Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial

Abstract

BackgroundNon-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave® Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients.Methods/DesignPatients- Chronic non-specific low back pain patients between ages of 18–65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders.Study design- Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period.Data collection- Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor.Interventions- H-Wave® device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours).Outcomes- Primary outcome measure: Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed.DiscussionStudy strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

Psychosocial Factors Related to Lateral and Medial Epicondylitis

“…(18) The remaining questions (questions 3, 4, 5, and 7) were developed by the research teams for these studies. The questions created for these studies have been used in other studies,(19-21) however they have not been validated. These psychosocial measures comprised: 1) general health compared to others, 2) depressive symptoms, 3) physical exhaustion after work, 4) mental exhaustion after work, 5) how well participants get along with coworkers, 6) job satisfaction, 7) how well participants get along with their closest or immediate supervisor, 8) degree to which participants would recommend their job to others, 9) if participants would take the job again, and 10) degree to which participants feel that their employer cares about their health and safety on the job.…”

Effects of transcutaneous electrical nerve stimulation on pain in patients with spinal cord injury: a randomized controlled trial

“…TENS is a simple and non-invasive analgesic treatment, which is extensively used by physiotherapists 12 ) . TENS is mainly used to relieve acute and non-malignant chronic pain.…”

Low Back Pain; Effectiveness of Tens With or Without Standard Physiotherapy Treatment

“…As an estimate report of low back pain to the physician or emergency departments are estimated 61 million visits in 2007 that is hugely increased up from 15 million in 1990. 5 This figures shows that there is a huge number of back pain from 90's till the present. The one of the reason of this could be adapting a more mechanical dependant or sedentary life style and reduction in physical activity that was being carried out in the era of 90's.…”

“…4 TENS is one of the most frequent causes for medical visits to physicians and emergency department with estimation of about 61 million visits alone in 2007, ranging highly increased in number from 15 million in 1990. 5 In TENS the two procedures commonly used are prolonged stimulation at low intensities through an active electrode over the painful area and stimulation at higher but not painful intensities over the painful area for short time. 6 TENS has been used to alleviate the post-operative pain and numerous forms of chronic pain with reportedly good results.…”