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1.  Enhanced function and quality of life following 5 months of exercise therapy for patients with irreparable rotator cuff tears – an intervention study 
Rotator cuff rupture is associated with dysfunction, pain and muscular weakness related to the upper extremity. Some evidence exists to support the beneficial effect of exercises but there is lack of evidence of which exercises imply the best effect and how physiotherapy should be administered. Therefore, the purpose of this study was to examine the effect of a neuromuscular exercise program for patients with irreparable rotator cuff rupture.
Based on sample-size calculations thirty patients with chronic irreparable rotator cuff tears (of at least m. supraspinatus and m. infraspinatus) was consecutively included. Twenty-four patients completed the five months training to restore function with focus on centering the humeral head in the glenoid cavity trough strengthening m. deltoideus anterior and m. teres minor. The primary outcome measure was Oxford Shoulder Score which was completed at baseline, 3 and 5 months follow-up. One-way, repeated-measure ANOVA was used if data was normally distributed. Secondary outcome measures included EQ-5D, range of motion, strength and muscle activity. Paired t-test and Wilcoxon Signed Ranks Test was used to the appropriate outcomes.
Improvements was seen for both primary and secondary outcomes from baseline to follow-up. Oxford Shoulder Score improved from 25.6 (SD 8.1) at baseline to 33.8 (SD 8.7) at 3 months (p = 0.004) and 37.2 (SD 8.2) at five months (p < 0.001). Range of motion in abduction significantly increased by 34.4° (95 % CI: 11.6–57.2). Strength measured in flexion 45, flexion 90 and abduction also significantly increased at 5 months by 10.2 (95 % CI: 0.8–19.6), 7.0 (95 % CI: 0.0–14.0) and 12.3 (95 % CI: 3.4–21.3) respectively. The remaining outcomes for range of motion and strengths only showed small and non-significant changes. Furthermore patients reported higher levels of quality of life and reduced level of pain after five months.
Following a five months exercise protocol patients with irreparable rotator cuff tears showed increased function in their symptomatic shoulder, reduced pain and increased quality of life. This study therefore supports the use of exercise therapy in patients with irreparable rotator cuff rupture.
Trial registration
This study is approved by The National Committee on Health Research Ethics (N-20120040) and registered retrospectively at in April 2016 (NCT02740946).
Electronic supplementary material
The online version of this article (doi:10.1186/s12891-016-1116-6) contains supplementary material, which is available to authorized users.
PMCID: PMC4898474  PMID: 27278468
Rotator cuff rupture; Conservative management; Rehabilitation; Exercise therapy; Tendon injuries
2.  The design of the run Clever randomized trial: running volume, −intensity and running-related injuries 
Injury incidence and prevalence in running populations have been investigated and documented in several studies. However, knowledge about injury etiology and prevention is needed. Training errors in running are modifiable risk factors and people engaged in recreational running need evidence-based running schedules to minimize the risk of injury. The existing literature on running volume and running intensity and the development of injuries show conflicting results. This may be related to previously applied study designs, methods used to quantify the performed running and the statistical analysis of the collected data. The aim of the Run Clever trial is to investigate if a focus on running intensity compared with a focus on running volume in a running schedule influences the overall injury risk differently.
The Run Clever trial is a randomized trial with a 24-week follow-up. Healthy recreational runners between 18 and 65 years and with an average of 1–3 running sessions per week the past 6 months are included. Participants are randomized into two intervention groups: Running schedule-I and Schedule-V. Schedule-I emphasizes a progression in running intensity by increasing the weekly volume of running at a hard pace, while Schedule-V emphasizes a progression in running volume, by increasing the weekly overall volume. Data on the running performed is collected by GPS. Participants who sustain running-related injuries are diagnosed by a diagnostic team of physiotherapists using standardized diagnostic criteria. The members of the diagnostic team are blinded. The study design, procedures and informed consent were approved by the Ethics Committee Northern Denmark Region (N-20140069).
The Run Clever trial will provide insight into possible differences in injury risk between running schedules emphasizing either running intensity or running volume. The risk of sustaining volume- and intensity-related injuries will be compared in the two intervention groups using a competing risks approach. The trial will hopefully result in a better understanding of the relationship between the running performed and possible differences in running-related injury risk and the injuries developed.
Trial registration
Clinical Trials NCT02349373 – January 23, 2015.
PMCID: PMC4842282  PMID: 27107810
Running; Musculoskeletal pain; Leg injuries; Athletic injuries; Recreational runners; Running schedule; Injury prevention; Running-related Injuries; Running volume; Running intensity
3.  Tourniquet induced ischemia and changes in metabolism during TKA: a randomized study using microdialysis 
Tourniquet use in total knee arthroplasty (TKA) surgery is applied to minimize blood loss thereby creating better overview of the surgical field. This induces ischemia in the skeletal muscle resulting in reperfusion injury. Our aim was to investigate the in vivo metabolic changes in the skeletal muscle during TKA surgery using microdialysis (MD).
Seventy patients were randomly allocated to tourniquet group (n = 35) or non-tourniquet group (n = 35). Prior to surgery, catheters were inserted in the operated leg and non-operated leg. Interstitial dialysate was collected before and after surgery and at 20 min intervals during a 5 h reperfusion period. Main variables were ischemic metabolites: glucose, pyruvate, lactate and glycerol and L/P ratio.
Significant difference in all metabolites was detected between the two groups, caused by tourniquet application. Tourniquet induced ischemia resulted in decreased levels of glucose and pyruvate to 54 and 60 % respectively, compared to baseline. Simultaneously, accumulation of lactate to 116 % and glycerol to 190 % was observed. L/P ratio was elevated indicating ischemia.
In the non-tourniquet group the metabolite changes were less profound and normalized within 60 min.
Microdialysis revealed that performing TKA with tourniquet is associated with increased ischemia. This affects all metabolites but the changes are normalized after 5 h
PMCID: PMC4625433  PMID: 26510621
Microdialysis; Tourniquet; Ischemia; Metabolism; TKA; RCT
4.  Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial 
Trials  2015;16:27.
Shoulder pain is the third most common musculoskeletal disorder, often affecting people’s daily living and work capacity. The most common shoulder disorder is the subacromial impingement syndrome (SIS) which, among other pathophysiological changes, is often characterised by rotator cuff tendinopathy. Exercise is often considered the primary treatment option for rotator cuff tendinopathy, but there is no consensus on which exercise strategy is the most effective. As eccentric and high-load strength training have been shown to have a positive effect on patella and Achilles tendinopathy, the aim of this trial is to compare the efficacy of progressive high-load exercises with traditional low-load exercises in patients with rotator cuff tendinopathy.
The current study is a randomised, participant- and assessor-blinded, controlled multicentre trial. A total of 260 patients with rotator cuff tendinopathy will be recruited from three outpatient shoulder departments in Denmark, and randomised to either 12 weeks of progressive high-load strength training or to general low-load exercises. Patients will receive six individually guided exercise sessions with a physiotherapist and perform home-based exercises three times a week. The primary outcome measure will be change from baseline to 12 weeks in the patient-reported outcome Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
Previous studies of exercise treatment for SIS have not differentiated between subgroups of SIS and have often had methodological flaws, making it difficult to specifically design target treatment for patients diagnosed with SIS. Therefore, it was considered important to focus on a subgroup such as tendinopathy, with a specific tailored intervention strategy based on evidence from other regions of the body, and to clearly describe the intervention in a methodologically strong study.
Trial registration
The trial was registered with (NCT01984203) on 31 October 2013.
PMCID: PMC4318133  PMID: 25622594
Shoulder; Impingement; Tendinopathy; Exercise; Rotator cuff
5.  Faster recovery without the use of a tourniquet in total knee arthroplasty 
Acta Orthopaedica  2014;85(4):422-426.
Background and purpose
Tourniquet application is still a common practice in total knee arthroplasty (TKA) surgery despite being associated with several adverse effects. We evaluated the effects of tourniquet use on functional and clinical outcome and on knee range of motion (ROM).
Patients and methods
70 patients who underwent TKA were randomized into a tourniquet group (n = 35) and a non-tourniquet group (n = 35). All operations were performed by the same surgeon and follow-up was for 1 year. Primary outcomes were functional and clinical outcomes, as evaluated by KOOS and knee ROM. Secondary outcomes were intraoperative blood loss, surgical time and visibility, postoperative pain, analgesic consumption, and transfusion requirements.
Patients in the non-tourniquet group showed a better outcome in all KOOS subscores and better early knee ROM from surgery to week 8. No difference was detected at the 6- and 12-month follow-ups. Postoperative pain and analgesic consumption were less when a tourniquet was not used. Surgical time and visibility were similar between groups. Intraoperative blood loss was greater when not using a tourniquet, but no postoperative transfusions were required.
This study shows that TKA without the use of a tourniquet results in faster recovery in terms of better functional outcome and improved knee ROM. Furthermore, reduced pain and analgesic use were registered and no intraoperative difficulties were encountered.
PMCID: PMC4105775  PMID: 24954487
6.  A Prospective Study on Time to Recovery in 254 Injured Novice Runners 
PLoS ONE  2014;9(6):e99877.
Describe the diagnoses and the time to recovery of running-related injuries in novice runners.
Prospective cohort study on injured runners.
This paper is a secondary data analysis of a 933-person cohort study (DANO-RUN) aimed at characterizing risk factors for injury in novice runners. Among those sustaining running-related injuries, the types of injuries and time to recovery is described in the present paper. All injured runners were diagnosed after a thorough clinical examination and then followed prospectively during their recovery. If they recovered completely from injury, time to recovery of each injury was registered.
A total of 254 runners were injured. The proportion of runners diagnosed with medial tibial stress syndrome was 15%, 10% for patellofemoral pain, 9% for medial meniscal injury, 7% for Achilles tendinopathy and 5% for plantar fasciitis. Among the 220 runners (87%) recovering from their injury, the median time to recovery was 71 days (minimum  = 9 days, maximum  = 617 days).
Medial tibial stress syndrome was the most common injury followed by patellofemoral pain, medial meniscal injury and Achilles tendinopathy. Half of the injured runners were unable to run 2×500 meters without pain after 10 weeks. Almost 5% of the injured runners received surgical treatment.
PMCID: PMC4055729  PMID: 24923269
Training guidelines for novice runners are needed to reduce the risk of injury. The purpose of this study was to investigate whether the risk of injury varied in obese and non‐obese individuals initiating a running program at different weekly distances.
A volunteer sample of 749 of 1532 eligible healthy novice runners was included in a 3‐week observational explorative prospective cohort study. Runners were categorized into one of six strata based on their body mass index (BMI) (≤30=low; >30=high) and running distance after 1 week (<3 km = low; 3 to 6 km = medium; >6 km = high). Data was collected for three weeks for the six strata. The main outcome measure was running‐related injury.
Fifty‐six runners sustained a running‐related injury during the 3‐week data collection. A significantly greater number of individuals with BMI>30 sustained injuries if they ran between 3 to 6 km (cumulative risk difference (CRD) = 14.3% [95%CI: 3.3% to 25.3%], p<0.01) or more than 6 km (CRD = 16.2% [95%CI: 4.4% to 28.0%], p<0.01) the first week than individuals in the reference group (low distance and low BMI). The effect‐measure modification between high running distance and BMI on additive scale was positive (11.7% [‐3.6% to 27.0%], p=0.13). The number of obese individuals needed to change their running distance from high to low to avoid one injury was 8.5 [95%CI: 4.6 to 52].
Obese individuals were at greater risk of injury if they exceeded 3 km during the first week of their running program. Because of a considerable injury risk compared with their non‐obese peers, individuals with a BMI>30 may be well advised to begin running training with an initial running distance of less than 3 km (1.9 miles) the first week of their running regime. Large‐scale trials are needed to further describe and document this relationship.
Level of Evidence:
Level 2b
PMCID: PMC4060311  PMID: 24944852
Body mass index; distance; injury risk; Running
8.  Blockade of glutamate release by botulinum neurotoxin type A in humans: A dermal microdialysis study 
In addition to its well-studied muscle-relaxant effects, botulinum neurotoxin A acts as an analgesic, an effect believed to be due to its suppression of the release of pain mediators, including glutamate. However, the research that led to these conclusions was conducted using animal models. Accordingly, the authors of this article aimed to determine whether the botulinum neurotoxin A has a similar effect on glutamate release in human skin.
The analgesic action of botulinum neurotoxin type A (BoNTA) has been linked to the blockade of peripheral release of neuropeptides and neurotransmitters in animal models; however, there is no direct evidence of this in humans.
To investigate the effect of BoNTA on glutamate release in humans, using an experimental model of pain and sensitization provoked by capsaicin plus mild heat.
Twelve healthy volunteers (six men, six women) were pretreated with BoNTA (10 U) on the volar forearm and with a saline control on the contralateral side. Dermal microdialysis was applied one week later to collect interstitial samples before and after the application of a capsaicin patch (8%) plus mild heat (40°C/60 min) to provoke glutamate release, pain and vasodilation. Samples were collected every hour for 3 h using linear microdialysis probes (10 mm, 100 kD). Dialysate was analyzed for glutamate concentration. Pain intensity and skin vasomotor reactions (temperature and blood flow changes) were also recorded.
BoNTA significantly reduced glutamate release compared with saline (P<0.05). The provoked pain intensity was lower in the BoNTA-pretreated arm (P<0.01). The reduction in pain scores was not correlated with glutamate level. Cutaneous blood flow (P<0.05), but not cutaneous temperature (P≥0.05), was significantly reduced by BoNTA. There was a correlation between glutamate level and skin blood flow (r=0.58/P<0.05) but not skin temperature (P≥0.05). No differences according to sex were observed in any response.
The present study provided the first direct evidence supporting the inhibitory effect of BoNTA on glutamate release in human skin, which is potentially responsible for some of the analgesic action of BoNTA.
PMCID: PMC4158957  PMID: 24851237
Botulinum neurotoxin type A; Capsaicin; Glutamate; Human experimental pain model; Microdialysis; Vasodilation
9.  High prevalence of daily and multi-site pain – a cross-sectional population-based study among 3000 Danish adolescents 
BMC Pediatrics  2013;13:191.
Daily pain and multi-site pain are both associated with reduction in work ability and health-related quality of life (HRQoL) among adults. However, no population-based studies have yet investigated the prevalence of daily and multi-site pain among adolescents and how these are associated with respondent characteristics. The purpose of this study was to investigate the prevalence of self-reported daily and multi-site pain among adolescents aged 12–19 years and associations of almost daily pain and multi-site pain with respondent characteristics (sex, age, body mass index, HRQoL and sports participation).
A population-based cross-sectional study was conducted among 4,007 adolescents aged 12–19 years in Denmark. Adolescents answered an online questionnaire during physical education lessons. The questionnaire contained a mannequin divided into 12 regions on which the respondents indicated their current pain sites and pain frequency (rarely, monthly, weekly, more than once per week, almost daily pain), characteristics, sports participation and HRQoL measured by the EuroQoL 5D. Multivariate regression was used to calculate the odds ratio for the association between almost daily pain, multi-site pain and respondent characteristics.
The response rate was 73.7%. A total of 2,953 adolescents (62% females) answered the questionnaire. 33.3% reported multi-site pain (pain in >1 region) while 19.8% reported almost daily pain. 61% reported current pain in at least one region with knee and back pain being the most common sites. Female sex (OR: 1.35-1.44) and a high level of sports participation (OR: 1.51-2.09) were associated with increased odds of having almost daily pain and multi-site pain. Better EQ-5D score was associated with decreased odds of having almost daily pain or multi-site pain (OR: 0.92-0.94).
In this population-based cohort of school-attending Danish adolescents, nearly two out of three reported current pain and, on average, one out of three reported pain in more than one body region. Female sex, and high level of sports participation were associated with increased odds of having almost daily pain and multi-site pain. The study highlights an important health issue that calls for investigations to improve our understanding of adolescent pain and our capacity to prevent and treat this condition.
PMCID: PMC3840664  PMID: 24252440
Adolescents; Pain; Cohort study; Paediatrics; Pain
10.  Hip and Knee Strength Is Not Affected in 12-16 Year Old Adolescents with Patellofemoral Pain - A Cross-Sectional Population-Based Study 
PLoS ONE  2013;8(11):e79153.
One of the rationales behind using strength training in the treatment of adolescents with Patellofemoral Pain (PFP) is that reduced strength of the lower extremity is a risk factor for PFP and a common deficit. This rationale is based on research conducted on adolescents >15 years of age but has never been investigated among young adolescents with PFP.
To compare isometric muscle strength of the lower extremity among adolescents with PFP compared to age- and gender-matched pain-free adolescents.
In 2011 a population-based cohort (APA2011-cohort) consisting of 768 adolescents aged 12–15 years from 8 local schools was formed. In September 2012, all adolescents who reported knee pain in September 2011 were offered a clinical examination if they still had knee pain. From these, 20 adolescents (16 females) were diagnosed with PFP. Pain-free adolescents from the APA2011-cohort (n = 20) were recruited on random basis as age- and gender-matched pairs. Primary outcome was isometric knee extension strength normalized to body weight (%BW) and blinded towards subject information. Secondary outcomes included knee flexion, hip abduction/adduction and hip internal/external rotation strength. Demographic data included Knee Injury and Osteoarthritis Outcome Score (KOOS) and symptom duration.
Adolescents with PFP reported long symptom duration and significantly worse KOOS scores compared to pain-free adolescents. There were no significant differences in isometric knee extension strength (Δ0.3% BW, p = 0.97), isometric knee flexion strength (Δ0.4% BW, p = 0.84) or different measures of hip strength (Δ0.4 to 1.1% BW, p>0.35).
Young symptomatic adolescents with PFP between 12 and 16 years of age did not have decreased isometric muscle strength of the knee and hip. These results question the rationale of targeting strength deficits in the treatment of adolescents with PFP. However, strength training may still be an effective treatment for those individuals with PFP suffering from strength deficits.
PMCID: PMC3827322  PMID: 24236101
11.  Care-seeking behaviour of adolescents with knee pain: a population-based study among 504 adolescents 
Knee pain is common during adolescence. Adolescents and their parents may think that knee pain is benign and self-limiting and therefore avoid seeking medical care. However, long-term prognosis of knee pain is not favourable and treatment seems to offer greater reductions in pain compared to a “wait-and-see” approach. The purpose of this study was to describe the determinants of care-seeking behaviour among adolescents with current knee pain and investigate what types of treatment are initiated.
An online questionnaire was forwarded to 2,846 adolescents aged 15–19 in four upper secondary schools. The questionnaire contained questions on age, gender, height, weight, currently painful body regions, frequency of knee pain, health-related quality of life measured by the EuroQol 5-dimensions, sports participation and if they had sought medical care. Adolescents who reported current knee pain at least monthly or more frequently were telephoned. The adolescents were asked about pain duration, onset of knee pain (traumatic or insidious) and if they were currently being treated for their knee pain.
504 adolescents currently reported at least monthly knee pain. 59% of these had sought medical care and 18% were currently under medical treatment . A longer pain duration and higher pain severity increased the odds of seeking medical care. Females with traumatic onset of knee pain were more likely to have sought medical care than females with insidious onset of knee pain. Females with traumatic onset of knee pain and increased pain severity were more likely to be undergoing medical treatment. The most frequently reported treatments were the combination of exercises and orthotics (68% of those undergoing medical treatment).
Females with insidious onset of knee pain do not seek medical care as often as those with traumatic onset and adolescents of both genders with insidious onset are less likely to be under medical treatment. These findings are important as knee pain with insidious onset has similar consequences as knee pain with traumatic onset regarding pain severity, pain duration and reductions in health-related quality of life.
PMCID: PMC3729825  PMID: 23899043
Adolescents; Knee pain; Care-seeking; Treatment
The purpose of this study was to investigate if the risk of injury declines with increasing weekly running volume before a marathon race.
The study was a retrospective cohort study on marathon finishers. Following a marathon, participants completed a web‐based questionnaire. The outcome of interest was a self‐reported running‐related injury. The injury had to be severe enough to cause a reduction in distance, speed, duration or frequency of running for at least 14 days. Primary exposure was self‐reported average weekly volume of running before the marathon categorized into below 30 km/week, 30 to 60 km/week, and above 60 km/week.
A total of 68 of the 662 respondents sustained an injury. When adjusting for previous injury and previous marathons, the relative risk (RR) of suffering an injury rose by 2.02 [95% CI: 1.26; 3.24], p < 0.01, among runners with an average weekly training volume below 30 km/week compared with runners with an average weekly training volume of 30‐60 km/week. No significant differences were found between runners exceeding 60 km/week and runners running 30‐60 km/week (RR=1.13 [0.5;2.8], p=0.80).
Runners may be advised to run a minimum of 30 km/week before a marathon to reduce their risk of running‐related injury.
Level of Evidence:
PMCID: PMC3625790  PMID: 23593549
Running‐related injury; marathon; risk factors; running volume.
Background and Purpose:
Many researchers acknowledge the importance of “training errors” as the main cause of running‐related injuries. The purpose of this clinical commentary is to present a theoretical framework for the assumption that some running‐related injuries among rear‐foot strikers develop due to rapidly changing running volume, while others develop due to rapidly changing running pace.
Description of Topic with Related Evidence:
Evidence from clinical and experimental studies is presented to support the assertion that rapid change in running volume may lead to the development of patellofemoral pain syndrome, iliotibial band syndrome, and patellar tendinopathy, while change in running pace may be associated with the development of achilles tendinopathy, gastrocnemius injuries, and plantar fasciitis.
Discussion/Relation to Clinical Practice:
If this assertion is correct, bias may be prevented in future studies by categorizing injuries into volume or pacing injuries. However, more work is needed to provide further evidence in support of this approach. Future investigations of the link between training patterns and injury development should be designed as large‐scale prospective studies using objective methods to quantify training patterns.
Level of evidence:
PMCID: PMC3625796  PMID: 23593555
Etiology; running pace; running‐related injury; training volume
14.  Predictors of Running-Related Injuries Among 930 Novice Runners 
Orthopaedic Journal of Sports Medicine  2013;1(1):2325967113487316.
To identify persons at high risk of sustaining running-related injuries, an evidence-based understanding of the risk factors associated with injury is needed.
To identify demographic and behavioral risk factors associated with running-related injuries.
Study Design:
Observational prospective cohort study with a 1-year follow-up.
Exposures including sex, age, body mass index (BMI), behavior (Type A Self-Rating Inventory [TASRI]), running experience, other sports activity, previous running-related injuries, and other injuries not related to running were assessed prior to or at baseline. The outcome of interest was a running-related injury, defined as any musculoskeletal complaint of the lower extremity or back caused by running that restricted the amount of running (volume, duration, pace, or frequency) for at least 1 week. All participants quantified their running volume by global positioning system (GPS) and used a neutral running shoe. Time to first injury for each exposure variable was analyzed using a generalized linear model, with cumulative kilometers of the training sessions as the time scale.
A total of 930 individuals were included in the study, of which 254 sustained a running-related injury during a total of 155.318 km of running. By calculating the cumulative injury risk differences (cIRDs) [95% confidence intervals] after 500 km of running, the TASRI Type B behavior (cIRD, 11.9% [−0.5%; 23.3%]; P = .04) was found to be a significant predictor of injury, while age between 45 and 65 years (cIRD, 14.7% [−2.1%; 31.5%]; P = .08) and previous injuries not related to running (cIRD, 11.1% [−0.2%; 22.4%]; P = .05) were considered clinically interesting, although not statistically significant. In addition, χ2 test results across 4 BMI groups also revealed a borderline significant relationship (P = .06). No significant or clinically relevant relationships were found for sex (P = .42), previous running-related injury (P = .47), running experience (P = .30), and other sports activities (P = .30).
The findings of the present study suggest BMI >30 kg/m2, age between 45 and 65 years, noncompetitive behavior, and previous injuries not related to running are associated with increased risk of injury among novice runners, while BMI <20 kg/m2 was protective. Still, the role of the risk factors in the causal mechanism leading to injury needs to be investigated.
PMCID: PMC4555503  PMID: 26535228
running-related injury; novice; BMI; behavior; age
15.  Autologous Blood Transfusion after Local Infiltration Analgesia with Ropivacaine in Total Knee and Hip Arthroplasty 
Aims. To study the safety of autotransfusion following local infiltration analgesia (LIA) with ropivacaine. Background. Knowledge of blood concentrations of ropivacaine after LIA and autotransfusion is crucial. However, very limited data are available for toxicological risk assessment. Methods. Autotransfusion was studied in patients after total knee arthroplasty (TKA: n = 25) and total hip arthroplasty (THA: n = 27) with LIA using 200 mg ropivacaine, supplemented with two postoperative bolus injections (150 mg ropivacaine). Drainage blood was reinfused within 6 h postoperatively. Results. Reinfusion caused a significant increase in the serum concentration of total ropivacaine for TKA from 0.54 ± 0.17 (mean ± SD) to 0.79 ± 0.20 μg/mL (P < 0.001) and a nonsignificant increase for THA from 0.62 ± 0.17 to 0.63 ± 0.18 μg/mL. The maximum free (unbound) concentration after reinfusion was 0.038 μg/mL. Peak total and free venous ropivacaine concentrations after 8 h and 16 h postoperative bolus injections were 2.6 μg/mL and 0.11 μg/mL, respectively. All concentrations observed were below the threshold for toxicity and no side effects were observed. Conclusion. Autotransfusion of patients undergoing knee or hip arthroplasty after local infiltration analgesia with 200 mg ropivacaine can be performed safely, even supplemented with 8 h and 16 h postoperative bolus injections.
PMCID: PMC3420087  PMID: 22919377
16.  Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study) 
There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain.
The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0–100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength.
This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA.
Trial registration reference: NCT01410409
PMCID: PMC3461437  PMID: 22571284
The purpose of this systematic review was to examine the link between training characteristics (volume, duration, frequency, and intensity) and running related injuries.
A systematic search was performed in PubMed, Web of Science, Embase, and SportDiscus. Studies were included if they examined novice, recreational, or elite runners between the ages of 18 and 65. Exposure variables were training characteristics defined as volume, distance or mileage, time or duration, frequency, intensity, speed or pace, or similar terms. The outcome of interest was Running Related Injuries (RRI) in general or specific RRI in the lower extremity or lower back. Methodological quality was evaluated using quality assessment tools of 11 to 16 items.
After examining 4561 titles and abstracts, 63 articles were identified as potentially relevant. Finally, nine retrospective cohort studies, 13 prospective cohort studies, six case-control studies, and three randomized controlled trials were included. The mean quality score was 44.1%. Conflicting results were reported on the relationships between volume, duration, intensity, and frequency and RRI.
It was not possible to identify which training errors were related to running related injuries. Still, well supported data on which training errors relate to or cause running related injuries is highly important for determining proper prevention strategies. If methodological limitations in measuring training variables can be resolved, more work can be conducted to define training and the interactions between different training variables, create several hypotheses, test the hypotheses in a large scale prospective study, and explore cause and effect relationships in randomized controlled trials.
Level of evidence:
PMCID: PMC3290924  PMID: 22389869
Duration; frequency; injuries; intensity; running; training; volume
18.  Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial 
Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents.
This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises.
The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months.
This study is designed to investigate the effectiveness of patient education compared with patient education combined with multimodal physiotherapy. If patient education and multimodal physiotherapy applied at an early stage of Patellofemoral Pain Syndrome proves effective, it may serve as a basis for optimising the clinical pathway for those suffering from the condition, where specific emphasis can be placed on early diagnosis and early treatment.
Trial Registration reference: NCT01438762
PMCID: PMC3328242  PMID: 22280484
Patellofemoral Pain Syndrome; Anterior Knee Pain; Physiotherapy; Adolescents
19.  Fusion mass bone quality after uninstrumented spinal fusion in older patients 
European Spine Journal  2010;19(12):2200-2208.
Older people are at increased risk of non-union after spinal fusion, but little is known about the factors determining the quality of the fusion mass in this patient group. The aim of this study was to investigate fusion mass bone quality after uninstrumented spinal fusion and to evaluate if it could be improved by additional direct current (DC) electrical stimulation. A multicenter RCT compared 40 and 100 μA DC stimulation with a control group of uninstrumented posterolateral fusion in patients older than 60 years. This report comprised 80 patients who underwent DEXA scanning at the 1 year follow-up. The study population consisted of 29 men with a mean age of 72 years (range 62–85) and 51 women with a mean age of 72 years (range 61–84). All patients underwent DEXA scanning of their fusion mass. Fusion rate was assessed at the 2 year follow-up using thin slice CT scanning. DC electrical stimulation did not improve fusion mass bone quality. Smokers had lower fusion mass BMD (0.447 g/cm2) compared to non-smokers (0.517 g/cm2) (P = 0.086). Women had lower fusion mass BMD (0.460 g/cm2) compared to men (0.552 g/cm2) (P = 0.057). Using linear regression, fusion mass bone quality, measured as BMD, was significantly influenced by gender, age of the patient, bone density of the remaining part of the lumbar spine, amount of bone graft applied and smoking. Fusion rates in this cohort was 34% in the control group and 33 and 43% in the 40 and 100 μA groups, respectively (not significant). Patients classified as fused after 2 years had significant higher fusion mass BMD at 1 year (0.592 vs. 0.466 g/cm2, P = 0.0001). Fusion mass bone quality in older patients depends on several factors. Special attention should be given to women with manifest or borderline osteoporosis. Furthermore, bone graft materials with inductive potential might be considered for this patient population.
PMCID: PMC2997208  PMID: 20429017
Spinal fusion; Randomised clinical trial; Bone mineral density; Electrical stimulation; Bone graft; Age; Smoking
20.  Microdialysis of paraspinal muscle in healthy volunteers and patients underwent posterior lumbar fusion surgery 
European Spine Journal  2009;18(11):1604-1609.
Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study was to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD). The basic interstitial metabolisms of the paraspinal muscle and the deltoid muscle were monitored using the MD technique in eight patients, who underwent posterior lumbar fusion surgery (six male and two female, median age 57.7 years, range 37–74) and eight healthy individuals for different positions (five male and three female, age 24.1 ± 0.8 years). Concentrations of glucose, glycerol, and lactate pyruvate ratio (L/P) in both tissues were compared. In the healthy group, the glucose and glycerol concentrations and L/P were unchanged in the paraspinal muscle when the body position changed from prone to supine. The glucose concentration and L/P were stable in the paraspinal muscle during the surgery. Glycerol concentrations increased significantly to 243.0 ± 144.1 μM in the paraspinal muscle and 118.9 ± 79.8 μM in the deltoid muscle in the surgery group. Mean glycerol concentration difference (GCD) between the paraspinal muscle and the deltoid tissue was 124.1 μM (P = 0.003, with 95% confidence interval 83.4–164.9 μM). The key metabolism of paraspinal muscle can be monitored by MD during the conventional posterior lumbar fusion surgery. The glycerol concentration in the paraspinal muscle is markedly increased compared with the deltoid muscle during the surgery. It is proposed that GCD can be used to evaluate surgery related paraspinal muscle damage. Changing body position did not affect the paraspinal muscle metabolism in the healthy subjects.
PMCID: PMC2899392  PMID: 19418074
Glucose; Lactate pyruvate ratio; Glycerol; Paraspinal muscle; Microdialysis

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