A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale

BMC Musculoskeletal Disorders

Study Protocol

Gerard P Brennan¹  Anne Thackeray²  Julie M Fritz²  John D Childs³ 

[1] Rehabilitation Agency, Intermountain Healthcare, Salt Lake City, Utah, USA;Rehabilitation Agency, Intermountain Healthcare, Salt Lake City, Utah, USA;Department of Physical Therapy, The University of Utah, Salt Lake City, Utah, USA;U.S. Army-Baylor University, Fort Sam Houston, Texas, USA;

关键词: Nerve Root;    Physical Therapist;    Mechanical Traction;    Lumbar Intervertebral Disk;    Lumbar Nerve Root;   

DOI  :  10.1186/1471-2474-11-81

 received in 2009-12-10, accepted in 2010-04-30,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPatients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery. A period of non-surgical management is recommended for most patients, but there is little evidence to guide non-surgical decision-making. We conducted a preliminary study examining the effectiveness of a treatment protocol of mechanical traction with extension-oriented activities for patients with low back pain and signs of nerve root irritation. The results suggested this approach may be effective, particularly in a more specific sub-group of patients. The aim of this study will be to examine the effectiveness of treatment that includes traction for patients with low back pain and signs of nerve root irritation, and within the pre-defined sub-group.Methods/DesignThe study will recruit 120 patients with low back pain and signs of nerve root irritation. Patients will be randomized to receive an extension-oriented treatment approach, with or without the addition of mechanical traction. Randomization will be stratified based on the presence of the pre-defined sub-grouping criteria. All patients will receive 12 physical therapy treatment sessions over 6 weeks. Follow-up assessments will occur after 6 weeks, 6 months, and 1 year. The primary outcome will be disability measured with a modified Oswestry questionnaire. Secondary outcomes will include self-reports of low back and leg pain intensity, quality of life, global rating of improvement, additional healthcare utilization, and work absence. Statistical analysis will be based on intention to treat principles and will use linear mixed model analysis to compare treatment groups, and examine the interaction between treatment and sub-grouping status.DiscussionThis trial will provide a methodologically rigorous evaluation of the effectiveness of using traction for patients with low back pain and signs of nerve root irritation, and will examine the validity of a pre-defined sub-grouping hypothesis. The results will provide evidence to inform non-surgical decision-making for these patients.Trial RegistrationThis trial has been registered with http://ClinicalTrials.gov: NCT00942227

【 授权许可】

CC BY   
© Fritz et al; licensee BioMed Central Ltd. 2010