scholarly journals Study protocol for a randomised, double-blind, placebo-controlled clinical trial of duloxetine for the treatment and prevention of musculoskeletal pain: altering the transition from acute to chronic pain (ATTAC pain)

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025002 ◽  
Author(s):  
Daniel H Strauss ◽  
Divya R Santhanam ◽  
Samuel A McLean ◽  
Francesca L Beaudoin
Keyword(s):  
Chronic Pain ◽  
Rhode Island ◽  
Musculoskeletal Pain ◽  
Scientific Journal ◽  
Current Treatment ◽  
Drop Out ◽  
Chronic Musculoskeletal Pain ◽  
Controlled Clinical Trial ◽  
Double Blind

IntroductionChronic musculoskeletal pain affects a substantial portion of adults visiting the emergency department (ED). Current treatment is limited in scope and does not effectively reduce musculoskeletal pain in patients. The study will evaluate the use of duloxetine, a serotonin-norepinephrine reuptake inhibitor Food and Drug Administration approved for the treatment of chronic pain, as a promising option in its prevention. The proposed study may present a well-tolerated and effective non-opioid treatment for patients with acute musculoskeletal pain that may also be effective in preventing the transition to persistent or chronic musculoskeletal pain.Methods and analysisThe primary outcome of this study will be to assess the tolerability and preliminary effectiveness of duloxetine in patients with acute musculoskeletal pain. The study will take place at two EDs in Rhode Island, USA. The study will involve randomisation to one of three arms: duloxetine 30 mg, duloxetine 60 mg or placebo. Tolerability will be assessed by comparing the proportion of participants that report an adverse event and that drop-out across the three study arms. Effectiveness will be determined by self-reported pain over 6 weeks of follow-up. Specifically, we will compare the proportion of participants with persistent pain (ongoing pain at 6-week follow-up), across the three study arms. 60 adults (aged 18–59) presenting to the ED with acute axial musculoskeletal pain within 7 days of onset are expected to be enrolled in the proposed study.Ethics and disseminationEthics approval was obtained by the Institutional Review Board (IRB). These results will be published in a peer reviewed scientific journal and presented at one or more scientific conferences.Trial registration numberNCT03315533.

Pain and Psychological Outcomes Among Iraq and Afghanistan Veterans with Chronic Pain and PTSD: ESCAPE Trial Longitudinal Results

Pain Medicine ◽  
2020 ◽  
Vol 21 (7) ◽  
pp. 1369-1376
Author(s):  
Matthew J Bair ◽  
Samantha D Outcalt ◽  
Dennis Ang ◽  
Jingwei Wu ◽  
Zhangsheng Yu
Keyword(s):  
Chronic Pain ◽  
Musculoskeletal Pain ◽  
Pain Catastrophizing ◽  
Psychological Outcomes ◽  
Stepped Care ◽  
Chronic Musculoskeletal Pain ◽  
Pain Severity ◽  
Analysis Of Covariance ◽  
Escape Trial ◽  
Care Intervention

Abstract Objective To compare pain and psychological outcomes in veterans with chronic musculoskeletal pain and comorbid post-traumatic stress disorder (PTSD) or pain alone and to determine if veterans with comorbidity respond differently to a stepped-care intervention than those with pain alone. Design Secondary analysis of data from the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial. Setting Six Veterans Health Affairs clinics. Subjects Iraq and Afghanistan veterans (N = 222) with chronic musculoskeletal pain. Methods Longitudinal analysis of veterans with chronic musculoskeletal pain and PTSD or pain alone and available baseline and nine-month trial data. Participants randomized to either usual care or a stepped-care intervention were analyzed. The pain–PTSD comorbidity group screened positive for PTSD and had a PTSD Checklist–Civilian score ≥41 at baseline. Results T tests demonstrated statistically significant differences and worse outcomes on pain severity, pain cognitions, and psychological outcomes in veterans with comorbid pain and PTSD compared with those with pain alone. Analysis of covariance (ANCOVA) modeling change scores from baseline to nine months indicated no statistically significant differences, controlling for PTSD, on pain severity, pain centrality, or pain self-efficacy. Significant differences emerged for pain catastrophizing (t = 3.10, P < 0.01), depression (t = 3.39, P < 0.001), and anxiety (t = 3.80, P < 0.001). The interaction between PTSD and the stepped-care intervention was not significant. Conclusions Veterans with the pain–PTSD comorbidity demonstrated worse pain and psychological outcomes than those with chronic pain alone. These findings indicate a more intense chronic pain experience for veterans when PTSD co-occurs with pain. PTSD did not lead to a differential response to a stepped-care intervention.

scholarly journals Patients’ Views on Self-Management of Chronic Musculoskeletal Pain

2020 ◽  
Vol 5 (4) ◽  
pp. 254-266
Author(s):  
Barbka Huzjan ◽  
Ivana Hrvatin
Keyword(s):  
Health Care ◽  
Chronic Pain ◽  
Musculoskeletal Pain ◽  
Health Care Providers ◽  
Multidisciplinary Approach ◽  
Research Question ◽  
Chronic Musculoskeletal Pain ◽  
Self Management ◽  
Care Providers ◽  
The Individual

Research Question (RQ): Chronic musculoskeletal pain is a complex condition and one of the most important causes of suffering of modern times. Self-management refers to the individual’s ability to manage the symptoms, treatment, physical and psychosocial consequences and life style changes inherent in living with a chronic condition. The research question is; what is the view on the selfmanagement of chronic musculoskeletal pain from the patient's perspective? Purpose: The purpose of this literature review was to review original articles that reported how selfmanagement educational programmes are viewed from the patient’s perspective. Method: We used an integrative review of the literature. The search was conducted from November 2019 to March 2020 on the PubMed, PEDro and OTseeker databases. We included original studies, written in English that examined the patients’ point of view on self-management. The included studies, needed to be conducted on adult patients of both sexes, that were suffering from chronic pain and were educated on self-management of their pain. Two authors independently searched for original studies. Results: Nine article were included in the review. Most of the studies included a multidisciplinary approach. Patients reported they more frequently used passive strategies to manage their pain. They want to be included in the management and be able to communicate with the provider of selfmanagement. There are several positive aspects of a multidisciplinary and groups approach. Organization: Health care providers can encourage an individual to proactively behave through ongoing processes of communication, partnerships and the creation of appropriate self-management plans over time. Society: We assume that the analysis will help to identify the social responsibility of the individual and society in the common concern for the health of the population and the individual within it. Originality: The research provides an up-to-date, new overview of the patients' perspective on self management on chronic pain. The review can be helpful to health care providers s they can compare their expectations with patients's. Limitations / further research: Further research would focus on high quality studies, and specific forms of multidisciplinary approach, and finding what patients use at a home setting and how to help them continue in the self management of their pain. Limitations of this review include the lack of risk of bias assessment and the fact that this is not a systematic review.

Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (11) ◽  
pp. 2811-2822
Author(s):  
Brandon C Yarns ◽  
Mark A Lumley ◽  
Justina T Cassidy ◽  
W Neil Steers ◽  
Sheryl Osato ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Musculoskeletal Pain ◽  
Behavioral Therapy ◽  
Emotional Awareness ◽  
Pain Reduction ◽  
Post Treatment ◽  
Chronic Musculoskeletal Pain ◽  
Comparison Trial ◽  
Secondary Outcomes

Abstract Objective Emotional awareness and expression therapy (EAET) emphasizes the importance of the central nervous system and emotional processing in the etiology and treatment of chronic pain. Prior trials suggest EAET can substantially reduce pain; however, only one has compared EAET with an established alternative, demonstrating some small advantages over cognitive behavioral therapy (CBT) for fibromyalgia. The current trial compared EAET with CBT in older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain. Design Randomized comparison trial. Setting Outpatient clinics at the West Los Angeles VA Medical Center. Subjects Fifty-three veterans (mean age = 73.5 years, 92.4% male) with chronic musculoskeletal pain. Methods Patients were randomized to EAET or CBT, each delivered as one 90-minute individual session and eight 90-minute group sessions. Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes were assessed at baseline, post-treatment, and three-month follow-up. Results EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively). At post-treatment, 41.7% of EAET patients had >30% pain reduction, one-third had >50%, and 12.5% had >70%. Only one CBT patient achieved at least 30% pain reduction. Secondary outcomes demonstrated small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance. Conclusions This trial, although preliminary, supports prior research suggesting that EAET may be a treatment of choice for many patients with chronic musculoskeletal pain. Psychotherapy may achieve substantial pain reduction if pain neuroscience principles are emphasized and avoided emotions are processed.

scholarly journals Central neurobiological effects of physical exercise in individuals with chronic musculoskeletal pain: a systematic review

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036151
Author(s):  
Rutger M J de Zoete ◽  
Kenneth Chen ◽  
Michele Sterling
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
High Risk ◽  
Physical Exercise ◽  
Clinical Outcomes ◽  
Musculoskeletal Pain ◽  
Exercise Intervention ◽  
Risk Of Bias ◽  
Chronic Musculoskeletal Pain ◽  
Brain Areas

ObjectivePrimary objectives: to investigate the central neurobiological effects (using MRI) of physical exercise in individuals with chronic pain. Secondary objectives: (1) to investigate the associations between central changes and clinical outcomes and (2) to investigate whether different types and dosages of physical exercise exert different central changes.DesignSystematic review searching four electronic databases up to September 2018: AMED, CINAHL, Embase and MEDLINE. Two reviewers independently assessed the methodological quality of included studies using the Cochrane Collaboration’s Risk of Bias in Non-Randomised Studies-I tool. A standardised extraction table was used for data extraction, which was performed by two reviewers.InterventionsStudies reporting any physical exercise intervention in any chronic musculoskeletal pain condition were included. Eligibility of 4011 records was screened independently by two reviewers, and four studies were included in the review.Primary and secondary outcome measuresPrimary outcome: any brain outcome assessed with any MR technique. Secondary outcomes: any self-reported clinical outcomes, and type and dosage of the exercise intervention.ResultsAll four studies had high risk of bias. There was heterogeneity between the brain areas studied and the types of exercise interventions delivered. All studies reported functional MRI changes in various brain areas following an exercise intervention. Insufficient data were available to conduct a meta-analysis or to answer the secondary aims.ConclusionsOnly a limited number of studies were available and all were at high risk of bias. None of the studies was randomised or included blinded assessment. Exercise may exert effects on brain neurobiology in people with chronic pain. Due to the high risk of bias, future studies should use a randomised study design. Investigation of morphological brain changes could be included.PROSPERO registration numberCRD42018108179.

Effects of individually chosen homoeopathic medicines on recurrent URTI in children

1996 ◽  
Vol 85 (01) ◽  
pp. 4-14
Author(s):  
J. Blommers ◽  
D.J. Kuik ◽  
L. Feenstra ◽  
P.D. Bezemer ◽  
E.S.M. De Lange-De Klerk
Keyword(s):  
Clinical Trial ◽  
University Hospital ◽  
Controlled Clinical Trial ◽  
Upper Respiratory Tract ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Respiratory ◽  
The University ◽  
Current Standards

AbstractThe effects of homoeopathic medicines on children suffering from recurrent upper respiratory tract infection (URTI) were studied in a randomized double-blind placebo-controlled clinical trial conducted at the paediatric outpatients department of the university hospital of the Vrije Universiteit in Amsterdam from 1987 to 1992.The study was designed to meet both the requirements of proper homoeopathic practice and the current standards of a clinical trial. The purpose of a randomized placebo-controlled double-blind trial is to identify the effects of the agents under investigation by equalizing the effects of other factors that may influence outcome.The object of the trial, eligibility criteria, follow-up period, treatments and concurrent interventions, data collection and effect measures are discussed in the light of homoeopathic thinking.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Effect of polymerized type I collagen in hyperinflammation of adult outpatients with symptomatic COVID-19: a double blind, randomised, placebo-controlled clinical trial.

2021 ◽  
Author(s):  
Silvia Mendez-Flores ◽  
Angel Alexis Priego-Ranero ◽  
Daniel Azamar-Llamas ◽  
Hector Olvera-Prado ◽  
Kenia Illian Rivas-Redondo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oxygen Saturation ◽  
Primary Outcome ◽  
Type I Collagen ◽  
Ambient Air ◽  
Controlled Clinical Trial ◽  
Type I ◽  
Double Blind ◽  
Duration Of Symptoms

BACKGROUND Currently, therapeutic options for ambulatory COVID-19 patients are limited. OBJECTIVE To evaluate the safety, efficacy and effect of the intramuscular administration of polymerized type I collagen (PTIC) on hyperinflammation, oxygen saturation and symptom improvement in adult outpatients with symptomatic COVID-19. DESIGN Double-blind, randomised, placebo-controlled clinical trial of PTIC vs placebo. SETTING Single Third-level hospital in Mexico City (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) PARTICIPANTS Eighty-nine adult participants with a confirmed COVID-19 diagnosis and symptom onset within the 7 days preceding recruitment were included from August 31, 2020 to November 7, 2020 and followed for 12 weeks. Final date of follow-up was February 4, 2021. INTERVENTIONS Patients were randomly assigned to receive either 1.5 ml of PTIC intramuscularly every 12 h for 3 days and then every 24 h for 4 days (n=45), or matching placebo (n=44). MAIN OUTCOMES AND MEASURES The primary outcome was a mean reduction of at least 50% in the level of IP-10 compared to baseline. The secondary outcomes were mean oxygen saturation >92% while breathing ambient air and duration of symptoms. RESULTS Of 89 patients who were randomised, 87 (97.8%) were included in an intention-to-treat analysis; 37 (41.6%) were male and mean age was 48.5+/-14.0 years. The IP-10 levels decreased 75% in the PTIC group and 40% in the placebo group vs baseline. The comparison between treatment vs placebo was also statistically significant (P=0.0047). The IL-8 (44%, P=0.045), M-CSF (25%, P=0.041) and IL-1Ra (36%, P=0.05) levels were also decreased in the PTIC group vs baseline. Mean oxygen saturation >92% was achieved by 40/44 (90%), 41/42 (98%) and 40/40 (100%) of participants that received PTIC at 8, 15 and 97 days of follow-up vs 29/43 (67%), 31/39 (80%) and 33/37 (89%) of patients treated with placebo (P=0.001). The unadjusted accelerated failure time model showed that patients treated with PTIC achieved the primary outcome 2.70-fold faster (P<0.0001) than placebo. In terms of risk, the group of patients treated with PTIC had a 63% lower risk of having a mean oxygen saturation <92% vs placebo (P<0.0001). Symptom duration in patients treated with PTIC was reduced by 6.1+/-3.2 days vs placebo. No differences in adverse effects were observed between the groups at 8, 15 and 97 days of follow-up. CONCLUSIONS In this study, treatment with PTIC down-regulated IP-10, IL-8, M-CSF and IL-Ra levels, which could explain the PTIC effect on the higher proportion of patients with mean oxygen saturation readings > 92% and a shorter duration of symptoms as compared to patients treated with placebo. Although results are encouraging, larger randomised trials are needed.

scholarly journals Physiotherapist-led rehabilitation for patients with chronic musculoskeletal pain: interventions and promising long-term outcomes

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna Trulsson Schouenborg ◽  
Marcelo Rivano Fischer ◽  
Elisabeth Bondesson ◽  
Anna Jöud
Keyword(s):  
Physical Activity ◽  
Musculoskeletal Pain ◽  
Clinical Results ◽  
Rehabilitation Program ◽  
Chronic Musculoskeletal Pain ◽  
Sensorimotor Training ◽  
Rehabilitation Programs ◽  
Pain Disability ◽  
Physical Activity Advice

Abstract Background There is no consensus on best content, set-up, category of involved healthcare professionals or duration of rehabilitation-programs for patients with chronic musculoskeletal pain, and outcomes show varying results. Individual care regimes for sub-groups of patients have been proposed. Aim To describe the type of interventions used in a physiotherapist-led, rehabilitation-program for patients with chronic musculoskeletal pain, refractory to preceding treatments. A second aim was to report clinical outcomes at 1-year follow-up after the intervention period. Methods All patients referred to physiotherapist within a specialist pain-unit due to being refractory to preceding treatments, and deemed fit to undergo physiotherapy-based, individualized rehabilitation during 2014–2018 were consecutively included and followed-up 1 year after ending the program. The inclusion was based on structured ‘clinical reasoning’ using the referral, examination and on patient-relevant outcome measures. The individual interventions, recorded according to a manual used when reading the patients’ medical records, were described. Primary outcomes were clinical results of perceived pain, disability and overall health at start, discharge and 1 year after discharge. Results In total, 274 patients (mean age 42 years, 71% women) were included, suffering from chronic, severe, musculoskeletal pain (VAS median 7/10, duration median 2.8 years) and moderate disability. The most frequent interventions were education, sensorimotor training, physical activity-advice and interventions for structures/functions (for example manual techniques, stretching) for a median of nine sessions during five months. Despite refractory to preceding treatments, 45% of the patients rated clinically important improvements on pain, 61% on disability and 50% on overall health at discharge and the figures were similar at 1-year follow-up. Conclusions A physiotherapist-led, one-to-one, rehabilitation-program of median nine sessions during five months, combining individualized education, sensorimotor training, physical activity-advice and interventions for structures/functions rendered clinically relevant improvements on pain, disability and overall health in half of the patients at 1-year follow-up. Since the cohort consisted of patients refractory to preceding treatments, we believe that these results warrant further studies to identify the subgroups of patients with chronic musculoskeletal pain that will improve from new, distinctive, resource-effective rehabilitation-programs involving individualized rehabilitation.

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