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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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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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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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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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Emergency department interventions for adult patients with low back pain: a systematic review of randomised controlled trials.
Oliveira, CB, Amorim, HE, Coombs, DM, Richards, B, Reedyk, M, Maher, CG, Machado, GC
Emergency medicine journal : EMJ. 2021;(1):59-68
Abstract
BACKGROUND Most low back pain trials have limited applicability to the emergency department (ED) because they provide treatment and measure outcomes after discharge from the ED. We investigated the efficacy and safety of pharmacological and non-pharmacological interventions delivered in the ED to patients with non-specific low back pain and/or sciatica on patient-relevant outcomes measured during the emergency visit. METHODS Literature searches were performed in MEDLINE, EMBASE and CINAHL from inception to week 1 February 2020. We included all randomised controlled trials investigating adult patients (≥18 years) with non-specific low back pain and/or sciatica presenting to ED. The primary outcome of interest was pain intensity. Two reviewers independently screened the full texts, extracted the data and assessed risk of bias of each trial using the Physiotherapy Evidence Database (PEDro) scale. The overall quality of evidence, or certainty, provided by a set of trials evaluating the same treatment was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which considers imprecision, inconsistency, indirectness and bias in the evidence. RESULTS Fifteen trials (1802 participants) were included with 12 of 15 at low risk of bias (ie, PEDro score >6). Based on results from individual trials and moderate quality evidence, ketoprofen gel was more effective than placebo for non-specific low back pain at 30 min (mean difference (MD) -15.0, 95% confidence interval (CI) -21.0 to -9.0). For those with sciatica (moderate quality evidence), intravenous paracetamol (acetaminophen) (MD -15.7, 95% CI -19.8 to -11.6) and intravenous morphine (MD -11.4, 95% CI -21.6 to -1.2) were both superior to placebo at 30 min. Based on moderate quality of evidence, corticosteroids showed no benefits against placebo at emergency discharge for non-specific low back pain (MD 9.0, 95% CI -0.71 to 18.7) or sciatica (MD -6.8, 95% CI -24.2 to 10.6). There were conflicting results from trials comparing different pharmacological options (moderate quality evidence) or investigating non-pharmacological treatments (low quality evidence). CONCLUSION Ketoprofen gel for non-specific low back pain and intravenous paracetamol or morphine for sciatica were superior to placebo, whereas corticosteroids were ineffective for both conditions. There was conflicting evidence for comparisons of different pharmacological options and those involving non-pharmacological treatments. Additional trials measuring important patient-related outcomes to EDs are needed.
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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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Efficacy and tolerability of orally administered tramadol/dexketoprofen fixed-dose combination compared to diclofenac/thiocolchicoside in acute low back pain: experience from an Italian, single-centre, observational study.
Meloncelli, S, Divizia, M, Germani, G
Current medical research and opinion. 2020;(10):1687-1693
Abstract
OBJECTIVES To compare the analgesic efficacy and tolerability of tramadol/dexketoprofen 75/25 mg (TRAM/DKP) versus diclofenac/thiocolchicoside 75/4 mg (DIC/THIO) in patients with moderate-to-severe acute low back pain (LBP). METHODS Single-centre, observational study in 82 adult outpatients with LBP due to disc herniation (≥4 Numerical Rating scale, NRS) who received either oral TRAM/DKP (n = 44) or intramuscular DIC/THIO (n = 38), both given every 12 h for 5 days. The primary endpoint was the change from baseline in pain intensity (PI) at pre-specified post-dose time points (t day1, t day3, t day7) and compared between the two treatments. Additional endpoints, all evaluated at day 7, included: the sum of PI difference (SPID), percentage of responders in terms of PI reduction versus baseline and change from baseline in Douleur Neuropathique (DN4) score. Tolerability and safety were also assessed. RESULTS Both treatment groups were comparable for demographic characteristics and comorbidities. Over the 5-day treatment period and up to day 7, compared to DIC/THIO, TRAM/DKP provided a significantly greater and sustained analgesia at day 3 and day 7 (p < .0001), with a higher proportion of responders at each time point [75% versus 71.1% (p = 0.687) at day 1, 93.2% versus 73.7% at day 3 (p = .016) and 95.5% versus 71.1% at day 7 (p = .003)], higher values of SPID (770.9 ± 23.5 vs. 507.1 ± 22.6; p < .0001) and significantly greater reduction in DN4 score [-62.7 ± 25.6 vs. -39.7 ± 31.2 (p < .0001)]. Both treatments were well tolerated. CONCLUSIONS Orally administered TRAM/DKP 75/25 mg can be a valuable and effective option in patients with acute LBP.
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Effect of Combined Diclofenac and B Vitamins (Thiamine, Pyridoxine, and Cyanocobalamin) for Low Back Pain Management: Systematic Review and Meta-analysis.
Calderon-Ospina, CA, Nava-Mesa, MO, Arbeláez Ariza, CE
Pain medicine (Malden, Mass.). 2020;(4):766-781
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Abstract
BACKGROUND Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, and cyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), particularly diclofenac, in a synergistic manner. The aim of this review was to determine the effects of diclofenac combined with TPC compared with diclofenac monotherapy for low back pain (LBP) management. METHODS We searched for randomized clinical trials on the MEDLINE, EMBASE, LILACS, and Cochrane databases of records of clinical trials, among other sources. We evaluated the risk of bias regarding randomization, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. A random-effects meta-analysis to examine patients with acute LBP (N = 1,108 adults) was performed, along with a subsequent sensitivity analysis. RESULTS Five studies in patients with LBP were included in the qualitative synthesis. Four of these studies in acute LBP were included in the first meta-analysis. A sensitivity test based on risk of bias (three moderate- to high-quality studies) found that the combination therapy of diclofenac plus TPC was associated with a significant reduction in the duration of treatment (around 50%) compared with diclofenac monotherapy (odds ratio = 2.23, 95% confidence interval = 1.59 to 3.13, P < 0.00001). We found no differences in the safety profile and patient satisfaction. CONCLUSIONS This meta-analysis demonstrated that combination therapy of diclofenac with TPC might have an analgesic superiority compared with diclofenac monotherapy in acute LBP. However, there is not enough evidence to recommend this therapy in other types of pain due to the scarcity of high-quality studies.
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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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A Multimodal Approach to Pain Management for Patients with Chronic Back Pain: Outcome Measures at 1 Year.
Eskander, JP, Beakley, BD, Zhang, S, Paetzold, J, Sharma, B, Kaye, AD, Sharma, S
Current pain and headache reports. 2019;(8):54
Abstract
PURPOSE OF REVIEW The purpose of this study is to evaluate the effectiveness of a multimodal approach to treating chronic low back pain. RECENT FINDINGS Chronic non-cancer-related back pain is often a frustrating and poorly managed problem for patients. It poses a significant public health issue worsened by the widespread use of narcotics. In 2016, the CDC released guidelines with noticeably more strict recommendations on prescription of narcotics for pain. Veterans at an interventional pain clinic presenting with chronic back pain refractory to medical and to surgical care were enrolled in an 8-week interdisciplinary pain management program. Pain scores were significantly reduced 1 year after completion of the program. Patients in this study benefitted from lower and sustained pain scores, a reduction in emergency room, and urgent care clinic visits, as well as generally high satisfaction with the interdisciplinary program.