Dataset Information

Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo-controlled trial.

ABSTRACT:

Introduction

The aim of the present study is to investigate the effectiveness of pulsed low-frequency magnetic field (PLFMF) on the management of chronic low back pain (CLBP).

Methods and analysis

A randomised double-blinded controlled clinical trial will be conducted, involving 200 patients with CLBP. Participants will be randomised in a 1:1 ratio to receive either active PLFMF (experimental arm) or sham treatment (control arm) using a permuted-block design which will be stratified according to three subtypes of musculoskeletal CLBP (nociceptive, peripheral neuropathic or central sanitisation). The intervention consists of three sessions/week for 6?weeks. The primary outcome is the percentage change in Numerical Rating Scale (NRS) pain at week 24 after treatment completion with respect to the baseline. Secondary outcomes include percentage NRS pain during treatment and early after treatment completion, short form 36 quality of life, Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21, Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index and Modified Fatigue Impact Scale. Measures will be taken at baseline, 3 and 6?weeks during the intervention and 6, 12 and 24?weeks after completing the intervention. Adverse events between arms will be evaluated. Data will be analysed on an intention-to-treat basis.

Ethics and dissemination

The study is funded by Imam Abdulrahman Bin Faisal University (IAU). It has been approved by the institutional review board of IAU (IRB- 2017-03-129). The study will be conducted at King Fahd Hospital of the University and will be monitored by the Hospital monitoring office for research and research ethics. The trial is scheduled to begin in September 2018. Results obtained will be presented in international conferences and will be published in peer-reviewed journals.

Trial registration number

ACTRN12618000921280, prospectively.

SUBMITTER: Abdulla FA

PROVIDER: S-EPMC6561444 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo-controlled trial.

Abdulla Fuad A FA Alsaadi Saad S Sadat-Ali Mir M Alkhamis Fahd F Alkawaja Hani H Lo Serigne S

BMJ open 20190609 6

<h4>Introduction</h4>The aim of the present study is to investigate the effectiveness of pulsed low-frequency magnetic field (PLFMF) on the management of chronic low back pain (CLBP).<h4>Methods and analysis</h4>A randomised double-blinded controlled clinical trial will be conducted, involving 200 patients with CLBP. Participants will be randomised in a 1:1 ratio to receive either active PLFMF (experimental arm) or sham treatment (control arm) using a permuted-block design which will be stratifi ...[more]

PMID: 31182440

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Project description:INTRODUCTION:Duloxetine has demonstrated efficacy in chronic low back pain (CLBP). We examined the predictors of response to duloxetine for CLBP. PATIENTS AND METHODS:This was a post hoc analysis of pooled data from 4 double-blind, ran-domized, placebo-controlled trials of duloxetine (60 mg/day for 12-14 weeks) in adult patients with CLBP. Primary outcome was proportion of patients with ?30% reduction in Brief Pain Inventory (BPI) average pain ("pain reduction") at 12-14 weeks. The proportion of patients with ?30% and ?50% (secondary outcome) pain reduction in duloxetine and placebo groups was compared. Variables for responder analyses were early improvement (?15% pain reduction at Week 2), sex, age, baseline BPI average pain score, duration of CLBP, and number of painful body sites according to the Michigan Body Map (?2 vs 1 [isolated CLBP]; 1 trial); relative risk (RR) and 95% confidence interval (CI) were calculated. RESULTS:Compared with placebo (n = 653), a greater proportion of duloxetine-treated patients (n = 642) achieved ?30% (59.7% vs 47.8%; P < 0.001) and ?50% pain reduction (48.6% vs 35.1%; P < 0.001). Among duloxetine-treated patients, early improvement was associated with greater likelihood of ?30% (RR [95% CI], 2.91 [2.30-3.67]) or ?50% (3.24 [2.44-4.31]) pain reduction. Women were slightly more likely than men to achieve ?30% (RR [95% CI], 1.14 [1.00-1.30]) or ?50% (1.17 [0.99-1.38]) pain reduction. Response rates were similar between age, CLBP duration, and baseline BPI average pain score subgroups. Patients with ?2 painful sites were more likely to respond to duloxetine 60 mg relative to placebo than patients with isolated CLBP (RR, duloxetine vs placebo [95% CI]: ?30% reduction, ?2 painful sites 1.40 [1.18-1.66], isolated CLBP 1.07 [0.78-1.48]; ?50% reduction, ?2 painful sites 1.51 [1.20-1.89], isolated CLBP 1.23 [0.81-1.88]). CONCLUSION:Early pain reduction was indicative of overall response. Patients with multiple painful sites had more benefit from duloxetine than patients with isolated CLBP.

Project description:A 14-week, randomized, double-blind, multicenter, placebo-controlled study of Japanese patients with chronic low back pain (CLBP) who were randomized to either duloxetine 60?mg once daily or placebo.This study aimed to assess the efficacy and safety of duloxetine monotherapy in Japanese patients with CLBP.In Japan, duloxetine is approved for the treatment of depression, diabetic neuropathic pain, and pain associated with fibromyalgia; however, no clinical study of duloxetine has been conducted for CLBP.The primary efficacy measure was the change in the Brief Pain Inventory (BPI) average pain score from baseline to Week 14. Secondary efficacy measures included BPI pain (worst pain, least pain, pain right now), Patient's Global Impression of Improvement, Clinical Global Impressions of Severity, and Roland-Morris Disability Questionnaire, among other measures, and safety and tolerability.In total, 458 patients were randomized to receive either duloxetine (n?=?232) or placebo (n?=?226). The BPI average pain score improved significantly in the duloxetine group compared with that in the placebo group at Week 14 [-2.43?±?0.11 vs. -1.96?±?0.11, respectively; between-group difference (95% confidence interval),?-?0.46 [-0.77 to-0.16]; P?=?0.0026]. The duloxetine group showed significant improvement in many secondary measures compared with the placebo group, including BPI pain (least pain, pain right now) (between-group difference: -1.69?±?0.10, P?=?0.0009; -2.42?±?0.12, P P?=?0.0230, respectively), Patient's Global Impression of Improvement (2.46?±?0.07, P?=?0.0026), Clinical Global Impressions of Severity (-1.46?±?0.06, P?=?0.0019), and Roland-Morris Disability Questionnaire (-3.86?±?0.22, P?=?0.0439). Adverse events occurring at a significantly higher incidence in the duloxetine group were somnolence, constipation, nausea, dizziness, and dry mouth, most of which were mild or moderate in severity and were resolved or improved.Duloxetine 60?mg was effective and well tolerated in Japanese CLBP patients.2.

Project description:BackgroundCo-occurring musculoskeletal pain is common among people with persistent low back pain (LBP) and associated with more negative consequences than LBP alone. The distribution and prevalence of musculoskeletal pain co-occurring with persistent LBP has not been systematically described, which hence was the aim of this review.MethodsLiterature searches were performed in MEDLINE, Embase, CINAHL and Scopus. We considered observational studies from clinical settings or based on cohorts of the general or working populations involving adults 18 years or older with persistent LBP (≥4 wks) and co-occurring musculoskeletal pain for eligibility. Study selection, data extraction and risk of bias assessment were carried out by independent reviewers. Results are presented according to study population, distribution and location(s) of co-occurring pain.ResultsNineteen studies out of 5744 unique records met the inclusion criteria. Studies were from high-income countries in Europe, USA and Japan. A total of 34,492 people with persistent LBP were included in our evidence synthesis. Methods for assessing and categorizing co-occurring pain varied considerably between studies, but based on the available data from observational studies, we identified three main categories of co-occurring pain - these were axial pain (18 to 58%), extremity pain (6 to 50%), and multi-site musculoskeletal pain (10 to 89%). Persistent LBP with co-occurring pain was reported more often by females than males, and co-occurring pain was reported more often in patients with more disability.ConclusionsPeople with persistent LBP often report co-occurring neck pain, extremity pain or multi-site pain. Assessment of co-occurring pain alongside persistent LBP vary considerable between studies and there is a need for harmonisation of measurement methods to advance our understanding of how pain in different body regions occur alongside persistent LBP.Systematic review registrationPROSPERO CRD42017068807 .

Project description:Study objectiveIn US emergency departments (EDs), patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and muscle relaxants. We compare functional outcomes among patients randomized to a 1-week course of naproxen+placebo versus naproxen+orphenadrine or naproxen+methocarbamol.MethodsThis was a randomized, double-blind, comparative effectiveness trial conducted in 2 urban EDs. Patients presenting with acute, nontraumatic, nonradicular low back pain were enrolled. The primary outcome was improvement on the Roland-Morris Disability Questionnaire (RMDQ) between ED discharge and 1 week later. All patients were given 14 tablets of naproxen 500 mg, to be used twice a day, as needed for low back pain. Additionally, patients were randomized to receive a 1-week supply of orphenadrine 100 mg, to be used twice a day as needed, methocarbamol 750 mg, to be used as 1 or 2 tablets 3 times per day as needed, or placebo. All patients received a standardized 10-minute low back pain educational session before discharge.ResultsTwo hundred forty patients were randomized. Baseline demographic characteristics were comparable. The mean RMDQ score of patients randomized to naproxen+placebo improved by 10.9 points (95% confidence interval [CI] 8.9 to 12.9). The mean RMDQ score of patients randomized to naproxen+orphenadrine improved by 9.4 points (95% CI 7.4 to 11.5). The mean RMDQ score of patients randomized to naproxen+methocarbamol improved by 8.1 points (95% CI 6.1 to 10.1). None of the between-group differences surpassed our threshold for clinical significance. Adverse events were reported by 17% (95% CI 10% to 28%) of placebo patients, 9% (95% CI 4% to 19%) of orphenadrine patients, and 19% (95% CI 11% to 29%) of methocarbamol patients.ConclusionAmong ED patients with acute, nontraumatic, nonradicular low back pain, combining naproxen with either orphenadrine or methocarbamol did not improve functional outcomes compared with naproxen+placebo.

Project description:BackgroundMultisite pain, including low-back and knee pain, is a major health issue that greatly decreases quality of life.ObjectivesThis study analyzed the effects of l-serine, which provides necessary components for nerve function, and EPA, which exerts anti-inflammatory properties, on pain scores of adults with pain in at least the low back and knee for ≥3 mo.MethodsThis was a randomized, double-blind, placebo-controlled, parallel-group study. The Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM) were applied as primary outcomes. The Brief Pain Inventory (BPI) and safety evaluation were secondary outcomes. We enrolled 120 participants aged ≥20 y (36 men and 84 women: mean ± SD age = 40.8 ± 10.9 y). The participants were randomly allocated to either the active group (daily ingestion of 594 mg l-serine and 149 mg EPA) or placebo group. The study period consisted of 8-wk dosing and 4-wk posttreatment observation. ANCOVA between groups for each time point was conducted using the baseline scores as covariates.ResultsThe JLEQ scores (active compared with placebo: 14.2 ± 11.2 compared with 19.0 ± 10.2) at week 8 were lower in the active group (P < 0.001). The JKOM scores at week 4 (11.7 ± 9.0 compared with 13.9 ± 7.9), week 8 (10.4 ± 7.9 compared with 13.1 ± 7.1), and week 12 (10.3 ± 7.4 compared with 13.8 ± 7.5) were lower in the active group (P ≤ 0.04). Additionally, the active group had 11-27% better scores compared with the placebo group for BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving) at week 4 (P ≤ 0.028) and week 8 (P ≤ 0.019), respectively, and BPI5D was 23% better in the active group at week 12 (P = 0.007). No adverse events were observed.Conclusionsl-Serine and EPA were effective for pain relief in adults with low-back and knee pain after multiplicity adjustment.This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000035056.

Dataset Information

Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo-controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo-controlled trial.

Similar Datasets

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