Improvement In Pain Interference Research Articles

The Benefits of an Integral HAMMAM Experience Combining Hydrotherapy and Swedish Massage on Pain, Subjective Well-Being and Quality of Life in Women with Endometriosis-Related Chronic Pelvic Pain: A Randomized Controlled Trial

Background and Objectives: To evaluate the effectiveness of an integral HAMMAM experience, a 4-week therapeutic program that combined hydrotherapy and Swedish massage, applied in a multisensorial immersive environment, on pain, well-being and quality of life (QoL) in women with endometriosis-related chronic pelvic pain that is unresponsive to conventional treatment. Materials and Methods: This randomized controlled trial included 44 women with endometriosis. They were randomly allocated to either the ‘HAMMAM’ group (n = 21) or to a control group (n = 23). The primary outcome, pain intensity, was evaluated using numeric rating scales (NRSs). The secondary outcomes were pain interference, pain-related catastrophic thoughts, pressure pain thresholds (PPTs), subjective well-being, functional capacity and QoL, which were evaluated using the brief pain inventory (BPI), the pain catastrophizing scale (PCS), algometry, the subjective well-being scale-20 (EBS-20), the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) and the Endometriosis Health Profile-30 Questionnaire (EHP-30), respectively. The primary and secondary outcomes were measured at the baseline and after the intervention. The statistical (between-group analyses of covariance) and clinical effects were analyzed by the intention to treat. Results: The adherence rate was 100.0% and the mean (± standard deviation) satisfaction was 9.71 ± 0.46 out of 10. No remarkable health problems were reported during the trial. The ‘HAMMAM’ intervention improved dysmenorrhea and dyspareunia after the intervention with large and moderate effect sizes, respectively. Improvements in pain interference during sleep and PPTs in the pelvic region were also observed in women allocated to the ‘HAMMAM’ group. No effects were observed in catastrophizing thoughts, well-being nor QoL, except for the sleep subscale. Conclusions: A 4-week program of an integral ‘HAMMAM’ experience combining hydrotherapy and massage in a multisensorial immersive environment is a feasible and effective intervention to alleviate pain during menstruation and sexual intercourse as well as pain interference with sleep in women with endometriosis.

Improvements in Pain Interference among Geographically Diverse Adults with Neurofibromatosis: Results from a Fully-Powered Randomized Controlled Trial

Abstract Background Pain is prevalent among adults with Neurofibromatoses (NF) and hinders quality of life. Pain management for NF is predominantly pharmacological and often ineffective. Psychosocial treatments improve pain outcomes in other chronic illness populations but have not been developed and tested in fully powered efficacy trials among adults with NF. Using data from a fully powered RCT of an 8-week mind-body program (Relaxation Response Resiliency Program for NF [3RP-NF]) versus a health education control (HEP-NF), we examined: 1) improvements in pain intensity and pain interference, and 2) mechanisms underlying improvements. Methods Participants (N=210, Mage=42.6, 73.4% female) were randomized to 3RP-NF vs HEP-NF. They completed measures of pain intensity, pain interference, and putative mechanisms (e.g., mindfulness, coping, and social support) at baseline, post-intervention, 6-month, and 12-month follow-up. Results There was a statistically significant change in pain interference over time F(3, 537.06)=7.21, p<.001, but not pain intensity. Neither group (3RP-NF vs. HEP-NF) nor the group-by-time interaction predicted change in pain interference. While the group-by-time interaction was not statistically significant across all time points, planned post-hoc analyses probing the interaction at specific time points revealed a statistically significant decrease in pain interference from baseline to post-intervention (p<.001), which was sustained (i.e., no subsequent change) from post-intervention through 6-month (p=1.00) and 12-month follow-ups (p=1.00) in the 3RP-NF group. The HEP-NF group had no significant changes in pain intensity or interference over time. The association between group (3RP-NF) and decreased pain interference from baseline to post-intervention was fully mediated by change in coping over the same period. Conclusions Participation in the 3RP-NF is associated with sustained improvement in pain interference. Improvement occurred through increased coping.

Outcomes after selective nerve root blockade for lumbar radicular pain from lumbar disc hernia or lumbar spinal stenosis assessed by the PROMIS-29 – a prospective observational cohort study

PurposeSelective nerve root blocks (SNRB) are used both as a therapeutic and diagnostic tool for lumbar radicular pain. Most studies evaluate the effect of SNRB simply by its relation to pain reduction. It is well known that pain is associated with other factors such as depression, anxiety, inactivity and sleeping disorders, but these patient-related outcomes are seldom evaluated. This study evaluated the influence of SNRB on pain-related outcomes including depression, anxiety, fatigue, pain interference, activity and sleep.MethodsOne hundred three patients with lumbar radicular pain were treated with a SNRB. Patient-reported outcome measures (PROMs) were assessed with the PROMIS-29 for 12 weeks (84 days) following the SNRB. Patients were stratified based on their pain reduction at the 14-day follow up as responders (≥ 30% pain reduction) and non-responders (< 30% pain reduction). Post-treatment duration was estimated with the Kaplan–Meier analysis with return to baseline as an event. A paired t-test was used to compare pre- and post-treatment responses at specific time intervals.ResultsForty-four percent (n = 45) of the patients were responders and showed significant improvement in all parameters throughout the 84-days follow-up, the exception was sleep that lost significance at day 70. The mean post-treatment duration among responders was 59 (52–67) days. Non-responders showed significant improvements in pain interference and pain intensity until day 35 and in ability for social participation until 21-day.ConclusionSNRB can improve pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance and the ability to participate in social roles.

Impact of Medical Cannabis on Recovery from Playing-Related Musculoskeletal Disorders in Musicians: An Observational Cohort Study.

Playing-related musculoskeletal disorders (PRMDs) are musculoskeletal symptoms that interfere with the ability to play at the level a musician is accustomed to. Musicians have an 84% lifetime prevalence of PRMD. Many types of analgesia are inappropriate for this population due to their risks, but cannabidiol (CBD) has been shown to have anti-inflammatory properties and can reduce the perception of pain. Medical cannabis has also been shown to be safer than other analgesia in terms of serious adverse events. This study explores the impact of medical cannabis for PRMD on perceptions of pain and mental health outcomes. Participants (n = 204) completed questionnaires at baseline and six months: the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM) and Depression, Anxiety and Stress Scale (DASS-21). Participants self-selected their group: non-cannabis users (n = 42), new medical cannabis users (n = 61), and long-term medical cannabis users (n = 101). Data were analyzed using paired t-tests for within-group and ANOVA for between-group differences. At six months, there was no difference (p = 0.579) in cannabidiol dose between new (24.87 ± 12.86 mg) and long-term users (21.48 ± 12.50 mg). There was a difference in tetrahydrocannabinol (THC) dose (p = 0.003) between new (3.74 ± 4.22 mg) and long-term users (4.41 ± 5.18 mg). At six months, new cannabis users had a significant reduction in pain intensity as measured by The Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM40) (p = 0.002). Non-users (p = 0.035), new users (p = 0.002), and long-term cannabis users (p = 0.009) all had significant reductions in pain interference (MPIIQM50) at six months. At six months, non-cannabis (p = 0.022) and long-term cannabis users (p = 0.001) had an improvement in DASS-21. The change in pain intensity was the only difference between groups, F(2, 201) = 3.845, p = 0.023. This difference was between long-term (0.83 ± 0.79) and new users (-2.61 ± 7.15). No serious adverse events occurred, and a minority experienced tiredness, cough, and dry mouth. This practice-based evidence demonstrated that the multidimensional approach to care provided by the Musicians' Clinics of Canada benefited all groups at six months. Medical cannabis significantly reduced pain intensity in new users of medical cannabis with PRMD, and all groups saw improvements in pain interference. In keeping with prior studies, medical cannabis seems to be effective at reducing perceptions of pain, including for PRMD. CBD/THC dosing was within guideline recommendations, and no patients experienced any serious adverse events. Limitations include multiple factors impacting patients' decisions to opt in or out of medical cannabis. These include cost, comorbidities, and disease chronicity. In conclusion, medical cannabis reduces pain intensity in new users, and when combined with a multidimensional approach to care, patients with PRMD can see improvements in pain as well as mental wellbeing.

Study protocol for the Treating Opioid Patients' Pain and Sadness (TOPPS) study — A randomized control trial to lower depression and chronic pain interference, and increase care retention among persons receiving buprenorphine

BackgroundPersons receiving prescription buprenorphine for opioid use disorder experience high rates of comorbid conditions such as chronic pain and depression, which present barriers to buprenorphine care retention. This paper describes the protocol of the TOPPS (Treating Opioid Patients' Pain and Sadness) study, which compares a values-based, behavioral activation intervention with a health education contact-control condition, with the aim of decreasing chronic pain and depression, and increasing buprenorphine care retention for persons with opioid use disorder. MethodsThis randomized controlled trial (RCT) enrolls and randomizes up to 250 participants currently being treated with buprenorphine to receive three months of either TOPPS, a six-session phone-based behavioral intervention, or a health education (HE) control condition. We compare the TOPPS intervention to HE on the following outcomes: 1) pain interference and pain severity over the 3-month treatment phrase; 2) depressive symptoms over the 3-month treatment phase; and 3) sustained improvements in pain interference, depressive symptoms, and buprenorphine treatment retention over the 12-month study period. We also examine mechanisms by which the intervention may reduce pain interference. DiscussionThis RCT explores a novel intervention to address chronic pain and depression for individuals receiving buprenorphine in office-based settings. TOPPS may lead to improved pain, depression, and substance use outcomes, and can utilize providers available within buprenorphine programs, broadening the disseminability of this intervention and heightening its public health impact. Clinical Trial#NCT03698669

Medical Cannabis for Patients Over Age 50: A Multi-site, Prospective Study of Patterns of Use and Health Outcomes

Objective: Cannabis is being used as a therapeutic option by patients around the globe, and older patients represent a rapidly growing subset of this population. This study aims to assess the patterns of medical cannabis use in patients over 50 years of age and its effect on health outcomes such as pain, sleep, quality of life, and co-medication. Method: The Medical Cannabis in Older Patients Study (MCOPS) is a multi-site, prospective observational study examining the real-world impact of medical cannabis use on patients over age 50 under the guidance of a health care provider. The study included validated instruments, with treating physicians collecting detailed data on participant characteristics, medical cannabis and co-medication use, and associated impacts on pain, sleep, quality of life, as well as adverse events. Results: Inclusion criteria were met by 299 participants. Average age of participants was 66.7 years, and 66.2% of respondents identified as female. Approximately 90% of patients used medical cannabis to treat pain-related conditions such as chronic pain and arthritis. Almost all patients reported a preference for oral cannabis products (e.g., extracts, edibles) rather than inhalation products (e.g., flower, vapes), and most preferred oral formulations high in cannabidiol and low in tetrahydrocannabinol. Over the six-month study period, significant improvements were noted in pain, sleep, and quality of life measures, with 45% experiencing a clinically meaningful improvement in pain interference and in sleep quality scores. Additionally, nearly 50% of patients taking co-medications at baseline had reduced their use by the end of the study period, and quality of life improved significantly from baseline to M3 and from baseline to M6, with an incremental cost per quality-adjusted life-year (QALY) of $25,357.20. No serious adverse events (SAEs) were reported. Conclusions: In this cohort of older patients, most of whom suffered from pain-related conditions, medical cannabis seemed to be a safe and effective treatment. Most patients experienced clinically significant improvements in pain, sleep, and quality of life and reductions in co-medication. The cost per QALY was well below the standard for traditional pharmaceuticals, and no SAEs were reported, suggesting that cannabis is a relatively safe and cost-effective therapeutic option for adults dealing with age-related health conditions.

Implementation of an integrated primary care prevention and management program for chronic low back pain (LBP): patient-reported outcomes and predictors of pain interference after six months

BackgroundIntegrated primary care programs for patients living with chronic pain which are accessible, interdisciplinary, and patient-centered are needed for preventing chronicity and improving outcomes. Evaluation of the implementation and impact of such programs supports further development of primary care chronic pain management. This study examined patient-reported outcomes among individuals with low back pain (LBP) receiving care in a novel interdisciplinary primary care program.MethodsPatients were referred by primary care physicians in four regions of Quebec, Canada, and eligible patients received an evidence-based interdisciplinary pain management program over a six-month period. Patients were screened for risk of chronicity. Patient-reported outcome measures of pain interference and intensity, physical function, depression, and anxiety were evaluated at regular intervals over the six-month follow-up. A multilevel regression analysis was performed to evaluate the association between patient characteristics at baseline, including risk of chronicity, and change in pain outcomes.ResultsFour hundred and sixty-four individuals (mean age 55.4y, 63% female) completed the program. The majority (≥ 60%) experienced a clinically meaningful improvement in pain intensity and interference at six months. Patients with moderate (71%) or high risk (81%) of chronicity showed greater improvement in pain interference than those with low risk (51%). Significant predictors of improvement in pain interference included a higher risk of chronicity, younger age, female sex, and lower baseline disability.ConclusionThe outcomes of this novel LBP program will inform wider implementation considerations by identifying key components for further effectiveness, sustainability, and scale-up of the program.

The efficacy of multimodal physiotherapy and usual care in chronic whiplash-associated disorders with facet-mediated pain undergoing platelet rich plasma (PRP) treatment: a series of single case experimental designs (SCEDs)

Purpose Chronic whiplash-associated disorders (WAD) is a heterogeneous condition with limited effective treatment options available. This study evaluated the efficacy of multimodal physiotherapy and usual care in chronic WAD with facet-mediated pain receiving platelet-rich plasma (PRP) injections to determine if pain interference and confidence completing activities in the presence of neck pain could be improved. Materials and methods A multiple-baseline, single-case experimental design was used to evaluate the 6-week effect of physiotherapy or usual care in two groups of three participants each. Results All six participants demonstrated a significant reduction in pain interference, and three participants showed improved confidence to perform daily activities when in pain. Weighted Tau-U demonstrated a significant reduction of pain interference with large to very large effect sizes (> 0.75) for both interventions in all participants irrespective of treatment allocation with no significant group difference demonstrated. Similar effects were demonstrated for the confidence to perform daily activities with neck pain (ES > 0.46), although this was only evident in three participants (two PT and one UC). Generalisation measures also showed improvements in pain and disability, psychological and quality of life outcomes. No adverse events were reported. Conclusions Both physiotherapy and usual care demonstrated improvements in pain interference and confidence to perform activities of daily living with neck pain in people with chronic WAD following cervical facet joint PRP. Trial Registration The trial was registered with ClinicalTrials.gov (Protocol Number: NCT03949959).

The interrelationship between pain, life satisfaction and mental health in adults with traumatic spinal cord injury, in the context of a developing country

Study designCross-sectional, analytical study design using a conveneient sampling strategy.ObjectivesTo examine the interrelationship between pain, life satisfaction and indices of negative mental well-being amongst the traumatic spinal cord injury (TSCI) population.SettingWestern Cape Rehabilitation Center in Cape Town, South Africa.MethodsParticipants (n = 70) were adults (mean age of 36.3, SD = 9.2) with TSCI. Participants completed the following instruments: 10 satisfaction items from the World Health Organization Quality of Life Brief Version, short forms of the Center for Epidemiological Studies Depression Scale and the trait scale of the State-Trait Anxiety Inventory, a one-item measure of pain intensity taken from the International Spinal Cord Injury Pain Basic Data Set and the interference scale of the Brief Pain Inventory.ResultsCorrelational analysis (Pearson r) demonstrated that all the indices of mental well-being as well as the two indices of pain was significantly negatively related to life satisfaction. In addition, life satisfaction mediated the relationship between pain intensity and depression as well as anxiety. Life satisfaction only mediated the relationship between pain interference and depression but not anxiety.ConclusionsAn improvement in life satisfaction may lead to improvements in pain interference, pain intensity as well as psychological distress, amongst persons suffering from TSCI Future research should focus on assessing measures/treatment which may improve life satisfaction in the TSCI population.

Online Chair Yoga and Digital Learning for Rural Underserved Older Adults at Risk for Alzheimer’s Disease and Related Dementias

ABSTRACT Objectives We evaluated the feasibility and preliminary efficacy of a home-based online chair yoga (OCY) program for racially and ethnically diverse rural community-dwelling older adults. Methods We randomly assigned participants to OCY or a computer brain game (CBG). After a computer literacy training led by high school students, participants engaged in remotely supervised OCY or CBG in twice-weekly 45-minute sessions for 12 weeks. Outcome data (pain interference, cognitive function, mobility, computer skills) were collected at baseline, post-intervention, and 3-month follow-up. Results A total of 32 eligible residents with mean age of 71 years participated in this intervention study. The interventions were feasible (100% recruitment rate, 96.8% retention rate, 100% safety rate). There were significant improvements in pain interference, cognitive function, mobility, and computer skills from baseline to follow-up among participants in both OCY and CBG but no significant differences in outcomes between groups. Conclusions Preliminary results indicated that the CBG was as effective as online OCY in clinical outcomes in these participants. However, this should be confirmed in future studies. Clinical Implications This telehealth-based intervention is feasible for older adults in rural and digitally underserved communities and could provide a strategy for delivering health-promoting interventions for home-bound older adults at risk for Alzheimer’s disease and related dementias (ADRD) and connect caregivers to online resources.

Transcranial Direct Current Stimulation combined with Physiotherapy in the control of Chronic Pelvic Pain: a case report

INTRODUCTION: Chronic Pelvic Pain (CPP) is a non-menstrual pain condition of intense pain that can cause dysfunctions in some aspects such as quality of life, sexual function, among others. OBJECTIVES: To evaluate the effects of transcranial direct current stimulation (tDCS) on pain, as well as pelvic floor functionality, sexual dysfunction and quality of life in a patient with CPP. METHODS AND MATERIALS: This is a case report of patients with significant CPP who underwent tDCS for 5 consecutive days, targeting the dorsolateral prefrontal cortex (DLFPC) at 2mA for 20 minutes, in combination with physiotherapy. Pain scales, a sexual function questionnaire, pelvic floor muscle function and quality of life measures were used for evaluation. RESULTS: There was a 62.06% improvement in pain intensity and a 22.91% improvement in pain interference. The average pain score decreased from 10 at the start of the intervention (D0) to 3 in the first week (D1) and 6 in the second week (D2) of post-intervention menstruation. Regarding sexual function, the results were 31.2 at D0, 31.8 at D1 and 29.3 at D2. Improvement was observed in pelvic floor muscle strength, endurance, and repetitions at D1 and D2, although there was a decrease in strength compared to D2. The average scores for domains of quality of life were as follows: physical (55.95), psychological (59.72), social relationships (69.44) and environment (82.29). CONCLUSION: tDCS positively affected pain management and pelvic floor muscle function in the patient. However, there were no significant gains observed in other domains.

Age differences in acceptance and commitment therapy for chronic pain

ObjectiveChronic pain is prevalent and debilitating, especially among older adults. Acceptance and commitment therapy (ACT) is an evidence-based treatment for chronic pain that, in a prior study, has shown greater benefit among older adults. Critical questions remain regarding the time course and extent of age differences in ACT for chronic pain. The current study sought to inform clinical decision-making by addressing these remaining questions. MethodsThis study reanalyzed data from a prior trial of ACT for chronic pain in US Veterans. We estimated piecewise latent curve models to capture the time course of change in pain intensity, pain interference, pain acceptance, and depression during and after ACT. Then, we examined age as a moderator of longitudinal effects and used pick-a-point models to generate age-specific trajectory predictions. ResultsOlder age was associated with significantly greater improvement in pain intensity (p = .003) and marginally greater improvement in pain interference (p = .078) at posttreatment. However, during the six-month follow-up period, older adults relapsed on these outcomes (ps ≤ .029), whereas younger adults maintained their gains or even continued to improve. Older age was only marginally associated with greater depression improvement during the intervention (p = .069), and other moderation effects on depression and pain acceptance were nonsignificant. ConclusionOlder adults may experience greater initial improvement than younger adults during ACT for chronic pain. However, older adults may then need adjunctive maintenance treatment. Future studies are needed to characterize the mechanisms driving this moderation effect.

Feasibility and preliminary efficacy of the Balance Program to reduce pain-related disability in pediatric sickle cell disease.

Sickle cell disease (SCD) pain is associated with functional impairment, and treatment is often limited to pharmacological approaches with unwanted side effects. Although behavioral interventions exist for non-SCD pain populations, interventions designed to address pain-related impairment in SCD are lacking. Twenty youth (9-17 years) with SCD completed a four-week telemedicine pain intervention (NCT04388241). Participants and caregivers completed baseline and post-intervention PROMIS pain measures and the Treatment Evaluation Inventory-Short Form (TEI-SF). Descriptive analyses assessed feasibility and acceptability. Reliable Change Index analyses assessed for significant post-intervention changes in pain functioning. Paired t test analyses compared baseline and post-intervention opioid prescription fills. All participants completed at least one treatment session. Eighteen (90%) youth completed all sessions. Youth (100%) and caregivers (94%) rated the intervention as moderately or highly acceptable on the TEI-SF. Forty-seven percent of caregivers and 44% of youth reported reliably significant improvements in pain interference after the intervention (median T-score differences: 24.8 and 23.5, respectively). Sixty-five percent of caregivers (T-score improvement difference: 19.3) and 31% of youth (T-score improvement difference: 32) reported improvements in pain behaviors. There was no significant difference in opioid prescription fills pre- and post-intervention (P>0.05). The Balance Program is feasible, highly acceptable, and can be delivered remotely to reduce barriers to care. Approximately half of youth and caregivers reported significant declines in pain interference following the intervention, with substantial improvements in functioning for treatment responders. Behavioral pain interventions are important adjunctive treatments to uniquely address functional impairment associated with acute and chronic pain in SCD.

Yoga is effective for treating chronic pain in veterans with Gulf War Illness at long-term follow-up

BackgroundClinical Practice Guidelines for Gulf War Illness (GWI) recommend integrative health approaches such as yoga for relief from symptoms, yet little is known about the long-term efficacy of yoga in reducing symptoms of GWI. Here, we evaluated the long-term efficacy of yoga and cognitive-behavioral therapy (CBT) chronic pain treatment in a randomized controlled trial (RCT) of 75 Veterans (57 men, 42–71 ± 7.1 years of age) with Gulf War Illness (GWI).MethodsParticipants received either 10 weeks of yoga or 10 weeks of CBT for chronic pain. The primary outcome measures were pain severity, and pain interference (Brief Pain Inventory-Short Form). The secondary outcome measures were fatigue, as indicated by a measure of functional exercise capacity (6-Minute Walk Test), depression, autonomic symptom severity, and quality of life. Piecewise linear mixed models were used to examine study hypotheses.ResultsCompared to the CBT group, yoga was associated with greater reductions in pain severity during the 6-month follow-up period (group × time interaction: b = 0.036, se = 0.014, p = .011). Although we did not find between-group differences in the other primary or secondary outcome measures during follow-up (p’s > 0.05), exploratory analyses revealed within-group improvements in pain interference, total pain (an experimental outcome variable which combines pain severity and interference), and fatigue in the yoga group (p’s < 0.05) but not in the CBT group.ConclusionsThis is the first study to report long-term follow-up results of yoga as a treatment for GWI. Our results suggest that yoga may offer long-term efficacy in reducing pain, which is a core symptom of GWI.Trial registrationSecondary analyses of ClinicalTrials.gov NCT02378025.

The effect of elexacaftor/tezacaftor/ivacaftor on non-pulmonary symptoms in adults with cystic fibrosis

BackgroundElexacaftor/Tezacaftor/Ivacaftor (ETI) is a CFTR modulator that has led to large benefits in lung function, pulmonary exacerbation rates, and respiratory symptoms. Less is known about the effect of ETI on non-pulmonary symptoms. The objective of this study was to examine the changes in patient reported outcomes after starting ETI in multiple non-pulmonary symptoms. MethodsThis was a prospective cohort study of adults with CF. Participants completed questionnaires prior to starting ETI and then at weeks 2, 4, 6, 8, 10, 12, and 14 after starting ETI. They completed the following validated instruments: PROMIS Pain Intensity, PROMIS Pain Interference, FACIT Fatigue, SNOT22, PAC-SYM, PHQ8, GAD7 and Pittsburgh Sleep Quality Index. Longitudinal changes for outcomes were modelled using linear regression based on general estimating equations. Results22 participants enrolled who answered questionnaires before and after starting ETI. The median age was 35.3 years (IQR 11.1) and 13 (59.1%) were male. In models adjusted for age, sex, and baseline value there were significant improvements in pain interference (β = −2.57; 95% CI -4.92, −0.23), sinus symptoms (β = −4.50; 95% CI -7.59, −1.41), and sleep disturbance (β = −1.90; 95% CI -2.71, −1.09) over 14 weeks after starting ETI. No symptom areas worsened over the study period. ConclusionsIn this prospective study we found statistically significant improvements in three different non-pulmonary symptom areas in people with CF started on ETI. While this was a small, uncontrolled study it suggests that use of highly effective CFTR modulators can result in benefits for patients beyond pulmonary symptoms.

Do baseline patient reported outcome measures predict changes in self-reported function, following a chronic pain rehabilitation programme?

Background Interdisciplinary pain management programmes, based on cognitive-behavioural principles, aim to improve physical and psychological functioning and enhance self-management in people living with chronic pain. Currently there is insufficient evidence about whether psychological, biological or social factors are predictive of positive outcomes following pain rehabilitation. This study aims to evaluate predictors of change in Brief Pain Inventory – pain interference score (BPI) in a clinical data set to determine whether age, sex and baseline outcome measures are predictive of improvement in pain interference following pain rehabilitation. Methods A retrospective, pragmatic observational analysis of routinely collected clinical data in two pain rehabilitation programmes, Balanced Life Programme (BLP) and Get Back Active (GBA) was conducted. Standard regression and hierarchical regression analyses were used to identify predictors of change to assess temporal changes in BPI. Responder analysis was also conducted. Results Standard regression analyses of 208 (BLP) and 310 (GBA) patients showed that higher baseline BPI and better physical performance measures predicted better improvement in BPI across both programmes. Hierarchical regression showed that age and sex accounted for 2.7% (BLP) and 0.002% (GBA) of the variance in change in BPI. After controlling for age and sex, the other measures explained an additional 23% (BLP) and 19% (GBA) of the variance, p = &lt; .001 where BPI and physical performance measures were consistently statistically significant predictors, p &lt; .05. Responder analysis also showed that pain interference and physical performance were significantly associated with improvement ( p = &lt; .0005). Conclusions The combination of high self-reported pain interference and better physical performance measures may be a useful indicator of who would benefit from interdisciplinary rehabilitation. Further validation of the results is required.

The effectiveness of progressive muscle relaxation technique in reducing cancer-related pain among palliative care patients: A randomized controlled trial.

Cancer-related pain (CRP) is a common and distressing symptom experienced by many patients receiving palliative care. The purpose of this trial was to evaluate the effectiveness of the progressive muscle relaxation (PMR) technique in reducing CRP in patients receiving palliative care. A total of 148 patients diagnosed with cancer and receiving palliative care were randomly allocated to either an intervention or control group. The intervention group received a 4-week daily course of PMR technique, while the control group received only usual care. Data was collected using a demographic and clinical characteristics form, as well as the Brief Pain Inventory (BPI). Blind evaluations were conducted prior to the start of the intervention (T0), at the end of the 4-week PMR intervention (T1), and at 1-month follow-up (T2). The results of this trial demonstrated a significant decrease in pain intensity scores for the PMR group compared to the control group at both T1 and T2 (p < 0.05). Furthermore, the PMR group also exhibited significant improvements in pain interference with general activity, mood, relations with others, sleep, and enjoyment of life scores compared to the control group at both T1 and T2 (p < 0.05). The results of this trial suggest that the PMR technique may be an effective intervention for reducing pain intensity and improving pain interference with life activities in cancer patients receiving palliative care. However, further research is needed to provide more robust evidence for the effectiveness of this intervention.Clinical trial registration number: NCT04436705. Registered at ClinicalTrials.gov.

Efficacy of Videoconference Group Acceptance and Commitment Therapy (ACT) and Behavioral Activation Therapy for Depression (BATD) for Chronic Low Back Pain (CLBP) Plus Comorbid Depressive Symptoms: A Randomized Controlled Trial (IMPACT Study)

This study examined the efficacy of adding a remote, synchronous, group, videoconference-based form of acceptance and commitment therapy (ACT) or behavioral activation therapy for depression (BATD) to treatment-as-usual (TAU) in 234 patients with chronic low back pain (CLBP) plus comorbid depressive symptoms. Participants were randomly assigned to ACT, BATD, or TAU. Compared to TAU, ACT produced a significant reduction in pain interference at posttreatment (d = .64) and at follow-up (d = .73). BATD was only superior to TAU at follow-up (d = .66). A significant reduction in pain catastrophizing was reported by patients assigned to ACT and BATD at posttreatment (d = .45 and d = .59, respectively) and at follow-up (d = .59, in both) compared to TAU. Stress was significantly reduced at posttreatment by ACT in comparison to TAU (d = .69). No significant between-group differences were found in depressive or anxiety symptoms. Clinically relevant number needed to treat (NNT) values for reduction in pain interference were obtained at posttreatment (ACT vs TAU = 4) and at follow-up (ACT vs TAU = 3; BATD vs TAU = 5). In both active therapies, improvements in pain interference at follow-up were significantly related to improvements at posttreatment in psychological flexibility. These findings suggest that new forms of cognitive-behavioral therapy are clinically useful in improving pain interference and pain catastrophizing. Further research on evidence-based change processes is required to understand the therapeutic needs of patients with chronic pain and comorbid conditions. Trial numberNCT04140838. PerspectiveGroup videoconference-based ACT and BATD showed greater efficacy than TAU for reducing pain interference and pain catastrophizing in patients with CLBP plus clinically relevant depression. Psychological flexibility appeared to be the main contributor to treatment effects for both ACT and BATD.

Impact of Sleep Disturbance on Clinical Outcomes in Lumbar Decompression.

To examine the impact of Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (PROMIS-SD) on clinical outcomes in patients undergoing lumbar decompression. Patients undergoing lumbar decompression with preoperative PROMIS-SD scores were retrospectively included. Patients were separated into 2 cohorts: none to slight sleep disturbance (PROMIS-SD <55) and mild to severe sleep disturbance (PROMIS-SD ≥55). Patient-reported outcome measures including PROMIS Physical Function, PROMIS Anxiety, PROMIS Pain Interference, PROMIS SD, 9-item Patient Health Questionnaire, visual analog scale back/leg, and Oswestry Disability Index were collected preoperatively and up to 1 year postoperatively. Of 87 patients identified, 48 patients had PROMIS-SD scores ≥55. Regardless of preoperative PROMIS-SD score, patients reported significant improvement in physical function, anxiety, pain interference, depression, pain, and disability outcomes in at least 1 time point. Patients in the PROMIS-SD ≥55 cohort reported postoperative improvement in sleep disturbance. Patients in the PROMIS-SD <55 cohort reported superior preoperative patient-reported outcome measures in all domains and superior postoperative improvement in pain interference and sleep disturbance. Minimum clinically important difference attainment rates were higher in the PROMIS-SD ≥55 cohort in physical function, anxiety, pain interference, sleep disturbance, and pain. Patients undergoing lumbar decompression demonstrated significant postoperative improvement in most clinical outcomes regardless of preoperative sleep disturbance. Patients with mild to severe sleep disturbance had higher minimum clinically important difference attainment rates for physical function, mental function, and pain. Patients undergoing lumbar decompression with greater preoperative sleep disturbance may experience more clinically noticeable improvement.

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis.

Objective: To investigate the safety and effectiveness of medical cannabis (MC) in the real-world clinical practice setting. Design: A 4-year prospective noncomparative registry of adult patients who initiated MC for a variety of indications. This paper reports on patients followed for up to 12 months, with interim visits at 3, 6, and 9 months after enrollment. Setting: Public or private outpatient clinics certified to authorize MC in the province of Quebec, Canada. Participants: Overall, 2991 adult (age ≥18 years) patients (mean age 51 years; 50.2% women) were enrolled between May 2015 and October 2018, with the last follow-up ending in May 2019. Interventions/Exposures: Cannabis products (dried, oil, or other) purchased from a Canadian licensed cannabis producer as authorized by physicians. Main Outcome Measures: The primary outcomes were self-reported pain severity, interference and relief (Brief Pain Inventory [BPI]), symptoms using the Revised Edmonton Symptom Assessment System (ESAS-r) and health-related quality of life dimensions (EQ-5D-5L) at baseline and each follow-up visit. The secondary outcomes were self-reported adverse events (AEs) and characteristics of cannabis treatment. Results: All patient-reported outcomes (BPI, ESAS-r, and EQ-5D-5L) showed a statistically significant improvement at 3 months (all p<0.01), which was maintained or further improved (for pain interference, tiredness, and well-being) over the remainder of the 12-month follow-up. Results also revealed clinically significant improvements in pain interference and tiredness, anxiety, and well-being from baseline. There were 79 AE reports (77 patients), 16 met the regulatory definition of seriousness, in which only 8 AEs were certainly or probably related to MC. Conclusions: MC directed by physicians appears to be safe and effective within 3 months of initiation for a variety of medical indications.