A New Innovative Home Exercise for Chronic Non-Specific Low Back Pain: A Twelve-Week Clinical Trial

Abstract

Background: Exercise therapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most exercise therapy modalities is weak or lacking. This study aimed to execute a high-quality, clinical trial of a single innovative new home exercise (“Farshad exercise”) to determine the efficacy for treatment of chronic non-specific low back pain patients. Methods: Patients: The cases included chronic non-specific low back pain patients aged between 19 and 64 years, with pain of at least three months in duration. Patients had no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. The study design involved CT with 113 subjects. Samples were stratified by workers compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study was “no statistically significant improvement in function of patients during and at the end of the 12-week treatment period”. Data collection: subjective data were collected using database management collection tools. Objective data were obtained through functional assessments. Data were collected at enrollment (baseline) and on the fourth, eighth, and twelfth week for each participant by a blinded assessor. Intervention: A new home exercise was designed by the author (Farshad exercise). Each patient had identical numbers of visits (4) and researcher contact time (approximately 15 hours). Results: The primary outcome measure was the Oswestry disability index. Secondary measures included visual analog scale (VAS) pain score. Outcome measures were assessed at baseline (0), fourth, eighth, and twelfth week. Treatment failure was defined if the patient terminated treatment for non-efficacy or underwent invasive procedure or other excluded co-interventions. Conclusions: Study strengths included controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing.