Integrating Epidemiological Information into MRI Reports Reduces Ensuing Radiologic Testing Costs Among Patients with Low Back Pain: A Controlled Study

The utilization of pedicle screw fixation as an adjunct to posterolateral lumbar fusion (PLF) has become routine, but demonstration of a definitive benefit remains problematic. The medical evidence indicates that the addition of pedicle screw fixation to PLF increases fusion rates when assessed with dynamic radiographs. More recent evidence, since publication of the 2005 Lumbar Fusion Guidelines, suggests a stronger association between radiographic fusion and clinical outcome, although, even now, no clear correlation has been demonstrated. Although several reports suggest that clinical outcomes are improved with the addition of pedicle screw fixation, there are conflicting findings from similarly classified evidence. Furthermore, the largest contemporary, randomized, controlled study on this topic failed to demonstrate a significant clinical benefit with the use of pedicle screw fixation in patients undergoing PLF for chronic low-back pain. This absence of proof should not, however, be interpreted as proof of absence. Several limitations continue to compromise these investigations. For example, in the majority of studies the sample size is insufficient to detect small increments in clinical outcome that may be observed with pedicle screw fixation. Therefore, no definitive statement regarding the efficacy of pedicle screw fixation as a means to improve functional outcomes in patients undergoing PLF for chronic low-back pain can be made. There appears to be consistent evidence suggesting that pedicle screw fixation increases the costs and complication rate of PLF. High-risk patients, including (but not limited to) patients who smoke, patients who are undergoing revision surgery, or patients who suffer from medical conditions that may compromise fusion potential, may appreciate a greater benefit with supplemental pedicle screw fixation. It is recommended, therefore, that the use of pedicle screw fixation as a supplement to PLF be reserved for those patients in whom there is an increased risk of nonunion when treated with only PLF.

Download Full-text

A Prospective Randomized Controlled Study of Auricular Point Acupressure to Manage Chronic Low Back Pain in Older Adults: Study Protocol

10.21203/rs.2.15609/v2 ◽

2019 ◽

Author(s):

Chao Hsing Yeh ◽

Cuicui Li ◽

Ronald Glick ◽

Elizabeth A. Schlenk ◽

Kathryn Albers ◽

...

Keyword(s):

Older Adults ◽

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Comparison Group ◽

Controlled Study ◽

Low Back ◽

Randomized Controlled ◽

Auricular Point

Abstract Background: Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those 60 years of age or older in the US. Despite the development of pharmacological and nonpharmacological interventions, cLBP outcomes have not improved and disability rates continue to rise. This study aims to test auricular point acupressure (APA) as a non-invasive, nonpharmacological self-management strategy to manage cLBP and to address current shortcomings of cLBP treatment. Methods: For this prospective randomized controlled study, participants will be randomly assigned into three groups: (1) APA (active points related to cLBP), (2) Comparison Group -1 (non-active points, unrelated to cLBP), (3) Comparison Group-2 (enhanced educational control, an educational booklet on cLBP will be given and the treatment used by participants for their cLBP will be recorded). The ecological momentary assessment smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. This proposed trial will evaluate the APA sustained effects for cLBP at 12-month follow-up. Monthly phone follow-up will be used to collect study outcomes. Blood will be collected during study visits at baseline, post-APA treatment, and follow-up study visits at 1-, 3-, 6-, 9- and 12-months post-completion of treatment for a total of 7 assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels. Discussion: This study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of APA on cLBP necessary for APA to gain acceptance from both healthcare providers and patients, which would provide a strong impetus for including APA as part of cLBP management in clinical and home settings. Trial registration: NCT03589703, Registered on May 22, 2018 Keywords: Chronic low back pain, auricular point acupressure, older adults, cytokines

Download Full-text

Changes in pain intensity and health related quality of life with Iyengar yoga in nonspecific chronic low back pain: A randomized controlled study

International Journal of Yoga ◽

10.4103/0973-6131.123481 ◽

2014 ◽

Vol 7 (1) ◽

pp. 48 ◽

Cited By ~ 22

Author(s):

GopalS Nambi ◽

Shanmugananth ◽

Surbala Devi ◽

Dipika Inbasekaran ◽

K Jagannathan ◽

...

Keyword(s):

Quality Of Life ◽

Low Back Pain ◽

Back Pain ◽

Controlled Study ◽

Low Back ◽

Health Related Quality ◽

Randomized Controlled ◽

Related Quality ◽

Health Related

Download Full-text

A Prospective Randomized Controlled Study of Auricular Point Acupressure to Manage Chronic Low Back Pain in Older Adults: Study Protocol

10.21203/rs.2.15609/v1 ◽

2019 ◽

Author(s):

Chao Hsing Yeh ◽

Cuicui Li ◽

Ronald Glick ◽

Elizabeth A. Schlenk ◽

Kathryn Albers ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Comparison Group ◽

Randomized Controlled Study ◽

Controlled Study ◽

Low Back ◽

Randomized Controlled ◽

Auricular Point

Abstract Background: Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those 60 years of age or older in the US. Despite the development of pharmacological and nonpharmacological interventions, cLBP outcomes have not improved and disability rates continue to rise. This study aims to test auricular point acupressure (APA) as a non-invasive, nonpharmacological self-management strategy to manage cLBP and to address current shortcomings of cLBP treatment. Methods: For this prospective randomized controlled study, participants will be randomly assigned into three groups: (1) APA (active points related to cLBP), (2) Comparison Group -1 (non-active points, unrelated to cLBP), (3) Comparison Group-2 (enhanced educational control, an educational booklet on cLBP will be given and the treatment used by participants for their cLBP will be recorded). The ecological momentary assessment smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. This proposed trial will evaluate the APA sustained effects for cLBP at 12-month follow-up. Monthly phone follow-up will be used to collect study outcomes. Blood will be collected during study visits at baseline, post-APA treatment, and follow-up study visits at 1-, 3-, 6-, 9- and 12-months post-completion of treatment for a total of 7 assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels. Discussion: This study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of APA on cLBP necessary for APA to gain acceptance from both healthcare providers and patients, which would provide a strong impetus for including APA as part of cLBP management in clinical and home settings. Trial registration: NCT03589703, Registered on May 22, 2018

Download Full-text

11:2287. A double blind placebo controlled study evaluating the effect of a metalloproteinase inhibitor in chronic low back pain secondary to degenerative disc disease

The Spine Journal ◽

10.1016/j.spinee.2005.05.089 ◽

2005 ◽

Vol 5 (4) ◽

pp. S46

Author(s):

Anthony Guarino ◽

Martha Cornell

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Degenerative Disc Disease ◽

Controlled Study ◽

Low Back ◽

Disc Disease ◽

Double Blind ◽

Double Blind Placebo ◽

Metalloproteinase Inhibitor

Download Full-text

Effect of a 12-week workplace interview intervention on physical activity and low back pain: a single-center, randomized controlled study

10.21203/rs.2.20881/v1 ◽

2020 ◽

Author(s):

Kazuhiro Shimo ◽

Mami Hasegawa ◽

Seiko Mizutani ◽

Tomomi Hasegawa ◽

Takahiro Ushida

Keyword(s):

Physical Activity ◽

Low Back Pain ◽

Back Pain ◽

Physical Therapist ◽

Intervention Group ◽

Office Workers ◽

Controlled Study ◽

Control Group ◽

Low Back ◽

Face To Face

Abstract Background Physical activity (PA) is essential in the management and rehabilitation of low back pain (LBP). However, it is not clear if workplace PA interventions can improve LBP. This study aimed to investigate the effects of workplace interview intervention on increasing PA and improving LBP among office workers. Methods We recruited 37 workers of a manufacturing company in Aichi, Japan. Participants were randomly assigned to the intervention group (n=20) or control group (n=17). We affixed waist-worn accelerometers to monitor PA in all participants, and provided face-to-face counseling with a physical therapist or nurse once a week for 12 weeks as workplace PA program to reassurance and encourage participants to keep high levels of PA. PA and LBP severity were assessed at baseline, 3 and 6 months. Results Baseline characteristics were similar in both groups, but PA was significantly higher in the intervention group than in the control group at 3 and 6 months. In the intervention group, was PA significantly increased at 3 and 6 months from baseline and LBP severity improved significantly at 6 months from baseline. We calculated the effect size of the interview intervention, and found that workplace interview intervention had a medium to large effect on PA and LBP severity. Conclusions Our data suggests that workplace PA intervention can increase PA and improve LBP among office workers. Trial registration UMIN-CTR Clinical Trial UMIN000038864 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044321). Registered 12 December 2019, retrospectively registered.

Download Full-text

Enhanced Therapeutic Alliance Modulates Pain Intensity and Muscle Pain Sensitivity in Patients With Chronic Low Back Pain: An Experimental Controlled Study

Physical Therapy ◽

10.2522/ptj.20130118 ◽

2014 ◽

Vol 94 (4) ◽

pp. 477-489 ◽

Cited By ~ 105

Author(s):

Jorge Fuentes ◽

Susan Armijo-Olivo ◽

Martha Funabashi ◽

Maxi Miciak ◽

Bruce Dick ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Physical Therapy ◽

Therapeutic Alliance ◽

Pain Intensity ◽

Muscle Pain ◽

Pain Sensitivity ◽

Controlled Study ◽

Low Back ◽

Mean Differences

Background Physical therapy influences chronic pain by means of the specific ingredient of an intervention as well as contextual factors including the setting and therapeutic alliance (TA) between provider and patient. Objective The purpose of this study was to compare the effect of enhanced versus limited TA on pain intensity and muscle pain sensitivity in patients with chronic low back pain (CLBP) receiving either active or sham interferential current therapy (IFC). Design An experimental controlled study with repeated measures was conducted. Participants were randomly divided into 4 groups: (1) AL (n=30), which included the application of active IFC combined with a limited TA; (2) SL (n=29), which received sham IFC combined with a limited TA; (3) AE (n=29), which received active IFC combined with an enhanced TA; and (4) SE (n=29), which received sham IFC combined with an enhanced TA. Methods One hundred seventeen individuals with CLBP received a single session of active or sham IFC. Measurements included pain intensity as assessed with a numerical rating scale (PI-NRS) and muscle pain sensitivity as assessed via pressure pain threshold (PPT). Results Mean differences on the PI-NRS were 1.83 cm (95% CI=14.3–20.3), 1.03 cm (95% CI=6.6–12.7), 3.13 cm (95% CI=27.2–33.3), and 2.22 cm (95% CI=18.9–25.0) for the AL, SL, AE, and SE groups, respectively. Mean differences on PPTs were 1.2 kg (95% CI=0.7–1.6), 0.3 kg (95% CI=0.2–0.8), 2.0 kg (95% CI=1.6–2.5), and 1.7 kg (95% CI=1.3–2.1), for the AL, SL, AE, and SE groups, respectively. Limitations The study protocol aimed to test the immediate effect of the TA within a clinical laboratory setting. Conclusions The context in which physical therapy interventions are offered has the potential to dramatically improve therapeutic effects. Enhanced TA combined with active IFC appears to lead to clinically meaningful improvements in outcomes when treating patients with CLBP.

Download Full-text

Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-217259 ◽

2020 ◽

pp. annrheumdis-2020-217259

Author(s):

Paula Dakin ◽

Alan J Kivitz ◽

Joseph S Gimbel ◽

Nebojsa Skrepnik ◽

Stephen J DiMartino ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Phase Ii ◽

Chronic Low Back Pain ◽

Randomised Clinical Trial ◽

Controlled Study ◽

Low Back ◽

Efficacy And Safety ◽

Double Blind ◽

And Function

ObjectivesTo study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).MethodsIn this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrolment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.ResultsSignificant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) −0.7 (0.3); both nominal p<0.05), but not 6 mg (–0.3 (0.3); p=0.39). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9 mg intravenous. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA (pOA) over 16 weeks. Treatment-emergent adverse events (AEs) occurred in 274/418 (65.6%) patients in the combined fasinumab groups and 94/140 (67.1%) placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients (3.8%) vs 1 event in 1 patient (0.7%) for placebo); all except one occurred in pOA patients.ConclusionsFasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA. Further study is needed of patients with CLBP with and without pOA to determine optimal benefit–risk.

Download Full-text