Tapering of prescribed opioids in patients with long-term non-malignant pain (TOPIO)—efficacy and effects on pain, pain cognitions, and quality of life: a study protocol for a randomized controlled clinical trial with a 12-month follow-up

Abstract Background Opioids are still widely prescribed to long-term pain patients although they are no longer recommended for long-term treatments due to poor evidence for long-term efficacy, risks of serious side effects, and the possibility of inducing opioid hyperalgesia. In a Cochrane study from 2017, the authors identified an urgent need for more randomized controlled trials investigating the efficiency and effects of opioid tapering. The study aimed to assess (1) the efficiency of a structured intervention in causing stable reductions of opioid consumption in a population with long-term non-malignant pain and (2) effects on pain, pain cognitions, physical and mental health, quality of life, and functioning in response to opioid tapering. Methods The study is a randomized controlled trial. The sample size was set to a total of 140 individuals after estimation of power and dropout. Participants will be recruited from a population with long-term non-malignant pain who will be randomly allocated to (1) the start of tapering immediately or (2) the control group who return to usual care and will commence tapering of opioids 4 months later. A 12-month follow-up is included. When all follow-ups are closed, data from the Swedish drug register of the National Board of Health and Welfare will be collected and individual mean daily opioid dose in morphine equivalents will be calculated at three time points: baseline, 4 months, and 12 months after the start of the intervention. At the same time points, participants fill out the following questionnaires: Numeric Pain Rating Scale (NPRS), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Chronic Pain Acceptance Questionnaire (CPAQ-8), Hospital Anxiety and Depression Scale (HADS), and RAND-36. At baseline and follow-up, a clinical assessment of opioid use disorder is performed. Discussion A better understanding of the efficiency and effects of opioid tapering could possibly facilitate attempts to taper opioid treatments, which might prove beneficial for both the individual and society. Trial registration ClinicalTrials.gov NCT03485430. Retrospectively registered on 26 March 2018, first release date. “Tapering of Long-term Opioid Therapy in Chronic Pain Population. RCT with 12 Months Follow up (TOPIO).” First patient in trial 22 March 2018.

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Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v4 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

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Chronic pain in multiple sclerosis: A10-year longitudinal study

Scandinavian Journal of Pain ◽

10.1016/j.sjpain.2017.04.070 ◽

2017 ◽

Vol 16 (1) ◽

pp. 198-203 ◽

Cited By ~ 12

Author(s):

Jamie Young ◽

Bhasker Amatya ◽

Mary P. Galea ◽

Fary Khan

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Chronic Pain ◽

Longitudinal Study ◽

The Mean ◽

The Impact ◽

Over Time

AbstractBackground and purposePain is a common symptom associated with multiple sclerosis (MS), and has lasting effects on an individual’s functional capacity and quality of life. A wide range of prevalence rates of pain (between 23% and 90%)have been reported in MS and this is mainly due to the methodological differences amongst the studies such as variability in patient sources, method of sampling and the definition of pain used. Chronic pain in MS, defined as pain lasting for greater than 3–6 months, can have a significant impact on their biopsychosocial health, including negative impact on activities of daily living, relationships and social participation. The long-term course of MS-related pain and its impact in an Australian cohort over a 7-year period has been investigated earlier. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period.MethodsThis was a prospective longitudinal study conducted at the Rehabilitation Department of Royal Melbourne Hospital (RMH), a tertiary referral hospital in Victoria and Australia. The source of participants was from the RMH MS database and contains detailed MS patient information including demographic data, diagnosis details (using McDonald’s criteria), pain characteristics. Structured face-face interviews and validated measures were used, which include the visual analogue scale (VAS); chronic pain grade (CPG); the assessment of quality of life (AQoL) and the carer strain index (CSI). The mean age of the participants (n = 70) was 55.3 years and majority (70%) were female.ResultsThe mean age of the participants (n = 70) was 55.3 years and majority (70%) were female. The findings show that over time (10 years), participants report having greater bilateral bodily pain and greater description of pain as ‘worse as it could be’. Pain types were similar to 7-years follow-up but remained higher than baseline. There was a significant deterioration in quality of life in those with more severe CPG over time. Almost half of the participants 31 (44%) required care either from a private carer, institution or from a family member. Although fear of taking medications and side effects were common barriers to treatment for pain, there was an increase in the use of pharmacological treatment over time and an increase in the use of healthcare services, mainly neurologists and general practitioners.ConclusionsThe pain measures reported by the participants were similar to those at the 7-year follow-up except there was a greater representation of bilateral pain locations (limb, trunk and facial pain) compared to baseline and 7-year follow-up. At 10-year follow-up, more participants used medications compared tc 7-year follow-up and there was an increase in the use of health professionals at the 10-year follow-up At the 10-year follow up QoL of the participants deteriorated significantly and more participants had progressed to higher CPGIII and CPGIV. This study demonstrates that chronic pain is a significant issue over time in MS, with clinical and health implications, impact on quality of life, disability and healthcare utilization.ImplicationsGreater awareness of chronic pain in pwMS, cognitive classifications and an interdisciplinary approach is required to improve long-term patient outcomes and well-being.Crown Copyright © 2017 Published by Elsevier B.V. on behalf of Scandinavian Association for the Study of Pain. All rights reserved.

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Long-term evaluation of fecal continence and quality of life in patients operated for anorectal malformations

Revista da Associação Médica Brasileira ◽

10.1590/1806-9282.62.06.544 ◽

2016 ◽

Vol 62 (6) ◽

pp. 544-552 ◽

Cited By ~ 5

Author(s):

Ana Cristina Aoun Tannuri ◽

Mariana Aparecida Elisei Ferreira ◽

Arthur Loguetti Mathias ◽

Uenis Tannuri

Keyword(s):

Quality Of Life ◽

Anorectal Malformations ◽

Fecal Continence ◽

Group Method ◽

Control Group ◽

Term Evaluation ◽

Associated Malformations

Summary Introduction: Patients operated for correction of anorectal malformations (ARM) can develop fecal incontinence, constipation, and soiling, with loss in quality of life. Objective: To evaluate, through the use of questionnaires, fecal continence, and quality of life of children in the late postoperative follow-up of ARM correction, both high and low. In addition, the levels of fecal continence and quality of life were compared with those of a control group. Method: A Fecal Continence Index Questionnaire (ICF) and a Questionnaire for Assessment of Quality of Life Related to Fecal Continence in Children and Adolescents (QQVCFCA) were administered to 63 patients with ARM, aged from 7 to 19 years, whose surgical treatment had been completed for at least 6 months. The patients were compared to a control group of 59 children. Results: In the control group, 25 (42.4%) patients had good continence and 34 (57.6%), normal continence. We found that the quality of life in children with ARM is compromised globally, in all areas and in the ICF questionnaire, compared to controls (p<0.001). There was no difference between patients with high and low defects. Thirty-two (50.8%) patients had other associated anomalies. Conclusion: In patients operated for ARM correction, quality of life and ICF were compromised, and there was no difference between patients with high-type and low-type of the disease. In about half the cases there are other associated malformations.

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Life Outcomes of Anterior Temporal Lobectomy

Neurosurgery ◽

10.1227/neu.0000000000000145 ◽

2013 ◽

Vol 73 (6) ◽

pp. 1018-1025 ◽

Cited By ~ 19

Author(s):

Jana E. Jones ◽

Jacquelyn B. Blocher ◽

Daren C. Jackson

Keyword(s):

Quality Of Life ◽

Independent Living ◽

Temporal Lobectomy ◽

Life Outcomes ◽

Financial Independence ◽

Anterior Temporal Lobectomy ◽

Time Points

Abstract BACKGROUND: At 3 time points, this study examined long-term psychosocial life outcomes of individuals who underwent anterior temporal lobectomy in comparison with individuals with temporal lobe epilepsy who were medically managed. OBJECTIVE: To examine seizure frequency, employment, driving, independent living, financial independence, mental health, and quality of life at each follow-up assessment, as well as predictors of outcomes. METHODS: All participants were diagnosed with medically intractable complex partial seizures of temporal lobe origin with or without secondary generalization. A structured clinical interview was used at all 3 time points. Information was obtained regarding seizure frequency, antiepilepsy medications, employment, driving status, financial assistance, and independent living. Additionally, questions regarding quality of life, satisfaction with surgery, and the presence of depression or anxiety were included. Participants were, on average, 17 years postsurgery. RESULTS: Surgery resulted in significantly improved and sustained seizure outcomes. At the first, second, and third follow-ups, 67%, 72%, and 67% of participants in the surgery group remained seizure-free in the year before the follow-up interview. At each follow-up, 97%, 84%, and 84% reported that they would undergo surgery again. Seizure freedom predicted driving outcomes at all 3 time points, but was not a significant predictor for employment, independent living, or financial independence. Psychosocial life outcomes in the surgical group were improved and maintained over time in comparison with the medically managed group. CONCLUSION: This systematic long-term investigation provides strong support for the positive impact of anterior temporal lobectomy on psychosocial life outcomes including driving, employment, independent living, and financial independence.

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Hopes and fears before opioid tapering: a quantitative and qualitative study of patients with chronic pain and long-term opioids

British Journal of Pain ◽

10.1177/2049463720974053 ◽

2020 ◽

pp. 204946372097405

Author(s):

Jane Quinlan ◽

Heather Willson ◽

Katheryn Grange

Keyword(s):

Quality Of Life ◽

Chronic Pain ◽

Side Effects ◽

Phenomenological Approach ◽

Free Text ◽

Significant Depression ◽

Opioid Tapering ◽

The Uk

Background: It is clear that the risks of opioids in chronic pain outweigh the benefits, creating a drive for clinicians to support patients taper and stop long-term opioids. However, it is not known how patients who have been taking these medicines for months or years feel about reducing them. Using quantitative and qualitative data, this study describes the psychological complexity of these patients and examines their hopes and fears before opioid reduction. Methods: Sixty patients attending the opioid clinic completed psychological and pain questionnaires, providing quantitative data, just before they commenced opioid tapering. They scored the severity of opioid side effects and completed a free text framework to express their beliefs about stopping or continuing opioids. A phenomenological approach was used to identify common qualitative themes. Results: Most patients were taking opioid doses above the UK recommended maximum dose and reported severe pain with high pain interference. Over 80% of patients described significant depression and 60% significant anxiety. Negative themes around stopping opioids were more common than positive ones, with 63% patients fearing increased pain. A quarter of patients referred to addiction and 16% feared withdrawal. Five patients hoped for a better quality of life; seven feared a worse one. Opioid side effects were common and severe. Conclusion: Patients with chronic pain taking long-term opioids demonstrate high psychological distress and low self-efficacy. Their concerns around opioid tapering relate to pain, quality of life and withdrawal. Identifying and addressing patients’ individual concerns should increase the likelihood of successful opioid tapering.

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Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial

The American Journal of Sports Medicine ◽

10.1177/0363546519877181 ◽

2019 ◽

Vol 47 (13) ◽

pp. 3238-3246 ◽

Cited By ~ 6

Author(s):

Joost C. Peerbooms ◽

Paul Lodder ◽

Brenda L. den Oudsten ◽

Kamiel Doorgeest ◽

Hans M. Schuller ◽

...

Keyword(s):

Quality Of Life ◽

Plantar Fasciitis ◽

Platelet Rich Plasma ◽

Corticosteroid Injection ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Scores

Background: When nonoperative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporary pain reduction but no healing. Platelet-rich plasma (PRP) has proven to be a safe therapeutic option in the treatment of tendon, muscle, bone, and cartilage injuries. Purpose: To determine the effectiveness of PRP as compared with corticosteroid injections for chronic plantar fasciitis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with chronic plantar fasciitis were allocated to have steroid injection or PRP. The primary outcome measure was the Foot Function Index (FFI) Pain score. Secondary outcome measures were function, as scored by the FFI Activity, FFI Disability, and American Orthopaedic Foot & Ankle Society, and quality of life, as scored with the short version of the World Health Organization Quality of Life (WHOQOL-BREF). All outcomes were measured at baseline and at 4, 12, and 26 weeks and 1 year after the procedure. Results: Of the 115 patients, 63 were allocated to the PRP group, of which 46 (73%) completed the study, and 52 were allocated to the control group (corticosteroid injection), of which 36 (69%) completed the study. In the control group, FFI Pain scores decreased quickly and then remained stable during follow-up. In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group. After adjusting for baseline differences, the PRP group showed significantly lower pain scores at the 1-year follow-up than the control group (mean difference, 14.4; 95% CI, 3.2-25.6). The number of patients with at least 25% improvement (FFI Pain score) between baseline and 12-month follow-up differed significantly between the groups. Of the 46 patients in the PRP group, 39 (84.4%) improved at least 25%, while only 20 (55.6%) of the 36 in the control group showed such an improvement ( P = .003). The PRP group showed significantly lower FFI Disability scores than the control group (mean difference, 12.0; 95% CI, 2.3-21.6). Conclusion: Treatment of patients with chronic plantar fasciitis with PRP seems to reduce pain and increase function more as compared with the effect of corticosteroid injection. Registration: NCT00758641 (ClinicalTrials.gov identifier).

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Effects of virtual reality associated with serious games for upper limb rehabilitation in patients with multiple sclerosis. A randomized controlled trial

10.21203/rs.3.rs-16509/v3 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance. Trial registration: This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908, Nov 2019.

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Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v2 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

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Long-term effect of physical activity on menopause-related quality of life – a 4 year follow-up study of a randomized controlled trial

Maturitas ◽

10.1016/j.maturitas.2015.02.122 ◽

2015 ◽

Vol 81 (1) ◽

pp. 139

Author(s):

Kirsi Mansikkamäki ◽

Jani Raitanen ◽

Clas-Håkan Nygård ◽

Eija Tomás ◽

Reetta Rutanen ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Term Effect ◽

Follow Up Study ◽

Randomized Controlled ◽

Long Term Effect ◽

Related Quality

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Effects Of Virtual Reality Associated With Serious Games For Upper Limb Rehabilitation In Patients With Multiple Sclerosis: A Randomized Controlled Trial

10.21203/rs.3.rs-16509/v1 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

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