Relief Of Low Back Pain Research Articles

Wednesday, September 26, 2018 1:00 PM – 2:00 PM Interventional Pain Management: 30. Two-year outcomes of patients treated with BVN ablation for the relief of chronic low back pain: results of the SMART trial

BACKGROUND CONTEXT Thirty percent of Americans have low back pain (LBP) at any given time, leading to approximately 50 million physician visits in the U.S. annually. For patients with chronic low back pain (CLBP), the etiology can be difficult to diagnose and then treat using either current nonsurgical therapies, with inherent patient adherence challenges, or surgical interventions, with associated long recovery times. Antonacci et al, following anatomic study, proposed that a portion of pain previously ascribed to the disc actually emanates from the vertebral body endplate nociceptors which communicate to the central nervous system (CNS) through the basivertebral nerve (BVN). We report on the two-year outcome data of the treatment arm patients in the SMART trial, which studied RF BVN ablation to treat CLBP. PURPOSE To determine the longer term efficacy of basivertebral nerve ablation, for the treatment of chronic low back pain. STUDY DESIGN/SETTING Prospective, randomized, double-blinded, sham control study that was an FDA approved clinical trial. Fifteen sites in the US and three in Germany participated. PATIENT SAMPLE Skeletally mature patients with chronic (>6 months), isolated low back (lumbar) pain and no neurogenic leg pain, who had not responded to at least six months of nonoperative management (conservative care) were eligible for the SMART study. Recent MRI had to demonstrate either Type 1 or 2 Modic changes at three or less contiguous vertebral bodies. OUTCOME MEASURES ODI, Safety, VAS. METHODS A total of 128 patients, from the per-protocol treatment arm of the SMART trial, a double-blind sham-controlled randomized trial, were followed for up to 24 months. ODI and VAS instruments were used to collect patient reported outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. RESULTS ODI and VAS data were available on 106 and 104 patients at 24 months respectively. The mean baseline ODI in the treatment arm was 42.4, decreasing to 22.6 at 12 months and 18.8 at 24 months. The mean baseline VAS in the treatment arm was 6.73, decreasing to 3.96 at 12 months and 3.13 at 24 months. Using a paired t-test comparing the 12 and 24-month VAS observations, the mean score at 24 months was significantly improved compared to 12 months (3.80 vs. 3.13, p=.004). CONCLUSIONS The SMART trial demonstrates that BVN ablation is statistically and clinically superior to the sham intervention, and that the degree of ODI improvement is approximately one disability category. Longitudinal follow-up of these patients demonstrates that ablation of the BVN for the relief of CLBP is a durable procedure with continuing improvement in patient reported ODI and VAS scores at up to two years. FDA DEVICE/DRUG STATUS Intracept System (Approved for this indication).

Spinal fluid taps provide temporary relief in patients with unexplained widespread pain and fibromyalgia

Chronic unexplained widespread pain (WSP) and fibromyalgia (FM) are generally assumed centralized pain disorders. However, FM shows characteristics of neurological disorder. Moreover, there are similarities between FM, WSP and cerebrospinal pressure dysregulation syndromes such as idiopathic intracranial hypertension and idiopathic normal pressure hydrocephalus. When intracranial pressure increases, drainage of excess CSF through the cranial and the spinal nerves increases. Increased CSF pressure inside the nerves irritates the nerve fibers and consequently causes widespread radicular pain. We hypothesized that the neurological symptoms may be caused by CSP dysregulation and that withdrawal of spinal fluid might relieve the pain in patients suffering from FM and unexplained WSP. Retrospectively, CSP measurements followed by spinal fluid taps in an attempt to relieve the pain were reviewed in 30 patients (12 males and 18 females, mean age 42.0 y + 11.2 y) suffering from debilitating WSP and FM. Within the first week postpuncture, patients were asked to observe to list the most striking changes of their symptoms. The opening pressure ranged from 12 to 32 cm H20 (mean 19.7 + 4.8 cm H20, median 20.0 cm H20). In 21 patients (70%), spinal fluid withdrawal had a favorable effect on the pain from a few hours to 8 weeks. Other improvements were: relief of low back pain, leg pain and/or coccygodynia; disappearance of headache; improved concentration; improved mood; improved sleep; more clear in the head; being able to sit longer without pain; being able to walk better; no more urinary frequency; more easy to empty the bowel and/or the bladder; less pain in the jaw. Exploring the issues on raised CSP may open perspectives for the diagnosis and treatment of unexplained WSP and fibromyalgia. In patients with chronic pain, when performing a lumbar puncture for diagnostic reasons, opening pressure should be measured.

Prospective, Randomized, Sham-Control, Double Blind, Crossover Trial of Subthreshold Spinal Cord Stimulation at Various Kilohertz Frequencies in Subjects Suffering From Failed Back Surgery Syndrome (SCS Frequency Study)

The increasing use of high frequency paresthesia-free spinal cord stimulation has been associated with improved outcomes in the therapy of neuropathic pain. What is unknown is the effect of varying frequency on pain relief and the placebo effect. This is a prospective, randomized, sham-controlled double blind crossover study. Subjects with predominantly axial low back pain undergoing spinal cord stimulation therapy for failed back surgery syndrome were randomized to sham, 1200 Hz, 3030 Hz, and 5882 Hz with a four-phase crossover design over 12 weeks. Twenty-four patients were randomized in the study. The mean low back pain score at baseline was 7.75. The mean low back pain scores on a 10 cm visual analog scale during the randomized crossover phase were 4.83, 4.51, 4.57, and 3.22, for sham, 1200 Hz, 3030 Hz, and 5882 Hz, respectively, with the lowest low back pain score observed in the 5882 Hz frequency group (p = 0.002). Of note, sham stimulation resulted in a reduction of pain by -2.92 cm and was not significantly different from stimulation at 1200 Hz and 3030 Hz. This randomized crossover study demonstrated that 5882 Hz stimulation can produce significant pain relief for axial low back pain compared with lower frequencies and sham stimulation. Sham stimulation produced similar analgesic effects to 1200 Hz and 3030 Hz and this effect may influence future neuromodulation clinical trial designs.

DIAGRAMMATIC ANALYSIS OF SUBARACHNOID CONTRAST SPREAD IN THE CONTRALATERAL OBLIQUE VIEW: A TECHNICAL REPORT

Interlaminar epidural steroid injections are commonly used in clinical practice for the relief of low back pain. Reliable deposition of medication in the epidural space is important in producing significant results. Pathological conditions, including vertebral osteoarthritis, degenerative disc disease, and spinal stenosis, are frequently treated with epidural steroid injections. Associated degenerative features such as ligamentum flavum hypertrophy, facet joint hypertrophy, and osteophyte formation can lead to significant alterations in the anatomy of the epidural space. Epidurograms, prior to steroid injection, aid the physician in identifying the epidural space, as a false loss of resistance can occur. Extradural, subdural, intradural, and subarachnoid contrast spread has been demonstrated in the anteroposterior and lateral views; but, has not previously been demonstrated in the contralateral oblique (CLO) view. This technical report is the first to demonstrate concomitant epidural and subarachnoid spread in the contralateral oblique view after inadvertent low volume subarachnoid injection, as might happen in clinical practice. In this technical report, we demonstrate both epidural and subarachnoid contrast spread in the contralateral oblique view and compare it to the anteroposterior view. In an oblique view, epidural contrast spread is observed to approximate the ventral margin of the superior aspect of the lamina while subarachnoid contrast spread has a distinct demarcation at the ventral laminar margin. In an anteroposterior view, epidural spread is confirmed by spread of the dye along the nerve roots and beyond the margins of the pedicles. The CLO view provides an accurate and consistent visualization of the epidural space; irrespective of the obliquity, epidural contrast is observed to approximate the ventral margin of the superior aspect of the lamina. In the CLO view, if contrast spread does not approximate the lamina, then intrathecal injection must be considered. Key words: Epidural steroid injection, epidurogram, epidural spread, subarachnoid injection, intrathecal spread, fluoroscopy, contralateral oblique view

Effectiveness of injecting lower dose subcutaneous sterile water versus saline to relief labor back pain: Randomized controlled trial.

INTRODUCTIONThe aim of this study was to investigate the effect of a lower dose subcutaneous sterile water injection technique versus subcutaneous saline injection, on the relief of low-back pain for women during childbirth, and to explore the lasting effects of pain relief after administration (followed at 15, 30, 45, 90 and 120 minutes).METHODSA prospective randomized controlled single-blinded study was conducted, with trial registration (NCT02813330). Women received one-time injections (sterile water or saline) and the effectiveness was observed at 15, 30, 45, 90 and 120 minutes after the intervention.RESULTSThe intervention group had statistically significant pain reduction. Assessment of subsequent pain, followed at 30, 45, 90 and 120 minutes, reflected an increasing change with a statistically significant difference. The intervention group had more burning sensations than the control group with a statistically significant difference.CONCLUSIONSThe modified technique of double injections of subcutaneous ‘water/ saline’ resulted in significant relief of low-back pain during childbirth.

Comparison of unilateral pedicle screw fixation and interbody fusion with PEEK cage vs. standalone expandable fusion cage for the treatment of unilateral lumbar disc herniation.

IntroductionThis study was conducted to compare the clinical effects of unilateral pedicle screw fixation and interbody fusion with PEEK cage (UPSFC) and standalone expandable fusion cage (SAEFC) on unilateral lumbar disc herniation.Material and methodsFrom September 2011 to July 2014, a respective investigation was performed on 130 lumbar disc herniation patients treated with SAEFC or UPSFC. The hospital stay, operating time, blood loss, Japanese orthopaedic association scores (JOA), and visual analogue score (VAS) in the two groups were compared using Student’s t-test.ResultsThe average of follow-up time was 25.6 ±6.4 and 25.2 ±5.8 months, respectively. No significant difference in the postoperative hospitalizsation, intraoperative blood loss, operative time, and postoperative fusion rate was detected between the two groups. VAS score in the UPSFC group was significantly lower than in the SAEFC group at 6 and 12 months after operation (p = 0.014, p = 0.004). X-ray images indicated that the subsidence rate was 8.1% (5/62) in the SAEFC group, while no subsidence was detected in UPSFC group 12 month after operation.ConclusionsBoth SAEFC and UPSFC are effective techniques. UPSFC may be a better choice for patients with lumbar disc herniation and unilateral limb symptoms of nerve root in view of the advantages of better low back pain relief and low subsidence rate.

Results of foot reflexotherapy in acute lower back pain of the nursing team: controlled randomized clinical test

ABSTRACT BACKGROUND AND OBJECTIVES: Musculoskeletal disorder is characterized by changes in neuromuscular, tendinous and joint functions that impact the functionality of the affected areas, especially with pain. The intervention with reflexotherapy is a non-invasive alternative and allows instant control of acute occupational low back pain. The objective of this study was to describe the results of foot reflexology in the relief of acute low back pain related to the nursing staff job. METHODS: Double-blind controlled clinical trial. Thirty-six effective participants were randomly assigned to experimental and control group. Reflexotherapy was applied for low back pain in the sample groups in two sessions with a 72-hour interval. Data collection was performed with the visual analog scale to assess pain before and after the interventions, and a questionnaire for low back pain at the beginning and end of the study. The data were analyzed with the following tests: Shapiro Wilk, for sample normality; Chi-square or Fisher’s Exact, for the association ­between categorical variables and t-test. RESULTS: There was statistical significance with the foot reflexology in the relief of acute low back pain, with p=0.000 for the visual analog scale and the data of the questionnaire for low back pain p=0.0002. CONCLUSION: Reflexotherapy showed to be effective in reducing the intensity of acute pain among nursing professionals in this study. The Brazilian Registry of Clinical Trials is RBR-5ndq22.

Ligamentum Flavum Hematoma Presented with Low Back Pain: A Case Report and Review of the Literature.

A 61-year-old woman with no past medical history presented with low back pain and radicular pain in the right lower extremity. Magnetic resonance imaging of the lumbar spine showed a heterogeneous intensity mass in the lateral recess of the spinal canal at the L4-5 disk level. Postoperatively, her radicular pain resolved within a few days with excellent low back pain relief. Ligamentum flavum hematoma is a rare differential diagnosis for cystic lesions in the lumbar spine that can be removed simply by surgery with excellent relief of symptoms and improvement in strength of the right lower extremity and increased sensitivity.

Low back pain due to superior cluneal nerve entrapment: A clinicopathologic study.

We studied the clinical and nerve pathologic features in 6 patients whose low back pain (LBP) was relieved by superior cluneal nerve (SCN) neurectomy to determine whether nerve compression was the mechanism underlying this type of LBP. All 6 patients (7 nerves) underwent SCN neurectomy for intractable LBP. Their clinical outcomes and the pathologic features of 7 nerves were reviewed. All patients reported LBP relief immediately after SCN neurectomy. Pathologic study of the 7 resected nerves showed marked enlargement, decreased myelinated fiber density, an increase in thinly myelinated fibers (n = 2), perineurial thickening (n = 5), subperineurial edema (n = 4), and Renaut bodies (n = 4). At the distal end of 1 enlarged nerve, we observed a moderate reduction in the density and marked reduction in the number of large myelinated fibers. The pathologic findings and effectiveness of neurectomy suggest that, in our patients, SCN neuropathy likely elicited LBP via nerve compression. Muscle Nerve 57: 777-783, 2018.

124Low-Back Pain Relief With a New 32-Contact Surgical Lead and Neural Targeting Algorithm.

124Low-Back Pain Relief With a New 32-Contact Surgical Lead and Neural Targeting Algorithm.

P.087 RETRACTION - Low back pain relief with a new 32-contact surgical lead and neural targeting algorithm

Background: Advances in surgical leads have been thought to potentially enable improved low-back pain relief using SCS. A recently introduced 32-contact surgical lead, which couples multiple independent current control and anatomically-based neural targeting stimulation algorithms, allows for patient-specific programming optimization. We present a real world study of this surgical lead. Methods: A multi-center, consecutive, observational study of a new 32-contact surgical lead was carried out, using the Precision Spectra SCS System (Boston Scientific) in 100 subjects out to 12 months post-implant. We examined procedural information, programming parameters, and clinical outcomes including pain reduction (NRS), activities of daily living, and change in pain medications. Results: Surgical lead placement distribution was between T7 and L2, with most at top of T9 (26%). A mean reduction of 5.1 points (SD 2.15, p<0.001) from 7.8 (baseline) to 2.6 in overall pain was observed. A subset of subjects reporting low-back pain only exhibited a mean decrease of 6.0 points (SD 2.12, p<0.001) from 8.3 (baseline) to 2.2. Of these, 83.1% of subjects showed ≥50% back pain reduction. Increases in activities of daily living and reduction in pain medication usage were also observed in majority of subjects. Conclusions: Subjects implanted with a 32-contact surgical lead using a neural targeting algorithm demonstrated significant low-back pain reduction.

Acupuncture and pregnancy: oriental medicine as an ally in the treatment of low back pain

Objective: to identify scientific evidence in the literature on the effect of acupuncture for the relief of low back pain during pregnancy. Methods: this is an integrative literature review. The bibliographic survey included articles indexed in the portal of six databases, using controlled keywords. Results: seven articles published in English were included. The studies using acupuncture for low back pain have been successful in reducing pain, as well as increased mobility, improved sleep, a sense of well-being, increased capacity for some physical activities and improved emotional reactions of pregnant women. Conclusion: acupuncture contributed to the reduction of low back pain in the pregnant women, among other benefits, contributing to the promotion of health in a pleasurable, simple, practical, risk-free, cheap and cost-effective way.

Counting the Cost of Failed Spinal Fusion for Relief of Low Back Pain: Does Primary Fusion With Bone Morphogenetic Protein Make Economic Sense From a Primary Payer Perspective?

A retrospective cohort study. To investigate the unknown direct costs of failed instrumented lumbar fusion using iliac crest bone graft (ICBG) and subsequent reoperation utilizing recombinant human bone morphogenetic protein-2 (rhBMP-2) from a primary payer perspective. Recent evidence has demonstrated increased rates of instrumented lumbar fusion and utilization of rhBMP-2 to treat a range of conditions causing lower back pain. For health care providers with finite financial resources, there is an increasing demand to evaluate economic costs of available treatment modalities. The high cost of rhBMP-2 has often been cited as a leading reason for delaying its universal acceptance as a preferred substitute to ICBG. It has been hypothesized that rhBMP-2 may demonstrate cost-effectiveness if pseudarthrosis and reoperation rates are decreased, thus avoiding subsequent expenditure. This was a retrospective cohort study of patients who underwent instrumented lumbar fusions utilizing rhBMP-2. Hospital finance records were used to calculate direct total expenditure incurred by the primary payer for the procedure using rhBMP-2. For patients who received rhBMP-2 in a secondary lumbar fusion, additional total expenditure related to the patients' failed primary instrumented fusion with ICBG was also sought. The mean total costs associated with failed instrumented lumbar fusion using ICBG and reoperation using rhBMP-2 totaled £47,734 per patient. The total direct costs of a policy of primary instrumented lumbar fusion with rhBMP-2 were less at £26,923 per patient; however, this was not significant. To date, this is the first study to report the costs of failed primary instrumented lumbar fusions using ICBG and subsequent secondary fusions using rhBMP-2 from a primary payer perspective. On the basis of this evidence, a policy of using rhBMP-2 in all patients undergoing a primary instrumented lumbar fusion cannot be recommended.

The effectiveness of transforaminal epidural steroid injection in patients with radicular low back pain: Combination of pain provocation with effectiveness results.

This study aims to investigate the efficacy of transforaminal epidural steroid injection (TFESI) on low back pain relief and functional impairments and whether pain provocation during injection has an effect on pain relief in mid-term. The study, which was conducted between September 2012 and September 2013, included 62 patients with low back pain (38 males, 24 females; median age 45 years; min 22 - max 88 years). All injections were applied under C-arm fluoroscopy guidance, using a mix of betamethasone and lidocaine. A 100 mm Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), and Short Form-36 were administered before the injection, and at post-injection second and 12th weeks. Presence of any pain provocation was questioned during injection. The most frequent level of intervention was L5 level. Median initial VAS score was 80.0 (50.0;100.0) mm, which was measured as 45.0 (0.0;90.0) mm and 30.0 (0.0;100.0) mm at the post-injection second and 12th weeks, respectively. Median initial ODI score was 25.0 (9.0;43.0) points, which was measured as 17.0 (3.0;38.0) and 12.5 (1.0;38.0) points at the post-injection second and 12th weeks, respectively. All subgroup scores of SF-36 improved significantly during the follow-up period. We detected statistically significant improvements in the outcome measurements at the post-injection second and 12th weeks (p<0.05). There were significant differences between patients with positive and moderate pain provocation in terms of VAS (p=0.004) and ODI (p=0.006) scores. In this follow-up study, transforaminal epidural steroid injection was found to be effective in both the early period and in the mid-term. Pain provocation was not clinically predictive for better outcome according to the results.

Spinopelvic parameter changes and low back pain improvement due to femoral neck anteversion in patients with severe unilateral primary hip osteoarthritis undergoing total hip replacement.

The study of the interrelation between hip and spine disorders is gaining increasing importance in the last years, but the link between Hip Osteoarthritis (HOA) and Low Back Pain (LBP) remains still unclear. Aim of the study is to assess the relationship between Femoral Neck Anteversion (FNA), LBP, and spinopelvic parameters in patients undergoing Total Hip Replacement (THR) for unilateral severe primary HOA. 91 patients were recruited. Inclusion criteria were: grade 5 or 6 unilateral HOA, according to Turmezei, and Harris Hip score (HHS) <60. Exclusion criteria were: secondary hip osteoarthritis (dysplasia of the hip, rheumatoid arthritis, and ankylosing spondylitis); previous surgery of the spine, hip or knee; scoliosis with a Cobb angle greater than 10°; spondylolisthesis; history of spine fractures; previous bone tuberculosis or any spine infections; any contraindications to CT; BMI >30. Patients were divided into two homogeneous Groups according to the presence (Group-A) or not of concomitant LBP (Group-B). All patients underwent preoperatively a hip CT scan to evaluate FNA, Acetabular Anteversion (AA), and Combined Anteversion (CA=FNA+AA). ΔFNA, ΔAA and ΔCA were calculated as the differences between the arthritic hip and the normal hip angles in each Group. Full spinal X-rays in upstanding position were performed before (baseline) and 6months after THR (follow-up) to calculate spinopelvic parameters. The health-related quality of life (HRQoL) was evaluated at baseline and at follow-up using Visual Analogue Scale (VAS), HHS, Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RM), and Short-Form Health Survey (SF-36). The intra-group and inter-group variability were assessed using, respectively, paired and unpaired t tests. At baseline, the association between HRQoL scores and ΔFNA, ΔAA, and ΔCA was analysed by the Pearson correlation test. At baseline, in Group-A, there was a significant difference between arthritic FNA and normal hip FNA, while no differences were found in AA between the two hips. A close correlation was observed between ΔFNA and Spine-VAS (r=0.788), ODI (r=0.824), and RM (r=0.775). In Group-B, there was not a significant difference in FNA and AA between the two hips. At recruitment, in Group-A patients, we recorded a higher LL, SS, PI, SVA(C7), and a lower PT and T1-SPI compared with Group-B subjects. Six months after THR, in Group-A, an improvement of all clinical scores was recorded, as well as, a significant reduction of SS, LL, T1PA, and SVA(C7) and an increment of PT. In Group-B, at follow-up, an improvement of HHS, Hip-VAS, and SF-36 was recorded, while the changes in spinopelvic parameters were not significant. Patients with concomitant unilateral HOA and LBP showed a marked anteverted FNA in the arthritic hip and a spinopelvic misalignment. After THR, a relief of both hip and low back pain and a change in spinopelvic parameters is observed.

Chiropractic management of post spinal cord stimulator spine pain: a case report

BackgroundA brief overview of failed back surgery syndrome, with emphasis on low back pain status post spinal cord stimulation, and post-surgical spinal manipulation is presented.Case PresentationFour cases of patients within the VA Connecticut Health Care System presenting between July 2014 and July 2015 reporting low back pain after surgical insertion of spinal cord stimulators are discussed. This study describes the outcomes experienced by four patients with low back pain status post implanted spinal cord stimulators receiving manual therapy in the form of lumbar spine manipulation or mobilization.ConclusionAll four patients denied adverse effects to spinal manipulation/mobilization and onset of new symptoms after treatment; two patients reported durable reduction in low back pain with increased tolerance to walking, standing, or lying down, one reported temporary relief of low back pain, and one reported no change in symptoms. Further investigation is needed to determine the benefit of spinal manipulation in patients with implanted spinal cord stimulators, but this study has shown the absence of adverse effects from manipulation or mobilization treatment, in regards to SCS.

Spinal Cord Stimulation (SCS) with Anatomically Guided (3D) Neural Targeting Shows Superior Chronic Axial Low Back Pain Relief Compared to Traditional SCS-LUMINA Study.

The aim of this study was to determine whether spinal cord stimulation (SCS) using 3D neural targeting provided sustained overall and low back pain relief in a broad routine clinical practice population. This was a multicenter, open-label observational study with an observational arm and retrospective analysis of a matched cohort. After IPG implantation, programming was done using a patient-specific, model-based algorithm to adjust for lead position (3D neural targeting) or previous generation software (traditional). Demographics, medical histories, SCS parameters, pain locations, pain intensities, disabilities, and safety data were collected for all patients. A total of 213 patients using 3D neural targeting were included, with a trial-to-implant ratio of 86%. Patients used seven different lead configurations, with 62% receiving 24 to 32 contacts, and a broad range of stimulation parameters utilizing a mean of 14.3 (±6.1) contacts. At 24 months postimplant, pain intensity decreased significantly from baseline (ΔNRS = 4.2, N = 169, P < 0.0001) and even more in in the severe pain subgroup (ΔNRS = 5.3, N = 91, P < 0.0001). Axial low back pain also decreased significantly from baseline to 24 months (ΔNRS = 4.1, N = 70, P < 0.0001, on the overall cohort and ΔNRS = 5.6, N = 38, on the severe subgroup). Matched cohort comparison with 213 patients treated with traditional SCS at the same centers showed overall pain responder rates of 51% (traditional SCS) and 74% (neural targeting SCS) and axial low back pain responder rates of 41% and 71% in the traditional SCS and neural targeting SCS cohorts, respectively. Lastly, complications occurred in a total of 33 of the 213 patients, with a 1.6% lead replacement rate and a 1.6% explant rate. Our results suggest that 3D neural targeting SCS and its associated hardware flexibility provide effective treatment for both chronic leg and chronic axial low back pain that is significantly superior to traditional SCS.

Synofit Premium in Refractory Low Back Pain: A Retrospective Observational Study

In this retrospective observational study, information about pain and quality of life was collected for analysis from medical records of 85 patients with chronic low back pain who were treated for 3 months with Synofit? Premium (2 - 3 capsules daily), a liquid mixture of green-lipped mussel from New Zealand, blackcurrant leaf, and curcuma extract. Within the first 6 weeks of therapy, a significant clinical benefit was observed for relief from pain, need for pain-relieving drugs, and the interference of pain with personal care and lifting. This benefit was more pronounced at 3 months. The mixture was well tolerated without significant side effects. Adherence was estimated to be “good” to “very good.” Patients assessed global improvement and efficacy as “sufficient” to “good.” Based on this study, the mode of action of Synofit? Premium appears mainly to be analgesic, as reported by patients, and allows them to reduce the consumption of other pain-relieving substances and improve their quality of life. In conclusion, Synofit? Premium holds potential as a promising candidate alternative therapy for relief of low back pain and likely other painful rheumatic conditions, with almost no or minor side effects.

Goshajinkigan for Low Back Pain: An Observational Study.

Low back pain (LBP) is a chronic condition. Although Western treatments are available, Kampo (traditional Japanese) medicine is widely prescribed and covered by health insurance in Japan. Goshajinkigan (GJG), a Kampo formula, is commonly used to treat LBP. However, cases we have occasionally been encountered in which GJG did not show the expected effects. Hence, the purpose of this retrospective study was to investigate patient factors important in developing the effects of GJG. This was a retrospective observational study based at the Center for Kampo Medicine, Keio University Hospital. Data were retrieved from the medical records of 28 patients who visited our hospital between May 2008 and March 2013 and who received GJG for LBP. The patients were divided into responders and non-responders based on whether their LBP improved post treatment. The groups were compared with respect to daily GJG dose, incidence of spine disease, and side effects. Ten patients (responders) reported an improvement in LBP within 6 months. One patient experienced decreased appetite as a side effect. Nine patients reported no improvement (non-responders). The number of patients prescribed the usual daily dose of GJG (7.5 g) was significantly higher among responders than it was among non-responders (p = 0.023), and the number of patients with spine disease was significantly greater among non-responders than it was among responders (p = 0.020). The number of patients with spinal stenosis was significantly higher among non-responders than it was among responders (p = 0.011). Therefore, the usual daily dose of GJG provided significant relief of LBP, particularly in patients without any spine disease. Routine daily administration of GJG in patients without spine disease seems to lead to the effects of the product. However, further investigations using the above-mentioned parameters are needed to confirm these findings.

Clinical and Radiological Study Focused on Relief of Low Back Pain After Decompression Surgery in Selected Patients With Lumbar Spinal Stenosis Associated With Grade I Degenerative Spondylolisthesis.

A retrospective study. The aim of the present study was to identify the clinical and radiological features of low back pain (LBP) that was relieved after decompression alone of lumbar spinal stenosis (LSS) associated with grade I lumbar degenerative spondylolisthesis (LDS). Although decompression and fusion are generally the recommended surgical treatments of LDS, several authors have reported that some patients with LDS could obtain good clinical results including relief from LBP by decompression alone. The pathogenesis of relief from LBP after decompression is, however, not known. Forty patients with LSS associated with grade I LDS, who underwent a minimally invasive surgical-decompression were enrolled in the present study. All patients complained preoperatively of predominantly leg-related symptoms and LBP (≥ 4 points on Numeric Rating Scale). Clinical and radiological assessments were performed 1 year after surgery (a relief of LBP: Numeric Rating Scale reduction ≥3 points and valuation ≤3 points) and at the last follow-up. We conducted a comparative study between patient groups with and without the relief from LBP (groups R and N, respectively). Twenty-nine patients were distributed to group R and the remaining 11 patients to group N. Preoperatively, there was a significant difference between the two groups for age and radiographic flexibility for lumbar extension. Postoperatively, there was a positive correlation between improvement in both LBP and leg symptoms. The clinical outcomes of group R were significantly better than those of group N throughout follow-up period (mean 37 mo). In group R, sagittal lumbopelvic radiographic parameters improved significantly after surgery. Although the causes of LBP are varied in each patients, our results show that concomitant LSS itself might cause LBP in some patients with grade I LDS, because it involves impingement of the neural tissue and discordant sagittal lumbopelvic alignment. 3.