scholarly journals Work Ability After Anterior Cervical Decompression and Fusion Followed by a Structured Postoperative Rehabilitation: Secondary Outcomes of a Prospective Randomized Controlled Multi-Centre Trial with a 2-year Follow-up

2021 ◽  
Author(s):  
Anneli Peolsson ◽  
Johanna Wibault ◽  
Håkan Löfgren ◽  
Åsa Dedering ◽  
Birgitta Öberg ◽  
...  
Keyword(s):  
Work Ability ◽  
Postoperative Treatment ◽  
Secondary Outcome ◽  
Group Differences ◽  
Postoperative Rehabilitation ◽  
Multi Centre Study ◽  
Work Related ◽  
Randomized Controlled ◽  
Anterior Cervical Decompression

AbstractPurpose Information on work ability after ACDF and postoperative rehabilitation is lacking. The aim of the present study is therefore to investigate the work ability benefits of a structured postoperative treatment (SPT) over a standard care approach (SA) in patients who underwent anterior cervical decompression and fusion (ACDF) for cervical radiculopathy and factors important to the 2-year outcome. Methods Secondary outcome and prediction model of a prospective randomized controlled multi-centre study with a 2-year follow-up (clinicaltrials.gov NCT01547611). The Work Ability Index (WAI) and Work Ability Score (WAS) were measured at baseline and up to 2 years after ACDF in 154 patients of working age who underwent SPT or SA after surgery. Predictive factors for the WAI at 2 years were analysed. Results Both WAI and WAS significantly improved with SPT and SA (p < 0.001), without any between-group differences. Thoughts of being able to work within the next 6 months, Neck Disability Index (NDI), and work-related neck load explained 59% of the variance in WAI at the 2-year follow-up after ACDF. Conclusions Patients improved over time without group differences, suggesting the improvement to be surgery related. Expectation to work within the next 6 months, self-reported neck functioning and work-related neck load were important to work ability and are central factors to ask early after ACDF, to identifying further interventions promoting return to work.

The effects of vestibular rehabilitation on dizziness and balance problems in patients after traumatic brain injury: a randomized controlled trial

2018 ◽  
Vol 33 (1) ◽  
pp. 74-84 ◽  
Author(s):  
Ingerid Kleffelgaard ◽  
Helene Lundgaard Soberg ◽  
Anne-Lise Tamber ◽  
Kari Anette Bruusgaard ◽  
Are Hugo Pripp ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Vestibular Rehabilitation ◽  
Secondary Outcome ◽  
Group Differences ◽  
Randomized Controlled ◽  
Balance Problems

Objective: To investigate the effects of group-based vestibular rehabilitation in patients with traumatic brain injury. Design: A single-blind randomized controlled trial. Setting: University Hospital (recruitment and baseline assessments) and Metropolitan University (experimental intervention). Subjects: A total of 65 patients (45 women) with mild-to-moderate traumatic brain injury (mean age 39.4 ± 13.0 years) were randomly assigned to intervention ( n = 33) or control group ( n = 32). Intervention: Group-based vestibular rehabilitation for eight weeks. Participants were tested at baseline (3.5 ± 2.1 months after injury) and at two post-intervention follow-ups (2.7 ± 0.8 and 4.4 ± 1.0 months after baseline testing). Main measures: Primary outcome: Dizziness Handicap Inventory. Secondary outcome: High-Level Mobility Assessment Tool. Other outcomes: Vertigo Symptom Scale; Rivermead Post-concussion Symptoms Questionnaire; Hospital Anxiety and Depression Scale; and Balance Error Scoring System. Between-group differences were analyzed with a linear mixed-model analysis for repeated measurements. Results: At baseline, no group differences were revealed (personal factors, clinical characteristics and outcome measures). At the first follow-up, statistically significant mean differences in favor of the intervention were found in the primary (−8.7, 95% confidence interval (CI): −16.6 to −0.9) and secondary outcomes (3.7 points, 95% CI: 1.4–6.0). At the second follow-up, no significant between-group differences were found. No significant between-group differences in the other outcomes were found at the two follow-ups. Conclusion: The intervention appeared to speed up recovery for patients with dizziness and balance problems after traumatic brain injury. However, the benefits had dissipated two months after the end of the intervention.

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

Scapular exercise combined with cognitive functional therapy is more effective at reducing chronic neck pain and kinesiophobia than scapular exercise alone: a randomized controlled trial

2020 ◽  
Vol 34 (12) ◽  
pp. 1485-1496 ◽  
Author(s):  
Norollah Javdaneh ◽  
Amir Letafatkar ◽  
Sadredin Shojaedin ◽  
Malihe Hadadnezhad
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Pain Intensity ◽  
Effect Size ◽  
Controlled Trial ◽  
Chronic Neck Pain ◽  
Secondary Outcome ◽  
Group Differences ◽  
Functional Therapy ◽  
Randomized Controlled

Objective: The aim of this study was to compare the effectiveness of scapular exercises alone and combined with cognitive functional therapy in treating patients with chronic neck pain and scapular downward rotation impairment. Design: Single-blind randomized controlled trial. Setting: Outpatient. Subjects: A total of 72 patients (20–45 years old) with chronic neck pain were studied. Intervention: Allocation was undertaken into three groups: scapular exercise ( n = 24), scapular exercise with cognitive functional therapy ( n = 24) and control ( n = 24) groups. Each programme lasted three times a week for six weeks. Main outcomes: The primary outcome measure was pain intensity measured by the visual analogue scale scores. The secondary outcome measures included kinesiophobia and muscles activity. Results: Statistically significant differences in pain intensity were found when multidisciplinary physiotherapy group including a cognitive functional approach was compared with the scapular exercise alone group at six weeks (effect size (95% CI) = −2.56 (−3.32 to −1.80); P = 0.019). Regarding kinesiophobia, a significant between-group difference was observed at six-week (effect size (95% CI) = −2.20 (−2.92 to −1.49); P = 0.005), with the superiority of effect in multidisciplinary physiotherapy group. A significant between-group differences was observed in muscle activity. Also, there were significant between-group differences favouring experimental groups versus control. Conclusion: A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.

scholarly journals P374 Safety and drug survival of methotrexate versus tioguanine after failure of conventional thiopurines in patients with Crohn’s disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S390-S391
Author(s):  
E Savelkoul ◽  
M Maas ◽  
A Bourgonje ◽  
F Crouwel ◽  
M Russel ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Biological Treatment ◽  
Biological Therapy ◽  
Secondary Outcome ◽  
Multi Centre Study ◽  
Drug Survival ◽  
Elevated Liver Enzymes

Abstract Background Both methotrexate (MTX) and tioguanine (TG) can be considered as viable treatment options before initiating biological therapy following failure of conventional thiopurines for Crohn’s disease. It is unclear how safety and effectiveness compare for both therapies. This study aimed to compare tolerability and drug survival of MTX and TG therapy after failure of conventional thiopurines in patients with Crohn′s disease. Methods We conducted a retrospective, multi-centre study in five Dutch hospitals, including patients initiating MTX or TG for Crohn’s disease after failure (all causes) of conventional thiopurines. Patients with prior MTX or TG use, MTX or TG not primarily prescribed for Crohn’s disease, or patients receiving concomitant biological treatment at baseline were excluded. Follow-up duration from starting treatment was 104 weeks or until treatment discontinuation. Primary outcome was therapy discontinuation rate due to adverse events (AE). Secondary outcome was ongoing treatment without initiation of biological treatment. Results In total, 221 patients with failure of conventional thiopurines and subsequent therapy with either MTX (n=106) or TG (n=115) were included. Median follow-up was 89 weeks (IQR 28-104). Previous biological failure was present in 28 (26%) MTX and 17 (15%) TG treated patients (p=0.044). Sixty-four (29%) patients (MTX 41.5%, TG 17.4%, p&lt;0.001) discontinued their treatment due to AE during follow-up (Figure 1). Median time until discontinuation due to AE was 16.5 weeks (IQR 8.0–39.0) for MTX and 17.5 weeks (IQR 1.3–69.8) for TG (p=0.925). MTX use was associated with a significantly higher risk of treatment failure due to AE (OR 3.37 [95% CI 1.82–6.25] p&lt;0.001). Previous biological failure was not predictive for MTX or TG failure due to AE (OR 1.086, p=0.828). The most frequent discontinuation reasons were nausea for MTX (n=11) and abdominal pain for TG (n=4). In both groups, 8 (MTX 8%, TG 7%) serious adverse events (SAE) occurred. Infections comprised the majority of all SAE, 4 (50%) for MTX and 7 (88%) for TG. Discontinuation because of elevated liver enzymes occurred in 5 (11%) MTX and 4 (20%) TG treated patients. There were no cases of histological nodular regenerative hyperplasia, liver fibrosis, or cirrhosis. Initiation of concomitant biological therapy was not significantly different (MTX: n=26, TG: n=30, p=0.877). Total monotherapy drug survival after 104 weeks was 46% for TG and 25% for MTX (p&lt;0.001). Conclusion Forty-two percent of MTX, compared to 17% of TG treated patients, discontinued therapy due to AE in patients with Crohn’s disease with prior failure of conventional thiopurines. These data may aid in the selection of subsequent therapy after failure of conventional thiopurine therapy.

scholarly journals Effect of a Parent-Focused eHealth Intervention on Children’s Fruit, Vegetable, and Discretionary Food Intake (Food4toddlers): Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Margrethe Røed ◽  
Anine C Medin ◽  
Frøydis N Vik ◽  
Elisabet R Hillesund ◽  
Wendy Van Lippevelde ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Fruits And Vegetables ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Differences ◽  
Randomized Controlled ◽  
Ehealth Intervention ◽  
Child Age

BACKGROUND In western countries, children’s diets are often low in fruits and vegetables and high in discretionary foods. Diet in early life tends to track through childhood and youth and even into adulthood. Interventions should, therefore, be delivered in periods when habitual traits are established, as in toddlerhood when children adapt to their family’s diet. OBJECTIVE In this study, we assessed the effect of the Food4toddlers eHealth intervention, which aimed to enhance toddlers’ diets by shaping their food and eating environment. METHODS The Food4toddlers randomized controlled trial was conducted in Norway in 2017-2018. Parent-child dyads were recruited through social media. In total, 298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2). Postintervention questionnaires were completed immediately after the intervention (ie, follow-up 1; mean child age 17.8 months, SD 1.3) and 6 months after the intervention (ie, follow-up 2; mean child age 24.2 months, SD 1.9). The intervention was guided by social cognitive theory, which targets the linked relationship between the person, the behavior, and the environment. The intervention group (148/298, 49.7%) got access to the Food4toddlers website for 6 months from baseline. The website included information on diet and on how to create a healthy food and eating environment as well as activities, recipes, and collaboration opportunities. To assess intervention effects on child diet from baseline to follow-up 1 and from baseline to follow-up 2, we used generalized estimating equations and a time × group interaction term. Between-group differences in changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods were assessed. RESULTS At follow-up 1, a significant time × group interaction was observed for the frequency of vegetable intake (<i>P</i>=.02). The difference between groups in the change from baseline to follow-up 1 was 0.46 vegetable items per day (95% CI 0.06-0.86) in favor of the intervention group. No other significant between-group differences in dietary changes from baseline to follow-up 1 or follow-up 2 were observed. However, there is a clear time trend showing that the intake of discretionary foods increases by time from less than 1 item per week at baseline to more than 4 items per week at 2 years of age (<i>P</i>&lt;.001), regardless of group. CONCLUSIONS A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2. No other between-group effects on diet were observed. eHealth interventions of longer duration, including reminders after the main content of the intervention has been delivered, may be needed to obtain long-terms effects, along with tailoring in a digital or a personal form. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 92980420; https://doi.org/10.1186/ISRCTN92980420

scholarly journals Treating Depression Mindfully in a Day Hospital: a Randomised Controlled Pilot Study

Mindfulness ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 384-400 ◽  
Author(s):  
Alice E. Buxton ◽  
Carina Remmers ◽  
Hans-Peter Unger ◽  
Nicole Plinz ◽  
Johannes Michalak
Keyword(s):  
Pilot Study ◽  
Work Ability ◽  
Small Sample ◽  
Post Treatment ◽  
Day Hospital ◽  
Depression Severity ◽  
Work Related ◽  
Mindfulness Skills ◽  
Randomised Controlled

Abstract Objectives Recent preliminary evidence suggests that mindfulness-based programmes may be beneficial in the treatment of patients suffering from current depression. Due to the heterogeneity of patients with this diagnosis, a specialisation in treatment concepts for subgroups of patients may be beneficial. Methods This randomised controlled pilot study investigated the effectiveness of an eight-week mindfulness-based day hospital treatment for patients with current depression and work-related conflicts (MDT-DH) under naturalistic conditions. Eighty-one currently depressed patients with work-related conflicts were randomly assigned to either MDT-DH (including personalised psychopharmacological treatment if necessary) or a waitlist condition including a psychopharmacological consultation (PCC). Outcomes were assessed at post-treatment and at 8-month follow-up. The primary outcome was depression severity (Beck Depression Inventory) at post-treatment. Secondary outcomes were work ability (Work Ability Index) and mindfulness (Kentucky Inventory of Mindfulness Skills). Results A multilevel analysis revealed that compared with patients in PCC, patients in the MDT-DH group showed a greater reduction in depression severity, higher work ability and heightened levels of mindfulness after 8 weeks than patients in the PCC group. These improvements were stable during the 8-month follow-up period. Conclusions Findings of the present pilot study suggest that a treatment concept involving intensive training in mindfulness can be successfully established in a day hospital and leads to clinically meaningful reductions in depression severity and increases in work ability in patients suffering from current depression. The generalisability of the findings may be limited due to small sample size, selective patient group and study design.

Postoperative structured rehabilitation in patients undergoing surgery for cervical radiculopathy: a 2-year follow-up of a randomized controlled trial

2019 ◽  
Vol 31 (1) ◽  
pp. 60-69 ◽  
Author(s):  
Anneli Peolsson ◽  
Håkan Löfgren ◽  
Åsa Dedering ◽  
Birgitta Öberg ◽  
Peter Zsigmond ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Neck Disability Index ◽  
Clinical Signs ◽  
Cervical Radiculopathy ◽  
Postoperative Rehabilitation ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Negative Side Effects ◽  
Neck Disability

OBJECTIVEInformation about postoperative rehabilitation for cervical radiculopathy (CR) is scarce. The aim of this study was to investigate the additional benefits of structured postoperative rehabilitation (SPT), which was performed in all patients, compared with a pragmatic standard postoperative approach (SA), in which rehabilitation was used as needed and patients sought physiotherapy on their own without a referral, in patients with MRI evidence of disc herniation and concomitant clinical signs who underwent surgery for CR.METHODSPatients (n = 202) were randomized to receive SPT or SA. Included key variables in the present study were primary and selected secondary outcomes of a prospective randomized controlled multicenter study. The main outcome was the Neck Disability Index (NDI) score. The NDI score, pain variables, self-efficacy, and health-related quality of life were investigated at baseline and 3, 6, 12, and 24 months postoperatively.RESULTSSPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up. Both groups improved over time (p < 0.0001), with no reported adverse effects.CONCLUSIONSOne can conclude that SPT offered no additional benefits over SA; however, patients tolerated postoperative neck exercises without any negative side effects. These findings are important for the development of future active and neck-specific postoperative rehabilitation interventions for patients with CR.Clinical trial registration no.: NCT01547611 (clinicaltrials.gov)

The effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Leonieke W Kranenburg ◽  
Jamie Gillis ◽  
Birgit Mayer ◽  
Witte JG Hoogendijk
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Dutch Population ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

Ankle Lateral Ligament Augmentation Versus the Modified Broström-Gould Procedure: A 5-Year Randomized Controlled Trial

2019 ◽  
Vol 47 (3) ◽  
pp. 659-666 ◽  
Author(s):  
Mark Porter ◽  
Bruce Shadbolt ◽  
Xuan Ye ◽  
Robert Stuart
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Repair ◽  
Controlled Trial ◽  
Lateral Ligament ◽  
Inclusion Criteria ◽  
Postoperative Rehabilitation ◽  
Randomized Controlled ◽  
Ligament Augmentation ◽  
Ligament Instability

Background: “Ankle sprain” is a common injury, and >20% of patients may develop chronic instability for which surgery is indicated. The modified Broström-Gould (MBG) procedure remains the gold standard; however, there are a number of relative contraindications to this procedure, and the longer-term outcomes after the MBG have been questioned. An alternative procedure is augmentation of a primary repair with a ligament augmentation reconstruction system (LARS). Purpose: To conduct a randomized controlled trial testing the null-hypothesis that there is no difference in patient scored outcomes and activity levels, between patients undergoing a MBG procedure compared with those undergoing a primary repair with LARS augmentation, for lateral ligament instability of the ankle. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients who satisfied the inclusion criteria were invited to take part in the study. Patients were randomly allocated to undergo the LARS or MBG procedure. Both groups followed similar postoperative rehabilitation. Patients completed the Foot and Ankle Outcome Score (FAOS) before surgery and then at 1, 2, and 5 years after surgery. Tegner activity scores were recorded at 5years. The scores in the 2 groups were compared via statistical analysis ( P < .05). Results: Of the 50 patients satisfying the inclusion criteria, 47 agreed to take part in the study. Twenty-two were randomized to the LARS group and 25 to the MBG group. At 5 years, follow-up data were complete for 20 patients in the LARS group and 21 in the MBG. There were 2 failures in the MBG group and 0 in the LARS group. The LARS group had significantly better improvement in total FAOS at 1 year (mean ± SD, 92.4 ± 2.5 vs 78.2 ± 3.4, P = .005), 2 years (94.0 ± 3.0 vs 78.0 ± 5.2, P = .003), and 5 years (93.7 ± 6.0 vs 75.1 ± 5.5, P = .002) after surgery. The 5-year Tegner activity scores were higher in the LARS group (8.25 ± 1.1 vs 7.2 ± 0.9, P = .03). Conclusion: Among physically active patients with chronic lateral ligament instability, primary repair combined with LARS results in better total FAOS at 5-year follow-up and higher Tegner activity scores as compared with the MBG procedure. Registration: ACTRN12618000906257 (Australia New Zealand Clinical Trial Registry).

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