Observational prospective study.
To assess the reliability, validity, and responsiveness of the French version of the Fear Avoidance Belief Questionnaire.
Fear, avoidance attitudes, and belief play ...pivotal roles in disability perceived by patients with chronic low back pain. The Fear Avoidance Belief Questionnaire is a two-part questionnaire assessing fear, avoidance, and beliefs about professional activity and physical activity.
The Fear Avoidance Belief Questionnaire was translated by use of the forward and backward translation procedure. Test-retest reliability was assessed in 31 patients (Group 1) with the intraclass correlation coefficient and the Bland and Altman method. Construct validity was assessed in two groups of patients (Group 2, n = 147; Group 3, n = 70) with the Spearman rank correlation coefficient and factor analysis. Responsiveness was assessed in Group 3, after they underwent a functional restoration program, by the effect size and the standardized response mean.
Test-retest reliability was good, with an intra-class correlation coefficient value of 0.88 and 0.72 for fear, avoidance, and beliefs about professional activity and physical activity, respectively. Use of the Bland and Altman method produced a homogeneous distribution of the differences, with no systematic trend observed. The expected divergent validity was observed in Groups 2 and 3. Factor analysis extracted four factors in Group 2 and the two original factors of the English Fear Avoidance Belief Questionnaire in Group 3. The lowest effect size and standardized response mean values (0.30 and 0.31, respectively) were observed with the fear, avoidance, and beliefs about professional activity.
The psychometric properties (test-retest reliability, construct validity, and responsiveness) of the French version of the Fear Avoidance Belief Questionnaire are acceptable, and fear, avoidance, and belief can now be assessed in French-speaking patients with low back pain.
To evaluate the validity, reliability, and responsiveness of the fingertip-to-floor test to assess total mobility when bending forward in standing position.
Experimental, prospective, correlational.
...Rehabilitation and radiology departments in a university hospital in France.
Ten patients (6 women, 4 men; mean age, 42yr) with chronic low back pain (LBP) in the validity study; 32 LBP patients (16 women, 16 men; mean age, 52yr) in the reliability study; and 72 LBP patients (22 women, 50 men; mean age, 30yr) in the responsiveness study.
Dynamic radiographs and fingertip-to-floor test.
For the validity study, 2 lateral radiographs of the upper dorsal spine, 1 in neutral position, and then 1 in full trunk flexion, were made. Validity was assessed by means of Spearman's correlation coefficient. Reliability was studied by using intraclass correlation coefficient (ICC) and the Bland and Altman method. Responsiveness was assessed by the effect size and the standardized response mean (SRM).
The Spearman's correlation coefficient for trunk flexion assessed by the test and the radiologic measure was excellent (r(s) = -.96). The intra- and interobserver reliability were excellent (ICC = .99). The Bland and Altman method showed no systematic trend. The values observed for the test were .97 for SRM and .87 for effect size.
Because the fingertip-to-floor test has excellent validity, reliability, and responsiveness, it can be used in clinical practice and therapeutic trials.
Summary
Background
Patient‐reported outcome measures (PROMs) aimed at assessing people with systemic sclerosis (SSc) have rarely involved the target population in the item‐ and domain‐generation ...stage of the instrument construction.
Objectives
To develop a new PROM assessing activities and participation in people with SSc.
Methods
A provisional International Classification of Functioning, Disability and Health (ICF)‐based 65‐item questionnaire previously developed from interviews of people with SSc was sent by email to all patients followed in the internal medicine department of Cochin hospital (n = 184) and enrolled in the Scleroderma Patient‐centered Intervention Network Cohort. Items were reduced according to their metric properties. Dimensional structure of the questionnaire was assessed by principal component analysis, convergent and divergent validities by Spearman's rank correlation coefficient, internal consistency by Cronbach's α, and reliability by a test–retest method using the intraclass correlation coefficient (ICC) and Bland–Altman analysis.
Results
Overall, 113 of 184 patients (61·4%) completed the provisional questionnaire. The item‐reduction process resulted in a 17‐item questionnaire, the Cochin 17‐item Scleroderma Functional scale (CSF‐17). Principal component analysis extracted two dimensions: 10 items related to mobility (CSF‐17 section A) and seven items related to general tasks (CSF‐17 section B). We observed convergent validity of the CSF‐17 total score with global activity limitation, pain, depression and aesthetic burden, and divergent validity with anxiety. Cronbach's α was 0·94 for section A and 0·95 for section B. ICC (n = 25 patients) was 0·92 for the CSF‐17 total score. Bland–Altman analysis did not reveal a systematic trend for the test–retest.
Conclusions
The CSF‐17 is a new PROM assessing activities and participation specifically in people with SSc. Its content and construct validities are very high.
What is already known about this topic?
In the earliest stages of construction patient‐reported outcomes (PROMs) for people with systemic sclerosis (SSc) rarely involve the target population.
Instruments able to capture the specific needs of people with SSc in terms of activities and participation are lacking.
What does this study add?
The Cochin 17‐item Scleroderma Functional Scale (CSF‐17) is a new PROM assessing global activities and participation specifically in people with SSc.
Patients’ perspectives were prioritized at all stages of construction.
What are the clinical implications of this work?
The CSF‐17 could be used in clinical practice and research to assess the efficacy of complex multidisciplinary interventions targeting activity limitations and participation restriction in people with SSc.
Linked Comment: Clark and Denton. Br J Dermatol 2020; 183:610.
Linked Comment: Clark and Denton. Br J Dermatol 2020; 183:610.
We aimed to compare serum biomarkers of inflammation, redox status and cartilage degradation between chronic low back pain (cLBP) patients with and without Modic 1 changes. We used a convenience ...sample of patients recruited from a single center, case-control study, conducted in a tertiary care center. From December, 2014 to May, 2016, 2,292 patients were consecutively screened, 34 met inclusion criteria and were prospectively enrolled in the present study. Cases (n = 13) were defined as patients with Modic 1 changes detected on MRI and controls (n = 21) as cLBP patients without (Modic 0). To assess serum biomarkers of inflammation, redox status and cartilage degradation, fasting serum samples were collected in a standardized manner and analyzed by immunoassays and spectrophotometry. Mean (95% CI) age was 44.1 (40.0-48.1) years and mean LBP duration was 72.5 (53.0-91.9) months. Serum biomarkers of inflammation (IL-1β, IL-6, IL-8 and TNF-α), redox status (total thiols, advanced oxidation protein products and carbonyl groups) and cartilage degradation (Coll2-1 and Coll2-1NO
) did not differ between cLBP patients with and without Modic 1 changes. In summary, we did not find any differences in serum biomarkers between cLBP patients with and without Modic 1 changes. Interpretation is limited by convenience sampling and small sample size.
Background: The contribution of osteoarthritis (OA) at the base of the thumb (BT) and digits 2–5 interphalangeal joints (IP) to disability in the hand has never been assessed.
Objectives: To evaluate ...and compare disability in patients with clinical hand OA and more severe symptoms at BT or IP.
Design: Observational, prospective, correlational.
Setting: Rheumatology and rehabilitation departments in two tertiary care teaching hospitals.
Participants: One hundred and sixteen patients (107 women, mean age 62±7 years) fulfilling the American College of Rheumatology criteria for OA in the hand, with more symptomatic BT (67 patients) or IP (49 patients).
Main outcome measure: Disability assessment with Cochin hand functional scale (CHFS) was the primary outcome. Assessment of impairment by the visual analog scale of pain (VAS pain), Ritchie articular index (RAI), modified Kapandji index (mKI), Kallman radiological classification and handicap assessment with visual analog scale (VAS
Hd) was the secondary outcome. Group comparisons were assessed by use of Student’s
t-test for quantitative variables and Chi-square test for categorical variables. Results of the CHFS analysis were assessed by factorial analysis followed by Varimax rotation. Correlation between scores of disability, impairment, and handicap measures were calculated with use of Spearman rank correlation coefficient.
Results: Demographic data, disease duration, and level of global pain were similar between the BT and IP groups. The BT and IP groups did not differ significantly according to disability and handicap level (
P=0.42 and
P=0.94 for CHFS total score and VAS
Hd, respectively). Factor analysis of the CHFS revealed similar results for the two groups of patients, especially for the first extracted factor. Disability scores correlated best with global hand pain (
r=0.65) in the BT group and with RAI scores (
r=0.71) in the IP group.
Conclusions: Disability and perceived handicap levels are comparable in clinical hand OA patients with more symptomatic BT or IP. These two groups should not be considered different during trials assessing treatments for hand OA when the primary outcome measure assesses disability.
There have been few randomized controlled trials evaluating nonoperative treatment of proximal humeral fractures. To investigate shortening the period of dependence, we assessed the feasibility and ...efficacy of early mobilization of the shoulder (within three days after the fracture) in comparison with those of conventional three-week immobilization followed by physiotherapy.
We randomly assigned seventy-four patients with an impacted proximal humeral fracture to receive early passive mobilization or conventional treatment. The primary outcome was the overall shoulder functional status (as measured with the Constant score) at three months. The secondary outcomes were the Constant score at six weeks and at six months, the change in pain (on a visual analog scale), and the active and passive range of motion.
At three months and at six weeks, the early mobilization group had a significantly better Constant score than did the conventional-treatment group (between-group difference, 9.9 95% confidence interval, 1.9 to 17.8 p = 0.02 and 10.1 95% confidence interval, 2.0 to 18.1 p = 0.02, respectively) and better active mobility in forward elevation (between-group difference, 12.0 95% confidence interval, 1.7 to 22.4 p = 0.02 and 28.1 95% confidence interval, 7.1 to 49.1 p = 0.01, respectively). At three months, the early mobilization group had significantly reduced pain compared with the conventional-treatment group (between-group difference, 15.7 95% confidence interval, 0.52 to 30.8 p = 0.04). No complications in displacement or nonhealing were noted.
Early mobilization for impacted nonoperatively treated proximal humeral fractures is safe and is more effective for quickly restoring the physical capability and performance of the injured arm than is conventional immobilization followed by physiotherapy.
Objective To assess the efficacy and safety of tumor necrosis factor (TNF)-α inhibition with infliximab (IFX) in treating recurrent and disabling chronic sciatica pain associated with post-operative ...peridural lumbar fibrosis. Methods A double-blind, randomized, placebo controlled study randomized 35 patients presenting sciatica pain associated with post-operative peridural lumbar fibrosis to 2 groups: IFX ( n = 18), a single intravenous injection of 3 mg/kg IFX; and placebo n = 17), a single saline serum injection. The primary outcome was a 50% reduction in sciatica pain on visual analog scale (VAS) at day 10. Secondary outcomes were radicular and lumbar VAS pain at day 0 and radicular and lumbar VAS pain, Québec disability score, drug sparing effect and tolerance at days 10, 30, 90, and 180. Results At day 10, the placebo and IFX groups did not differ in the primary outcome (50% reduction in sciatica pain observed in 3 17.6% vs 5 27.8% patients, p = 0.69). The number of patients reaching the Patient Acceptable Symptom State for radicular pain was significantly higher in the placebo than IFX group after injection (12 70.6% vs 5 27.8%, p = 0.01). The 2 groups were comparable for all other secondary outcomes. Conclusion Treatment with a single 3-mg/kg IFX injection for post-operative peridural lumbar fibrosis-associated sciatica pain does not significantly reduce radicular symptoms at day 10 after injection.
We report a series of 10 patients with unilateral, dynamic, winged scapula (WS), without cause, that was diagnosed as voluntary winging of the scapula (VWS). We compared clinical, electrodiagnostic, ...and other examination data for 10 patients with VWS and 146 with dynamic WS‐related neuromuscular disorders, to establish a detailed pattern of the VWS subtype. In VWS, electrodiagnostic and other examinations did not reveal any neuromuscular or orthopedic cause. Winging was dynamic, obvious, neither medial nor lateral, and mainly involved the inferior angle of the scapula, in young patients. VWS never appeared during floor push‐ups. Patients could produce WS at will with the index and healthy shoulder, between 25° and 65° of anterior elevation, or with shoulder internal rotation. VWS is a benign disorder that can be distinguished from neuromuscular WS by normal electrodiagnostic results for muscles and nerves of both shoulders and two specific clinical tests.