[Analysis conducted on completion of all data collection]