scholarly journals Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study (Preprint)

2018 ◽  
Author(s):  
Robert Froud ◽  
Carol Fawkes ◽  
Jonathan Foss ◽  
Martin Underwood ◽  
Dawn Carnes
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Outcome Measures ◽  
Roc Curves ◽  
Low Back ◽  
Metric Properties ◽  
Android Apps ◽  
Patient Reported ◽  
Transition Question

BACKGROUND The Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) of pain intensity, and numerical rating scale (NRS) are among the most commonly used outcome measures in trials of interventions for low back pain. Their use in paper form is well established. Few data are available on the metric properties of electronic counterparts. OBJECTIVE The goal of our research was to establish responsiveness, minimally important change (MIC) thresholds, reliability, and minimal detectable change at a 95% level (MDC95) for electronic versions of the RMDQ, VAS, and NRS as delivered via iOS and Android apps and Web browser. METHODS We recruited adults with low back pain who visited osteopaths. We invited participants to complete the eRMDQ, eVAS, and eNRS at baseline, 1 week, and 6 weeks along with a health transition question at 1 and 6 weeks. Data from participants reporting recovery were used in MIC and responsiveness analyses using receiver operator characteristic (ROC) curves and areas under the ROC curves (AUCs). Data from participants reporting stability were used for analyses of reliability (intraclass correlation coefficient [ICC] agreement) and MDC95. RESULTS We included 442 participants. At 1 and 6 weeks, ROC AUCs were 0.69 (95% CI 0.59 to 0.80) and 0.67 (95% CI 0.46 to 0.87) for the eRMDQ, 0.69 (95% CI 0.58 to 0.80) and 0.74 (95% CI 0.53 to 0.95) for the eVAS, and 0.73 (95% CI 0.66 to 0.80) and 0.81 (95% CI 0.69 to 0.92) for the eNRS, respectively. Associated MIC thresholds were estimated as 1 (0 to 2) and 2 (–1 to 5), 13 (9 to 17) and 7 (–12 to 26), and 2 (1 to 3) and 1 (0 to 2) points, respectively. Over a 1-week period in participants categorized as “stable” and “about the same” using the transition question, ICCs were 0.87 (95% CI 0.66 to 0.95) and 0.84 (95% CI 0.73 to 0.91) for the eRMDQ with MDC95 of 4 and 5, 0.31 (95% CI –0.25 to 0.71) and 0.61 (95% CI 0.36 to 0.77) for the eVAS with MDC95 of 39 and 34, and 0.52 (95% CI 0.14 to 0.77) to 0.67 (95% CI 0.51 to 0.78) with MDC95 of 4 and 3 for the eNRS. CONCLUSIONS The eRMDQ was reliable with borderline adequate responsiveness. The eNRS was responsive with borderline reliability. While the eVAS had adequate responsiveness, it did not have an attractive reliability profile. Thus, the eNRS might be preferred over the eVAS for measuring pain intensity. The observed electronic outcome measures’ metric properties are within the ranges of values reported in the literature for their paper counterparts and are adequate for measuring changes in a low back pain population.

scholarly journals Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026874 ◽  
Author(s):  
Saurab Sharma ◽  
Mark P Jensen ◽  
G Lorimer Moseley ◽  
J Haxby Abbott
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Outcome Measures ◽  
Randomised Clinical Trial ◽  
Education Intervention ◽  
Low Back ◽  
Pain Education ◽  
Pain Catastrophising

ObjectivesThe aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal.DesignA two-arm, parallel, assessor-blinded, feasibility RCT.SettingA rehabilitation hospital in Kathmandu, Nepal.ParticipantsForty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women).InterventionsEligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session.Primary outcome measuresThe primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment.Secondary outcome measuresPain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation.ResultsForty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported.ConclusionWe conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted.Trial registration numberNCT03387228; Results.

Cognitive functional therapy (CFT)-based rehabilitation improves clinical outcomes in UK military personnel with persistent low back pain

2019 ◽  
Vol 166 (5) ◽  
pp. 336-341 ◽  
Author(s):  
Dean Conway ◽  
P Ladlow ◽  
J Ferreira ◽  
S Mani-Babu ◽  
A N Bennett
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Psychosocial Outcomes ◽  
Medical Rehabilitation ◽  
Low Back ◽  
Functional Therapy ◽  
Multidisciplinary Rehabilitation ◽  
British Military ◽  
Patient Reported

IntroductionLow back pain (LBP) has been reported as the most common reason for presentation to the Medical Centre in the British Military, and the most common re-referral for the same condition. In 2015, the UK Defence Medical Rehabilitation Centre (DMRC) adopted a cognitive functional therapy (CFT) approach to spinal rehabilitation in line with National Institute for Health and Care Excellence and military best practice guidelines. The aim of this study is to evaluate the functional and psychosocial outcomes of all patients with chronic LBP treated with CFT-based multidisciplinary rehabilitation at DMRC, Headley Court.MethodsA prospective observational service evaluation of British Military patients (n=238) with LBP who attended 3 weeks of inpatient multidisciplinary CFT-based programme from 2015 to the end of 2017 at DMRC was analysed. Functional outcomes include: multistage locomotion test (MSLT) and sit and reach test. Psychosocial outcomes include: Tampa Scale of Kinesiophobia, Oswestry Disability Index, Brief Pain Inventory (BPI), General Anxiety Disorder-7 and Patient Health Questionnaire-9.ResultsThere were significant improvements in endurance (MSLT), range of motion, kinesiophobia, pain-related lifestyle interference (BPI-Lifestyle), anxiety and depression (p≤0.001). However, no improvements in pain intensity (BPI-Intensity) were demonstrated (p>0.05).ConclusionAfter 3 weeks of CFT-based multidisciplinary rehabilitation, function and psychosocial health improved with symptoms of pain being less obtrusive to activities of daily activity. There were however no patient-reported reductions in pain intensity. The improvements demonstrated are indicative of outcomes that facilitate greater integration back to work or into society.

scholarly journals Effectiveness of Back School Versus McKenzie Exercises in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

2013 ◽  
Vol 93 (6) ◽  
pp. 729-747 ◽  
Author(s):  
Alessandra Narciso Garcia ◽  
Lucíola da Cunha Menezes Costa ◽  
Tatiane Mota da Silva ◽  
Francine Lopes Barreto Gondo ◽  
Fábio Navarro Cyrillo ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Low Back ◽  
Back School ◽  
Blinded Assessor

Background Back School and McKenzie methods are popular active treatment approaches that include both exercises and information for patients with chronic nonspecific low back pain. Objective The purpose of this study was to compare the effectiveness of Back School and McKenzie methods in patients with chronic nonspecific low back pain. Design The study was a prospectively registered, 2-arm randomized controlled trial with a blinded assessor. Setting The study was conducted in the outpatient physical therapy clinic in São Paulo, Brazil. Patients The study participants were 148 patients with chronic nonspecific low back pain. Interventions The 4-week treatment program (one session/week) was based on the Back School (delivered to the group) or McKenzie (delivered individually) principles. The participants also were instructed to perform a daily set of home exercises. Measurements Clinical outcomes were assessed at follow-up appointments at 1, 3, and 6 months after randomization. Primary outcome measures were pain intensity (measured by the 0–10 pain numerical rating scale) and disability (measured by the 24-item Roland-Morris Disability Questionnaire) 1 month after randomization. Secondary outcome measures were pain intensity and disability at 3 and 6 months after randomization, quality of life (measured by the World Health Organization Quality of Life–BREF instrument) at 1, 3, and 6 months after randomization, and trunk flexion range of motion measured by an inclinometer at 1 month after randomization. The data were collected by a blinded assessor. Results Participants allocated to the McKenzie group had greater improvements in disability at 1 month (mean effect=2.37 points, 95% confidence interval=0.76 to 3.99) but not for pain (mean effect=0.66 points, 95% confidence interval=−0.29 to 1.62). No between-group differences were observed for all secondary outcome measures. Limitations It was not possible to monitor the home exercise program. Therapists and participants were not blinded. Conclusions The McKenzie method (a more resource-intensive intervention) was slightly more effective than the Back School method for disability, but not for pain intensity immediately after treatment in participants with chronic low back pain.

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