Self-report outcome assessments
In addition to sensorimotor function, we are also collecting
data on sociodemographic characteristics, back
pain history, potential confounders, and back pain outcome
measures (Table 2). The data are collected at BL1,
BL2, week 2 and week 6The modified Roland-Morris Disability Questionnaire
(RMDQ) 24 item version assesses LBP-related disability.
The RMDQ may be the most common and
respected LBP assessment instrument in LBP outcome
research [81]. Clinical improvement over time is
graded based on the analysis of serial questionnaire
scores. The minimum clinically important difference
(MCID) is estimated at 2 points [82]. The RMDQ is a
one-page questionnaire related to LBP disability with
documented reliability and validity [83] that has been
shown to be sensitive to clinical change in patients
with low back pain [84-86].
Participants are asked to rate their level of pain on an
ordinal 11-box scale (0 = no LBP; 10 = worst LBP possible)
at baseline and before each treatment. The numerical
pain rating scale (NRS) has excellent metric
properties, is easy to administer and score, and has
received much use in LBP research [87]. The question
captures information pertaining to pain over the past 24
hours. The MCID is a change of 2.5 points [87].
The bothersomeness of symptoms commonly associated
with LBP is measured using an existing instrument from
the LBP literature. We ask volunteers to rate the bothersomeness
of their LBP are during the past week, measured
on a 1 to 5 scale (1 = not at all bothersome and 5
= extremely bothersome). Bothersomeness questions are
practical and have demonstrated good internal consistency,
construct validity, and responsiveness to change
with time in patients with LBP and sciatica [88].
The Medical Outcomes Study 36-Item Short-Form
Health Survey version 2 (SF-36v2) is used for characterizing
the physical and mental health of our patients. It
has been used extensively in LBP research [89,90]. The
metric properties of the SF-36 as an outcome instrument
have been exhaustively studied with generally
excellent results [91]. For the purposes of this study we
Table 2 Baseline and follow-up assessments
Measures Baseline 1 Baseline 2 Week 2 Week 6
Baseline Information
Sociodemographic characteristics X
Back pain history X
Sensorimotor Functions Measurements
Postural Sway Pre & Post
Treatment
Pre & Post
Treatment
Pre & Post
Treatmentt
Response to Sudden Impact Loads Pre & Post
Treatment
Pre & Post
Treatment
Pre & Post
Treatment
Lumbar Repositioning Accuracy Pre & Post
Treatment
Pre & Post
Treatment
Pre & Post
Treatment
Self-report Outcome Assessments
Roland Morris Disability Questionnaire (RMDQ) X X X
Numerical Pain Rating Scale (NRS) X X X X
Quality of Life (SF-36) X X
Beck Depression Inventory (BDI-II) X X
Bothersomeness of low back pain X X X X
Low Back Pain Definition X
Fear Avoidance Beliefs Questionnaire X X
Satisfaction with back care X
Treatment-Related Information*
Adverse experiences X X X
Patient’s Quality of Treatment Perception X X X
Clinician’s Quality of Treatment Perception X X X
Assessment of Potential Confounders
Use of co-intervention: medications* X X X X
Use of co-intervention: manual therapy* X X X X
Exercise and job work load X
Smoking status X
Body Mass Index X
*-Also occurs at all treatment visits
Wilder et al. Trials 2011, 12:161
http://www.trialsjournal.com/content/12/1/161
Page 10 of 15
are interested in looking at physical function and bodily
pain. The MCID for physical function is 1 point and
bodily pain is 4 points [92].
Self-report outcome assessmentsIn addition to sensorimotor function, we are also collectingdata on sociodemographic characteristics, backpain history, potential confounders, and back pain outcomemeasures (Table 2). The data are collected at BL1,BL2, week 2 and week 6The modified Roland-Morris Disability Questionnaire(RMDQ) 24 item version assesses LBP-related disability.The RMDQ may be the most common andrespected LBP assessment instrument in LBP outcomeresearch [81]. Clinical improvement over time isgraded based on the analysis of serial questionnairescores. The minimum clinically important difference(MCID) is estimated at 2 points [82]. The RMDQ is aone-page questionnaire related to LBP disability withdocumented reliability and validity [83] that has beenshown to be sensitive to clinical change in patientswith low back pain [84-86].Participants are asked to rate their level of pain on anordinal 11-box scale (0 = no LBP; 10 = worst LBP possible)at baseline and before each treatment. The numericalpain rating scale (NRS) has excellent metricproperties, is easy to administer and score, and hasreceived much use in LBP research [87]. The questioncaptures information pertaining to pain over the past 24hours. The MCID is a change of 2.5 points [87].The bothersomeness of symptoms commonly associatedwith LBP is measured using an existing instrument fromthe LBP literature. We ask volunteers to rate the bothersomenessof their LBP are during the past week, measured
on a 1 to 5 scale (1 = not at all bothersome and 5
= extremely bothersome). Bothersomeness questions are
practical and have demonstrated good internal consistency,
construct validity, and responsiveness to change
with time in patients with LBP and sciatica [88].
The Medical Outcomes Study 36-Item Short-Form
Health Survey version 2 (SF-36v2) is used for characterizing
the physical and mental health of our patients. It
has been used extensively in LBP research [89,90]. The
metric properties of the SF-36 as an outcome instrument
have been exhaustively studied with generally
excellent results [91]. For the purposes of this study we
Table 2 Baseline and follow-up assessments
Measures Baseline 1 Baseline 2 Week 2 Week 6
Baseline Information
Sociodemographic characteristics X
Back pain history X
Sensorimotor Functions Measurements
Postural Sway Pre & Post
Treatment
Pre & Post
Treatment
Pre & Post
Treatmentt
Response to Sudden Impact Loads Pre & Post
Treatment
Pre & Post
Treatment
Pre & Post
Treatment
Lumbar Repositioning Accuracy Pre & Post
Treatment
Pre & Post
Treatment
Pre & Post
Treatment
Self-report Outcome Assessments
Roland Morris Disability Questionnaire (RMDQ) X X X
Numerical Pain Rating Scale (NRS) X X X X
Quality of Life (SF-36) X X
Beck Depression Inventory (BDI-II) X X
Bothersomeness of low back pain X X X X
Low Back Pain Definition X
Fear Avoidance Beliefs Questionnaire X X
Satisfaction with back care X
Treatment-Related Information*
Adverse experiences X X X
Patient’s Quality of Treatment Perception X X X
Clinician’s Quality of Treatment Perception X X X
Assessment of Potential Confounders
Use of co-intervention: medications* X X X X
Use of co-intervention: manual therapy* X X X X
Exercise and job work load X
Smoking status X
Body Mass Index X
*-Also occurs at all treatment visits
Wilder et al. Trials 2011, 12:161
http://www.trialsjournal.com/content/12/1/161
Page 10 of 15
are interested in looking at physical function and bodily
pain. The MCID for physical function is 1 point and
bodily pain is 4 points [92].
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