Oswestry Disability Index Version Research Articles

Expectations in patients undergoing spine surgery are high and unmet

BACKGROUND CONTEXTDefining success in spine surgery lacks a standardized approach, and all existing concepts are based on registrations after surgery. PURPOSETo examine patients’ expectations before spine surgery assessed by a modified Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS). The authors asked: how do the expectations align with actual outcomes and can a patient's individual expectations be used as a success criterion in itself? STUDY DESIGN /SETTINGProspective single-center study. PATIENT SAMPLEPatients scheduled for spine surgery at Akershus University Hospital (AHUS) were included in the study. They underwent 1 of 3 procedures: decompression for spinal stenosis, disc removal for lumbar disc herniation, or spinal fusion for degenerative disc disease. OUTCOME MEASURESModified and standard version of ODI and NRS (back and leg pain). METHODSPreoperatively, the patients were given a modified ODI and NRS questionnaire in which they were asked to register the minimum acceptable functional impairment and pain they anticipated to have postsurgery. The patients’ expectations were compared with 3-and 12-month follow-up data from the Norwegian Registry for Spine Surgery (NORspine) with ODI, NRS and Global Perceived Effect (GPE) scale. We used simple descriptive statistics. RESULTSA total of 93 patients completed the pre-op questionnaire. Of these, 65 responded to the 3-month follow-up and 53 at 12-month follow-up. The mean (95%CI) ODI before surgery was 38.3 (34.2–42.3), the mean (95% CI) preoperative NRS back pain was 6.34 (5.81–6.88), and leg pain was 6.67 (6.08–7.26). The patients expected a mean (95% CI) ODI of 10.5 (7.5–13.5), mean (95%CI) NRS back pain of 2.5 (2.1–3.0), and NRS leg pain of 1.8 (1.5–2.2). The actual clinical outcome after 12 months were a mean (95% CI) ODI of 21.7 (17.0–26.5), NRS back pain of 3.4 (2.8–4.1), and leg pain of 2.8 (2.0–3.5). Only 12 (30.8%) patients achieved their expected ODI, while 26 (65.0%) classified themselves as significantly better according to GPE. CONCLUSIONSPatients seem to have high expectations before spine surgery, and the expectations may exceed the clinical outcome. Only 30.8% had their ODI expectations met, but perceived benefit was higher. High expectations may be due to inadequate preoperative information and/or the unsuitability of ODI for capturing expectations.

Why do we encounter studies with older versions of the Oswestry Disability Index? Awareness of researchers about the version updates and the lifespan of older versions.

The Oswestry Disability Index (ODI) is a common outcome-measure used for assessment of spinal disorders with three officially updated versions. However, there are recently published articles that still use ODI-1.0. This suggests the existence of a block on information flow between developers and end-users. To investigate the articles with missing citation to the latest ODI version, to calculate the life span of previous ODI version and to investigate the existence of a block on information flow. PMC-PubMed citation dataset is analyzed by CNA and text processing methods. The most important finding of this study is that there is no block on information flow between developers and users in terms of visibility in citations and full text access restrictions. Three different sub-networks are identified between ODI-1.0 and ODI-2.0 articles. 14% (165) of articles have citation to ODI-1.0 and ODI-2.0 version-articles. The time limit that is required for the new ODI version to become dominant in the literature is between 4 and 9 years. There is a missing citation problem in the ODI literature which is not a result of a block on information flow between developers and end-users.

Translation, cross-cultural adaptation, and psychometric properties of the Urdu version of Rand Short Form 36-item survey (SF-36) among patients with lumbar radiculopathy

Background and aimsAlthough Rand Short Form 36-item (SF-36) questionnaire is a frequently used tool for evaluating a patient's quality of life in both clinical and research settings, but its translation into Urdu language and its psychometric properties has not been tested before, in accordance to the pre-established guidelines. This study aimed to translate and assess the psychometric properties of Urdu version of SF-36 (SF-36-U) in lumbar radiculopathy patients. MethodsIn this cross-sectional study, one hundred and eight patients of lumbar radiculopathy filled SF-36-U questionnaire, Urdu version of Oswestry Disability Index (ODI-U) and visual analogue scales for pain (VAS pain) at baseline and after 7 days. Two types of reliability i.e. internal consistency and test-retest reliability while three types of validity i.e. face, content, and construct validity were evaluated. Psychometric properties were assessed contrary to the a priori hypothesis and alpha level was kept at < 0.05. ResultsSF-36-U presented good to excellent test-retest reliability for all eight domains (ICC2,1 = 0.75–0.92). Internal consistency was also acceptable for all domains (Cronbach's alpha = 0.73–0.90). Face and content validity were found to be good. Pearson correlation revealed moderate to strong correlations of SF-36-U domains with ODI-U (r = 0.43–0.54), VAS pain (r = 0.32–0.49) and each of its own question (r = 0.37–0.88) which shows good construct validity. ConclusionSF-36-U revealed acceptable psychometric properties and is considered as a reliable and valid questionnaire for assessing the health-related quality of life in Urdu-speaking patients having lumbar radiculopathy.

Effects of non-surgical decompression therapy in addition to routine physical therapy on pain, range of motion, endurance, functional disability and quality of life versus routine physical therapy alone in patients with lumbar radiculopathy; a randomized controlled trial

BackgroundLumbar radiculopathy is an extensively common complaint reported by patients of low back pain (LBP), resulting in several impairments. A comparatively novel technique, non-surgical spinal decompression (NSD), is introduced, which uses a sensitive computerized feedback mechanism and decompresses the spinal nerve roots through segmental distraction. The objective of this study was to determine the effects of NSD therapy in addition to routine physical therapy on pain, lumbar range of motion (ROM), functional disability, back muscle endurance (BME), and quality of life (QOL) in patients with lumbar radiculopathy.MethodsA total of sixty patients with lumbar radiculopathy were randomly allocated into two groups, an experimental (n = 30) and a control (n = 30) group, through a computer-generated random number table. Baseline values were recorded before providing any treatment by using a visual analogue scale (VAS), Urdu version of Oswestry disability index (ODI-U), modified-modified Schober’s test (MMST), prone isometric chest raise test, and Short Form 36-Item Survey (SF-36) for measuring the pain at rest, functional disability, lumbar ROM, BME, and QOL, respectively. All patients received twelve treatment sessions over 4 weeks, and then all outcome measures were again recorded.ResultsBy using the ANCOVA test, a statistically significant (p < 0.05) between-group improvement was observed in VAS, ODI-U, BME, lumbar ROM, role physical (RP), and bodily pain (BP) domains of SF-36, which was in favour of NSD therapy group. The between-group difference was 1.07 ± 0.32 cm (p < .001) for VAS, 5.65 ± 1.48 points (p < .001) for ODI-U, 13.93 ± 5.85 s (p = 0.002) for BME, 2.62 ± 0.27 cm (p < .001) for lumbar flexion, 0.96 ± 0.28 (p < .001) for lumbar extension, 5.77 ± 2.39 (p = 0.019) for RP and 6.33 ± 2.52 (p = 0.016) for BP domain of SF-36. For these outcomes, a medium to large effect size (d = 0.61–2.47, 95% CI: 0.09–3.14) was observed.ConclusionIt was concluded that a combination of non-surgical spinal decompression therapy with routine physical therapy is more effective, statistically and clinically, than routine physical therapy alone in terms of improving pain, lumbar range of motion, back muscle endurance, functional disability, and physical role domain of quality of life, in patients with lumbar radiculopathy, following 4 weeks of treatment.Trial registrationWHO Iranian registry of clinical trials (IRCT20190717044238N1) Dated: 23.12.2019.

Effect of proprioceptive training on lower back muscle performance in patients with chronic non-specific low back pain: a randomized controlled trial

IntroductionThis study was conducted to investigate the impact of proprioceptive training in patients with chronic non-specific low back pain on lower back muscle performance.MethodsOverall, 43 participants of both genders (28 females and 15 males) with chronic non-specific low back pain aged 18–26 years were randomly assigned to 2 groups (A and B). Group A (&lt;i&gt;n&lt;/i&gt; = 22) received proprioceptive training and conventional strengthening and stretching exercises 3 times per week for 8 weeks. Group B (&lt;i&gt;n&lt;/i&gt; = 21) received conventional strengthening and stretching exercises 3 times per week for 8 weeks. To assess lower back muscle performance (peak torque) and the repositioning error of the lumbar spine, a Biodex System 3 Pro isokinetic dynamometer was used. A pressure pain algometer served to measure the pain level, and the functional level was evaluated with the Arabic version of Oswestry Disability Index. All subjects’ outcomes were assessed before and after treatment. For statistical analysis, mixed ANOVA was conducted to investigate the effect of treatment.ResultsA statistically significant effect (&lt;i&gt;p&lt;/i&gt; &lt; 0.0001) of treatment and time was revealed in both groups for all measured variables. Between-group analysis implied a higher improvement in post-intervention results in group A (&lt;i&gt;p&lt;/i&gt; &lt; 0.05).ConclusionsThis study indicated improvement in both groups, but adding proprioceptive training to conventional therapy resulted in more improvement in all measured variables.

Validity and Reliability of WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Type 12 Questions Indonesian Version on Back Pain

The study was to prove the validity and reliability of the WHODAS 2.0 Indonesian version questionnaire in patients with back pain. This study was an observational cross-sectional study conducted in 2018. The study included the filling of WHODAS 2.0 Indonesian version, Indonesian version of Oswestry Disability Index (ODI) questionnaire, Wong-Baker Scale, conducted at Department of Rehabilitative Medicine, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia, against 82 respondents with back pain. Each respondent was given informed consent. The validity of the WHODAS 2.0 Indonesian version questionnaire was measured using Pearson's test on the correlation of WHODAS 2.0 Indonesian version questionnaire and Oswestry Disability Index questionnaire with r &gt;0.3 (0.862). WHODAS 2.0 Indonesian version questionnaire and Wong-Baker Scale had r &gt;0.3 (0.449–0.785). The reliability of the WHODAS 2.0 Indonesian version questionnaire was measured using Pearson's correlation test with r &gt;0.3 (0.764–0.866). WHODAS 2.0 Indonesian version's internal reliability was tested using Cronbach-Alfa Test with alpha &gt;0.6 (0.634–, 853). In conclusion, the WHODAS 2.0 - Indonesian version is a valid and reliable questionnaire for patients with back pain.

Responsiveness of Nepali version of Oswestry Disability Index (ODI) on individuals with non-specific low back pain

BackgroundLow back pain (LBP) is a common musculoskeletal problem, associated with disability and high societal costs. The Oswestry Disability Index (ODI) is among the most commonly used patient reported outcome measures to measure disability due to LBP. Evidence supporting the reliability and validity of the Nepali Version of Oswestry Disability Index (NODI) exists, but its responsiveness is yet to be assessed.ObjectiveWe aimed to assess the responsiveness of NODI in participants with non-specific low back pain.MethodsThe study included 102 (Male 41, Female 61) participants with non-specific low back pain, attending the physiotherapy outpatient department of a tertiary care hospital and nearby community. The NODI was administered to the patients at baseline and again 2 weeks later along with a 7-item Nepali Version of Global Rating of Change (GROC-NP). Responsiveness of NODI was assessed by plotting Receivers Operating Characteristics (ROC) curve.ResultsThe area under curve (AUC) of NODI was 0.88. The best cut-off point on the NODI for improvement on the GROC-NP or the minimal clinical important change (MIC) was 4.22 and ranged from 3.11 to 6.34. The sensitivity and specificity was 77.4% and 84.2% respectively.ConclusionNODI is a responsive scale which can discriminate between participants whose level of disability due to LBP is stable or improving. The result for minimal clinically important change, sensitivity and specificity are consistent with other cross culturally adopted versions.

Direct Sciatic Nerve Electrical Stimulation for Complex Regional Pain Syndrome Type 1

Foot and leg pain in complex regional pain syndrome (CRPS) presents a challenge even with neuromodulation techniques such as spinal cord stimulation (SCS). We report our experience with a novo technique of direct sciatic nerve electrical stimulation (DISNES) for intractable foot and leg pain in CRPS I. Following Research Ethics Board (REB) approval, data were gathered for 16 patients (10 women and 6 men, age 26-61 years) who had been subjected to ipsilateral DISNES. All 16 patients had failed conventional medical management. As well, seven subjects were previously treated with SCS for CRPS I pain. These subjects reported pain relief in the thigh and leg, however the SCS was unable to alleviate the disabling foot pain despite varied and multiple programming techniques. The remaining nine subjects were treated primarily with DISNES. Evaluation was done using visual analog scale (VAS), Oswestry Disability Index version 2 (ODI), and quality of life (EQ-5D and SF-36) scores done both pre-DISNES and at two follow-ups. VAS scores decreased by 59% at follow-up (F/U) 1 (P=0.00001) and 46% F/U 2. ODI improving by 40% F/U 1 (P=0.0038) and 37% F/U 2. SF-36 scores improved by 69% F/U 1 (P=0.015) and 80% F/U 2. EQ-5D scores improved significantly by F/U 1 (P=0.00030) but insignificantly at F/U 2 (P=0.81). There was also a rapid resolution of autonomic features such as edema, hyperemia, and allodynia (within 7-10 days). Three subjects returned to work post-DISNES. Our study shows that DISNES helps to control the disabling foot pain in CRPS I, thus improving the quality of life, improving ambulation and decreasing disability. DISNES also alleviates autonomic features and dystonia in CRPS I. Further studies are needed to determine long-term efficacy as this study pool is limited in size and follow-up period.

Cross-cultural adaptation of Cantonese (Hong Kong) Oswestry Disability Index version 2.1b.

Oswestry Disability Index (ODI) was established by Fairbank in 1989 to assess functional disabilities in low back pain (LBP). It was last updated in 2019 as ODI version 2.1b (ODI AU_2.1b). ODI was first translated into Simplified Chinese Oswestry Disability Index (CODI) in 2008 by Lue. The construct validity, internal consistency, level of agreement and the floor and ceiling effects of CODI were found unclear by Yao in 2016. This study will verify how well the adapted Cantonese-Hong Kong Oswestry Disability Index version 2.1b (HKCODI) aligns with ODI AU_2.1b in the Southern Chinese population. The translation of ODI AU_2.1b was performed according to guidelines from MAPI Research Trust and American Association of Orthopaedic Surgeons. Psychometric properties of HKCODI were tested statistically by Pearson's correlation, Cronbach's Alpha and Intraclass Correlation Coefficient (ICC). A total of 200 subjects (109 males, 91 females) aged from 15 to 85 (mean age = 58.91) with LBP scored from 3/10 to 10/10 in the Visual Analogue Scale (VAS) were recruited in the Occupational Therapy Department of a tertiary referral center. HKCODI demonstrated strong construct validity in comparing with Hong Kong Roland-Morris Disability Questionnaire (HKRMDQ) (r = 0.666, p = 0.000), Short Form Health Survey (SF-36) Physical Composite Summary (- 0.700, p = 0.000) and VAS (0.487, p = 0.000). Excellent internal consistency and test-retest reliability were confirmed with Cronbach's Alpha of 0.997 and ICC of 0.993 at 95% confidence level. Cross-cultural adaptation of ODI AU_2.1b has been translated and validated as HKCODI and Item-8 (Sex Life) was suggested to skip for patient older than 60. HKCODI is a fully self-administered and highly reliable tool in assessing the functional disability of patients with LBP in the Southern Chinese population.

Proprioceptive Neuromuscular Facilitation versus Sensory Motor Training in Non-Specific Low Back Pain

Background: Non-specific low back pain is a type of pain that is located in spine area and does not radiate to the legs. Non-specific low back pain can limit daily activities and cause inability to do work. The aim of this study is to compare the effectiveness of proprioceptive neuromuscular facilitation (PNF) versus sensory motor training (SMT) in the treatment of ultrasound therapy (UST) and kinesio tape (KT) insertion in non-specific low back pain. &#x0D; Methods: This research is an experimental with a randomized pre-test and post-test control group design, in which the study participants were divided into two groups randomly. The control group (n = 10) is given UST+PNF+KT combination, while the treatment group (n = 10) is given UST+SMT+KT combination. Therapeutic evaluation measures include: pain scale with a numeric rating scale, range of motion with a goniometer, and lower back disability with the Indonesian Version of Oswestry Disability Index. The intervention is given 3 times per 1 week for 3 weeks.&#x0D; Results: The results showed improvement in pain, range of motion, and lower back disability in each group (p&lt;0.05). However, there were no significant differences when compared between groups.&#x0D; Conclusion: Based on these results, it can be concluded that the UST+PNF+KT combination has the same good results as the UST+SMT+KT combination in improving pain, range of motion, and lower back disability in non-specific low back pain.

Urdu version of Oswestry disability index; a reliability and validity study

BackgroundOswestry Disability Index (ODI) is broadly used in clinical and research settings for assessing the disability level in patients with lumbar radiculopathy but it has not been translated into Urdu language according to the pre-established translation guidelines as well as the validity and reliability of ODI Urdu version has not been tested yet. The aim of this study was to translate ODI in native Urdu language (ODI-U) according to recommended guidelines and to measure its psychometric properties in Urdu speaking patients suffering from lumber radiculopathy.MethodsOut of 108 participants, 54 were healthy (who filled ODI-U) and 54 were patients of lumber radiculopathy. The patients were administered through ODI-U, visual analogue scales for disability (VAS disability), pain intensity (VAS pain) and SF-36 at baseline and after 3 days. Reliability was investigated through test-retest method, internal consistency, standard error of measurement (SEM) and smallest detectable change (SDC). ODI-U was assessed for exploratory factor analysis, construct (convergent and discriminative) validity and content validity. Alpha level < 0.05 was considered statistically significant and psychometric standards were evaluated contrary to priori hypothesis.ResultsODI-U revealed excellent test-retest reliability for total score (ICC2,1 = 0.95) and for all item (ICC2,1 = 0.72–0.98). Cronbach’s alpha of 0.89 showed excellent internal consistency and moderate correlation between ODI-U total score and each item through spearman’s correlation coefficient (r = 0.51–0.76). One factor structure was created, explaining 52.5% variance. There was no floor and ceiling effect of total ODI-U score. Content validity was assessed through conducting interviews with patients and incorporating expert’s opinions. The discriminative validity was measured by independent sample t-test, where significant difference between healthy and patients (P < 0.001) was observed. The convergent validity was evaluated through Pearson’s correlation showing moderate positive correlation of ODI-U with VAS pain (r = 0.49) and VAS disability (r = 0.51) but moderate negative correlation with all SF-36 domains (r = − 0.43to − 0.63).ConclusionODI-U showed adequate psychometric properties. ODI-U was found to be a reliable and a valid tool to measure the level of disability in Urdu-speaking patients with lumber radiculopathy.

Cross-cultural adaptation and psychometric validation of the Indonesian version of the Oswestry Disability Index.

The Oswestry Disability Index (ODI) is one of the most common patient-reported outcome measures used for low back pain (LBP). Since it was not available in Indonesian, this study aimed to perform a cross-cultural adaptation of ODI to Indonesian and evaluate its psychometric properties. We performed a cross-cultural adaptation of ODI v2.1a into Indonesian language (ODI-ID) and determined its internal consistency, test-retest reliability, measurement error, confirmatory factor analysis, floor-ceiling effect, and construct validity by hypotheses testing of its correlation with Short Form-36 (SF-36) and visual analog scale (VAS). Adults (> 17years of age) diagnosed with low back pain were included. A total of 96 subjects were included in this study. The original ODI questionnaire was translated into an Indonesian version and showed a good internal consistency (Cronbach's alpha = 0.90) and good reliability (intraclass correlation = 0.97). The standard error of measurement values of 3.35 resulted in a minimal detectable change score of 9. Nine out of nine (100%) a priori hypotheses were met, confirming the construct validity. A strong correlation was found with the physical component of SF-36 (0.77 and 0.76 for pain and physical function, respectively) and VAS (0.79). Confirmatory factor analysis resulted in a poor but significant fit to the original one-factor structure and the static-dynamic two-factor structure. Floor-ceiling effects were not found. The Indonesian version of ODI displayed similar reliability, validity, and psychometric characteristics to the original ODI. This questionnaire will be a suitable instrument for assessing LBP-related disability for Indonesian-speaking patients.

Reliability and validity of Punjabi version of Oswestry Disability Index in patients with mechanical low back pain

ObjectiveOswestry disability Index(ODI) is the commonest patient reported outcome for assessment of disability due to low back pain. Its application to non-English speaking Punjabi population is limited as a validated and cross culturally adapted Punjabi version of ODI is not available. The purpose of the study was to analyse the psychometric properties of Punjabi version of Oswestry disability index (ODI-P) in patients with mechanical low back pain. Materials and methodsThe translation and cross-cultural adaptation of Punjabi version of ODI was done according to well recommended guidelines. The prefinal version was tested on a set of 15 patients and suitable modifications were made. The final version was administered to 113 patients with mechanical low back pain of more than two weeks duration. Psychometric properties comprising of internal consistency, test retest reliability, floor and ceiling effect, construct validity and factorial structure of the questionnaire were determined. ResultsODI-P showed excellent internal consistency (Chronbach alpha of ODI-P is 0.72), test retest reliability (ICC 0.891) and construct validity (Spearman correlation coefficient with VAS 0.424). Factor analysis proved the questionnaire to be having a 1-factor structure with a total variance of 48.61%. ConclusionsODI (P) is a reliable and valid instrument for measurement of disability related to mechanical low back pain in Punjabi population. It can be used both in research and clinical care settings in future.

Validation of the Sinhalese version of the Oswestry Disability Index for low back pain

Introduction: Low back pain (LBP) is a major cause of disability. Oswestry Disability Index (ODI) is used to evaluate the impact of LBP) on daily activities. The objective of the current study was to validate and culturally adapt the ODI to the Sinhalese speaking Sri Lankan population. Methods: The study was conducted at National Hospital, Sri Lanka, including an 18-65 years aged cohort of 100 patients with chronic LBP. The Sinhalese ODI version 2.1a was validated by assessing the test-retest reliability (Intraclass correlation coefficient), internal consistency (Cronbach α) and constructs validity comparing the ODI with the Roland Morris Disability Questionnaire (RDQ) and Visual Analog Scale for pain intensity (Pearson correlation coefficient). Results: The mean age (±SD) of the study participants was 50.17±11.20 years and mean duration of LBP among participants were 34.00±43.58 months. The ODI had an overall Cronbach α coefficient of 0.811 (95% CI 0.746- 0.865). An excellent agreement was detected between test and re-test ODI scores, indicated by an ICC of 0.983 (95% CI: 0.975-0.989. The Pearson’s correlation test revealed a significant strong positive correlation between ODI and RDQ (r=0.989, p&lt;0.001) and a moderate positive correlation between ODI and VAS pain intensity (r=0.568, p&lt;0.001). Conclusion: The Sinhalese translation of the ODI version 2.1a had good reliability, temporal stability, and validity when assessed compared to other standard measures. The ODI can be employed in future studies assessing LBP disability in Sri Lanka.

Cross-cultural adaptation and psychometric evaluation of the Yoruba version of Oswestry disability index.

Low-Back Pain (LBP) is a common public health problem that is often worsened by maladaptive beliefs and disability. Thus, necessitating the need for availability of outcome measures to assess these sequelae among patients with chronic LBP. This study aimed to cross-culturally adapt and determine the psychometric properties of the Yoruba version of the ODI (ODI-Y). The ODI-Y was cross-culturally adapted following the process involving forward translation, synthesis, backward translation, expert review, and pilot testing. Internal consistency and test-retest reliability of the ODI-Y were determined using the Cronbach's alpha and intra-class correlation. Other psychometric properties explored included the factor structure, convergent validity, standard error of measurement and the minimal detectable change. One hundred and thirty-six patients with chronic LBP took part in the validation of the ODI-Y; 86 of these individuals took part in the test-retest reliability (within 1-week interval) of the translated instrument. The mean age of the respondents was 50.5±10.6years. The ODI-Y showed a high internal consistency, with a Cronbach's alpha (α) of 0.81. Test-retest of the Yoruba version of the ODI within 1-week interval yielded an Intra-Class Correlation coefficient of 0.89. The ODI-Y yielded a three-factor structure which accounted for 61.56% of the variance. Correlation of ODI-Y with the visual analogue scale was moderate (r = 0.30; p = 0.001). The standard error of measurement and minimal detectable change of the ODI-Y were 2.0 and 5.5. The ODI was adapted into the Yoruba language and proved to have good psychometric properties that replicated the results of other obtainable versions. We recommend it for use among Yoruba speaking patients with LBP.

Responsiveness and Minimal Important Change for Pain and Disability Outcome Measures in Pregnancy-Related Low Back and Pelvic Girdle Pain

Pregnancy-related low back pain and pelvic girdle pain (LBP/PGP) are common and negatively impact the lives of many pregnant women. Several patient-based outcome instruments measure treatment effect, but there is no consensus about which measure to use with women who have these pain presentations. The objective was to compare the responsiveness of 3 outcome measures in LBP/PGP: Oswestry Disability Index-version 2.0 (ODI), Pelvic Girdle Questionnaire (PGQ), and 0 to 10 numerical rating scale for pain severity (NRS); and to estimate a minimal important change (MIC) for these measures in pregnancy-related LBP/PGP. This was a methodology study using data from a pilot randomized controlled trial. Women (N=124) with pregnancy-related LBP/PGP were recruited to a pilot randomized controlled trial evaluating the benefit of adding acupuncture to standard care, of whom 90 completed an 8-week follow-up. Responsiveness was evaluated by examining correlation between change score and the external anchor (6-point global perceived effect scale) and by using receiver operating characteristic curve analysis. MIC was estimated using anchor-based methods. All measures showed good responsiveness, with areas under the receiver operating characteristic curve ranging from 0.77 to 0.90. The estimated MICs were 3.1, 11.0, 9.4, 13.3, and 1.3 for the ODI, PGQ-total, PGQ-activity, PGQ-symptoms, and NRS, respectively. All the measures, apart from ODI, had MICs larger than the measurement error. The lack of an optimal "gold standard" or external criterion for assessing responsiveness and MIC was a limitation of this study. All 3 outcome measures demonstrated good responsiveness. MICs were derived for each instrument. The PGQ at 8weeks postrandomization was identified as an appropriate outcome measure for pregnancy-related LBP/PGP because it is specific to these pain presentations and assesses both activity limitations and symptoms. The NRS is an efficient, shorter alternative.

Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial

BackgroundFusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study.MethodsThe NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion.Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10 years.ConclusionThe NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group.Trial registrationClinicalTrials.gov Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018.

Development of the Marathi version of the Tampa scale of kinesiophobia 11: Cross-cultural adaptation, validity, and test–retest reliability in patients with low back pain

Background: The Tampa Scale of Kinesiophobia-11 (TSK-11) is used to assess fear of movement in patients with musculoskeletal dysfunction. However, for Indian-specific population, this scale is not available. We aim to cross-culturally adapt the TSK-11 into a regional Indian language (Marathi) and to assess its psychometric properties, validity, and reliability. Materials and Methods: The American Association of Orthopedic Surgeons guidelines were used for cross-cultural adaptation and psychometric testing. Psychometric testing included assessment of internal consistency (Cronbach's alpha) and test–retest repeatability (intraclass coefficient correlation), construct validity (Pearson correlation) by comparing the TSK-11 score to a visual analog scale (VAS) of confidence and pain, as well as the Marathi version of Oswestry Disability Index (ODI). Results: A total of 100 individuals with mean age of 38.9 years (Standard deviation = 11.34) completed the translated TSK-11 questionnaire on two occasions with an interval of one day. The translated Marathi version demonstrated excellent internal consistency (α = 0.85) and test–retest reliability (intraclass correlation coefficient = 0.93, confidence interval 95% = 0.90–0.95). There were moderate correlations between the total score of the TSK-11 questionnaire Marathi version and ODI score (r = 0.72), VAS pain score (r = 0.635), and VAS confidence score (r = −0.603). Receiver operating characteristics analysis indicated that the TSK-11 score was significantly able (P

Hidden association between the presence and severity of striae gravidarum and low back pain in pregnancy

Objective(s)To investigate the association between striae gravidarum and low back pain in pregnancy. Study Design200 healthy pregnant women with first, uncomplicated and singleton pregnancy at a gestation age of 36–37 weeks were evaluated for striae gravidarum Davey score. Back pain was assessed by Visual Analogue Scale and functional disability by the Turkish version of Oswestry Disability Index. Results118 (59%) had low back pain. The Davey score was higher in women with low back pain (6.6 ± 2.2 vs. 4.4 ± 2.1; p < 0.001). Davey score and total Oswestry Disability Index score were positively correlated with Visual Analogue Scale in women with low back pain (r = 0.570, p < 0.001 and r = 0.329, p < 0.001, respectively). There were also significant positive correlations between Davey scores and Oswestry Disability Index scores of each different situation (pain intensity, personal care and lifting, walking, sitting, standing, sleeping, sexual life, social life and travelling). ConclusionPresence and severity of low back pain is correlated with the presence and severity of striae gravidarum in pregnant women. Therefore, the presence of low back pain can be predicted by simple striae gravidarum evaluation and follow-up. So, necessary precautions can be recommended to prevent pain and functional limitations that can occur during pregnancy.

Core outcome measurement instruments for clinical trials in nonspecific low back pain.

To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments.