Randomized controlled trial investigating the effectiveness of a multimodal mobile application for the treatment of chronic pain
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SUBMITTER: Thomson C
PROVIDER: S-EPMC11340744 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
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Project description:Studies have shown that musculoskeletal pain is one of the most prevalent health conditions that affects many individuals worldwide. In older adults, persistent pain is a widely prevalent and a disabling condition of multiple contributing factors: physical, mental, and social. Consequently, their quality of life is hampered. We aimed to analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disabling in older adults. This is a randomized parallel study (two arms) with blinded outcome assessments. The participants' recruitment will be done by a non-probabilistic sampling resulting from invitations to Basic Health Units (BHU). The sample size estimation indicated 164 participants. Participants will be allocated, by means of a randomization process, to one of two groups (82 for each group): Experimental Group (multimodal circuit exercise) or Control Group (cycle of multidisciplinary lectures on pain and stretching exercise). All analyses will be processed using the RStudio software, with significance when a p-value of 2 tails is less than 5% (p<0.05). Statistical analysis will follow the intention to treat. Trial registration: ClinicalTrials.gov NCT04719130, January 20, 2021.
| S-EPMC9433943 | biostudies-literature
Project description:Active physiotherapy (APT) embraces a patient-centered approach, prioritizing self-management within the biopsychosocial model and involving active patient movements. Beyond structured exercise, APT incorporates pain neuroscience education, Mulligan Mobilization (MWM), and active myofascial release techniques to integrate sensory-motor information for functional recovery and pain relief. This study aims to rigorously compare the effectiveness of APT versus conventional physical therapy (CPT) on pain and functional outcomes in patients with chronic knee pain. Eighty-seven patients with symptomatic and radiographically confirmed knee pain were included in this 12-month follow-up of a randomized controlled trial, conducted at a national institute and a rehabilitation clinic. Patients were randomized to either APT (n = 44) or CPT (n = 43). The APT protocol integrated pain neuroscience education, MWM, active myofascial release techniques, and structured exercises focusing on flexibility, stability, neuromuscular control, and coordination. The CPT protocol included health education, laser therapy, ultrasound therapy, and exercise. Both interventions were performed for 60 min twice a week for 3 months. The primary outcome was the Knee Injury and Osteoarthritis Outcome Score-4 domain version (KOOS4). Secondary outcomes included pain intensity (VAS), KOOS-pain, activities of daily living (ADL), function in sport and recreation (Sports/Rec), knee-related quality of life, global rating of change (GROC), quality of life (SF-36), Tampa Scale for Kinesiophobia (TSK), and functional performances measured at different intervals. Intention-to-treat analyses were performed. Of the 87 patients, 70 (80.5%) completed the 12-month follow-up. KOOS4 improved more in the APT group (16.13; 95% CI, 10.39-21.88) than in the CPT group (11.23; 95% CI, 5.42-17.04). APT showed additional improvement in KOOS4 compared to CPT (2.94; 95% CI: 0.04 to 5.85, p = 0.047). The VAS difference was -3.41 mm (95% CI: -6.40 to -0.43, p = 0.025), favoring APT. APT also showed more improvements in KOOS-pain, KOOS-ADL, KOOS-Sports/Rec, and TSK (p < 0.05). No differences between groups were observed in GROC and SF-36. APT significantly improved most functional performance variables compared to CPT (p < 0.05). Active Physiotherapy outshines conventional physical therapy by delivering more substantial reductions in pain intensity and marked enhancements in function among patients with knee pain. This distinctive efficacy underscores the invaluable role of APT in the management of chronic knee pain. By actively involving patients in their recovery journey, APT not only fosters superior results but also emphasizes the critical need to integrate these advanced therapeutic strategies into everyday clinical practices.
| S-EPMC11614761 | biostudies-literature
Project description:BackgroundCombination therapies delivered remotely via the internet or mobile devices are increasingly being used to improve and promote the self-management of chronic conditions. However, little is known regarding the long-term effects of these interventions.ObjectiveThe aim of this study is to evaluate the effectiveness of a multimodal intervention program that measures associated variables such as catastrophizing, pain acceptance, and quality of life using a mobile device in people with chronic pain in an outpatient setting.MethodsA randomized controlled clinical trial was performed using parallel treatment groups. A total of 209 patients with chronic musculoskeletal pain were randomly assigned to one of the two study arms. The intervention group received a standard web-based psychosocial therapy-type program of activities through a smartphone for 6 weeks. The control group only had access to the Find out more section of the app, which contained audiovisual material for pain management based on a self-help approach. The primary outcome was catastrophizing measured using the Pain Catastrophizing Scale (PCS). Secondary outcomes were pain acceptance measured using the Chronic Pain Acceptance Questionnaire and health-related quality of life measured using the EuroQol Visual Analogue Scale. Assessments were conducted at baseline (T1), after treatment (T2), and at the 3-month follow-up (T3). The variations between the different phases were assessed using the percentage change rescaled with log base 2. The Cohen d was calculated based on the results of the linear mixed model. The investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to the group assignment.ResultsPositive effects were found in the intervention group (T2-T1) in catastrophizing between the baseline and posttreatment phases (P<.001) and in helplessness (-0.72 vs 0.1; P=.002), rumination (-1.59 vs -0.53; P<.001), acceptance (0.38 vs 0.05; P=.001), and quality of life (0.43 vs -0.01; P=.002), although no significant changes were found for magnification (0.2 vs 0.77; P=.14) and satisfaction with health (0.25 vs -0.27; P=.13). Three months after treatment, significant differences were observed in the intervention group for the outcome variable of catastrophizing (PCS; -0.59 vs 0.2; P=.006) and the PCS subscales of helplessness (-0.65 vs 0.01; P=.07), rumination (1.23 vs -0.59; P=.04), and magnification (0.1 vs 0.86; P=.02).ConclusionsThe results of our study suggest that app-based mobile multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. Moreover, they promote self-management and can be used to complement face-to-face pain treatments.Trial registrationClinicalTrials.gov NCT04509154; https://clinicaltrials.gov/ct2/show/NCT04509154.
| S-EPMC9133987 | biostudies-literature
Project description:IntroductionApproximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate a novel implementation strategy to maximize the public health impact of the intervention including the determination of adoption, reach, and sustainability of WebMAP in specialty clinics serving children with chronic pain in the United States.MethodsThis hybrid effectiveness-implementation cluster randomized controlled trial employs a stepped wedge design in which the WebMAP mobile intervention is sequentially implemented in 8 specialty pain clinics following a usual care period. This trial aims to enroll a minimum of 120 youth (ages 10-17) who have chronic pain. Outcome analyses will determine effectiveness of treatment on adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance.ConclusionsThis trial examines an innovative approach to evaluate a technology-delivered pain self-management program for youth with chronic pain. Findings are expected to yield a strategic approach for delivering a digital pain management program for youth with chronic pain that can be sustained in clinical settings. Clinical Trial Registration #: NCT03332563.
| S-EPMC7080266 | biostudies-literature
Project description:BackgroundWork disability involves large costs to the society as well as to the individual. Work disability is common among people with chronic pain conditions, yet few effective interventions exist. Individual Placement and Support (IPS) is an evidence-based work rehabilitation model originally developed to help people with severe mental illness obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but the model has never before been tested for patients with chronic pain.Methods/designThe aim of the IPS in Pain trial is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic. The study is a randomized controlled trial comparing pain treatment with integrated IPS to treatment as usual in unemployed patients suffering from various chronic pain conditions. The primary outcome of the study is labor market participation during 12 months after enrollment, and secondary outcomes include physical and mental health and well-being, collected at baseline, 6, and 12 months. Finally, there will be an additional long-term follow-up for the primary outcome, which will be collected through a brief phone interview at 24 months.DiscussionThe IPS in Pain trial will be the first report of the effectiveness of the IPS model of supported employment applied in an outpatient setting for chronic pain patients. It will thus provide important information about the effectiveness of repurposing IPS to a new patient group in great need of job support.Trial registrationClinicaltrials.gov: NCT02697656 . Registered January 15th, 2016.
| S-EPMC5809966 | biostudies-literature
Project description:We hypothesized that seminal plasma, the acellular seminal fluid component, influences the endometrium stimulating the immune system and facilitating the implantation. We designed a randomized, double-blinded, placebo-controlled trial, and we used microarray analysis to evaluate differences in the endometrial transcriptomic profile after vaginal seminal plasma application. Differential gene pathways analysis showed an upregulation of pathways associated with the immune response, cell viability, proliferation and cellular movement, implantation, embryo development, oocyte maturation and angiogenesis. We compared our results with similar studies in pigs, mice and in vitro human endometrial cells and found similar and found comparable results. Our data show that seminal plasma has a positive effect on the endometrium during the implantation window.
2024-04-24 | GSE241134 | GEO
Project description:BackgroundChronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.ObjectiveThe aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.MethodsAn unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.ResultsOnly 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up-characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=-2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=-3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).ConclusionsThis study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.Trial registrationClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762.
| S-EPMC7592067 | biostudies-literature
Project description:BackgroundChronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with CMP compared with care as usual.Methods/designPragmatic multicentre parallel group randomized controlled trial. Randomization by minimization (ratio 1:1) and treatment allocation will be concealed, computer-generated and performed by an independent organization. After randomization, data collection and researchers remain blinded. Inclusion of 124 adolescents and their parents is intended. This sample size is based on a 25 % difference in group mean on the primary outcome, with α = 5 %, β = 80 % and expected 15 % loss to follow up. Study population are adolescents (12-21 years) with CMP with an indication for outpatient rehabilitation treatment in the Netherlands. The intervention group receives a Multimodal Rehabilitation Program (MRP), a multidisciplinary outpatient individual rehabilitation program. MRP consists of 2 different treatment approaches: A graded exposure module or a combination module of graded exposure and physical training. Selection of a module depends on the needs of the patient. To both modules a parent module is added. The control group receives care as usual, which is the care currently provided in Dutch rehabilitation centres. Treatment duration varies between 7 and 16 weeks, depending on treatment allocation. Self-reported measurements are at baseline, and at 2, 4, 10 and 12 months after start of treatment. Intention to treat analysis for between group differences on all outcome variables will be performed. Primary outcome is functional disability (Functional Disability Inventory). Secondary outcome variables are fear of pain, catastrophizing, perceived harmfulness, pain intensity, depressive symptoms, and quality of life. Total direct and indirect costs and health related quality of life will be measured. Process evaluation focuses on protocol adherence, patient centeredness and treatment expectations.DiscussionA pragmatic approach was chosen, to ensure that results obtained are most applicable to daily practice.Trial registrationClinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante.
| S-EPMC4964076 | biostudies-literature
Project description:ObjectivesOpioids and non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for chronic musculoskeletal pain, despite limited evidence of effectiveness and well-documented adverse effects. We assessed the effects of participating in a structured, personalized self-experiment ("N-of-1 trial") on analgesic prescribing in patients with chronic musculoskeletal pain.MethodsWe randomized 215 patients with chronic pain to participate in an N-of-1 trial facilitated by a mobile health app or to receive usual care. Medical records of participating patients were reviewed at enrollment and 6 months later to assess analgesic prescribing. We established thresholds of ≥ 50, ≥ 20, and > 0 morphine milligram equivalents (MMEs) per day to capture patients taking relatively high doses only, patients taking low-moderate as well as relatively high doses, and patients taking any dose of opioids, respectively.ResultsThere was no significant difference between the N-of-1 and control groups in the percentage of patients prescribed any opioids (relative odds ratio (ROR) = 1.05; 95% confidence interval [CI] = 0.61 to 1.80, p = 0.87). There was a clinically substantial but statistically not significant reduction of the percentage of patients receiving ≥ 20 MME (ROR = 0.58; 95% CI = 0.33 to 1.04, p = 0.07) and also in the percentage receiving ≥ 50 MME (ROR = 0.50; 95% CI = 0.19 to 1.34, p = 0.17). There was a significant reduction in the proportion of patients in the N-of-1 group prescribed NSAIDs compared with control (relative odds ratio = 0.53; 95% CI = 0.29 to 0.96, p = 0.04), with no concomitant increase in average pain intensity. There was no significant change in use of adjunctive medications (acetaminophen, gabapentenoids, or topicals).DiscussionThese exploratory results suggest that participation in N-of-1 trials may reduce long-term use of NSAIDs; there is also a weak signal for an effect on use of opioids. Additional research is needed to confirm these results and elucidate possible mechanisms.Trial registrationClinicalTrials.gov Identifier: NCT02116621.
| S-EPMC6957655 | biostudies-literature
Project description:BackgroundCognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated.ObjectiveThis study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing.MethodsThis study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility.ResultsIn the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (P=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (-1.43, 95% CI -2.49 to -0.37, df=24; P=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (-9.42, 95% CI -14.47 to -4.36, df=25; P=.001) and in disability by using the Pain Disability Assessment Scale (-1.95, 95% CI -3.33 to -0.56, df=24; P=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained.ConclusionsThe findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size.Trial registrationUniversity Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb.
| S-EPMC8663446 | biostudies-literature