scholarly journals An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Louise Fleng Sandal ◽  
Mette Jensen Stochkendahl ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Cecilie K Øverås ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Low Back ◽  
Current Case ◽  
Randomized Controlled

BACKGROUND Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. OBJECTIVE The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. METHODS This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. RESULTS The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. CONCLUSIONS This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. CLINICALTRIAL ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14720

scholarly journals An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

10.2196/14720 ◽  
2019 ◽  
Vol 8 (12) ◽  
pp. e14720 ◽  
Author(s):  
Louise Fleng Sandal ◽  
Mette Jensen Stochkendahl ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Cecilie K Øverås ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Low Back ◽  
Current Case ◽  
Randomized Controlled

Background Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. Conclusions This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. Trial Registration ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288 International Registered Report Identifier (IRRID) DERR1-10.2196/14720

The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial

2018 ◽  
Vol 32 (9) ◽  
pp. 1249-1257 ◽  
Author(s):  
David Cruz-Díaz ◽  
Marta Romeu ◽  
Carmen Velasco-González ◽  
Antonio Martínez-Amat ◽  
Fidel Hita-Contreras
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Analogue Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Low Back ◽  
Randomized Controlled ◽  
Disability Questionnaire

Objective: To assess the effectiveness of 12 weeks of Pilates practice on disability, pain and kinesiophobia in patients with chronic non-specific low back pain. Design: This is a randomized controlled trial. Setting: This study was conducted in the university laboratory. Subjects: A total of 64 participants with chronic non-specific low back pain were included. Interventions: Participants were randomly allocated to intervention group consisted in Pilates intervention during 12 weeks ( n = 32) or control group who received no treatment ( n = 32). Main measures: Disability, pain and kinesiophobia were assessed by Roland Morris Disability Questionnaire, visual analogue scale and Tampa Scale of Kinesiophobia, respectively. Measurements were performed at baseline, at 6 and 12 weeks after study completion. Results: There were significant differences between groups with observed improvement in Pilates intervention group in all variables after treatment ( P < 0.001). Major changes on disability and kinesiophobia were observed at six weeks of intervention with no significant difference after 12 weeks ( P < 0.001). Mean changes of the intervention group compared with the control group were 4.00 (0.45) on the Roland Morris Disability Questionnaire and 5.50 (0.67) in the Tampa Scale of Kinesiophobia. Pain showed better results at six weeks with a slightly but statistically significant improvement at 12 weeks with Visual Analogue Scale scores of 2.40 (0.26) ( P < 0.001). Conclusion: Pilates intervention in patients with chronic non-specific low back pain is effective in the management of disability, pain and kinesiophobia.

scholarly journals Efficacy Of A Multidimensional Versus Usual Care Physiotherapy On Pain And Electroencephalography (EEG) Spectrum In Chronic Nonspecific Low Back Pain: Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Sanaz Bemani ◽  
Shohreh Noorizadeh Dehkordi ◽  
Javad Sarrafzadeh ◽  
Saeed Talebian ◽  
Reza Salehi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Usual Care ◽  
Controlled Trial ◽  
Biomechanical Model ◽  
Clinical Findings ◽  
Control Group ◽  
Low Back ◽  
Randomized Controlled

Abstract Background: Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on biopsychosocial approach compared to usual care physiotherapy, on clinical findings and Electroencephalography spectrum in non-specific chronic low back pain.Methods: This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4-months follow-up. 70 NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy), each group will receive 6-weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion and psychosocial correlates. Assessment will be performed at baseline, post-treatment and at 1- and 4-months follow-up.Discussion: Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain.Trial registration: ClinicalTrials.gov Identifier: NCT04270422, Registered 17 February 2020, https://clinicaltrials.gov/ct2/show/NCT04270422?term=NCT04270422&draw=2&rank=1IRCT Identifier: IRCT20140810018754N11

scholarly journals App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation (Preprint)

2020 ◽  
Author(s):  
Charlotte Diana Nørregaard Rasmussen ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Barbara I Nicholl ◽  
Frances S Mair ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Mixed Methods ◽  
Usual Care ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Self Management ◽  
Low Back ◽  
Randomized Controlled

BACKGROUND Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. OBJECTIVE This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. METHODS The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. RESULTS The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. CONCLUSIONS This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. CLINICALTRIAL ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20308

scholarly journals App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation

10.2196/20308 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e20308
Author(s):  
Charlotte Diana Nørregaard Rasmussen ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Barbara I Nicholl ◽  
Frances S Mair ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Mixed Methods ◽  
Usual Care ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Self Management ◽  
Low Back ◽  
Randomized Controlled

Background Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. Objective This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. Methods The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. Results The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. Conclusions This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. Trial Registration ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288 International Registered Report Identifier (IRRID) DERR1-10.2196/20308

Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pain Assessment ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

scholarly journals Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Lu Zhang ◽  
Howard L McLeod ◽  
Ke-Ke Liu ◽  
Wen-Hui Liu ◽  
Hang-Xing Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Pain Management ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Scores

BACKGROUND Self-management of ambulatory cancer pain is full of challenges. Motivated by the need for better pain management, we developed a WeChat-supported platform, Medication Housekeeper (MediHK), to enhance communication, optimize outcomes, and promote self-management in the home setting. OBJECTIVE We conducted a randomized controlled trial to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain. METHODS Patients were randomly assigned to either an intervention group or control group. During the 4-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every 3 days, and the Brief Pain Inventory form every 15 days to patients in the intervention group via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the control group received conventional care and did not receive reminders to fill out the forms. However, if the control group patients filled out a form via MediHK, the pain management team would review and respond in the same way as for the intervention group. The primary outcomes included pain intensity and pain interference in daily life. Secondary outcomes included patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates. RESULTS A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group. The worst pain scores, least pain scores, and average pain scores in the intervention group and the control group were statistically different, with median values of 4 (IQR 3-7) vs 7 (IQR 6-8; <i>P</i>=.001), 1 (IQR 0-2) vs 2 (IQR 1-3; <i>P</i>=.02), and 2 (IQR 2-4) vs 4 (IQR 3-5; <i>P</i>=.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationships with others, and interests was reduced, but the difference was not statistically significant compared with the control group (<i>Ps</i>=.10-.76). The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (<i>P</i>&lt;.001). The overall number of ADRs increased at 4 weeks, and more ADRs were monitored in the intervention group (<i>P</i>=.003). Rehospitalization rates were similar between the 2 groups. CONCLUSIONS The joint physician-pharmacist team operating through MediHK improved pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900023075; https://www.chictr.org.cn/showproj.aspx?proj=36901

scholarly journals Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Sarina Francescato Torres ◽  
Ana Carolina Brandt de Macedo ◽  
Mateus Dias Antunes ◽  
Ingred Merllin Batista de Souza ◽  
Francisco Dimitre Rodrigo Pereira Santos ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Controlled Trial ◽  
Adult Population ◽  
Control Group ◽  
Supporting Evidence ◽  
Low Back ◽  
Randomized Controlled

Abstract Background Low back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults. Objective The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP. Methods A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low, high, and alternating frequency); one control group; and one placebo group. The electroacupuncture will be applied twice a week (30 min per session) for five weeks. The primary clinical outcome measure will be pain intensity. The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed up after six and 12 months to check the medium- and long-term effects. Discussion Although electroacupuncture is increasingly used to treat LBP, there is no guidance regarding the parameters used, which leads to inconsistent results. Thus, the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies, especially in the older adult population. Conclusion This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults. This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population. Trial registration Clinicaltrials.gov, NCT03802045. Registered on 14 January 2019.

Does Dynamic Taping Affect Pain, Endurance, Disability, Mobility, and Kinesiophobia in Individuals with Chronic Nonspecific Low Back Pain? A Randomized Controlled Trial

2021 ◽  
pp. 47
Author(s):  
Kanagaraj Rengaramanujam
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Control Group ◽  
Low Back ◽  
Short Term ◽  
Randomized Controlled ◽  
Pain Disability

Introduction: Evidence suggests that the application of Kinesio tape (KT) on patients with chronic nonspecific low back pain (CNLBP) is inconclusive. Dynamic tape (DT) is a relatively new treatment technique, which is increasingly being used as an adjunctive method to treat musculoskeletal problems. To the best of our knowledge, no study has investigated the application of DT in individuals with CNLBP. Thus, there is a need to compare the immediate and short-term effects of DT versus KT and no tape among patients with CNLBP on pain, endurance, disability, mobility, and kinesiophobia. Methodology: Forty-five patients with CNLBP were randomly divided into three groups: the DT group (n = 15), the KT group (n = 15), and the control group (n = 15). No tape was applied to the control group. The allocation and assessment procedures were blinded. The outcome measures were assessed before the tape application (baseline), 15 min after the tape application (immediate effect), and on the third day post tape application (short-term effect). The primary outcomes of pain, endurance, and disability were measured through the visual analog scale (VAS), Biering–Sorensen test, and Oswestry disability index (ODI), respectively. Secondary outcome measures of mobility and kinesiophobia were measured using the modified Schober test and the Tampa Scale of Kinesiophobia, respectively. Result: The demographic and baseline characteristics between groups were compared by the one-way analysis of variance (ANOVA) for parametric variables and the Chi-square test for nonparametric variables. A mixed-methods ANOVA (3 ´ 3) was used to analyze the main effect (group effect and time effect) and time ´ group interaction. No significant immediate and short-term differences were found between DT and KT in pain, disability, mobility, and kinesiophobia. Improved back extensor endurance was observed for the DT group compared to the KT (p = 0.023) and control (p = 0.006) groups. Conclusion: This randomized controlled trial showed that the DT does not have a significant additional effect on pain, disability, mobility, and kinesiophobia among individuals with CNLBP compared to KT. However, participants experienced significant improvement in back muscular endurance after the application of DT. This finding suggests that DT controls the processes that lead to back muscle fatigue. Therefore, more studies are required to examine the therapeutic benefits of DT in treating patients with CNLBP.

A randomized controlled trial of a brief educational and psychological intervention for patients presenting to a cardiac clinic with palpitation

2002 ◽  
Vol 32 (4) ◽  
pp. 699-706 ◽  
Author(s):  
R. MAYOU ◽  
D. SPRIGINGS ◽  
J. BIRKHEAD ◽  
J. PRICE
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Number Needed To Treat ◽  
Treatment Needs ◽  
Randomized Controlled

Background. We sought to determine whether a brief psycho-educational intervention reduced disability in patients with benign palpitation.Method. In a pragmatic randomized controlled trial within a cardiology clinic at a district general hospital, 80 consecutive patients diagnosed as having benign palpitation – either palpitation due to awareness of extrasystoles or sinus rhythm – with associated distress or disability were randomized to an intervention group (usual care plus nurse-delivered intervention based on cognitive-behavioural principles) or to a control group (usual care). Principal outcome was difference in proportion of participants with good or excellent researcher-rated activity levels at 3 months. Subsidiary outcomes were self-rated symptoms, distress and disability, researcher-rated unmet treatment needs.Results. The principal outcome showed a statistically and clinically significant benefit for the intervention group, with a number needed to treat of 3 (95% CIs 2 to 7). All but one subsidiary outcomes also showed a difference in favour of the intervention group, and several differences reached statistical significance. Significantly more of the control group had unmet treatment needs at 3 months.Conclusions. A brief, nurse-delivered, psycho-educational intervention, was an effective treatment for benign palpitation. Further evaluation, including assessment of cost-effectiveness, is needed. The findings have application to the care of patients presenting with other types of ‘unexplained’ medical symptoms.

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