Dataset Information

U-PAIN cohort study among patients with chronic pain in specialised pain care: a feasibility study.

ABSTRACT:

Objectives

To examine acceptability of study participation and feasibility of (1) recruitment, (2) data collection and (3) outcome measures for the prospective U-PAIN cohort.

Design

Internal feasibility study of a prospective cohort.

Participants and setting

64 patients, >18 years, with chronic pain at a multidisciplinary pain centre at a university hospital in Sweden.

Outcome measures

Acceptability of study participation was measured with a study-specific 10-item Likert scale. A score <3 was considered feasible, for the two items that assessed respondent burden a higher score indicated lesser participant burden and a score >3 was feasible. Recruitment was assessed by participation rates at baseline and retention at the 1-year follow-up, with threshold values for feasibility at 75% and 80%, respectively. Data collection and outcome measures were examined by completions rates of study procedures (90% was considered feasible), sample scores, internal consistency (α>0.70 was considered feasible), and agreement between self-reported data and data retrieved from medical records on opioid use (ICC or κ>0.60 was considered feasible).

Results

Acceptability for study procedures was feasible, but participation rates were low: 25%. The retention rate at 1-year follow-up was 81% for those included in the feasibility study, that is, filling out computerised patient-reported outcome measures, and 65% for those using paper and pencil format. The completion rates for the different data collection methods ranged from 83% to 95%. Agreement between self-reported opioid use and prescribed dose and between opioid use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and clinical International Classification of Diseases-10 (ICD-10) diagnoses for opioid dependence were almost perfect (κ=0.91 and κ=0.90, respectively).

Conclusions

This feasibility study has helped to explore and improve methods for recruitment, data collection and use of outcome measures for the U-PAIN cohort. Low participation rate and high refusal rate at baseline is a challenge that needs to be further addressed.

SUBMITTER: Ljungvall H

PROVIDER: S-EPMC9756188 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

U-PAIN cohort study among patients with chronic pain in specialised pain care: a feasibility study.

Ljungvall Hanna H Lind Anne-Li AL Zetterberg Hedvig H Wagner Sofia S Ekselius Lisa L Karlsten Rolf R Heilig Markus M Åsenlöf Pernilla P

BMJ open 20221214 12

<h4>Objectives</h4>To examine acceptability of study participation and feasibility of (1) recruitment, (2) data collection and (3) outcome measures for the prospective U-PAIN cohort.<h4>Design</h4>Internal feasibility study of a prospective cohort.<h4>Participants and setting</h4>64 patients, <u>></u>18 years, with chronic pain at a multidisciplinary pain centre at a university hospital in Sweden.<h4>Outcome measures</h4>Acceptability of study participation was measured with a study-specific 10- ...[more]

PMID: 36517106

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Project description:BACKGROUND:Chronic musculoskeletal pain has a vast global prevalence and economic burden. Conservative therapies are universally recommended but require patient engagement and self-management to be effective. OBJECTIVE:This study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain. METHODS:A longitudinal observational study was conducted using a remote DCP available through a mobile app. Subjects participated in a 12-week multimodal DCP incorporating education, sensor-guided exercise therapy (ET), and behavioral health support with 1-on-1 remote health coaching. The primary outcome was pain measured by the visual analog scale (VAS). Secondary measures included engagement levels, program completion, program satisfaction, condition-specific pain measures, depression, anxiety, and work productivity. RESULTS:A total of 10,264 adults with either knee (n=3796) or low back (n=6468) pain for at least three months were included in the study. Participants experienced a 68.45% average improvement in VAS pain between baseline intake and 12 weeks. In all, 73.04% (7497/10,264) participants completed the DCP into the final month. In total, 78.60% (5893/7497) of program completers (7144/10,264, 69.60% of all participants) achieved minimally important change in pain. Furthermore, the number of ET sessions and coaching interactions were both positively associated with improvement in pain, suggesting that the amount of engagement influenced outcomes. Secondary outcomes included a 57.9% and 58.3% decrease in depression and anxiety scores, respectively, and 61.5% improvement in work productivity. Finally, 3 distinct clusters of pain response trajectories were identified, which could be predicted with a mean 76% accuracy using baseline measures. CONCLUSIONS:These results support the efficacy and scalability of a DCP for chronic low back and knee pain in a large, diverse, real-world population. Participants demonstrated high completion and engagement rates and a significant positive relationship between engagement and pain reduction was identified, a finding that has not been previously demonstrated in a DCP. Furthermore, the large sample size allowed for the identification of distinct pain response subgroups, which may prove beneficial in predicting recovery and tailoring future interventions. This is the first longitudinal digital health study to analyze pain outcomes in a sample of this magnitude, and it supports the prospect for DCPs to serve the overwhelming number of musculoskeletal pain sufferers worldwide.

Project description:BackgroundChronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed.ObjectiveThis feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain.MethodsThe EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire.ResultsParticipants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, "totally agree" or "agree"; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).Conclusions Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress.Trial registrationClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Project description:BackgroundLow back pain (LBP) is the most common diagnosis responsible for sick leave, long-term disability payments, and early retirements. Studies have suggested that the relatively small proportion of patients referred to a specialist for treatment, either conservative or surgical, accounts for most of the total costs of back pain. However, a complete and long-term picture of the socioeconomic burden associated with these two treatment regimens is lacking.MethodsFrom a cohort encompassing the entire population in Denmark (5.8 million inhabitants), we identified patients with LBP referred to specialised treatment, either conservative or surgical, during 2007-2016. According to treatment modality, two different cohorts were constructed. Each patient was matched with ten background population controls based on age, sex, region of residency and time of treatment (month and year). Using extensive, nationwide register data, the healthcare costs and loss of productivity from two years before the first intervention until 2018 was investigated.FindingsA total of 56,694 patients underwent surgical treatment, and 72,915 patients conservative treatment. Both cohorts had a significantly higher baseline cost two years before treatment compared with the background population controls. These measures increased sharply during the year after treatment. Five years after treatment, healthcare costs and loss of productivity remained proportionally similarly increased for the two treatment groups compared to the background population. Multiple surgeries had detrimental effects on long term productivity for the patients, and spouses to patients had marginally increased loss of productivity.InterpretationThe results show that patients referred to specialised treatment of LBP display poor socioeconomic prognosis, regardless of conservative or surgical treatment modality. This development was reinforced in patients undergoing multiple surgeries and was also observed among spouses to the patients. Our findings of substantial loss of productivity across subgroups indicate that measures of successful treatment need to be more nuanced.

Project description:IntroductionAround 30%-50% of adults suffer moderate to severe chronic pain not caused by cancer. Significant numbers are treated with opioids which over time may cease to be effective and produce side effects (eg, nausea, drowsiness and constipation). Stopping taking opioids abruptly can cause unpleasant withdrawal effects. Tapering in small steps is recommended, though some patients might struggle and need support, particularly if they have limited access to pain management alternatives. Awareness of the potential risks as well as benefits of tapering should be explored with patients.Methods and analysisA randomised controlled pilot feasibility study to investigate the effectiveness and feasibility of reducing high doses of opioids through a tapering protocol, education and support in primary care. Working with NHS Knowsley Place, we will identify patients taking 50 mg or above morphine equivalent dose of opioids per day to be randomly allocated to either the tapering group or tapering with support group. At an initial joint appointment with a pain consultant and General Practitioner (GP) GP tapering will be discussed and negotiated. Both groups will have their opioid reduced by 10% per week. The taper with support group will have access to additional support, including motivational counselling, realistic goal setting and a toolkit of resources to promote self-management. Some patients will successfully reduce their dose each week. For others, this may be more difficult, and the tapering reduction will be adjusted to 10% per fortnight. We assess opioid use, pain and quality of life in both groups at the start and end of the study to determine which intervention works best to support people with chronic pain who wish to stop taking opioids.Ethics and disseminationThe Behavioural Intervention for Opioid Reduction feasibility study has been granted full approval by Liverpool Central Research Ethics Committee on 7 April 2022 (22/NW/0047). The current protocol version is V.1.1, date 6 July 2022. Results will be published in peer-reviewed journals and disseminated to patient stakeholders in a lay summary report available on the project website and in participating GP surgeries.Trial registration numberISRCTN 30201337.

Project description:BackgroundQigong includes training for body and mind, one method is Zhineng Qigong. Scientific literature on qigong for chronic low back pain (LBP) is sparse. This study aimed to investigate feasibility including evaluation of a Zhineng Qigong intervention for pain and other lumbar spine-related symptoms, disability, and health-related quality of life in patients with chronic LBP and/or leg pain.MethodsProspective interventional feasibility study without control group. Fifty-two chronic pain patients (18-75 years) with LBP and/or leg pain (Visual Analogue Scale ≥ 30) were recruited from orthopaedic clinics (spinal stenosis, spondylolisthesis, or segmental pain) and primary healthcare (chronic LBP). Patients from orthopaedic clinics were 1-6 years postoperative after lumbar spine surgery or on lumbar surgery waiting list. Patients received a 12-week training intervention with European Zhineng Qigong. The intervention consisted of face-to-face group activities in non-healthcare setting (4 weekends and 2 evenings per week), and individual Zhineng Qigong training. Main health outcomes were self-reported in a 14-day pain diary, Oswestry Disability Index (ODI), Short Form 36 version 2 (SF-36v2), and EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), once directly before and once directly after the intervention.ResultsRecruitment rate was 11% and retention rate was 58%. Dropouts did not report higher pain (baseline), only 3 dropped out because of lumbar spine-related pain. Adherence was median 78 h group attendance (maximum 94 h) and 14 min daily individual training. Ability to collect outcomes was 100%. Thirty patients completed (mean 15 years symptom duration). Twenty-five had degenerative lumbar disorder, and 17 history of lumbar surgery. Results showed statistically significant (within-group) improvements in pain, ODI, all SF-36v2 scales, and EQ-5D-5L.ConclusionsDespite low recruitment rate, recruitment was sufficient. A multicentre randomized controlled trial is proposed, with efforts to increase recruitment and retention rate. After this Zhineng Qigong intervention patients with chronic LBP and/or leg pain, also patients with considerable remaining LBP/sciatica after lumbar surgery, had significantly improved in pain and function. Results support involvement of postoperative patients in a future study. The results are promising, and this intervention needs to be further evaluated to provide the most reliable evidence.Trial registrationNCT04520334. Retrospectively registered 20/08/2020.

Project description:BackgroundChronic pain management is challenging for health systems worldwide. Clinical practice guidelines recommend interprofessional chronic pain management, but chronic pain clinics often have lengthy wait-lists. Advanced practice physiotherapists (APP) in orthopedic clinics and emergency departments have provided effective care and reduced wait times. The purpose of this study is to determine the feasibility of a clinical trial to evaluate the effects of integrating an APP into a chronic pain clinic setting. The primary objectives are as follows: (1) determine the feasibility of implementing trial methods by evaluating participant recruitment rates, retention, and assessment completion; (2) determine the feasibility of implementing the APP model of care by monitoring care provided and treatment fidelity; and (3) assess contextual factors that may influence implementation of the APP model of care by exploring the perspectives of patient participants and healthcare providers related to the model of care.MethodsThis will be a single-arm feasibility study with embedded qualitative interviews to assess contextual factors influencing implementation by exploring participant and provider perspectives. Approximately 40 adults with chronic musculoskeletal pain referred for care at an interprofessional chronic pain clinic will be invited to participate in the feasibility study. Approximately 10-12 patient participants and 5-10 health professionals from the interprofessional team will be interviewed using an interpretive description approach. The APP model of care will involve participants seeing a physiotherapist as the first point of contact within the interprofessional team. The APP will complete an initial assessment and make care recommendations. Outcome measures planned for the full trial will be reported descriptively, including pain severity, pain interference, health-related quality of life, psychosocial risk factors for chronic pain, treatment satisfaction, perceived change, healthcare utilization, and healthcare costs over one year.DiscussionThis study will inform plans to implement a full-scale study to evaluate the impact of an APP model of care in an interprofessional chronic pain management program. The results of the full study are intended to inform stakeholders considering this model to improve patient-centered and health system outcomes in interprofessional pain management program settings.Trial registrationClinicalTrials.gov, NCT05336903 (Registered April 5, 2022).

Dataset Information

U-PAIN cohort study among patients with chronic pain in specialised pain care: a feasibility study.

Objectives

Design

Participants and setting

Outcome measures

Results

Conclusions

Publications

U-PAIN cohort study among patients with chronic pain in specialised pain care: a feasibility study.

Similar Datasets

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