A randomised controlled study of reflexology for the management of chronic low back pain

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.

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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

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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

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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

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Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials

BMJ ◽

10.1136/bmj.l689 ◽

2019 ◽

pp. l689 ◽

Cited By ~ 29

Author(s):

Sidney M Rubinstein ◽

Annemarie de Zoete ◽

Marienke van Middelkoop ◽

Willem J J Assendelft ◽

Michiel R de Boer ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Adverse Events ◽

Confidence Interval ◽

Chronic Low Back Pain ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Low Back ◽

Short Term ◽

Randomised Controlled

Abstract Objective To assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Medline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews. Eligibility criteria for selecting studies Randomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting. Review methods Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months. Quality of evidence was assessed using GRADE. A random effects model was used and statistical heterogeneity explored. Results 47 randomised controlled trials including a total of 9211 participants were identified, who were on average middle aged (35-60 years). Most trials compared SMT with recommended therapies. Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief (mean difference −3.17, 95% confidence interval −7.85 to 1.51) and a small, clinically better improvement in function (SMD −0.25, 95% confidence interval −0.41 to −0.09). High quality evidence suggested that compared with non-recommended therapies SMT results in small, not clinically better effects for short term pain relief (mean difference −7.48, −11.50 to −3.47) and small to moderate clinically better improvement in function (SMD −0.41, −0.67 to −0.15). In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy. Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Statistical heterogeneity could not be explained. About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event (relative risk 1.24, 95% confidence interval 0.85 to 1.81) or duration of the event (1.13, 0.59 to 2.18) compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT. Conclusion SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

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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.

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