Nocturnal pain and fatigue in middle-aged persons with hip symptoms suspected to be osteoarthritis, is there a link in 10-year follow-up of the CHECK study?

Objective: To explore the prevalence of nocturnal pain and fatigue in participants with hip symptoms suspected to be early osteoarthritis (OA) and to test the mediating effect of nocturnal pain on the association between hip OA pain and fatigue. Methods: We included participants with hip pain but no knee pain at baseline, from the Cohort Hip and Cohort Knee (CHECK)-study. Severity of hip OA pain was determined using the Numeric-Rating-Scale-pain-score last week. Fatigue was assessed using the SF-36 Fatigue subscale. Nocturnal pain was determined using the WOMAC-question: "How much pain have you experienced in the last 48 â€‹h at night while in bed?". Hip OA pain, nocturnal pain and fatigue were measured repeatedly during 10-year follow-up. Path analysis were used per time point to determine the direct effect of OA pain on fatigue and the indirect effect through nocturnal pain. Results: In 170 participants (female: 76%; mean age: 55.7 years; mean BMI: 25.5 â€‹kg/m2) the prevalence of nocturnal pain varied between 22 and 35% and the prevalence of fatigue ranged between 14 and 18%. Hip OA pain was associated with nocturnal pain and fatigue. The direct effect of hip OA pain on fatigue was significant at all-time points. No significant mediating effect of nocturnal pain was found. Conclusion: In this cohort of participants suspected to have early hip OA, the prevalence of fatigue remained stable and the prevalence of nocturnal pain decreased slightly over 10-year follow-up. We did not find a mediating effect of nocturnal pain in the pathway between hip OA pain and fatigue.

Course of pain and fluctuations in pain related to suspected early hip osteoarthritis: the CHECK study.

OBJECTIVES: To evaluate the prevalence during a 10-year follow-up of clinically relevant fluctuations in pain and the course of hip pain in participants with hip complaints suspected to be early stage hip osteoarthritis (OA). To distinguish between participants with relevant fluctuations in pain and those without based on baseline characteristics. METHODS: Data were collected at baseline and after 2, 5, 8, and 10 years on 495 participants from the Cohort Hip and Cohort Knee Study (CHECK) with hip pain at baseline. Baseline demographic, anamnestic, and physical-examination characteristics were assessed. The primary outcome was levels of pain in the past week (scored using 0-10 Numeric Rating Scale) at follow-up assessments. Relevant fluctuation was defined as average absolute residuals greater than 1 after fitting a straight line to the participant's pain scores over time. RESULTS: The majority of the participants (76%) had stable or decreasing pain. Relevant fluctuations were found in 37% of the participants. The following baseline variables were positively associated with the presence of relevant fluctuations: higher levels of pain in the past week, use of pain transformation as a coping style, higher number of comorbidities, use of pain medication, and higher levels of high-sensitivity C-reactive protein. No associations were found for baseline radiographic hip OA or clinical hip OA. CONCLUSION: During a 10-year follow-up, the majority of participants had stable or decreasing pain levels. In those participants with relevant fluctuation (37%), a limited number of baseline variables were associated with increased odds of having relevant fluctuations in pain.

Pain appears to be an important reason for consulting the general practitioner (GP) for hip osteoarthritis (OA) complaints. We know that hip pain remained quite stable over 10 years. Also is known that there is considerable variety between patients in pain. In this study, we found relevant pain fluctuations in 37% of primary care patients with hip complaints over a period of 10 years. The pain fluctuation was not associated with having osteoarthritis, neither radiographic hip OA (diagnosed based on a X-ray) or clinical hip OA (determined according to the American College of Rheumatology (ACR) criteria) at baseline. More research is needed to discover why some people experience fluctuations in time than others.

Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study).

INTRODUCTION: Shoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care. METHODS AND ANALYSIS: The SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient's reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient's global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NL8854).

Characteristics associated between the incidence of hip osteoarthritis and early hip complaints (CHECK study) within 10 years.

OBJECTIVE: To determine which baseline characteristics, especially clinically variables like pain, stiffness, physical functioning and disease variables, are associated with incident hip OA within 10 years in first presenters with hip complaints. Rheumatology key messages History taking and not physical exam variables are associated with incident hip osteoarthritis. Specific questions about daily life activities are associated with incident hip OA. These questions are about pain while walking/shopping, difficulties putting socks on/off and rising from bed. METHODS: Data were obtained from the nationwide prospective Cohort Hip and Cohort Knee (CHECK) study (n = 1002). Incident hip OA was defined as fulfilling the clinical ACR criteria for hip OA, a Kellgren and Lawrence score ≥2 with hip pain, or received a hip replacement during follow-up. Baseline measurements were used of participants with hip complaints and without hip OA. Principal component analysis (PCA) was used to reduce the number of correlated variables. Associations between baseline characteristics (including PCA components) and incident hip OA were investigated using logistic regression analysis, adjusted for age, sex and BMI. RESULTS: In total, 312 participants (85% female and 98% Caucasian) were included, 181 developed hip OA. PCA resulted in four components. Incident hip OA was associated with (i) component 1 (general presence of pain and symptoms) [odds ratio (OR) = 1.46 (95%CI: 1.08, 1.98)], (ii) component 3 (relatively high levels of pain during shopping/walking combined with less difficulty with putting socks on/off and rising from bed) [OR = 1.58 (95%CI: 1.18, 2.12)] and (iii) knee pain [OR = 0.34 (95% CI: 0.17, 0.66)]. CONCLUSION: In first presenters with hip complaints, use of a few history-taking variables might allow better recognition of those at higher odds for incident hip OA within 10 years.

10-Year natural course of early hip osteoarthritis in middle-aged persons with hip pain: a CHECK study.

OBJECTIVE: To explore the natural course of hip osteoarthritis (OA) in a population of first-time presenters with hip complaints. METHODS: Data were collected at baseline and after 2, 5, 8 and 10 years on participants from the Cohort Hip and Cohort Knee study with early symptomatic hip OA. Descriptive statistics were used to analyse the natural course of the hip complaints with respect to clinical signs and symptoms, physical functioning and radiographic osteoarthritis (ROA) features. RESULTS: In total, 588 participants were included with hip complaints and 86% completed the 10-year follow-up. The 10-year follow-up showed that 12% (69 participants) underwent hip replacement (HR), an increase of ROA of the hip (Kellgren and Lawrence score≥2) from 19% to 49%, and an increase in clinical hip OA according to the American College of Rheumatology criteria from 27% to 43%. All Western Ontario and McMaster Osteoarthritis Index subscales and physical activity remained on average constant during the 10-year follow-up for those who did not undergo an HR. The use of pain medication increased from 43% at baseline to 50% after 10 years. CONCLUSION: One out of nine participants with early hip problems received an HR during the 10-year follow-up. Prevalence of clinical hip OA and hip ROA increased steadily during the 10-year follow-up. Overall, we observed more hip OA, but fewer or stable complaints with respect to clinical signs and symptoms, and physical functioning. So it could be cautiously concluded that after 10 years, first-time presenters with hip complaints either received an HR or their symptoms remained stable.

Online multifactorial prevention programme has no effect on the number of running-related injuries: a randomised controlled trial.

OBJECTIVE: To examine the effect of a multifactorial, online injury prevention programme on the number of running-related injuries (RRIs) in recreational runners. METHODS: Adult recreational runners who registered for a running event (distances 5 km up to 42.195 km) were randomised into the intervention group or control group. Participants in the intervention group were given access to the online injury prevention programme, which consisted of information on evidence-based risk factors and advices to reduce the injury risk. Participants in the control group followed their regular preparation for the running event. The primary outcome measure was the number of self-reported RRIs in the time frame between registration for a running event and 1 month after the running event. RESULTS: This trial included 2378 recreational runners (1252 men; mean [SD] age 41.2 [11.9] years), of which 1196 were allocated to the intervention group and 1182 to the control group. Of the participants in the intervention group 37.5% (95% CI 34.8 to 40.4) sustained a new RRI during follow-up, compared with 36.7% (95% CI 34.0 to 39.6) in the control group. Univariate logistic regression analysis showed no significant difference between the intervention and control group (OR 1.08; 95% CI 0.90 to 1.30). Furthermore, the prevention programme seemed to have a negative impact on the occurrence of new RRIs in the subgroup of runners with no injuries in the 12 months preceding the trial (OR 1.30; 95% CI 0.99 to 1.70). CONCLUSION: A multifactorial, online injury prevention programme did not decrease the total number of RRIs in recreational runners. TRIAL REGISTRATION NUMBER: NTR5998.

Subgroup characteristics of patients with chronic ankle instability in primary care.

OBJECTIVES: To examine clinical and radiological characteristics of participants with an ankle sprain in general practice, classified into subgroups of a previously described chronic ankle instability (CAI) model. DESIGN: Cross-sectional study. METHODS: 206 participants, who visited their general practitioner with a lateral ankle sprain 6-12 months before inclusion, completed a questionnaire, physical examination, radiography and magnetic resonance imaging. They were classified into three subgroups of the previously described CAI-model: mechanical instability (MI), perceived instability (PI) and recurrent sprains (RS). Regression analyses were applied to evaluate differences in subgroup characteristics. RESULTS: A total of 192 participants were eligible to be classified into the model. Of these participants, 153 participants were classified into the subgroups and 39 could not be classified. With overlap between the subgroups and patients falling into more than one subgroup, 59 were classified having MI, 145 having PI and 30 having RS. Participants with RS and PI were more often sports participants (OR 6.83;95%CI 1.35-34.56 and OR 4.44;95%CI1.06-18.63 respectively) than participants without RS and PI. Participants with MI more often had a tenderness on palpation of the anterior talofibular ligament (OR 4.09;95%CI 1.91-8.72) and a KL-score≥1 in the talonavicular joint on X-ray (OR 2.24;95%CI 1.09-4.58), compared to participants without MI. CONCLUSIONS: Sports participation, tenderness on palpation of the anterior talofibular ligament and early signs of osteoarthritis were variables that discriminated between subgroups of CAI. However, further research is mandatory in order to examine the usefulness of the CAI model in relation to prognosis and suitable intervention.

Clinical and radiological predictors for persistent complaints five years after a lateral ankle sprain: A long-term follow-up study in primary care.

OBJECTIVES: To examine the five-year prognosis and potential prognostic factors of patients with an acute lateral ankle sprain in primary care setting. DESIGN: Observational study. METHODS: 206 patients who participated in a cross-sectional study and visited their general practitioner with an acute lateral ankle sprain 6-12 months prior to inclusion were approached for a 5-year follow-up measurement consisting of an online questionnaire. At baseline patients completed standardized questionnaires, underwent a standardized physical examination and radiological examination (radiography and Magnetic Resonance Imaging) and scored their perceived recovery. Logistic regression analysis was used to examine potential predictive factors at baseline for the presence of persistent complaints after 5 years. RESULTS: 132 (64.1%) patients completed the 5-year follow-up. 18.2% reported persistent complaints and 30.3% had a re-sprain during follow-up. Baseline persistent complaints 6-12 months after an acute lateral ankle sprain (OR 6.38; CI 95% 1.54-26.44), dominant leg injury (OR 4.89; CI 95% 1.16-20.62) and a recurrent ankle sprain (OR 9.81; CI 95% 2.17-44.47) were significant predictors for persistent complaints 5 years after an acute ankle sprain. Physical examination and radiological findings did not add to the predictive value of the prognostic model. CONCLUSIONS: Almost 20% of patients with an acute lateral ankle sprain experience persistent complaints after 5 years follow-up. Predictive factors for persistent complaints can be identified.

Preventing running-related injuries using evidence-based online advice: the design of a randomised-controlled trial.

INTRODUCTION: Running-related injuries (RRIs) are frequent and can lead to cessation of health promoting activities. Several risk factors for RRIs have been identified. However, no successful injury prevention programme has been developed so far. Therefore, the aim of the present study is to investigate the effect of an evidence-based online injury prevention programme on the number of RRIs. METHODS AND ANALYSIS: The INSPIRE trial is a randomised-controlled trial with a 3-month follow-up. Both novice and more experienced runners, aged 18 years and older, who register for a running event (distances 5 km up to 42.195 km) will be asked to participate in this study. After completing the baseline questionnaire, participants will be randomised into either the intervention group or control group. Participants in the intervention group will get access to the online injury prevention programme. This prevention programme consists of information on evidence-based risk factors and advices to reduce the injury risk. The primary outcome measure is the number of self-reported RRIs in the time frame between registration for a running event and 1 month after the running event. Secondary outcome measures include the running days missed due to injuries, absence of work or school due to injuries, and the injury location. ETHICS AND DISSEMINATION: An exemption for a comprehensive application is obtained by the Medical Ethical Committee of the Erasmus University Medical Centre Rotterdam, Netherlands. The results of the study will be published in peer-reviewed journals and presented on international congresses. TRIAL REGISTRATION NUMBER: NTR5998. Pre-results.

Association between Patient History and Physical Examination and Osteoarthritis after Ankle Sprain.

Structural abnormalities on MRI are frequent after an ankle sprain. To determine the association between patient history, physical examination and early osteoarthritis (OA) in patients after a previous ankle sprain, 98 patients with persistent complaints were selected from a cross-sectional study. Patient history taking and physical examination were applied and MRI was taken. Univariate and multivariable analyses were used to test possible associations. Signs of OA (cartilage loss, osteophytes and bone marrow edema) were seen in the talocrural joint (TCJ) in 40% and the talonavicular joint (TNJ) in 49%. Multivariable analysis showed a significant positive association between swelling (OR 3.58, 95%CI 1.13;11.4), a difference in ROM of passive plantar flexion (OR 1.09, 95%CI 1.01;1.18) and bone edema in the TCJ. A difference in ROM of passive plantar flexion (OR 1.07, 95%CI 1.00;1.15) and pain at the end range of dorsiflexion/plantar flexion (OR 5.23, 95%CI 1.88;14.58) were associated with osteophytes in the TNJ. Pain at the end of dorsiflexion/plantar flexion, a difference in ROM of passive plantar flexion and swelling seem to be associated with features of OA (bone marrow edema, osteophytes) in the TCJ and TNJ. Our findings may guide physicians to predict structural joint abnormalities as signs of osteoarthritis. LEVEL OF EVIDENCE: 1b.

Center of pressure during stance and gait in subjects with or without persistent complaints after a lateral ankle sprain.

STUDY AIM: To investigate differences in the center of pressure (COP) during gait and single leg stance between subjects with persistent complaints (PC) and without persistent complaints (NPC) after a lateral ankle sprain. METHODS: 44 patients who consulted the general practitioner, 6-12 months prior to inclusion, with a lateral ankle sprain were included for the current study purpose. Using a 7-point Likert scale patients were divided into the PC or NPC group. All subjects filled out an online questionnaire, walked along a walkway and performed a single leg stance, both on the RSscan. Primary outcomes included the COP displacement, range and percentage used in mediolateral and anterioposterior direction. RESULTS: There was a trend (p<0.05) towards a more medially COP trajectory during walking at 34-46% and 83-96% and more anteriorly at 21-31% and 91-100% of the stance phase in the PC group compared to NPC group. Additionally, the COP was more laterally located in the sprained leg compared to the non-sprained leg in the PC group in the loading response phase (p<0.05). An interaction was found for the percentage of anterior-posterior range used in single leg stance without vision. CONCLUSION: The COP trajectory discriminates between patients with PC and NPC. This indicates that roll off during gait might play an important role in the recovery of patients after a lateral ankle sprain and could be used to monitor treatment.

Magnetic resonance imaging abnormalities after lateral ankle trauma in injured and contralateral ankles.

PURPOSE: To compare the prevalence of abnormal MRI findings associated with lateral ankle trauma in injured and contralateral ankles to identify lesions that may be pre-existent. MATERIAL AND METHODS: The study was approved by the institutional review board and informed consent was obtained from all subjects. 195 patients (mean age 37.5+14.7 years; 43% male) who visited their general practitioner 6-12 months earlier with an ankle sprain were selected. All patients completed a standardized questionnaire and underwent MRI (1.5T) of both ankles. Structural MRI abnormalities in the injured and contralateral ankle were compared using the McNemar test (for paired samples). RESULTS: Bone marrow edema was frequently seen in the injured and contralateral ankle at the talocrural joint (25.1% versus 14.8%) and subtalar joint (24.6% versus 8.7%), but significantly more frequently in the injured ankle. Anterior talofibular ligament (ATFL) and calcaneofibular ligament (CFL) lesions were frequently found in both ankles, in 55.9% and 37.4% of injured ankles respectively and in 17.9% and 5.6% of contralateral ankles respectively. Fractures, anterior and posterior tibiofibular ligament lesions, deltoid ligament lesions and signs of talonavicular osteoarthritis were almost exclusively found in injured ankles. Peroneal ligament lesions were not frequently found in both ankles. CONCLUSIONS: The prevalence of structural MRI abnormalities in patients presenting with a previous ankle sprain in primary care is very high. However, especially bone marrow edema and lateral ligament lesions can also be found in a substantial percentage of contralateral ankles and may be either pre-existent or due to increased stress on the contralateral ankle after an ankle injury Correlation with clinical findings is essential.

The trAPP-study: cost-effectiveness of an unsupervised e-health supported neuromuscular training program for the treatment of acute ankle sprains in general practice: design of a randomized controlled trial.

BACKGROUND: Ankle sprains are one of the most frequent injuries of the musculoskeletal system, with yearly around 680.000 new sprains in The Netherlands. Of these, about 130.000 people will visit the general practitioner (GP) each year. In addition, patients have an increased risk of a recurrent ankle sprain and about a third report at least one re-sprain. No optimal treatment strategy has proven to be effective in general practice, however promising results were achieved in a preventive trial among athletes. Therefore, the objective is to examine the (cost)-effectiveness of an unsupervised e-health supported neuromuscular training program in combination with usual care in general practice compared to usual care alone in patients with acute ankle sprains in general practice. METHOD/DESIGN: This study is a multi-center, open-label randomized controlled trial, with a one-year follow-up. Patients with an acute lateral ankle sprain, aged between 14 and 65 years and visiting the GP within three weeks of injury are eligible for inclusion. Patients will be randomized in two study groups. The intervention group will receive, in addition to usual care, a standardized eight-week neuromuscular training program guided by an App. The control group will receive usual care in general practice alone. The primary outcome of this study is the total number of ankle sprain recurrences reported during one year follow-up. Secondary outcomes are subjective recovery after one year follow-up, pain at rest and during activity, function, return to sport, cost-effectiveness and compliance of the intervention. Measurements will take place monthly for the study period of 12 months after baseline measurement. DISCUSSION: For general practitioners the treatment of acute ankle sprains is a challenge. A neuromuscular training program that has proven to be effective for athletes might be a direct treatment tool for acute ankle sprains in general practice. Positive results of this randomized controlled trial can lead to changes in practice guidelines for general practitioners. In addition, since this training program is e-health supported, positive results can also lead to a novel way of injury prevention. TRIAL REGISTRATION: Dutch Trial Registration: NTR4765.

Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments.

STUDY DESIGN: Systematic review. Objective To determine the effectiveness of treatments for patients with chronic complaints after ankle sprain. BACKGROUND: Though most people recover completely after a lateral inversion ankle injury, a considerable percentage have persistent complaints. Currently, it is still unclear which treatment options are best for these patients. METHODS: Major databases, including PubMed, Embase, CINAHL, and PEDro, were searched for randomized controlled trials and controlled clinical trials conducted from 1966 to October 2012. Due to clinical heterogeneity, the data were analyzed using a best-evidence synthesis. RESULTS: A total of 20 randomized controlled trials and 1 controlled clinical trial were included in the analysis. The included studies compared different treatments (training programs, physiotherapy, chiropractic/manual therapy, surgery, postoperative training, and functional treatment). For pain and function outcomes, limited to moderate evidence was found for effectiveness of a training program compared to conservative treatment. Two studies found a decrease of recurrences after a proprioceptive training program. Four studies showed good results for different surgical methods but did not include a nonsurgical control group for comparison. Limited evidence was found for the effectiveness of an early mobilization program after surgery. CONCLUSION: In chronic ankle complaints after an ankle sprain, a training program gives better results for pain and function, and a decrease of recurrent ankle sprains, than a wait-and-see policy. There was insufficient evidence to determine the most effective surgical treatment, but limited evidence suggests that postoperative, early mobilization was more effective than a plaster cast. LEVEL OF EVIDENCE: Therapy, level 1a-.

Structural abnormalities and persistent complaints after an ankle sprain are not associated: an observational case control study in primary care.

BACKGROUND: Persistent complaints are very common after a lateral ankle sprain. AIM: To investigate possible associations between structural abnormalities on radiography and MRI, and persistent complaints after a lateral ankle sprain. DESIGN AND SETTING: Observational case control study on primary care patients in general practice. METHOD: Patients were selected who had visited their GP with an ankle sprain 6-12 months before the study; all received a standardised questionnaire, underwent a physical examination, and radiography and MRI of the ankle. Patients with and without persistent complaints were compared regarding structural abnormalities found on radiography and MRI; analyses were adjusted for age, sex, and body mass index. RESULTS: Of the 206 included patients, 98 had persistent complaints and 108 did not. No significant differences were found in structural abnormalities between patients with and without persistent complaints. In both groups, however, many structural abnormalities were found on radiography in the talocrural joint (47.2% osteophytes and 45.1% osteoarthritis) and the talonavicular joint (36.5% sclerosis). On MRI, a high prevalence was found of bone oedema (33.8%) and osteophytes (39.5) in the talocrural joint; osteophytes (54.4%), sclerosis (47.2%), and osteoarthritis (55.4%, Kellgren and Lawrence grade >1) in the talonavicular joint, as well as ligament damage (16.4%) in the anterior talofibular ligament. CONCLUSION: The prevalence of structural abnormalities is high on radiography and MRI in patients presenting in general practice with a previous ankle sprain. There is no difference in structural abnormalities, however, between patients with and without persistent complaints. Using imaging only will not lead to diagnosis of the explicit reason for the persistent complaint.