The effectiveness of vitamin D3 supplementation in improving functional outcome of non-surgically treated symptomatic lumbar spinal stenosis: Randomized controlled clinical trial - Pilot study.

BACKGROUND: Although vitamin D is one of the essential nutrients associated with musculoskeletal system function, there is no standard treatment method for vitamin D deficiency. This study aimed to investigate the effects of vitamin D supplementation on the improvement in symptoms, functional recovery of the spine, and changes in the quality of life in patients with spinal stenosis. METHODS: In this prospective study, patients with spinal stenosis and serum 25-hydroxy vitamin D levels < 10 ng/mL were randomly assigned to a supplementation group (Group S) and a non-supplementation group (Group NS): 26 participants in Group S (16 females and 10 males) and 25 in Group NS (15 females and 10 males). The degree of lower back pain in both groups was assessed using the visual analog scale; spine function was assessed using the Oswestry disability index and Roland-Morris disability questionnaire; and patient quality of life was assessed using the 36-item short form health survey. We compared and analyzed the values that were measured at baseline, between 4 and 6 weeks (V1), 10 and 12 weeks (V2), and 22 and 26 weeks (V3). RESULTS: No statistically significant difference was observed in lower back pain, spine function, or quality of life between both groups at baseline. In terms of lower back pain in V1, Group S scored 4.15 ±â€…3.12, while Group NS scored 5.64 ±â€…1.85 (P = .045). In V2, Group S scored 3.15 ±â€…2.38, while Group NS scored 4.52 ±â€…1.87 (P = .027). Moreover, in V3, Group S scored 3.58 ±â€…1.65, while Group NS scored 4.60 ±â€…1.68 (P = .033), indicating a statistically significant improvement in each period. CONCLUSION: If a vitamin D deficiency that does not require surgical treatment exists in patients with lumbar spinal stenosis, high-dose vitamin D injections can improve lower back pain, which is the main symptom of lumbar spinal stenosis, as well as the functional outcomes of the spine and quality of life.

Add-on Effect and Safety of Pharmacopuncture Therapy in the Treatment of Patients with Lumbar Spinal Stenosis.

Background: Recently, Korean Medicine treatment with pharmacopuncture therapy (PPT) has been increasingly used in clinical practice to improve symptoms in patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effectiveness and safety of PPT in addition to conventional Korean Medicine treatment (CKMT) for the treatment of patients with LSS, compared with CKMT alone. Methods: This study is designed as a pragmatic, randomized, two-armed, parallel, stratified (by sex), controlled pilot trial. Forty patients diagnosed with LSS will be randomly allocated to the PPT + CKMT group or the CKMT group. Patients in the two groups will receive treatment two times weekly for 5 weeks. The primary outcome will be the mean change in the 100-mm visual analog scale score from the baseline to the end of treatment (week 5). The secondary outcomes will include the clinically important difference, Zurich Claudication Questionnaire score, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and Patients' Global Impression of Change. Adverse events will be assessed at each visit. Discussion: The results of this study will provide meaningful data to evaluate the add-on effect and safety of PPT in the medical care of patients with LSS.

A comparison between effectiveness of gluteal trigger point and epidural steroid injection in lumbosacral canal stenosis patients: a randomized clinical trial.

BACKGROUND: Lumbosacral Spinal Stenosis (LSS) is a degenerative spine disease and a major cause of pain and disability, especially in geriatrics. Primary symptom control in patients with LSS includes conservative treatment and non-surgical methods. In this study, we aimed to compare the effect of steroid injection via epidural and gluteal trigger point techniques. METHODS: Patients aged 40-75 years old who had pain and other clinical signs of spinal stenosis in the last 6 months were included in our study and divided into two groups of gluteal trigger point (TP) or epidural steroid injection (ESI). The patients were evaluated based on the visual analog scale (VAS), Roland-Morris Disability Questionnaire (RDQ), Oswestry Disability Index (ODI), and the Quebec back pain disability scales during their pre-injection period and 2 weeks after follow-ups till 8 weeks. A P value of less than 0.05 was considered significant. RESULTS: A total of 44 patients were included in our study. The TP group had a significant decrease in comparison with their follow-ups; however, in the epidural group, the significant decrease was only observed compared to the pre-injection period and the scores did not have any significant decreases after the second week regarding the ODI, RQM, and VAS scales. The TP group demonstrated significantly higher scores of decreases of ODI and Quebec score compared to the epidural group at weeks 4 and 8. Regarding RQM, the TP groups demonstrated significantly higher scores of decreases compared to the epidural group at weeks 2, 4 and 8. (p < 0.001 p = 0.008, and p < 0.001, respectively). CONCLUSION: Both epidural and TP steroid injection significantly reduced the patients' pain and improved their QoL and function; however, more satisfactory results were observed in the TP group during the patients' follow-ups, while the epidural group demonstrated only statistically significant improvement during the short-term follow-up.

Artificial Intelligence Algorithm-Based Lumbar and Spinal MRI for Evaluation of Efficacy of Chinkuei Shin Chewan Decoction on Lumbar Spinal Stenosis.

The study aimed to explore the application value of lumbar Magnetic Resonance Imaging (MRI) images processed by artificial intelligence algorithms in evaluating the efficacy of chinkuei shin chewan decoction (a traditional Chinese medicine to nourish the kidney) in the treatment of lumbar spinal stenosis (LSS). Specifically, 110 LSS patients admitted to the hospital were selected as the research subjects. They were randomly divided into the control group (n = 55) and experimental group (n = 55) according to different treatment methods. The control group was treated with traditional medicine, and the experimental group additionally took chinkuei shin chewan decoction on its basis. Based on the traditional U-net algorithm, a U-net registration algorithm based on artificial intelligence was designed by introducing the information entropy theory, and the algorithm was applied to the lumbar MRI image evaluation of LSS patients. Compared with the traditional U-net algorithm, the artificial intelligence-based U-net registration algorithm had a decreased noise level (P < 0.05), the Jaccard (J) value (0.84) and the Dice value (0.93) increased significantly versus the traditional algorithm (J = 0.63, Dice = 0.81), and the characteristics of the image were more accurate. Before treatment, the Oswestry Disability Index (ODI) scores of the experimental group and the control group were 44.32 ± 6.45 and 43.32 ± 5.45, respectively. After treatment, the ODI scores of the two groups were 10.21 ± 5.05 and 17.09 ± 5.23, respectively. Both showed significant improvement, while the improvement of the experimental group was more obvious than that of the control group (P < 0.05). The overall effective rates of the two groups of patients were 96.44% and 82.47%, respectively, and the experimental group was significantly higher than the control group (P < 0.05). Under the U-net registration algorithm based on artificial intelligence, the diagnostic accuracy of lumbar MRI in the experimental group was 94.45%, significantly higher than 67.5% before the introduction of the algorithm (P < 0.05). In conclusion, chinkuei shin chewan decoction are effective for the treatment of LSS, and lumbar MRI based on the artificial intelligence U-net registration algorithm can evaluate the efficacy of LSS well and is worthy of promotion.

Single dose epidural methylprednisolone as a treatment and predictor of outcome following subsequent decompressive surgery in degenerative lumbosacral stenosis with foraminal stenosis.

Alternative treatments to surgery in canine degenerative lumbosacral stenosis (DLSS) remain limited and reliable predictors of outcome are lacking. The aims of this clinical trial were threefold: to assess the usefulness of single epidural steroid injection (ESI) in DLSS, to compare the outcomes of ESI and decompressive surgery, and evaluate ESI as a predictor of outcome following decompressive surgery. Dogs diagnosed with DLSS were prospectively recruited and administered an ESI. If clinical signs persisted or relapsed, decompressive surgery was recommended. Follow-up was obtained. Thirty-two dogs underwent ESI with 17 having subsequent surgery. Improvement after ESI was seen in 27/32 dogs (84.4%), with 17/22 (77.2%) relapsing within 6 months (n = 15/17 relapsing within 2 months). Five dogs failed to respond to ESI and another five (15.6%) presented a persistent post-ESI favourable response (mean follow-up time, 9.4 months). Post-surgical improvement occurred in all dogs. Outcome appeared more favourable following surgical decompression, with a trend towards reduced pain, increased mobility, and greater quality of life score. This study was unable to demonstrate that ESI could predict surgical outcome. ESI was confirmed as an effective treatment in most but not all cases, leading to transient alleviation of clinical signs for longer than previously reported. ESI provided a complete and apparently long-term sustained resolution of clinical signs in a subset of dogs. Despite this, there was indication that surgical decompression can lead to a more favourable outcome. Epidural steroid injection has a role in the management of DLSS dogs, particularly when surgery is not an option.

Survey of integrative lumbar spinal stenosis treatment in Korean medicine doctors: preliminary data for clinical practice guidelines.

BACKGROUND: Considering that large variations exist amongst practitioners in lumbar disorder management and the significant costs that lumbar disorders incur, determining clinical practice patterns to provide preliminary data for standardization should be given higher priority. Lumbar spinal stenosis (LSS) is commonly treated using integrative non-surgical methods by Korean medicine doctors (KMDs) in Korea, and this is the first study to assess current Korean medicine practice trends for LSS. METHODS: A survey on KMD diagnosis, treatment, prognosis and decision-making in LSS treatment was developed in a 3-step procedure of preliminary drafting, revision based on extramural expert opinion, and final editing. The survey was conducted at the internal conference of a spine-specialty Korean medicine hospital on January 25th, 2015. RESULTS: The response rate was high at 79.19% (n = 118/149). Participants replied that they treated 7.3 ± 6.8 LSS patients/day using a multimodal treatment method consisting of acupuncture, pharmacopuncture, herbal medicine, Chuna manipulation, and electroacupuncture. Acupuncture mainly used Ashi points and MSAT, and pharmacopuncture mainly Shinbaro solution. The most frequently prescribed herbal medicine was Chungpa-jun, and the most commonly applied Chuna techniques were sidelying lumbar extension dysfunction correction technique, and prone lumbosacral joint distraction method. Radiological findings were mainly referred to for diagnosis, and clinical symptoms, age, radiological findings, and medical history were regarded to be important for prognosis. Participants replied that 7.8 ± 3.3 weeks were required for 50% reduction in pain, and 16.1 ± 7.7 weeks for 80% reduction. CONCLUSIONS: These results suggest that KMDs in Korea combine a conventional approach to LSS and a Korean medicine approach to low back pain for integration of empirical- and evidence-based diagnosis and treatment. The findings may contribute in bridging the divide between evidence and clinical practice guidelines for Korean medicine treatment of LSS and real-world clinical practice in future research.

[Panlongqi tablet (Chinese characters) combined with lumbar facet joint release for the treatment of lumbar spinal stenosis of Fengshi Bizu (Chinese characters)].

OBJECTIVE: To investigate the clinical efficacy of Panlongqi tablet (Chinese characters) combined with lumbar facet joint release for lumbar spinal stenosis of type Fengshi Bizu (Chinese characters). METHODS: Since February 2012 to February 2013, 120 patients with lumbar spinal stenosis of Fengshi Bizu (Chinese characters) syndrome were retrospectively studied. According to different treatment methods, 120 patients with lumbar spinal stenosis were divided into Panlongqi tablet (Chinese characters)group and control groups, respectively. In Panlongqi tablet (Chinese characters)group, 60 patients were treated by Panlongqi tablet (Chinese characters) combined with lumbar facet joints release solution including 26 males and 34 females with an average age of (60.40±3.36) years old ranging from 46 to 65 ; the course of the disease was 2 to 15 years (averaged 7.6 years). In control group the other 60 patients were treated with lumbar facet joint release including 24 males and 36 females with an average age of (61.20±2.47) years old ranging from 48 to 63; the course was 3 to 14 years (averaged 6.9 years). The clinical effect of patients were evaluated by JOA and ODI score before treatment, at 4 weeks and 3 months after treatment. RESULTS: All patients were followed up for 4 to 7 months (means 5.6 months). After 3 months,7 cases in control group recurrenced symptoms,only 1 case in Panlongqi tablet (Chinese characters) group recurrenced. At 4 weeks and 3 months of follow-up, ODI score and JOA score of Panlongqi tablet group were much better than those of the control group. CONCLUSION: For lumbar spinal stenosis of type Fengshi Bizu (Chinese characters),which were treated with lumbar facet joint release with Panlongqi tablet(Chinese characters), supplemented by back muscle exercise, in relieving waist and low back pain symptoms and improving functional status of lower lumbar spine, can obtain satisfactory clinical outcome, is a good method of conservative treatment for such diseases.

[Lumbar spinal stenosis: clinical course, pathophysiology and treatment]. / Canal lombaire étroit: clinique, physiopathologie et traitement.

The lumbar spinal stenosis is a radiological description of a pathology that can present clinically by a neurogenic intermittent claudication; its diagnosis is mainly clinical. After listing the main criteria allowing the clinician to make a diagnosis, a review of available treatments is proposed. There are few quality studies and an empirical approach is often necessary. In severe cases, very disabling despite correct treatment, a surgical approach may be considered and discussed with the patient to avoid failure, sometimes linked to excessive expectations.

Dual pathology as a result of spinal stenosis and vitamin B12 deficiency.

Vitamin B12 deficiency can confound the clinical assessment of patients presenting with features of spinal disorders. Speciality practice within spinal surgery may lead the clinician to a focus upon spinal explanations for symptoms and that belief may be reinforced by supporting imaging. In the presence of mainly sensory symptoms consideration and exclusion of non surgical causes needs to occur. This study aimed at identifying the prevalence of vitamin B12 deficiency; the presence of dual pathology on imaging performed; the implementation of replacement therapy and their subsequent clinical response as perceived by patients. This was performed through a retrospective review of patients presenting to specialist spine out-patient clinics over a 4-year period via access to pathology reports followed by a telephone survey. 457 patients were investigated of which 8.5% were vitamin B12 deficient. 70% of patients had repeat levels and 31% continued to be deficient. 26% of these patients were not placed on any supplemental therapy. 72% of patients on treatment had self perceived improved outcomes as compared with 55% not on treatment. 73% of patients underwent MRI/CT imaging. 59% of which had evidence of spinal stenosis. In older patients with sensory symptoms, the coexistence of B12 deficiency should be considered. Detection of deficiency with consequent treatment results in better global outcomes than no treatment. Unless the correct blood test is done, the pathology will remain undetected, and patients may continue with their primary symptoms despite high-risk spinal surgical procedures.

[Pain-relieving effect of cantharidin blister on lumbar spinal stenosis]. / Schmerzlindernde Wirkung von Cantharidenpflaster bei lumbaler Spinalkanalstenose.

OBJECTIVE: Lumbar spinal stenosis (LSS) is a common cause of chronic lumbar pain and disability. Conventional therapy approaches include analgesics and spinal surgery. Topical cantharidin applications are used for the treatment of severe chronic lumbar pain in traditional European medicine (TEM). We tested the pain-relieving effect of lumbar cantharidin blisters in a non-randomised controlled pilot study. PATIENTS AND METHODS: 28 consecutive patients with manifest LSS were included. The first 20 patients received a cantharidin blister, 8 patients served as controls (waiting list). Pain was assessed by means of a numeric visual analogue scale (VAS; 0 indicating no pain, 10 indicating strongest pain). Treatment started after a 3-day run-in phase, the blister was applied once for 12 h. RESULTS: Patients were comparable with respect to baseline pain. In the blister group, the pain score continuously improved from 7.2 +/- 2.1 at baseline to 2.9 +/- 2.3 (VAS) at day 7, whereas the score remained unchanged in control patients. Adjusted for baseline, the difference between the blister and the control group was estimated at 4.1 (95% CI: 2.4-5.9, p < 0.0001). The use of analgesics was slightly higher in the control group. No serious adverse events were observed. CONCLUSION: In this first study on the efficacy of cantharidin blisters, a clinically relevant pain-relieving short-term effect on LSS was observed. As the trial was non-randomised and only included a limited number of patients, the results should be interpreted with caution.

Ne-Osteo bone growth factor for posterolateral lumbar spine fusion: results from a nonhuman primate study and a prospective human clinical pilot study.

STUDY DESIGN: Prospective animal and human clinical pilot trial. OBJECTIVES: The purpose of this study was to determine and test the dose of Ne-Osteo growth factor extract and carrier required for consistent radiographic bone induction in humans. SUMMARY OF BACKGROUND DATA: Preclinical studies have demonstrated that Ne-Osteo, an extract-containing bone morphogenetic proteins, was successful at generating spine fusion in rabbits and rhesus monkeys. Consistent fusions have yet to be achieved in nonhuman primates and humans. METHODS: Adult rhesus monkeys underwent single-level posterolateral intertransverse lumbar arthrodesis with either 3.0 mg (N = 4), 5.0 mg (N = 4), 12.5 mg (N = 4), or 25 mg (N = 4) of Ne-Osteo per side. Animals were killed after 24 weeks. In the human clinical trial, 22 patients (18 females, 4 males) had lumbar spinal stenosis and/or spondylolisthesis requiring spine arthrodesis. To minimize patient risk of nonunion, patients received autogenous bone graft from the posterior iliac crest on one side and Ne-Osteo growth factor on the other. The dose was 12.5 mg, 25 or 50 mg, or 25 mg Ne-Osteo per side performed in the three phases, respectively. RESULTS: Three of four monkeys that received 12.5 mg Ne-Osteo per side and four of four that received 25 mg per side achieved solid fusions. In phase I of the human clinical trial, two of six patients showed radiographic bone induction (plain radiograph, CT scans-blindly evaluated) on the Ne-Osteo side (12.5-mg dose). In phase II, both sides were graded as fused in five of six patients. Although graded as fused, the 6-month scans demonstrated a ring of new bone with the center filling in slower (12-24 mo) than was predicted by nonhuman primate studies. As a result, phase III carrier was designed to have a more porous/open early fusion mass than with the dense DBM paste (used in phase I and II) by mixing in local bone or cancellous allograft chips. Results using the 25- and 50-mg doses were the same, so 25 mg was used in phase III. In phase III, 9 of 10 autograft were fused by 12 months. Five of five patients with Ne-Osteo plus local bone and four of five with allograft chips were fused by 6 months. The one patient in this group that did not heal on either the autograft or the Ne-Osteo side was a smoker. CONCLUSIONS: A graft composite of Ne-Osteo bone growth factor with human DBM with or without cancellous allograft or local bone autograft was capable of achieving a contiguous spine fusion mass in 15 of 16 patients at a dose of at least 25 mg per side. This result was comparable with the results using iliac crest autograft (94%) in this side-by-side model. These results warrant confirmation in a definitive trial using Ne-Osteo on both sides of the spine and thus avoiding the need for iliac crest bone graft harvest.