The patient-specific functional scale is more responsive than the Roland Morris disability questionnaire when activity limitation is low

The primary objective of this study was to determine which questionnaire, the Roland Morris disability questionnaire (RMDQ) or the patient-specific functional scale (PSFS), was better at detecting change in activity limitation in a large cohort of patients with low back pain undergoing rehabilitation. A secondary aim was to determine if the responsiveness of the questionnaires was influenced by the patient’s level of activity limitation at baseline. Responsiveness statistics, including effect size statistics, Pearson’s r correlations and receiver operative characteristic (ROC) curve analysis were used to determine ability to detect change in activity limitation on 831 patients with low back pain. Data were analysed at two time points; directly after treatment (termed short-term) and several weeks post-treatment (termed mid-term). The data were subsequently re-analysed on sub-sets of the full cohort according to the level of activity limitation from RMDQ baseline scores. In the total cohort we found that the PSFS was more responsive than the RMDQ; however, in the subgroup with high activity limitation this pattern was not observed. This is true for time points up to 6 months post-treatment. In conclusion, the RMDQ and PSFS both demonstrate good responsiveness according to the definitions given in previous guidelines. The PSFS is more responsive than the RMDQ for patients with low levels of activity limitation but not for patients with high levels of activity limitation.     

Danish version of the Oswestry disability index for patients with low back pain. Part 2: Sensitivity, specificity and clinically significant improvement in two low back pain populations

In studies evaluating the efficacy of clinical interventions, it is of paramount importance that the functional outcome measures are responsive to clinically relevant change. Knowledge thereof is in fact essential for the choice of instrument in clinical trials and for clinical decision-making. This article endeavours to investigate the sensitivity, specificity and clinically significant improvement (responsiveness) of the Danish version of the Oswestry disability index (ODI) in two back pain populations. Two hundred and thirty three patients with low back pain (LBP) and/or leg pain completed a questionnaire booklet at baseline and 8 weeks follow-up. Half of the patients were seen in the primary (PrS) and half in the secondary sectors (SeS) of the Danish Health Care System. The booklet contained the Danish version of the ODI, along with the Roland Morris Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. At follow-up, a 7-point transition question (TQ) of patient perceived change and a numeric rating scale relating to the importance of the change were included. Responsiveness was operationalised using three strategies: change scores, standardised response means (SRM) and receiver operating characteristic (ROC) analyses. All methods revealed acceptable responsiveness of the ODI in the two patient populations which was comparable to the external instruments. SRM of the ODI change scores at 2 months follow-up was 1.0 for PrS patients and 0.3 for SeS (raw and percentage). A minimum clinically important change (MCID) from baseline score was established at 9 points (71%) for PrS patients and 8 points (27%) for SeS patients using ROC analyses. This was dependable on the baseline entry score with the MCID increasing with 5 points for every 10 points increase in the baseline score. We conclude that the Danish version of the ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in low back pain patients receiving conservative care in both the primary and secondary sector.     

Low back pain does not improve with surgical treatment of pelvic organ prolapse

Introduction and hypothesis

Our goal was to determine if there is a correlation between low back pain (LBP) and pelvic organ prolapse (POP) by assessing for change in LBP after surgical correction of prolapse.

Methods

Patients undergoing POP surgery were recruited to participate. They completed the Oswestry Disability Index (ODI), a validated back pain questionnaire, at their preoperative and postoperative visits at 1, 3, and 6 months. A higher ODI score (0–100) represents more severe disability. A 9-point change represents a minimal clinically important difference (MCID). The primary outcome was the change in ODI scores from preoperative to 3 months postoperative. We analyzed ODI scores with repeated measures analysis of variance (ANOVA). Power analysis showed that a sample size of 50 was needed for 88 % power to resolve a MCID on ODI.

Results

A total of 51 patients were recruited and 43 (84 %), 34 (67 %), and 36 (71 %) completed the 1-, 3-, and 6-month follow-up, respectively. The mean ODI scores at the preoperative and the 1-, 3-, and 6-month postoperative visits were 15, 19, 9, and 9. The mean ODI score from preoperative to 3 months postoperative improved by 5 points [confidence interval (CI) ?9.2 to ?0.5, p?=?0.03]. Of the participants 7 (20.6 %, CI 11–35 %) experienced a MCID improvement, 24 (70.6 %, CI 56–83 %) reported no substantial change, and 3 (8.8 %, CI 3–20 %) experienced a MCID worsening.

Conclusions

Our study found a statistically significant but not clinically significant improvement of LBP after surgical repair of prolapse.     

What is an acceptable outcome of treatment before it begins? Methodological considerations and implications for patients with chronic low back pain

Understanding changes in patient-reported outcomes is indispensable for interpretation of results from clinical studies. As a consequence the term “minimal clinically important difference” (MCID) was coined in the late 1980s to ease classification of patients into improved, not changed or deteriorated. Several methodological categories have been developed determining the MCID, however, all are subject to weaknesses or biases reducing the validity of the reported MCID. The objective of this study was to determine the reproducibility and validity of a novel method for estimating low back pain (LBP) patients’ view of an acceptable change (MCID_pre) before treatment begins. One-hundred and forty-seven patients with chronic LBP were recruited from an out-patient hospital back pain unit and followed over an 8-week period. Original and modified versions of the Oswestry disability index (ODI), Bournemouth questionnaire (BQ) and numeric pain rating scale (NRS_pain) were filled in at baseline. The modified questionnaires determined what the patient considered an acceptable post-treatment outcome which allowed us to calculate the MCID_pre. Concurrent comparisons between the MCID_pre, instrument measurement error and a retrospective approach of establishing the minimal clinically important difference (MCID_post) were made. The results showed the prospective acceptable outcome method scores to have acceptable reproducibility outside measurement error. MCID_pre was 4.5 larger for the ODI and 1.5 times larger for BQ and NRS_pain compared to the MCID_post. Furthermore, MCID_pre and patients post-treatment acceptable change was almost equal for the NRS_pain but not for the ODI and BQ. In conclusion, chronic LBP patients have a reasonably realistic idea of an acceptable change in pain, but probably an overly optimistic view of changes in functional and psychological/affective domains before treatment begins.     

Minimal clinically important difference in patients who underwent decompression alone for lumbar degenerative disease

Background ContextThe minimal clinically important difference (MCID) represents the smallest change in an outcome measure recognized as clinically meaningful to a patient after receiving a clinical intervention. Most studies that discussed the MCIDs for lumbar spinal stenosis (LSS) included mixed pathologies or procedures despite that the MCID value should be different depending on the intervention. Moreover, despite the efficacy of adopting percentage-change improvement for the MCID threshold, there are limited reports and discussions in the field of lumbar surgery.PurposeThe aim of the present study was to elucidate the MCIDs for the Oswestry Disability Index (ODI), EuroQOL 5-dimension 3-level (EQ-5D-3L), physical component summary (PCS) of the Short Form of the Medical Outcomes Study, and Numeric Rating Scale (NRS) in patients with degenerative LSS treated with decompression surgery without fusion.Study Design/SettingA multicenter retrospective cohort study was performed.Patient SampleA total of 422 patients who underwent decompression surgery for LSS and answered a complete set of questionnaires were included in the study. Patients who underwent endoscopic or revision surgery were excluded.Outcome MeasuresPreoperative and 1-year postoperative scores of each health-related quality of life questionnaires (HRQOLs) and patient satisfaction questionnaire responseMethodsThe patient satisfaction question was used as an anchor, and the cutoff values were estimated based on absolute point improvement from baseline using a receiver-operating characteristic (ROC) curve analysis and the “mean change” method for MCIDs. The MCID values for percentage-change in HRQOLs were also calculated using ROC curve analysis. The three cutoff values for each HRQOL were validated using the Youden index for determining the most robust MCIDs.ResultsOf the patients, 356 (84.4%) were at least “somewhat satisfied” with the treatment results. The two cutoff values of absolute point-change in each HRQOL, which were estimated by two different anchor-based methods, were similar. The area under the curve of the ROC curve for percentage-change tended to be higher than that for absolute point-change. Moreover, the Youden index of the percentage-change in each HRQOL was higher than that of the absolute point-change calculated by either the “mean change” method or the ROC curve analysis. Based on these results, it was proposed that MCID was 42.4% for percentage-change in ODI, 22.0% for EQ-5D-3L, 13.7% for PCS, 25.0% for NRS (low back pain), 55.6% for NRS (leg pain), 22.2% for NRS (leg numbness).ConclusionsThe MCIDs of HRQOLs were calculated in patients with LSS treated with decompression surgery without concomitant fusion procedure. The MCID cutoffs based on percentage-change from baseline were more effective than those of absolute point-change.     

Responsiveness of the Chinese version of the Oswestry disability index in patients with chronic low back pain

The Oswestry Disability Index (ODI) is one of the most widely used questionnaires that assess disability in patients with low back pain (LBP). Responsiveness is both an important psychometric property of an instrument and a key issue for clinicians when choosing suitable outcome measures. The objective of this study was to examine the responsiveness of the Chinese version of the ODI (ODI-Chinese) for subjects with chronic LBP following a physical therapy program. In total, 76 patients with chronic LBP completed the ODI-Chinese, a visual analog scale (VAS) of pain, and the Chinese version of Short Form-36 (SF-36) before and after treatment. All patients also completed a global perception of change Likert scale in condition after the program. The scale was collapsed to produce a dichotomous variable outcome, improved or non-improved. The responsiveness of the instruments was determined using the standardized response means (SRM) and receiver operating characteristics (ROC). After treatment, 56 patients considered themselves to be improved. The SRM of the ODI-Chinese was −1.2 in the improved group and −0.4 in the non-improved group. The area of the ROC curve for the ODI-Chinese was 0.77 (95% CI 0.66–0.89). Therefore, the Chinese version of the ODI is both responsive and appropriate for use in chronic LBP patients after conservative therapy.     

How little pain and disability do patients with low back pain have to experience to feel that they have recovered?

Epidemiological and clinical studies of people with low back pain (LBP) commonly measure the incidence of recovery. The pain numerical rating scale (NRS), scores from 0 to 10, and Roland Morris disability questionnaire (RMDQ), scores from 0 to 24, are two instruments often used to define recovery. On both scales higher scores indicate greater severity. There is no consensus, however, on the cutoff scores on these scales that classify people as having recovered. The aim of this study was to determine which cutoff scores most accurately classify those who had recovered from LBP. Subjects from four clinical studies were categorized as ‘recovered’ or ‘unrecovered’ according to their self-rating on a global perceived effect scale. Odd ratios were calculated for scores of 0, 1, 2, 3 and 4 on the NRS and RMDQ to predict perceived recovery. Scores of 0 on the NRS and ≤2 on the RMDQ most accurately identify patients who consider themselves completely recovered. The diagnostic odds ratio (OR) for predicting recovery was 43.9 for a score of 0 on the NRS and 17.6 for a score of ≤2 on the RMDQ. There was no apparent effect of LBP duration or length of follow-up period on the optimal cutoff score. OR for the NRS were generally higher than those for RMDQ. Cutoffs of 0 on the NRS and 2 on the RMDQ most accurately classify subjects as recovered from LBP. Subjects consider pain more than disability when determining their recovery status.     

Measuring clinically relevant improvement after lumbar spine surgery: is it time for something new?

BACKGROUND CONTEXTMinimum clinically important difference (MCID) for patient-reported outcome measures is commonly used to assess clinical improvement. However, recent literature suggests that an absolute point-change may not be an effective or reliable marker of response to treatment for patients with low or high baseline patient-reported outcome scores. The multitude of established MCIDs also makes it difficult to compare outcomes across studies and different spine surgery procedures.PURPOSETo determine whether a 30% reduction from baseline in disability and pain is a valid method for determining clinical improvement after lumbar spine surgery.STUDY DESIGNRetrospective analysis of prospective data from a national spine registry, the Quality Outcomes Database.PATIENT SAMPLEThere were 23,280 participants undergoing elective lumbar spine surgery for degenerative disease who completed a baseline and follow-up assessment at 12 months.OUTCOME MEASURESPatient-reported disability (Oswestry Disability Index [ODI]), back and leg pain (11-point Numeric Rating Scale [NRS]), and satisfaction (NASS scale).METHODSPatients completed baseline and a 12-month postoperative assessment to evaluate the outcomes of disability, pain, and satisfaction. The change in ODI and NRS pain scores was categorized as met (≥30%) or not met (<30%) percent reduction MCID. The 30% reduction from baseline was compared with a wide range of well-established absolute point-change MCID values. The relationship between 30% reduction and absolute change values and satisfaction were primarily compared using receiver operating characteristic (ROC) curves, area under the curve (AUROC), and logistic regression analyses. Analyses were conducted for overall scores and for disability and pain severity categories and by surgical procedure.RESULTSThirty percent reduction in ODI and back and leg pain predicted satisfaction with more accuracy than absolute point-change values for the total population and across all procedure categories (p<.001), except for when compared with the highest absolute point-change threshold for leg pain (3.5-point reduction). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0–20%: 21.8%) and bed-bound disability (ODI 81%–100%: 13.9%) categories. For pain, there was a 3.4%–12.4% and 1.3%–9.8% AUROC difference for no/mild back and leg pain (NRS 0–4), respectively, in favor of a 30% reduction threshold.CONCLUSIONSA 30% reduction MCID either outperformed or was similar to absolute point-change MCID values. Results indicate that a 30% reduction (baseline to 12 months after surgery) in disability and pain is a valid method for determining clinically relevant improvement in a broad spine surgery population. Furthermore, a 30% reduction was most accurate for patients in the lowest and highest disability and lowest pain severity categories. A 30% reduction MCID allows for a standard cut-off for disability and pain that can be used to compare outcomes across various spine surgery procedures.     

Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales

BACKGROUND CONTEXT: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. PURPOSE: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study. OUTCOME MEASURES: Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. METHODS: ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). RESULTS: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. CONCLUSIONS: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCS, 1.2 points for back pain, and 1.6 points for leg pain.     

Long-term reduction in pain and disability after surgery with the interspinous device for intervertebral assisted motion (DIAM) spinal stabilization system in patients with low back pain: 4-year follow-up from a longitudinal prospective case series

Patients with low back pain (LBP) suffer chronic disability. In 40% of LBP patients degenerative disc disease (DDD) seems to be the cause. This prospective case series assessed the efficacy of the interspinous device for intervertebral assisted motion (DIAM™) in patients with LBP resulting from DDD. All patients were initially assessed by physical examinations, magnetic resonance imaging, dynamic X-rays and provocative discography. Eligible patients (n = 52) had LBP for a minimum of 4 months, and received surgery with the DIAM™ system 2–4 weeks after diagnosis. Patients were evaluated pre-/post-operatively for pain severity using a visual analogue scale (VAS), and for dysfunction and disability with the Roland–Morris Disability Questionnaire (RMDQ). VAS and RMDQ score changes were assessed using the appropriate contrasts and Bonferroni-corrected P values. As a result, significant (P < 0.0001) pain score reductions were observed between baseline values, and 2 (3.7, 95% CI 3.1; 4.2) and 48 (3.1, 95% CI 2.5; 3.6) months follow-up (intent-to-treat population). Disability scores were significantly (P < 0.0001) reduced between baseline and 2 (8.6, 95% CI 7.4; 9.9) and 48 (7.5, 95% CI 6.1; 8.9) months. Disability scores were similar from months 2 to 48. At 48 months, 67.3% of patients reached the minimum clinically important difference (MCID; ≥1.5-unit improvement) in VAS score and 78.9% of patients reached the MCID (≥30% improvement) in RMDQ score. No complications were associated with surgery. In conclusion, patients with LBP treated with the interspinous DIAM™ system showed significant and clinically meaningful improvements in pain and disability for up to 4 years.     

Clinimetric properties of the EuroQol-5D in patients with chronic low back pain

Background context

Clinimetric properties of the EuroQol-5D (EQ-5D) in patients with nonspecific chronic low back pain (CLBP) are largely unknown.

Purpose

To study the criterion validity, responsiveness, and minimal clinically important change (MCIC) of EQ-5D in patients with CLBP.

Study design

Prospective study design carried out in a multispecialist Spine Center in The Netherlands.

Patient sample

One hundred fifty-one patients with CLBP.

Outcome measures

Quality of life (QOL) was measured with EQ-5D, consisting of two scales: one scale measuring QOL with five categorical questions and the other measuring health state on a visual analog scale (0–100). Criterion measures were disability, measured with the Pain Disability Index (PDI) and the Roland Morris Disability Questionnaire (RMDQ), and pain intensity, measured with a numeric rating scale (NRS).

Methods

Pearson correlation coefficients between the EQ-5D and RMDQ, PDI, and NRS were calculated to test the criterion validity. Correlations were interpreted based on predefined criteria. Responsiveness of the EQ-5D was calculated with area under the receiver operating characteristics (ROC) curve. Minimal clinically important change was calculated with the optimal cutoff point under the ROC curve, and sensitivity and specificity were also calculated.

Results

Correlations between EQ-5D and criterion measures ranged between 0.39 and 0.59 and were considered moderate to good. Areas under the ROC curve ranged from 0.59 to 0.72 depending on the external criterion and EQ-5D subscale. The MCIC was 0.03 points for the categorical scales of the EQ-5D and 10.5 points for the EQ-5D visual analog scale.

Conclusions

The EQ-5D is a valid and responsive QOL scale in patients with CLBP.     

Determination of minimum clinically important difference (MCID) in pain,disability, and quality of life after revision fusion for symptomatic pseudoarthrosis

Background contextSpinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis.PurposeTo determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis.Study design/ settingRetrospective cohort study.MethodsIn 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index).ResultsAll patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state.ConclusionsUsing subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.     

Responsiveness of the Brazilian–Portuguese version of the Oswestry Disability Index in subjects with low back pain

When quality of life questionnaires are used as measures of treatment outcomes, it is essential to know how well these can respond to clinical changes. The objective of this study is to examine the responsiveness of the Brazilian–Portuguese version of the Oswestry Disability Index (ODI-Brazil) in subjects with chronic low back pain submitted to a physical therapy program. Thirty subjects with chronic low back pain completed the ODI-Brazil questionnaire, along with an 11-point pain visual analogue scale (Pain VAS), and the Brazilian–Portuguese version of Roland–Morris disability questionnaire before and after the program. All patients also completed a global perception of change Likert scale in condition after the program. This scale was collapsed to produce a dichotomous variable outcome: improved and non-improved. Responsiveness was determined using effect size statistics and receiver operating characteristic curve (ROC curve), with best cut-point analysis. The best change score cut-off was identified when equally balanced sensitivity and specificity was found, as an expression of the minimum clinically important difference (MCID). After treatment, 19 patients considered themselves improved. Both the effect size (0.37) and the area under the ROC curve (0.73) for ODI-Brazil score in relation to global outcome after program indicated that the ODI-Brazil showed responsiveness. The ROC curve for ODI-Brazil was distributed at the upper corners of the diagonal line, indicating that the questionnaire presents discriminative ability. The best cut-off point for ODI-Brazil was approximately 4.45 points (63.2% sensitivity, 81.8% specificity). The Brazilian–Portuguese version of ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in chronic low back pain patients receiving conservative care.     

Results of pulsed radiofrequency technique with two laterally placed electrodes in the annulus in patients with chronic lumbar discogenic pain

Discogenic pain is an important cause of low back pain (LBP). We have developed a pulsed radiofrequency (P-RF) technique, using two electrodes placed bilaterally in the annulus, for applying radiofrequency current in the disc (bi-annular P-RF disc method). The purpose of this study was to investigate the effect of the bi-annular P-RF disc method, using Diskit needles (Neurotherm, Middleton, MA, USA) in patients with discogenic LBP. The subjects were 15 patients with a mean age of 37.3 ± 8.63 years with chronic discogenic lower back pain that was not responsive to aggressive nonoperative care. Two Diskit II needles (15-cm length, 20G needles with a 20-mm active tip) were placed bilaterally in the annulus in the disc. Pulsed radiofrequency was applied for 12 min at a setting of 5 × 50 ms/s and 60 V. The pain intensity scores on a 0–10 numeric rating scale (NRS) and the Roland–Morris Disability Questionnaire (RMDQ) were measured pretreatment, and at 1 week and 1, 3, and 6 months post-treatment. The mean pain severity score (NRS) improved from 7.27 ± 0.58 pretreatment to 2.5 ± 0.94 at the 6-month follow-up (p < 0.01). The RMDQ showed significant (p < 0.01) improvement, from 10.70 ± 2.35 pretreatment to 2.10 ± 1.85 at the 6-month follow up (p < 0.01). The bi-annular P-RF disc method with consecutive P-RF 5/5/60 V, 12-min (with Diskit needle), appears to be a safe, minimally invasive treatment option for patients with chronic discogenic LBP.     

Responsiveness of the Oswestry Disability Index and the Roland Morris Disability Questionnaire in Italian subjects with sub-acute and chronic low back pain

Introduction  

An ability to assess longitudinal changes in health status is crucial for the outcome measures used in treatment efficacy trials. The aim of this study was to verify the responsiveness of the Italian versions of the Oswestry Disability Index (ODI) and the Roland Morris Disability Questionnaire (RMDQ) in subjects with subacute or chronic low back pain (LBP).     

Construct validity and responsiveness of commonly used patient reported outcome instruments in decompression for lumbar spinal stenosis

BackgroundValidity and responsiveness of Oswestry disability index (ODI), Roland Morris disability questionnaires (RMDQ), Short Form-12 Physical Component Score (SF-12 PCS) and Short Form-12 Mental Component Score (SF-12 MCS) in patients undergoing open decompression for lumbar canal stenosis has not been previously reported.MethodsOutcome assessment was prospectively evaluated using the ODI, RMDQ, SF-12 PCS and SF-12 MCS pre-intervention and at average follow-up of three months post-intervention. Pearson correlation coefficient was used to evaluate the association between change in values of ODI, RMDQ, SF-12 PCS and SF-12 MCS. Distribution based methods (Effect size [ES], standardised response mean [SRM]) and anchor based method (Area under the curve [AUC] of receiver operating curve [ROC]) were used to determine responsiveness. AUC value ≥ 0.70 is considered as adequate level of responsiveness and the outcome instrument with the largest AUC is considered to be the most responsive outcome instrument.ResultsThis study included 77 participants. Responsiveness was assessed at a mean follow-up of 12 weeks postoperatively. There was significant strong correlation between ODI and RMDQ (r = 0.65, p < 0.0001). The ES of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 1.54, 1.48, 1.85 and 0.51 respectively. The SRM of RMDQ, ODI, SF-12 PCS and SF-12 MCS were 1.22, 1.17, 1.0 and 0.47 respectively. AUC of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 0.83–0.88, 0.82 to 0.86, 0.78 to 0.81 and 0.69 to 0.70 respectively.ConclusionIt is recommended to use either ODI or RMDQ as region specific patient reported outcome instrument and SF-12 PCS as a health related quality of life outcome instrument to evaluate outcome after decompressive laminectomy for lumbar canal stenosis.     

Low back pain: critical assessment of various scales

To study the various pain assessment tools based on their psychometric properties and ease of use. Published articles on psychometric properties of pain tools were accessed and data collected for low back pain (LBP)-specific tools, generic tools, neuropathic LBP tools, tools for cognitively impaired patients, and tools for acute LBP. Among the LBP-specific tools, Roland Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI) have good construct validity and reliability, and responsiveness over short intervals. Quebec Back Pain Disability Scale (QBPDS) gauges only disability and sleep. Among the generic tools, McGill Pain Questionnaire (MPQ), West Haven-Yale Multidimensional Pain Inventory (MPI), and Brief Pain Inventory (BPI) show good responsiveness, but BPI is the only tool validated for LBP. Neuropathic Pain Scale (NPS) and Short Form-MPQ-2 (SF-MPQ-2) are both reliable tools for neuropathic LBP. For cognitively impaired patients, Pain Assessment in Advanced Dementia (PAINAD), Abbey Pain Scale (APS), and Doloplus-2 are all reliable tools, but PAINAD has good construct validity. For acute pain, Clinically Aligned Pain Assessment (CAPA) is reliable and responsive, but presently, unidimensional tools and SF-MPQ-2 are the tools most preferred. Based on psychometric properties and ease of use, the best tools for LBP seem to be RMDQ/ODI (among LBP-specific tools), BPI (among generic tools), SF-MPQ-2/NPS (for neuropathic LBP), PAINAD (for cognitively impaired patients), and unidimensional tools and SF-MPQ-2 (for acute pain). Overall, BPI seems to be a tool that can be relied upon the most. These slides can be retrieved under Electronic Supplementary Material.     

Item response theory analysis to evaluate reliability and minimal clinically important change of the Roland-Morris Disability Questionnaire in patients with severe disability due to back pain from vertebral compression fractures

Background Context

The majority of validation done on the Roland-Morris Disability Questionnaire (RMDQ) has been in patients with mild or moderate disability. There is paucity of research focusing on the psychometric quality of the RMDQ in patients with severe disability.

Management of facet joints osteoarthritis associated with chronic low back pain: A systematic review

IntroductionFacet joint injections (FJI) and medial branch blocks (MBB) can be employed for chronic low back pain (LBP) using different drugs such as corticosteroids, hyaluronic acid, sarapin and local anaesthetics. This systematic review compares the results of injections obtained with different compounds in the management LBP originating from facet joints.MethodsThe present systematic review was conducted according to the PRISMA statement. The literature search was performed in October 2020. All the randomized clinical trials concerning injection treatments for chronic LBP. Drugs rather than steroids, hyaluronic acid, anaesthetics and sarapin were not considered, as well as those reporting outcomes from combined treatments. The Oswestry Disability Index (ODI) and the numeric rating scale (NRS) were retrieved.ResultsData from 587 patients were retrieved. The mean follow-up was 12.4 ± 10.5 months. The mean age was 51.3 ± 9.6 years old. 57% (335/587) of patients were women. Steroids promoted a reduction of NRS by 28% (P < 0.0001) and an improvement of the ODI by 13.2% (P = 0.005), and local anaesthetics produced an improvement of the ODI by 9.8% (P < 0.0001). Sarapin resulted in a reduction of NRS by 44% (P = 0.04) and an improvement the ODI by 14.9% (P = 0.004); sarapin combined with steroids promoted a reduction of NRS by 47% (P = 0.04) and an improvement of the ODI by 11.7% (P = 0.001).ConclusionInjections for chronic LBP deriving from facet joints osteoarthritis are encouraging, especially when considering MBB.Level of evidenceI, systematic review of RCTs.     

Responsiveness and minimal clinically important difference for pain and disability instruments in low back pain patients

Background  

The choice of an evaluative instrument has been hampered by the lack of head-to-head comparisons of responsiveness and the minimal clinically important difference (MCID) in subpopulations of low back pain (LBP). The objective of this study was to concurrently compare responsiveness and MCID for commonly used pain scales and functional instruments in four subpopulations of LBP patients.