Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 5: Using Patient Records: Selection, Protection, and Abstraction.

OBJECTIVES: The purpose of this paper is to describe the 4-step process (consent, selection, protection, and abstraction) of acquiring a large sample of chiropractic patient records from multiple practices and subsequent data abstraction. METHODS: From April 2017 to December 2017, RAND acquired patient records from 99 chiropractic practices across the United States. The records included patients enrolled in a survey e-study (prospective sample) and a random sample of all clinic patients (retrospective sample) with chronic back or neck pain. Clinic staff were trained to collect the sample, scan, and transfer the records. We designed an online data collection tool for abstraction. Protocols were instituted to protect patient confidentiality. Doctors of chiropractic were selected and trained as abstractors, and a system was established to monitor data collection. RESULTS: In compliance with data protection protocols, 3603 patient records were scanned, including 1475 in the prospective sample and 2128 in the random sample. A total of 1716 patients (prospective sample) consented to having their records scanned, but only 1475 could be retrieved. Of records scanned, 19% were unusable owing to illegibility, no care during the period of interest, or poor scanning. The abstractor interrater reliability for appropriateness of care decisions was fair to moderate (κ .38-.48). CONCLUSION: The acquisition, handling, and abstraction of a large sample of chiropractic records was a complex task with challenges that necessitated adapting planned approaches. Of the records abstracted, many revealed incomplete provider documentation regarding the details of and rationale for care. Better documentation and more standardized record keeping would facilitate future research using patient records.

Sample size calculations for blinding assessment.

Blinding is a critical component in randomized clinical trials along with treatment effect estimation and comparisons between the treatments. Various methods have been proposed for the statistical analyses of blinding-related data, but there is little guidance for determining the sample size for this type of data, especially if blinding assessment is done in pilot studies. In this paper, we try to fill this gap and provide simple methods to address sample size calculations for a "new" study with different research questions and scenarios. The proposed methods are framed in terms of estimation/precision or statistical testing to allow investigators to choose the best suited method for their goals. We illustrate the methods using worked examples with real data.

Responsiveness and minimal important change of the NeckPix© in subjects with chronic neck pain undergoing rehabilitation.

PURPOSE: The NeckPix© is a simple and rapid means of measuring the beliefs of subjects with chronic neck pain concerning pain-related fears of a specific set of activities of daily living. The original version showed satisfactory psychometric properties. This observational study is aimed at evaluating its responsiveness and minimal important changes (MICs) in subjects with chronic neck pain. METHODS: At the beginning, at the end of an 8-week rehabilitation programme as well as at the one-year follow-up, 153 subjects completed the NeckPix©. After the programme and at follow-up, subjects and physiotherapists also completed the global perceived effect (GPE) scale, which was divided to produce a dichotomous outcome. Responsiveness was calculated by distribution [effect size (ES); standardised response mean (SRM)] and anchor-based methods [receiver-operating characteristics (ROC) curves; correlations between change scores of the NeckPix© and GPEs]. ROC curves were also used to compute MICs. RESULTS: The ES ranged from 0.95 to 1.26 and the SRM from 0.84 to 0.98 at post-treatment and follow-up based on subjects' and physiotherapists' perspective. The ROC analyses revealed AUCs of 0.89 and 0.97 at post-treatment and follow-up, respectively; MICs (sensitivity; specificity) were of 6 (0.82; 0.88) and 8 (0.80; 0.92) at post-treatment and of 8 (0.95; 0.90 based on subjects and 0.95; 0.92 based on physiotherapists perspective) at follow-up. The correlations between change scores of the NeckPix© and GPEs ranged from -0.69 to -0.82. CONCLUSIONS: The NeckPix© was sensitive in detecting clinical changes in subjects with chronic neck pain undergoing rehabilitation. We recommend taking the MICs provided into account when assessing subjects' improvement or planning studies in this clinical context.

Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: a randomized controlled trial with one-year follow-up.

OBJECTIVE: To evaluate the effect of a group-based multidisciplinary rehabilitation programme on disability, pain and quality of life in subjects with chronic neck pain. DESIGN: Randomized controlled trial. SETTING: Specialized rehabilitation centre. SUBJECTS: A total of 170 patients (mean age of 53 years (13); 121 females). INTERVENTIONS: The multidisciplinary group underwent a multidisciplinary rehabilitation programme combining multimodal exercises with psychologist-lead cognitive-behavioural therapy sessions. The general exercise group underwent general physiotherapy. Both groups followed group-based programmes once a week for ten weeks. Additionally, the multidisciplinary group met with the psychologist once a week for a 60-minute session. MAIN MEASURES: The Neck Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale and the Short-Form Health Survey. The participants were evaluated before, after training and after 12 months. RESULTS: A linear mixed model for repeated measures was used for each outcome measure. Significant effects ( p-value <0.001) were found over time and between groups for all outcome measures. After training, significant improvements were found for both groups for all outcome measures except kinesiophobia and catastrophizing, which did not change in the control group; however, the improvements were significantly greater for the multidisciplinary group. At 12-month follow-up a clinically meaningful between-group difference of 12.4 Neck Disability Index points was found for disability. CONCLUSIONS: A group-based multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to group-based general physiotherapy in improving disability, pain and quality of life of subjects with chronic neck pain. The effects lasted for at least one year.

The Effect of Phase of Menstrual Cycle on Joint Mobility in the Cervical Spine and Extremities in Nulliparous Women: A Cross-Sectional Study.

OBJECTIVE: The purpose of this study was to investigate the range of motion (ROM) of various joints in women throughout the menstrual cycle to determine whether there would be a difference in the ROM between the luteal and follicular phases during extension at the fifth metacarpophalangeal joint and bilateral rotation of the cervical spine in young adult nulliparous women. METHODS: Sixteen nulliparous women of childbearing age (mean age, 26 years) were recruited from the academic institution where the study was being performed. Participants were randomized into and tested during either the luteal or follicular phases of the menstrual cycle. In the following month, participants were tested in the opposite phases of the menstrual cycle. All testing was performed by a doctor of chiropractic. Differences in ROM were measured in single joint movements (fifth digit hyperextension) and in multijoint movements (bilateral cervical rotation) using an electromagnetic sensor system. RESULTS: No significant effects of phase were found on peak ROM of the fifth digit or during cervical spine rotation (left, right, or bilaterally), irrespective of trial. CONCLUSION: There is no difference in ROM of the cervical spine or the fifth metacarpophalangeal joint, regardless of the phase of menses, suggesting there is likely no hormonal influence on these structures during the follicular or luteal phases.

The NeckPix(©): development of an evaluation tool for assessing kinesiophobia in subjects with chronic neck pain.

PURPOSE: To develop and validate NeckPix(©), a multi-image instrument for assessing daily activities in the context of pain-related fear, in order to allow its use in patients with chronic neck pain (NP). METHODS: The measure was developed by means of item generation followed by reduction/selection. The psychometric testing included exploratory factor analysis; content validity by investigating clarity, specificity, appropriateness for the target population, relevance and completeness; reliability by internal consistency (Cronbach's alpha) and test-retest stability (intra-class coefficient correlation, ICC); and construct validity by comparing NeckPix with the Tampa Scale of Kinesiophobia (TSK), the Pain Catastrophising Scale (PCS), the Neck Disability Index (NDI) and a Numerical Rating Scale of pain intensity (NRS) (Pearson's correlation). RESULTS: The measure, which includes ten images used to assess everyday activities in the context of pain-related fear, was administered to 118 subjects with chronic non-specific NP, and proved to be acceptable and feasible. Factor analysis revealed a one-factor solution (which explained 71.12 % of variance). The content of the images was considered adequate, appropriate for the target population, comprehensive, and relevant for evaluating activity-related kinesiophobia. The instrument's internal consistency was good (α = 0.954), as was its test-retest stability (ICC 0.979). Construct validity demonstrated a close correlation with the TSK (r = 0.759), and moderate correlations with the PCS (r = 0.583), the NDI (r = 0.520), and a NRS (r = 0.455). CONCLUSION: NeckPix(©), which was successfully developed following international recommendations, proved to have a good factorial structure and satisfactory psychometric properties. Its use is recommended for research purposes.

Responsiveness and minimal important changes for the Neck Disability Index and the Neck Pain Disability Scale in Italian subjects with chronic neck pain.

PURPOSE: To evaluate the responsiveness and minimal important changes (MICs) for the Italian Neck Disability Index (NDI) and Neck Pain Disability Scale (NPDS) as well as which questionnaire was the most responsive in subjects with chronic neck pain (NP). METHODS: At the beginning and end of an 8-week rehabilitation programme, 200 patients completed the NDI and NPDS. After the programme, the global perceived effect (GPE) was also evaluated and collapsed to produce a dichotomous outcome (improved vs. stable). Responsiveness was calculated by distribution [effect size (ES); standardised response mean (SRM)] and anchor-based methods (ROC curves; correlations between change scores of NPDS and NDI, and GPE). ROC curves were also used to compute the best cutoff levels between improved and stable subjects (MICs). RESULTS: The ES was 0.66 and 0.73, and the SRM was 1.09-1.26 for the NDI and NPDS, respectively. The ROC analyses revealed AUCs of 0.96 and 0.91 for the NDI and NPDS, respectively; the MICs were 7-percentage points for the NDI (sensitivity: 98%; specificity: 81%) and 10 for NPDS (93; 83%), showing equivalent responsiveness properties. Baseline NPDS scores did not affect MIC estimate for the NPDS, while, for the NDI, higher MICs were found for patients with worst disability levels. Correlations between change scores of the NDI and NPDS and GPE were, respectively, high (0.71) and moderate (0.59). CONCLUSIONS: The Italian NDI and NPDS were equally sensitive in detecting clinical changes in subjects with chronic NP undergoing rehabilitation. We recommend taking the MICs into account when assessing patient improvement or planning studies in this clinical context.

Development of the headache activities of daily living index: initial validity study.

PURPOSE: The purpose of this study was to develop a novel instrument for assessing headache-related disability focusing solely on important activities of daily living. METHODS: Part 1: A literature search was conducted in PubMed and Google Scholar, supplemented by hand searches in bibliographies to retrieve the original article for any instrument for the assessment of headache-related disability. Each instrument was evaluated for item categories, specific item content, measurement scale format for each item, and instructions to users. Together, these features constituted the construct validity of these instruments. Qualitative evaluations of these results were summarized with respect to the adequacy of each component. Psychometric features such as reliability and validity were not assessed. Part 2: An existing instrument for assessing self-rated disability, the Neck Disability Index, was modified for content and format and subjected to 2 rounds of clinician and patient review. Item contents and formats received final consensus, resulting in a 9-item instrument: the Headache Activities of Daily Living Index (HADLI). This instrument was tested in a sample of headache patients. Cronbach α and individual item correlations were obtained. Principal Components Analysis was performed. RESULTS: Part 1: The search identified 6 reports on 5 preexisting instruments for self-rating of headache-related disability. Problems in content were found in all instruments, especially relating to the lack of items for specific activities of daily living. Problems were noted in most of the instruments for scaling and instructions with respect to the effect of headache on activities of daily living. Part 2: The authors first identified suitable items from an existing instrument for self-rating of disability. These were supplemented by items drawn from the literature. A panel of 3 clinicians and 2 laypersons evaluated these items. Two more focus groups of 7 headache sufferers each reviewed the new instrument. After this, a 9-item instrument for assessing activities of daily living in headache sufferers, the HADLI, was finalized. After this, 53 participants were recruited to study the face validity of the instrument. The sample consisted of 41 women and 12 men with a mean age of 37.3 (12) years; mean duration of headaches was 7.4 (8.3) years; mean frequency of headaches per week was 3.4 (2.4); and the intensity was 6 (2.4). The mean HADLI score was 26.2 (13.4), or 52%. There were no floor or ceiling effects for total score. The total Index Cronbach α was 0.96. The Principal Components Analysis identified one component which accounted for 75% of the variance. CONCLUSIONS: The HADLI was created using theory and empirical-based methods. Face validity was assessed by focus group input and by first-level psychometrics. The HADLI has good face validity and is suitable for further reliability and validity testing.

A Randomized Pragmatic Clinical Trial of Chiropractic Care for Headaches With and Without a Self-Acupressure Pillow.

OBJECTIVE: The purpose of this study was to determine if the addition of a self-acupressure pillow (SAP) to typical chiropractic treatment results in significantly greater improvement in tension-type and cervicogenic headache sufferers. METHODS: A pragmatic randomized clinical trial was conducted in a chiropractic college teaching clinic. Thirty-four subjects, including tension-type and cervicogenic headache sufferers, 21 to 60 years of age, male or female, completed the study. Group A (n = 15) received typical chiropractic care only (manual therapy and exercises), and group B (n = 19) received typical chiropractic care with daily home use of the SAP. The intervention period was 4 weeks. The main outcome measure was headache frequency. Satisfaction and relief scores were obtained from subjects in the SAP group. Analysis of variance was used to analyze the intergroup comparisons. RESULTS: Owing to failure of randomization to produce group equivalence on weekly headache frequency, analysis of covariance was performed showing a trend (P = .07) favoring the chiropractic-only group; however, this was not statistically significant. Group A obtained a 46% reduction of weekly headache frequency (t = 3.1, P = .002; d = 1.22). The number of subjects in group A achieving a reduction in headaches greater than 40% was 71%, while for group B, this was 28%. The mean benefit score (0-3) in group B of the use of the SAP was 1.2 (.86). The mean satisfaction rating of users of the SAP was 10.4 (2.7) out of 15 (63%). CONCLUSION: This study suggests that chiropractic care may reduce frequency of headaches in patients with chronic tension-type and cervicogenic headache. The use of a self-acupressure pillow (Dr Zaxx device) may help those with headache and headache pain relief as well as producing moderately high satisfaction with use.

Immediate effects of spinal manipulative therapy on regional antinociceptive effects in myofascial tissues in healthy young adults.

OBJECTIVE: The purpose of this study was to investigate if spinal manipulative therapy (SMT) can evoke immediate regional antinociceptive effects in myofascial tissues by increasing pressure pain thresholds (PPTs) over myofascial trigger points in healthy young adults. METHODS: A total of 36 participants (19 men, 17 women; age, 28.0 [5.3] years; body mass index, 26.5 [5.7] kg/m(2)) with clinically identifiable myofascial trigger points in the infraspinatus and gluteus medius muscles were recruited from the University of Guelph, Ontario, Canada. Participants were randomly allocated to 2 groups. Participants in the test group received chiropractic SMT targeted to the C5-C6 spinal segment. Participants in the control group received sham SMT. The PPT was recorded from the right infraspinatus and gluteus medius muscles at baseline (preintervention) and 1, 5, 10, and 15 minutes postintervention. RESULTS: Three participants were disqualified, resulting in a total of 33 participants analyzed. Significant increases in the PPT (decreased pain sensitivity) were observed in the test infraspinatus group when compared with test gluteus medius, control infraspinatus, and control gluteus medius groups (P < .05). No significant differences in PPT were observed at any time point when comparing test gluteus medius, control infraspinatus, and control gluteus medius groups (P > .05). CONCLUSIONS: This study showed that SMT evokes short-term regional increases in PPT within myofascial tissues in healthy young adults.

Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

OBJECTIVE: Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. METHODS: A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. RESULTS: Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). CONCLUSIONS: This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials.

Cross-Cultural Adaptation and Psychometric Validation of the Hindi Version of the Neck Disability Index in Patients With Chronic Neck Pain.

STUDY DESIGN: Translation and psychometric testing. OBJECTIVES: To cross-culturally adapt the Neck Disability Index (NDI) into the Hindi language, the local language of India, and to investigate the psychometric properties of the Neck Disability Index-Hindi (NDI-H) version in patients with neck pain. SUMMARY OF BACKGROUND DATA: The NDI is the most used self-reported outcome measure for neck pain. The previous NDI-H version did not obtain advance permission from Mapi trust to translate this scale. As a result, this scale's availability is limited. MATERIALS AND METHODS: Following established guidelines, the NDI was translated and culturally adapted into Hindi. A total of 120 chronic neck pain patients (20 for cognitive interviews and 100 for psychometric testing) participated in this study. The content validity, construct validity, internal consistency, test-retest reliability, and responsiveness of the NDI-H were all evaluated. The intraclass correlation coefficient was computed to determine test-retest reliability. Internal consistency was assessed using Cronbach α. The NDI's factor structure was investigated using principal component factor analysis. The Neck Pain and Disability Scale, Numeric Pain Rating Scale, and Anxiety and Depression scales were used to test criterion validity. The receiver operating characteristic curve analysis was used to determine the cut-off point and the area under the curve. RESULTS: The NDI-H demonstrated good test-retest reliability (intraclass correlation coefficient = 0.92) and excellent internal consistency (Cronbach α = 0.90). The one-factor structure was revealed by the factor analysis. The NDI has a strong relationship with the Neck Pain and Disability Scale and Numeric Pain Rating Scale, as well as the Anxiety and Depression scales. The cut-point for detecting a change was 9.3. CONCLUSIONS: The NDI was successfully translated into Hindi in this study. The NDI-H is a reliable and valid and responsive instrument that can be used to treat patients with chronic neck pain in clinical and research settings.

Clinimetric properties of the Turkish translation of a modified neck disability index.

BACKGROUND: Neck pain is a common problem that can greatly affect a person's activities of daily living. Functional status questionnaires are important in assessing this effect, and are used to follow up neck pain management programs. The Neck Disability Index (NDI) is the first-created scale for neck pain-related disability and is widely translated and in common used in many countries. Our aim is investigate to clinometric properties of a Turkish version of modified NDI and to give a choice in daily practise of versions to be used. METHODS: The modified NDI was applied to 30 patients for reliability. 185 patients participated in the validity study. All patients were recruited from the outpatient clinic of our department. The scale was translated by the forward and backward translation procedure according to the COSMIN criteria. The test was repeated at 48 hours interval for reliability study. SPSS-10.0, software was used for statistical analyses. The Intraclass correlation coefficient was used for the test- retest reliability of the modified NDI. Cronbach α was used for internal consistency. Factor analysis was used for construct validity. The validity of the modified NDI with respect to the SF-36, HAD, VAS pain, VAS disability was assessed using Spearman correlations. RESULTS: The Intraclass correlation coefficient between first and second (within 48 hours) evaluation of test (rs) was 0.92. Questions 1,4,6,8,10 were shown to have excellent reliability. (rs > 0.9). Question 10 was the most frequently challenged question because "recreational and social activities" do not have not the same meanings in Turkey than in western countries. This required that detailed explanations be provided by the investigators. Cronbach's alpha for the total index was 0.88. A single factor accounting for 80.2% of the variance was obtained. Validity studies demonstrated good and moderate correlations (rs) among NDI, HAD, VAS, physical function subtitle of SF 36 (0.62, 0.76, 0.68). CONCLUSIONS: The modified NDI-Turkish version is a reliable and valid test and is suitable for daily practise.

Cerebral perfusion in patients with chronic neck and upper back pain: preliminary observations.

OBJECTIVE: The purpose of this study was to determine the correlation between cerebral perfusion levels, Neck Disability Index (NDI) scores, and spinal joint fixations in patients with neck pain. METHODS: Forty-five adult patients (29 were female) with chronic neck/upper thoracic pain during exacerbation were studied. The subjects were grouped according to NDI scores: mild, moderate, and severe. The number of painful/blocked segments in the cervical and upper thoracic spine and costovertebral joints, pain intensity using the visual analog scale, and regional cerebral blood flow of the brain using single-photon emission computed tomography (SPECT) were obtained. The SPECT was analyzed semiquantitatively. Analysis of variance tests were conducted on total SPECT scores in each of the NDI groups (P < .05). Univariate correlations were obtained between blockage, pain, and SPECT scores, as well as age and duration. A multivariate analysis was then conducted. RESULTS: Group 1 (mild) consisted of 14 patients. Cerebral perfusion measured by SPECT was normal in all 8 brain regions. Group 2 (moderate) consisted of 16 patients. In this group, a decrease in cerebral perfusion was observed (range, 20%-35%), predominantly in the parietal and frontal zones. Group 3 (severe) consisted of 15 patients. In this group, the decrease in cerebral perfusion observed was from 30% to 45%, again predominantly in the parietal and frontal zones. A significant difference was found between NDI groups ("moderate" and "severe" showed significantly greater hypoperfusion than "mild"). Total blockage score correlated with SPECT scores at r = 0.47, P = .001. In a multivariate analysis, NDI scores contributed 39% of the variance of SPECT scores. CONCLUSION: In this group of patients with neck and/or upper back pain, NDI scores strongly predicted cerebral hypoperfusion. Spinal joint dysfunction may be involved via hyperactivity in the regional sympathetic nervous system.

The relationship between self-rated disability, fear-avoidance beliefs, and nonorganic signs in patients with chronic whiplash-associated disorder.

OBJECTIVES: The purpose of this study was to determine the role of standard and novel (cervical) nonorganic signs in patients with chronic whiplash-associated disorder (WAD). METHODS: Chronic WAD I to III patients (>3 months) were recruited from private chiropractic practice in Canada. Subjects completed a Neck Disability Index (NDI), Tampa Scale for Kinesiophobia (TSK), pain visual analog scale, and pain diagram. Clinical and demographic data were also obtained. Nine standard nonorganic pain behavior tests and 4 novel cervical nonorganic simulation signs (C-NOSS) tests were applied. Bivariate correlations were obtained with the Pearson correlation coefficient. Items achieving statistical significance on univariate analysis were loaded in a sequential linear regression analysis. Post hoc analyses were conducted with analysis of variance tests of NDI and TSK scores. RESULTS: Ninety-one subjects were investigated (49 males and 42 females), with a mean age of 41.7 (SD, 14.7) years and a mean duration of 9.4 (SD, 11.2) months. Because mean NDI scores were 57.5 (SD, 17.8) and mean pain scores were 68.3 (SD, 21.0), this sample represents moderate-to-severe WAD. Fair to moderately strong correlations were obtained between the NDI and the TSK, pain visual analog scale and nonorganic symptoms and signs (NOS-9) and C-NOSS scores, but not with "age," "sex," or "duration." The NOS-9 and C-NOSS scores correlated most strongly at 0.70. A multivariate model accounting for 53% of the variance of the NDI scores (P < .001) was obtained with the TSK, pain severity, and NOS-9 scores. There was no significant correlation between C-NOSS and TSK scores. At least 25% of subjects scored either 5 of 9 or 2 of 4 on the NOS-9 and C-NOSS tests, respectively. CONCLUSIONS: Based on the findings of this study, nonorganic signs should be considered in the interpretation of self-rated disability in patients with moderate-to-severe chronic WAD.

Reliability and Validity of Cross Culturally Adapted Punjabi Version of NDI (NDI-P) in Patients with Neck Pain: A Psychometric Analysis.

BACKGROUND: Neck disability index (NDI) is one of the commonest patient-reported outcome measures used to evaluate disability related to neck pain. Its application to non-English-speaking Punjabi population is limited as a validated and cross-culturally adapted Punjabi version of NDI is not available. The purpose of the study was to analyze the psychometric properties of Punjabi version of neck disability index (NDI-P) in patients with neck pain. MATERIALS AND METHODS: The translation and cross-cultural adaptation of Punjabi version of NDI was done according to well-recommended guidelines. The pre-final version was tested on a set of 15 patients and suitable modifications were made. The final version was administered to 100 patients with neck pain of more than 2 weeks duration. Psychometric properties comprising internal consistency, test-re-test reliability, construct validity and factorial structure of the questionnaire were determined. RESULTS: The developed NDI-P showed excellent internal consistency (Chronbach alpha of NDI-P is 0.87), test-re-test reliability (ICC 0.840) and construct validity (Spearman correlation coefficient with VAS 0.547). Factor analysis proved the questionnaire to be having a 2-factor structure with a total variance of 56.58%. CONCLUSION: NDI (P) is a reliable and valid instrument for measurement of disability related to neck pain in Punjabi population. It can be used both in research and clinical care settings in future.

Simulation tests for cervical nonorganic signs: a study of face validity.

OBJECTIVES: The purpose of this study was to develop and determine the face validity of additional cervical nonorganic simulation tests. METHODS: Four simulation tests were either selected from the literature or newly designed: simulated sitting trunk/shoulder rotation (SR; test no. 1), active vs passive cervical rotation (CR; test no. 2), Libman's test (LT; test no. 3) of pressure over the mastoid process, and side-lying passive shoulder abduction (SA; test no. 4). Three groups, 1 without neck pain (n = 44) and 2 with neck pain (n = 43 and 27), were formed. Outcome measures consisted of questions on provocation of pain (Yes/No) and appropriateness (Yes/No) as well as measurements of cervical rotation (goniometric) and pressure pain threshold (pressure algometer). Group test responses were evaluated and scored. A threshold of acceptance was established at 80% agreement for face validity. Ranges of rotation and pressure threshold values were analyzed with the Student t test. RESULTS: In nonneck pain subjects, all 4 tests were rated as nonpainful and 3 were rated as "appropriate" for neck pain examination (not SR). In neck pain subjects, this test and SA were rated as nonpainful, whereas LT was rated as painful in 26% of subjects. Only CR and LT were rated as "appropriate." In neck pain subjects, passive rotations exceeded actives by 10% to 14% (P = .000). On a second round of testing with a slightly modified method, SR and SA achieved acceptable "appropriateness." CONCLUSIONS: Once 2 tests were slightly modified, all 4 tests were found to have acceptable face validity. Further research into the reliability of these tests as well as into the combinations of these tests is warranted.

Reliability, responsiveness and minimal clinically important difference of the two Fear Avoidance and Beliefs Questionnaire scales in Italian subjects with chronic low back pain undergoing multidisciplinary rehabilitation.

BACKGROUND: The Fear-Avoidance Beliefs Questionnaire (FABQ) is a widely used outcome measure. There is still a lack of information concerning responsiveness and minimal clinically important difference (MCID), limiting its use for clinical and research purposes. AIM: The aim of this study was to examine reliability, responsiveness and MCID of the two FABQ scales in subjects with chronic low back pain. DESIGN: Methodological research based on a prospective single-group observational study. SETTING: Outpatient, Unit of rehabilitation. POPULATION: Chronic non-specific low back pain. METHODS: At the beginning and the end of a multidisciplinary program (8-week), 129 subjects completed the FABQ scales. Reliability was determined as internal consistency (Cronbach's alpha) and test-retest reliability (96-hour interval; N.=64; Interclass correlation coefficient [ICC 2.1]). Responsiveness was calculated both by distribution-based and anchor-based methods, using as external criterion the Global Perceived Effect Scale (GPE: 7 levels), rated by each individual. RESULTS: Cronbach's alpha and ICC(2,1) were respectively: 0.75 and 0.90 for FABQ-Physical Activity Scale (FABQ-PA), and 0.85 and 0.95 for FABQ-Work Scale (FABQ-W). Minimum detectable change (MDC95) values were 3.69 points for FABQ-PA, and 5.95 points for FABQ-W. In receiver-operating characteristic curves, splitting GPE data into null/minimal/moderate improvement vs. large improvement (GPE 0-2 vs. GPE 3): 1) for FABQ-PA, the area under the curve (AUC) was 0.97 and the best cutoff score identifying meaningful change in fear-avoidance beliefs about physical activity was a change of 4 points; 2) for FABQ-W, the AUC was 0.97 and the best cutoff score for meaningful change in fear-avoidance beliefs about work activities was a change of 7 points. CONCLUSIONS: After triangulation of the above results, a change of 4 points for FABQ-PA and 7 points for FABQ-W were selected as MCID. These two values represent cutoffs that seem to accurately identify meaningful change in fear-avoidance beliefs, according to subject's judgement. CLINICAL REHABILITATION IMPACT: The present study calculated - in a sample of people with chronic low back pain - the minimal clinically important change of the two FABQ scales (FABQ-Physical Activity Scale and FABQ-Work Scale). These values increase confidence in interpreting score changes, thus enhancing their meaningful use in both research and clinical contexts.

Clinical Scenarios for Which Cervical Mobilization and Manipulation Are Considered by an Expert Panel to Be Appropriate (and Inappropriate) for Patients With Chronic Neck Pain.

OBJECTIVES: Cervical mobilization and manipulation are 2 therapies commonly used for chronic neck pain (CNP). However, safety, especially of cervical manipulation, is controversial. This study identifies the clinical scenarios for which an expert panel rated cervical mobilization and manipulation as appropriate and inappropriate. METHODS: An expert panel, following a well-validated modified-Delphi approach, used an evidence synthesis and clinical acumen to develop and then rate the appropriateness of cervical mobilization and manipulation for each of an exhaustive list of clinical scenarios for CNP. Key patient characteristics were identified using decision tree analysis (DTA). RESULTS: Three hundred seventy-two clinical scenarios were defined and rated by an 11-member expert panel as to the appropriateness of cervical mobilization and manipulation. Across clinical scenarios more were rated inappropriate than appropriate for both therapies, and more scenarios were rated inappropriate for manipulation than mobilization. However, the number of patients presenting with each scenario is not yet known. Nevertheless, DTA indicates that all clinical scenarios that included red flags (eg, fever, cancer, inflammatory arthritides, or vasculitides), and some others involving major neurological findings, especially if previous manual therapy was unfavorable, were rated as inappropriate for both cervical mobilization and manipulation. DTA also identified the absence of cervical disk herniation, stenosis, or foraminal osteophytosis on additional testing as the most important patient characteristic in predicting ratings of appropriate. CONCLUSIONS: Clinical guidelines for CNP should include information on the clinical scenarios for which cervical mobilization and manipulation were found inappropriate, including those with red flags, and others involving major neurological findings if previous manual therapy was unfavorable.

Chiropractic management of myofascial trigger points and myofascial pain syndrome: a systematic review of the literature.

OBJECTIVES: Myofascial pain syndrome (MPS) and myofascial trigger points (MTrPs) are important aspects of musculoskeletal medicine, including chiropractic. The purpose of this study was to review the most commonly used treatment procedures in chiropractic for MPS and MTrPs. METHODS: The Scientific Commission of the Council on Chiropractic Guidelines and Practice Parameters (CCGPP) was charged with developing literature syntheses, organized by anatomical region, to evaluate and report on the evidence base for chiropractic care. This article is the outcome of this charge. As part of the CCGPP process, preliminary drafts of these articles were posted on the CCGPP Web site www.ccgpp.org (2006-8) to allow for an open process and the broadest possible mechanism for stakeholder input. PubMed, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature, and databases for systematic reviews and clinical guidelines were searched. Separate searches were conducted for (1) manual palpation and algometry, (2) chiropractic and other manual therapies, and (3) other conservative and complementary/alternative therapies. Studies were screened for relevance and rated using the Oxford Scale and Scottish Intercollegiate Guidelines Network rating system. RESULTS: A total of 112 articles were identified. Review of these articles resulted in the following recommendations regarding treatment: Moderately strong evidence supports manipulation and ischemic pressure for immediate pain relief at MTrPs, but only limited evidence exists for long-term pain relief at MTrPs. Evidence supports laser therapy (strong), transcutaneous electrical nerve stimulation, acupuncture, and magnet therapy (all moderate) for MTrPs and MPS, although the duration of relief varies among therapies. Limited evidence supports electrical muscle stimulation, high-voltage galvanic stimulation, interferential current, and frequency modulated neural stimulation in the treatment of MTrPs and MPS. Evidence is weak for ultrasound therapy. CONCLUSIONS: Manual-type therapies and some physiologic therapeutic modalities have acceptable evidentiary support in the treatment of MPS and TrPs.