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1.
A novel (targeted) kinesio taping application on chronic low back pain: Randomized clinical trial.
Peñalver-Barrios, ML, Lisón, JF, Ballester-Salvador, J, Schmitt, J, Ezzedinne-Angulo, A, Arguisuelas, MD, Doménech, J
PloS one. 2021;(5):e0250686
Abstract
The aim of the present clinical trial is to evaluate the efficacy of kinesio taping on patients with chronic low back pain, when the exploration identifies skin/fascia mobilization as a factor that could modify the treatment effect. This study is a randomized controlled trial with intention-to-treat analysis. Sixty-two participants with chronic low back pain were therefore recruited from a tertiary referral hospital. Targeted kinesio taping, according to skin/fascia mobility exploration, was applied in the experimental group (17 female/13 male; 49.47 ± 11.15 years) once a week for four sessions. The control group (17 female/14 male; 48.87 ± 9.09 years) underwent a placebo taping application. At post-treatment time there was a statistically significant reduction both in disability (Roland-Morris Disability Questionnaire) and pain (Numeric Pain Rating Scale) in the experimental group (disability: -2.88, 95% confidence interval [CI] -4.56 to -1.21, P < .001; pain: -1.58, 95% CI -2.67 to -0.54 P = .001) and the control group (disability: -1.82, 95% CI -3.46 to -0.17 P = .025; pain: -1.30, 95% CI -2.32 to -0.28 P = .008). However, at six months, these changes only remained significant in the experimental group (disability: -2.95, 95% CI -4.72 to -1.18, P < .001; pain: -1.06, 95% CI -2.07 to -0.04, P < .05). As a conclusion, the application of targeted kinesio taping produced a significant reduction in pain and disability, at 4 weeks and at 6 moths follow-up, although there were no differences between groups at any measurement time point.
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2.
The effectiveness of intradermal sterile water injection for low back pain in the emergency department: A prospective, randomized controlled study.
Tekin, E, Gur, A, Bayraktar, M, Ozlu, I, Celik, BK
The American journal of emergency medicine. 2021;:103-109
Abstract
AIM: Low back pain (LBP) is a common musculoskeletal complaint among emergency department (ED) admissions. In this study, it was aimed to compare the effectiveness of systemic treatment with intradermal sterile water injection (ISWI) treatment protocol combined with systemic therapy in patients with LBP of unclear chronicity. METHODS A prospective randomized, unblinded, controlled clinical study was conducted on patients admitted to the ED for LBP of unclear chronicity. One hundred twelve patients were randomly assigned to two groups; Group ISWI (n = 56) administered ISWI in the LBP region of patients along with systemic intravenous dexketoprofen therapy, while the other group (n = 56) received only systemic intravenous dexketoprofen therapy. The treatment methods' effectiveness was compared by measuring the pain intensity with the Visual Analog Scale (VAS) at admission, 10th minutes, 20th minutes, 30th minutes, and 24 h later. Also, opioid and analgesic consumptions in 24 h after treatment and patient satisfactions were compared. RESULTS In the treatment of LBP, ISWI treatment was found to be more effective in relieving pain than systemic therapy alone (p < 0.001). Also, it was observed that opioid consumption in the ED and analgesic consumption within 24 h after treatments were decreased in the ISWI group (p < 0.001). The patient satisfaction in the ED was statistically increased (p < 0.001). DISCUSSION In this unblinded study, ISWI with systemic therapy improved pain outcomes more than systemic therapy alone. Further research is needed to determine whether this was due entirely to placebo effect.
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3.
The effect of oral magnesium supplementation on acute non-specific low back pain: Prospective randomized clinical trial.
Bayram, S, Şahin, K, Anarat, FB, Chousein, CM, Kocazeybek, E, Altan, M, Akgül, T
The American journal of emergency medicine. 2021;:125-130
Abstract
OBJECTIVE We aimed to investigate the effect of oral magnesium supplementation for acute low back pain. METHODS This is a three-arm, prospective randomized open label clinical trial, which included two hundred and forty patients. We based our sample size calculation assumptions on a recently published clinical trial, thus we enrolled 80 patients for each group. NSAID alone group included (400 mg etodolac twice a day), NSAID + mg group included NSAID - magnesium combination treatment (400 mg etodolac twice a day with 365 mg oral magnesium supplementation) and NSAID + paracetamol group included NSAID - paracetamol combination treatment (400 mg etodolac twice a day with 500 mg paracetamol twice a day). Follow-up visits after initiation of relevant treatment were performed at 4th and 10th days and outcome measures included pain (Visual analogue scale - VAS), mobility of lumbar spine and functional outcome (RMDQ). RESULTS Thirty-one patients were considered lost to follow-up or excluded due to use of other medications and final analysis was performed with 209 participants in three groups (71 patients in NSAID alone group, 68 patients in NSAID + mg group and 70 patients in NSAID + paracetamol group). NSAID + mg showed a significantly higher improvement in RMDQ and VAS scores at acute stage (at 4th day visit) compared to two other study groups However, there was no significant difference between three groups in terms of mean improvement of RMDQ, VAS scores and lumbar mobility between initial visit and 10-day. CONCLUSION Results of this study suggest that addition of magnesium to acute low-back pain treatment does not significantly improve final clinical outcomes. LEVEL OF EVIDENCE Level I, prospective randomized controlled study.
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4.
TEXT4myBACK: A Text Message Intervention to Improve Function in People With Low Back Pain-Protocol of a Randomized Controlled Trial.
Fritsch, CG, Ferreira, PH, Prior, JL, Clavisi, O, Chow, CK, Redfern, J, Thiagalingam, A, Lung, T, McLachlan, AJ, Ferreira, ML
Physical therapy. 2021;(7)
Abstract
OBJECTIVE The authors sought to describe the protocol of a randomized controlled trial that will investigate the effects of the TEXT4myBACK self-management text message intervention compared with control in people with low back pain (LBP). METHODS A single-blind (assessor and statistician), randomized controlled trial with economic analysis and process evaluation will be conducted. A total of 304 people with non-specific LBP of less than 12 weeks will be enrolled and randomly allocated either to TEXT4myBACK intervention or control groups. The TEXT4myBACK intervention group will receive 4 semi-personalized text messages per week providing advice, motivation, and information about LBP, physical activity, sleep, mood, use of care, and medication during 12 weeks. The control group will receive 1 text message with a link to a LBP and diet online information package. Outcomes will be assessed at baseline and 3, 6, and 12 months. The primary outcome will be function assessed with the Patient-Specific Functional Scale. Secondary outcomes will include pain intensity, physical activity participation, sedentary behavior, global impression of change, health-related quality of life, and eHealth literacy. Data on demographic characteristics, smallest worthwhile change (ie, smallest function scored needed to be achieved at the end of the intervention to consider it to be worthwhile), health care utilization, and adverse events (ie, any new health issue that occurs during participation in the study) will be collected. An economic and process evaluation will also be conducted. IMPACT This study will assess if a self-management text message intervention is effective and cost-effective in improving function of people with LBP. This study can inform clinical practice of a simple, scalable, and affordable intervention for managing LBP.
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5.
Quality of life and functional outcomes with tapentadol prolonged release in chronic musculoskeletal pain: post hoc analysis.
Ferri, CM, Natoli, S, Sanz-Ayan, P, Magni, A, Guerrero, C, Lara-Solares, A, Liedgens, H, Thömmes, G, Karra, R
Pain management. 2021;(2):173-187
Abstract
Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: All SF-36 subdomain scores improved progressively to week 3 of tapentadol titration and were sustained during 12-week maintenance treatment. Improvements in SF-36 scores were similar between tapentadol dose groups (e.g., 200 to <300 mg vs ≥500 mg), with no greater effect from higher doses. QOL and functionality improvements were consistently greater with tapentadol PR than oxycodone controlled release. Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.
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6.
Feasibility and impact of sit-stand workstations with and without exercise in office workers at risk of low back pain: A pilot comparative effectiveness trial.
Johnston, V, Gane, EM, Brown, W, Vicenzino, B, Healy, GN, Gilson, N, Smith, MD
Applied ergonomics. 2019;:82-89
Abstract
The aim of this study was to compare the feasibility and impact of sit-stand workstations plus advice, with or without exercise, on back pain and sitting time in office workers at risk of low back pain (LBP). Eligible participants (n = 29/169; 17% overall) were randomized to receive a sit-stand workstation and advice with (n = 16) or without (n = 13) progressive resistance exercise training for 4-weeks. Feasibility (recruitment, acceptability, adherence) and impact (LBP severity during a standardized standing task, workplace-sitting time) were assessed. Intervention acceptability (87.5% very satisfied) was good and adherence (60% completed all 12 exercise sessions) was satisfactory. Maximum LBP severity (mean difference of -1.3 (-2.0, -0.6) and workplace sitting time (82.7-99.3 min/8-hr workday reduction) were similarly reduced in both groups. The introduction of a sit-stand workstation with advice was feasible and achieved similar outcomes for LBP and workplace sitting time when administered with or without exercise.
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7.
Probiotics for chronic low back pain with type 1 Modic changes: a randomized double-blind, placebo-controlled trial with 1-year follow-up using Lactobacillus Rhamnosis GG.
Jensen, OK, Andersen, MH, Østgård, RD, Andersen, NT, Rolving, N
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2019;(11):2478-2486
Abstract
PURPOSE To investigate whether treatment by lactic acid bacteria for 100 days is associated with change of disability and pain in chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up. METHODS Eighty-nine patients with CLBP and type 1 MC or mixed MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100 days. RESULTS Missing values at 1 year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups. At 1 year, back pain had on average decreased by 1.1 more on a 0-10 scale (95% confidence interval 0.20-1.97) in the group treated by lactic acid bacteria than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at 1 year. Nine per cent of the patients reported gastrointestinal side effects without difference between groups. CONCLUSIONS No differences were found regarding the predefined outcomes. Overall, there was little improvement during the 1-year observation period. A small, though hardly clinically relevant, effect on back pain was seen after treatment by Lactobacillus Rhamnosis GG, and the treatment was without side effects in comparison with the control group.
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8.
Economic evaluation of a healthy lifestyle intervention for chronic low back pain: A randomized controlled trial.
Williams, A, van Dongen, JM, Kamper, SJ, O'Brien, KM, Wolfenden, L, Yoong, SL, Hodder, RK, Lee, H, Robson, EK, Haskins, R, et al
European journal of pain (London, England). 2019;(3):621-634
Abstract
BACKGROUND Economic evaluations which estimate cost-effectiveness of potential treatments can guide decisions about real-world healthcare services. We performed an economic evaluation of a healthy lifestyle intervention targeting weight loss, physical activity and diet for patients with chronic low back pain, who are overweight or obese. METHODS Eligible patients with chronic low back pain (n = 160) were randomized to an intervention or usual care control group. The intervention included brief advice, a clinical consultation and referral to a 6-month telephone-based healthy lifestyle coaching service. The primary outcome was quality-adjusted life years (QALYs). Secondary outcomes were pain intensity, disability, weight and body mass index. Costs included intervention costs, healthcare utilization costs and work absenteeism costs. An economic analysis was performed from the societal perspective. RESULTS Mean total costs were lower in the intervention group than the control group (-$614; 95%CI: -3133 to 255). The intervention group had significantly lower healthcare costs (-$292; 95%CI: -872 to -33), medication costs (-$30; 95%CI: -65 to -4) and absenteeism costs (-$1,000; 95%CI: -3573 to -210). For all outcomes, the intervention was on average less expensive and more effective than usual care, and the probability of the intervention being cost-effective compared to usual care was relatively high (i.e., 0.81) at a willingness-to-pay of $0/unit of effect. However, the probability of cost-effectiveness was not as favourable among sensitivity analyses. CONCLUSIONS The healthy lifestyle intervention seems to be cost-effective from the societal perspective. However, variability in the sensitivity analyses indicates caution is needed when interpreting these findings. SIGNIFICANCE This is an economic evaluation of a randomized controlled trial of a healthy lifestyle intervention for chronic low back pain. The findings suggest that a healthy lifestyle intervention may be cost-effective relative to usual care.
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9.
Effects of Qigong practice in office workers with chronic non-specific low back pain: A randomized control trial.
Phattharasupharerk, S, Purepong, N, Eksakulkla, S, Siriphorn, A
Journal of bodywork and movement therapies. 2019;(2):375-381
Abstract
OBJECTIVE To investigate the effects of Qigong practice, Guan Yin Zi Zai Gong level 1, compared with a waiting list control group among office workers with chronic nonspecific low back pain (CNLBP). METHODS A randomized controlled trial was conducted at offices in the Bangkok Metropolitan Region. Seventy-two office workers with CNLBP were screened for inclusion/exclusion criteria (age 20-40 years; sitting period more than 4 h per day) and were allocated randomly into two groups: the Qigong and waiting list groups (n = 36 each). The participants in the Qigong group took a Qigong practice class (Guan Yin Zi Zai Gong level 1) for one hour per week for six weeks at their workstation. The participants were encouraged to conduct the Qigong exercise at home every day. The waiting list group received general advice regarding low back pain management. The primary outcomes were pain intensity, measured by the visual analog scale, and back functional disability, measured by the Roland and Morris Disability Questionnaire. The secondary outcomes were back range of motion, core stability performance index, heart rate, respiratory rate, the Srithanya Stress Scale (ST-5), and the global perceived effect (GPE) questionnaire. RESULTS Compared to the baseline, participants in the Qigong group experienced significantly decreased pain intensity and back functional disability. No statistically significant difference in these parameters was found in the waiting list group. Comparing the two groups, Qigong exercise significantly improved pain intensity, back functional impairment, range of motion, core muscle strength, heart rate, respiratory rate, and mental status. The Qigong group also had a significantly higher global outcome satisfaction than the waiting list group. CONCLUSION Qigong practice is an option for treatment of CNLBP in office workers.
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10.
Methylsulfonylmethane for treatment of low back pain: A safety analysis of a randomized, controlled trial.
Crawford, P, Crawford, A, Nielson, F, Lystrup, R
Complementary therapies in medicine. 2019;:85-88
Abstract
OBJECTIVE To ensure that 16 weeks of methylsulfonylmethane (MSM) does not cause adverse effects in patients with the musculoskeletal disorders of osteoarthritis and back pain. DESIGN We carried out a subgroup analysis on data from a randomized, double-blind, placebo-controlled trial, "The use of Methylsulfonylmethane (MSM) in the treatment of low back pain," to determine the safety of taking 6 g daily of MSM (OptiMSM®, Bergstrom Nutrition). We monitored metabolic parameters to determine whether MSM altered hematologic, liver or kidney function. We also monitored physiologic parameters of blood pressure and weight. SETTING Family Medicine Residency, Mike O'Callaghan Military Medical Center. MAIN OUTCOME MEASURES Metabolic parameters as measured by hematologic function - white blood cells (WBC), platelets, hemoglobin (Hb), glucose; liver function as measured by - total bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Physiologic parameters as measured by weight, diastolic (DBP) and systolic blood pressure (SBP); kidney function as measured by creatinine. RESULTS Analysis of outcome measures showed no significant difference between MSM and placebo (p < 0.05) safety values. CONCLUSION MSM has no effects on WBC, platelets, Hb, total bilirubin, AST, ALT, creatinine weight, DBP, or SBP in this study.