Dataset Information

Early Effects of a Pain-Informed Movement Program in Patients with Post-COVID-19 Condition Experiencing Persistent Pain: Protocol for a Randomized Controlled Trial.

ABSTRACT: (1) Background: The COVID-19 pandemic has generated 771 million confirmed cases. Of these patients, 60% have developed persistent symptoms including pain. This pain is a complex symptom that needs comprehensive therapeutic strategies to address it holistically. The main objective of this study will be to evaluate the early impact of the Pain Informed Movement (PIM) program in patients with post-COVID-19 conditions experiencing new-onset persistent pain. (2) Methods: A randomized, single-blind clinical trial will be performed. Patients will be randomly assigned (1:1) to the experimental or control group. The experimental group will undergo a PIM program consisting of low-intensity functional exercises, pain neuroscience education, and relaxation techniques. The control group will receive no intervention. (3) Results: The results will be published as a peer-reviewed article. (4) Conclusions: This study will provide a basis for future research to support the implementation of comprehensive therapeutic approaches in the care of patients with post-COVID-19 persistent pain.

SUBMITTER: Calvache-Mateo A

PROVIDER: S-EPMC10816970 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Early Effects of a Pain-Informed Movement Program in Patients with Post-COVID-19 Condition Experiencing Persistent Pain: Protocol for a Randomized Controlled Trial.

Calvache-Mateo Andrés A López-López Laura L Heredia-Ciuró Alejandro A Martín-Núñez Javier J Valenza-Peña Geraldine G Cabrera-Martos Irene I Valenza Marie Carmen MC

Journal of clinical medicine 20240120 2

(1) Background: The COVID-19 pandemic has generated 771 million confirmed cases. Of these patients, 60% have developed persistent symptoms including pain. This pain is a complex symptom that needs comprehensive therapeutic strategies to address it holistically. The main objective of this study will be to evaluate the early impact of the Pain Informed Movement (PIM) program in patients with post-COVID-19 conditions experiencing new-onset persistent pain. (2) Methods: A randomized, single-blind cl ...[more]

PMID: 38276103

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Project description:BackgroundPersistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction.ObjectiveThe purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function.DesignAn assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted.SettingThe study will be conducted in a community setting.ParticipantsThe participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA.InterventionParticipants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention.MeasurementsOutcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks.LimitationsA self-reported diagnosis of persistent hip pain will be used.ConclusionsThe findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision.

Project description:ImportancePost-COVID-19 condition (PCC) is emerging as a common and debilitating condition with few treatment options.ObjectiveTo assess the effectiveness of a brief outpatient rehabilitation program based on a cognitive and behavioral approach for patients with PCC.Design, setting, and participantsPatients with mild to moderate PCC were randomized 1:1 to an established transdiagnostic rehabilitation program or care as usual at a single referral center recruiting from the region of the South-Eastern Norway Regional Health Authority. Participants were followed up after treatment completion and 12 months after enrollment using participant-reported outcome measures. Data were collected from February 22, 2022, until April 15, 2024. Intention-to-treat analysis was performed.InterventionThe program consisted of 2 to 8 outpatient encounters with approximately 2 to 6 weeks between each encounter. The intervention was theoretically grounded in the cognitive activation theory of stress, and physicians and physiotherapists were trained in cognitive and behavioral approaches with targeted negative stimuli and response outcome expectancies being particularly important.Main outcomes and measuresParticipant-reported physical function assessed by the Short-Form Health Survey 36 Physical Function Subscale (SF-36-PFS) served as the primary outcome. Secondary outcome measures were the remaining subscales of the SF-36, return to work self-efficacy and symptom scores on fatigue, postexertional malaise, breathlessness, cognitive difficulties, sleep problems, anxiety and depression symptoms, and smell and taste abnormalities. Safety measures included primary health care contacts; hospital admissions; initiation of pharmacologic and/or nonpharmacologic therapy; occurrence of novel disease, illness, or other health problems; worsening of selected key symptoms; working abilities; and thoughts of suicide.ResultsA total of 473 patients with mild to moderate PCC were assessed for eligibility (n = 364 physician referred; n = 109 self-referred); 314 were included (225 females [72%]; mean [SD] age, 43 [12] years) and 231 completed the primary end point evaluation. The SF-36-PFS scores improved statistically and clinically significantly in the intervention group (score difference between groups, 9.2; 95% CI, 4.3-14.2; P < .001; Cohen d = 0.43; intention-to-treat analysis). The effect was sustained over time. Most secondary and safety measures favored the intervention.Conclusions and relevanceIn this randomized clinical trial, a brief outpatient rehabilitation program with a cognitive and behavioral approach in patients with PCC was effective and safe. This trial adds to the evidence supporting such interventions in routine clinical care. Future research should investigate which elements of this approach are the most effective and identify subgroups for which the current treatment is most relevant.Trial registrationClinicalTrials.gov Identifier: NCT05196451.

Project description:BackgroundA consistently demonstrated overlap exists between the occurrence of domestic violence and child maltreatment, yet these issues are historically addressed by distinct systems and programming. The randomized control trial pilot study presented in this article adapts, implements, and tests a new approach for addressing family violence for Latinx families with co-occurring risk for domestic violence and child maltreatment. In doing so, this pilot study addresses the clear need for collaboration between the two fields and focuses on Latinx families, who often face specific challenges regarding seeking and receiving needed services. The primary aim of the current study is a pilot implementation of SafeCare+®, an evidence-based parenting curriculum (SafeCare®) augmented with a healthy relationships curriculum (SafeCare+®). The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.MethodsThis protocol outlines a feasibility, randomized control trial to examine the potential efficacy of SafeCare+. The pilot study is divided into two phases. Components of phase one involve developing a detailed implementation and evaluation plan, including a community needs assessment, determining screening and outcome measures, and assuring all components are culturally appropriate for the target population. Phase two implements the randomization of parents, who are involved in the child welfare system and referred for in-home parenting services, into SafeCare+ or SafeCare as usual. Participants complete assessments regarding mental health, provider-parent relationship, interpersonal violence experiences, and fidelity to the intervention. Analyses will focus on improvement on target outcomes for the intervention group, as well as comparison to the control group.DiscussionThis study will provide evidence on the feasibility and potential effectiveness of an early intervention program aimed at improving communication skills and mental health and reducing incidents of violence for Latinx parents who are involved with the child welfare service system. The findings of the study will inform the decision to progress to a full scale, definitive randomized control trial to test the effectiveness of an intervention, delivered as part of home visitation, for improving outcomes for families with histories of domestic violence.Trial registrationClinicalTrials.gov, NCT03041558; registered 2 February, 2017-retrospectively registered.

Dataset Information

Early Effects of a Pain-Informed Movement Program in Patients with Post-COVID-19 Condition Experiencing Persistent Pain: Protocol for a Randomized Controlled Trial.

Publications

Early Effects of a Pain-Informed Movement Program in Patients with Post-COVID-19 Condition Experiencing Persistent Pain: Protocol for a Randomized Controlled Trial.

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