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1.
Spine (Phila Pa 1976) ; 48(23): 1663-1669, 2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-36727992

RESUMEN

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.


Asunto(s)
Dolor Crónico , Comparación Transcultural , Humanos , Dolor de Cuello/diagnóstico , Reproducibilidad de los Resultados , Psicometría , Encuestas y Cuestionarios , Evaluación de la Discapacidad , Traducciones , Dimensión del Dolor , Índice de Severidad de la Enfermedad
2.
Indian J Orthop ; 55(4): 918-924, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34194648

RESUMEN

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.

3.
Eur J Phys Rehabil Med ; 56(5): 600-606, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32420712

RESUMEN

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.


Asunto(s)
Dolor Crónico/psicología , Dolor Crónico/rehabilitación , Miedo/psicología , Dolor de la Región Lumbar/psicología , Dolor de la Región Lumbar/rehabilitación , Encuestas y Cuestionarios/normas , Adulto , Evaluación de la Discapacidad , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Diferencia Mínima Clínicamente Importante , Dimensión del Dolor , Estudios Prospectivos , Psicometría , Reproducibilidad de los Resultados
4.
Clin J Pain ; 36(4): 273-280, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-31985500

RESUMEN

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.


Asunto(s)
Dolor Crónico , Manipulación Espinal , Dolor de Cuello , Dolor Crónico/terapia , Técnica Delphi , Humanos , Dolor de Cuello/terapia
5.
J Manipulative Physiol Ther ; 42(5): 327-334, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-31257004

RESUMEN

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.


Asunto(s)
Indización y Redacción de Resúmenes , Seguridad Computacional , Confidencialidad , Registros Médicos , Selección de Paciente , Instituciones de Atención Ambulatoria , Quiropráctica , Dolor Crónico/terapia , Recolección de Datos , Humanos , Consentimiento Informado , Dolor de la Región Lumbar/terapia , Manipulación Quiropráctica , Dolor de Cuello/terapia , Estados Unidos
6.
Pain Physician ; 22(2): E55-E70, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30921975

RESUMEN

BACKGROUND: Mobilization and manipulation therapies are widely used by patients with chronic nonspecific neck pain; however, questions remain around efficacy, dosing, and safety, as well as how these approaches compare to other therapies. OBJECTIVES: Based on published trials, to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic nonspecific neck pain. STUDY DESIGN: A systematic literature review and meta-analysis. METHODS: We identified studies published between January 2000 and September 2017, by searching multiple electronic databases, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation and/or mobilization therapies to sham, no treatment, each other, and other active therapies, or when combined as multimodal therapeutic approaches. We assessed risk of bias by using the Scottish Intercollegiate Guidelines Network criteria. When possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation was applied to determine the confidence in effect estimates. This project was funded by the National Center for Complementary and Integrative Health under award number U19AT007912 and ultimately used to inform an appropriateness panel. RESULTS: A total of 47 randomized trials (47 unique trials in 53 publications) were included in the systematic review. These studies were rated as having low risk of bias and included a total of 4,460 patients with nonspecific chronic neck pain who were being treated by a practitioner using various types of manipulation and/or mobilization interventions. A total of 37 trials were categorized as unimodal approaches and involved thrust or nonthrust compared with sham, no treatment, or other active comparators. Of these, only 6 trials with similar intervention styles, comparators, and outcome measures/timepoints were pooled for meta-analysis at 1, 3, and 6 months, showing a small effect in favor of thrust plus exercise compared to an exercise regimen alone for a reduction in pain and disability. Multimodal approaches appeared to be effective at reducing pain and improving function from the 10 studies evaluated. Health-related quality of life was seldom reported. Some 22/47 studies did not report or mention adverse events. Of the 25 that did, either no or minor events occurred. LIMITATIONS: The current evidence is heterogeneous, and sample sizes are generally small. CONCLUSIONS: Studies published since January 2000 provide low-moderate quality evidence that various types of manipulation and/or mobilization will reduce pain and improve function for chronic nonspecific neck pain compared to other interventions. It appears that multimodal approaches, in which multiple treatment approaches are integrated, might have the greatest potential impact. The studies comparing to no treatment or sham were mostly testing the effect of a single dose, which may or may not be helpful to inform practice. According to the published trials reviewed, manipulation and mobilization appear safe. However, given the low rate of serious adverse events, other types of studies with much larger sample sizes would be required to fully describe the safety of manipulation and/or mobilization for nonspecific chronic neck pain. KEY WORDS: Chronic neck pain, nonspecific, chiropractic, manipulation, mobilization, systematic review, meta-analysis, appropriateness.


Asunto(s)
Manipulaciones Musculoesqueléticas/métodos , Dolor de Cuello/terapia , Dolor Crónico/terapia , Humanos
8.
Eur J Phys Rehabil Med ; 54(6): 890-899, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-29984567

RESUMEN

BACKGROUND: Current models of pain behavior suggest that kinesiophobia prevents the reacquisition of normal function, promotes the development of maladaptive coping strategies, and contributes to the disability associated with chronic neck pain (NP). AIM: Comparing two brief cognitive-behavioral programs aimed at managing kinesiophobia to understand which one induces better short-term improvements in disability, fear of movement, catastrophizing, adaptive coping strategies, quality of life (QoL), and pain intensity of chronic NP. DESIGN: Pilot, randomized, controlled trial, 3-months follow-up. SETTING: Outpatients. POPULATION: Subjects with chronic NP. METHODS: The population was randomized into two groups: group A (N.=15) underwent four sessions of cognitive-behavioral therapy (CBT) based on the NeckPix© (1-week duration); group B (N.=15) received four sessions of CBT based on the Tampa Scale of Kinesiophobia (TSK) (1-week duration). Afterwards, both groups attended 10 sessions of multimodal exercises (5-week duration). Primary measure: Neck Disability Index (NDI). Secondary measures: NeckPix©, TSK, Pain Catastrophizing Scale, Chronic Pain Coping Inventory, EuroQol-Five Dimensions, and pain intensity Numerical Rating Scale. STATISTICS: Linear mixed model analyses for repeated measures for each outcome measure to evaluate changes over time and between group. RESULTS: A significant effect of time was found for all outcomes, while no outcomes showed group and/or interaction effects. No changes were found in terms of NDI at the end of CBT, while a significant improvement of about 13 points was found for both groups at the end of the motor training (P=0.001). Similarly, in terms of quality of life there was no change after the CBT program, and a significant change at the end of the motor training, with a partial loss at follow-up. From CBT sessions to follow-up both groups showed a progressive reduction in kinesiophobia, with each group achieving a bigger change in the specific scale used for the CBT program. CONCLUSIONS: Two brief cognitive-behavioral rehabilitation programs based on different methodologies of managing fear-avoidance beliefs induced similar short-term improvements in subjects with chronic NP. Clinically significant changes in terms of disability were found in both groups only at the end of a 5-week motor training, regardless of the cognitive-behavioral rehabilitation program previously administrated. CLINICAL REHABILITATION IMPACT: Treatment of chronic NP requires cognitive modifications closely linked to physical performances in order to achieve mental adjustments and guarantee cognitive-behavioral as well as motor lasting changes.


Asunto(s)
Dolor Crónico/terapia , Terapia Cognitivo-Conductual , Dolor de Cuello/terapia , Adulto , Catastrofización , Dolor Crónico/psicología , Miedo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Actividad Motora , Dolor de Cuello/psicología , Proyectos Piloto , Calidad de Vida , Resultado del Tratamiento
10.
Spine J ; 18(5): 866-879, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29371112

RESUMEN

BACKGROUND CONTEXT: Mobilization and manipulation therapies are widely used to benefit patients with chronic low back pain. However, questions remain about their efficacy, dosing, safety, and how these approaches compare with other therapies. PURPOSE: The present study aims to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic low back pain. STUDY DESIGN/SETTING: This is a systematic literature review and meta-analysis. OUTCOME MEASURES: The present study measures self-reported pain, function, health-related quality of life, and adverse events. METHODS: We identified studies by searching multiple electronic databases from January 2000 to March 2017, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation or mobilization therapies with sham, no treatment, other active therapies, and multimodal therapeutic approaches. We assessed risk of bias using Scottish Intercollegiate Guidelines Network criteria. Where possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was applied to determine the confidence in effect estimates. This project is funded by the National Center for Complementary and Integrative Health under Award Number U19AT007912. RESULTS: Fifty-one trials were included in the systematic review. Nine trials (1,176 patients) provided sufficient data and were judged similar enough to be pooled for meta-analysis. The standardized mean difference for a reduction of pain was SMD=-0.28, 95% confidence interval (CI) -0.47 to -0.09, p=.004; I2=57% after treatment; within seven trials (923 patients), the reduction in disability was SMD=-0.33, 95% CI -0.63 to -0.03, p=.03; I2=78% for manipulation or mobilization compared with other active therapies. Subgroup analyses showed that manipulation significantly reduced pain and disability, compared with other active comparators including exercise and physical therapy (SMD=-0.43, 95% CI -0.86 to 0.00; p=.05, I2=79%; SMD=-0.86, 95% CI -1.27 to -0.45; p<.0001, I2=46%). Mobilization interventions, compared with other active comparators including exercise regimens, significantly reduced pain (SMD=-0.20, 95% CI -0.35 to -0.04; p=.01; I2=0%) but not disability (SMD=-0.10, 95% CI -0.28 to 0.07; p=.25; I2=21%). Studies comparing manipulation or mobilization with sham or no treatment were too few or too heterogeneous to allow for pooling as were studies examining relationships between dose and outcomes. Few studies assessed health-related quality of life. Twenty-six of 51 trials were multimodal studies and narratively described. CONCLUSION: There is moderate-quality evidence that manipulation and mobilization are likely to reduce pain and improve function for patients with chronic low back pain; manipulation appears to produce a larger effect than mobilization. Both therapies appear safe. Multimodal programs may be a promising option.


Asunto(s)
Dolor Crónico/terapia , Dolor de la Región Lumbar/terapia , Manipulación Quiropráctica/métodos , Ensayos Clínicos como Asunto , Humanos , Manipulación Quiropráctica/efectos adversos
11.
Spine J ; 18(4): 682-690, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29253633

RESUMEN

BACKGROUND CONTEXT: Muscle tissue is known to remodel in response to changes to its mechanical environment. Alterations in passive mechanical properties of muscles can influence spine stiffness and stability. PURPOSE: This study aimed to determine whether passive muscle elastic moduli and passive muscle stresses increased 28 days following mechanical disruption of the thoracolumbar fascia and erector spinae aponeurosis, and injury induced by facet joint compression. STUDY DESIGN: Male Sprague Dawley rats were randomly assigned to three groups (Incision n=8; Injury n=8; and Control n=6). METHODS: The thoracolumbar fascia and erector spinae aponeurosis were incised in the Incision and Injury groups to expose the left L5-L6 facet joint. In the Injury group, this facet was additionally compressed for three minutes to induce facet injury and cartilage degeneration. Twenty-eight days after surgery, rats were sacrificed and muscle samples were harvested from lumbar and thoracic erector spinae and multifidus for mechanical testing. RESULTS: Histologic staining revealed mild cartilage degeneration and boney remodeling in the Injury group. However, the hypotheses that either (1) disruption of the thoracolumbar fascia and erector spinae aponeurosis (Incision group) or (2) the addition of facet compression (Injury group) would increase the passive elastic modulus and stress of surrounding muscles were rejected. There was no effect of surgery (Incision or Injury) on the passive elastic modulus (p=.6597). Passive muscle stresses were also not different at any sarcomere length between surgical groups (p>.7043). CONCLUSION: Disruption of the thoracolumbar fascia and erector spinae aponeurosis and mild facet damage do not lead to measurable changes in passive muscle mechanical properties within 28 days. These findings contribute to our understanding of how spine muscles are affected by injury and fundamental aspects of the initial stages of spine surgery.


Asunto(s)
Aponeurosis/fisiopatología , Músculos de la Espalda/fisiopatología , Fascia/lesiones , Animales , Elasticidad , Humanos , Masculino , Ratas , Ratas Sprague-Dawley
12.
J Biopharm Stat ; 28(5): 857-869, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29157126

RESUMEN

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.


Asunto(s)
Interpretación Estadística de Datos , Bases de Datos Factuales/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Método Doble Ciego , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Tamaño de la Muestra
13.
Eur Spine J ; 27(6): 1324-1331, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29052814

RESUMEN

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.


Asunto(s)
Dolor Crónico/psicología , Dolor de Cuello/psicología , Trastornos Fóbicos/diagnóstico , Psicometría/métodos , Actividades Cotidianas , Adulto , Área Bajo la Curva , Dolor Crónico/rehabilitación , Evaluación de la Discapacidad , Miedo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Dolor de Cuello/rehabilitación , Trastornos Fóbicos/etiología , Curva ROC , Autoimagen
14.
Spine J ; 17(3): 445-456, 2017 03.
Artículo en Inglés | MEDLINE | ID: mdl-27888138

RESUMEN

BACKGROUND CONTEXT: Spinal manipulative therapy (SMT) has been attributed with substantial non-specific effects. Accurate assessment of the non-specific effects of SMT relies on high-quality studies with low risk of bias that compare with appropriate placebos. PURPOSE: This review aims to characterize the types and qualities of placebo control procedures used in controlled trials of manually applied, lumbar and pelvic (LP)-SMT, and to evaluate the assessment of subject blinding and expectations. STUDY DESIGN: This is a systematic review of randomized, placebo-controlled trials. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Index to Chiropractic Literature, and relevant bibliographies. We included randomized, placebo or sham-controlled trials where the index treatment was manually applied LP-SMT. There were no restrictions on the type of condition being investigated. Two independent reviewers selected the studies, assessed study quality, and extracted the data. Relevant data were the type and quality of placebo control(s) used, the assessment of blinding and expectations, and the results of those assessments. RESULTS: Twenty-five randomized, placebo-controlled trials were included in this review. There were 18 trials that used a sham manual SMT procedure for their placebo control intervention; the most common approach was with an SMT setup but without the application of any thrust. One small pilot study used an unequivocally indistinguishable placebo, two trials used placebos that had been validated as inert a priori, and eight trials reported on the success of subject blinding. Risk of bias was high or unclear, for all included studies. CONCLUSIONS: Imperfect placebos are ubiquitous in clinical trials of LP-SMT, and few trials have assessed for successful subject blinding or balanced expectations of treatment success between active and control group subjects. There is thus a strong potential for unmasking of control subjects, unequal non-specific effects between active and control groups, and non-inert placebos in existing trials. Future trials should consider assessing the success of subject blinding and ensuring inertness of their placebo a priori, as a minimum standard for quality.


Asunto(s)
Manipulación Espinal/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Humanos , Región Lumbosacra , Pelvis , Placebos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Proyectos de Investigación/normas , Resultado del Tratamiento
15.
Clin Rehabil ; 31(6): 742-752, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-27246516

RESUMEN

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.


Asunto(s)
Dolor Crónico/rehabilitación , Terapia Cognitivo-Conductual/métodos , Evaluación de la Discapacidad , Terapia por Ejercicio/métodos , Dolor de Cuello/rehabilitación , Calidad de Vida , Adulto , Anciano , Dolor Crónico/diagnóstico , Terapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Dolor de Cuello/diagnóstico , Dimensión del Dolor , Grupo de Atención al Paciente/organización & administración , Centros de Rehabilitación , Medición de Riesgo , Análisis y Desempeño de Tareas , Factores de Tiempo , Resultado del Tratamiento
16.
J Can Chiropr Assoc ; 60(2): 137-45, 2016 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-27385833

RESUMEN

OBJECTIVE: To investigate the summative effect of two consecutive spinal manipulative therapy (SMT) interventions within the same session on the pain pressure sensitivity of neurosegmentally linked myofascial tissues. METHODS: 26 participants were recruited and assessed for the presence of a clinically identifiable myofascial trigger point in the right infraspinatus muscle. Participants were randomly assigned to test or control group. Test group received two consecutive real cervical SMT interventions to C5-C6 segment while controls received one real SMT followed by one validated sham SMT intervention to C5-C6 segment. Participants received the two consecutive SMT interventions 30 minutes apart. Pain pressure threshold (PPT) readings were recorded at pre-SMT1 and 5, 10, 15, 20 and 25 minutes post-SMT1 and post-SMT2. PPT readings were normalized to pre-SMT1 values and averaged. RESULTS: Repeated measures ANOVA demonstrated a significant main effect of SMT intervention [F(1,24)=8.60, p<0.05] but not group [F(1.24)=0.01] (p=0.91). Post-hoc comparisons demonstrated a statistically significant (p<0.05) increase in SMT2 versus SMT1 (18%) in the test group but not in controls (4%) (p=0.82). CONCLUSIONS: Two consecutive SMT interventions evoke significant decreases in mechanical pressure sensitivity (increased PPT) within neurosegmentally linked myofascial tissues. The antinociceptive effects of SMT may be summative and governed by a dose-response relationship in myofascial tissues.


OBJECTIF: Étudier l'effet sommatif de deux interventions consécutives de manipulation vertébrale (MV) dans la même session sur la sensibilité à la pression douloureuse des tissus myofasciaux liés par des neurosegments. MÉTHODOLOGIE: 26 participants ont été recrutés, chez qui on a étudié la présence d'un point de déclenchement myofascial cliniquement identifiable dans le muscle infraépineux droit. Les participants ont été répartis au hasard au groupe expérimental ou au groupe témoin. Le groupe expérimental a subi deux interventions consécutives réelles de MV cervicales au niveau de C5­C6, tandis que le groupe témoin a subi une MV réelle suivie d'une manipulation factice confirmée, au niveau de C5­C6. Les participants ont subi les deux interventions consécutives de MV à un intervalle de 30 minutes. Les seuils de pression douloureuse (PPT) ont été enregistrés avant les MV-1 et 5, 10, 15, 20 et 25 minutes après la MV-1 et après la MV-2. Les PPT ont été normalisés et ramenés à la moyenne, sur les valeurs pré-MV-1. RÉSULTATS: Les mesures répétées ANOVA ont montré un effet principal significatif de l'intervention MV [F (1,24) = 8,60, p <0,05], mais pas du groupe [F (1,24) = 0,01] (p = 0,91). Des comparaisons subséquentes ont montré une augmentation statistiquement significative (p <0,05) dans MV-2 par rapport au MV-1 (18 %) chez le groupe expérimental, mais pas chez le groupe témoin (4 %) (p = 0,82). CONCLUSIONS: Deux interventions consécutives de MV évoquent une diminution significative de la sensibilité à la pression mécanique (augmentation de la PPT) dans les tissus myofasciaux liés par des neurosegments. Les effets antinociceptifs de la MV peuvent être sommatifs et régis par une relation de « réponse à la dose ¼ dans les tissus myofasciaux.

17.
J Manipulative Physiol Ther ; 39(6): 393-400, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27346859

RESUMEN

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.


Asunto(s)
Ciclo Menstrual , Rango del Movimiento Articular , Adulto , Vértebras Cervicales , Estudios Transversales , Femenino , Humanos , Cuello
18.
PLoS One ; 11(4): e0153606, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27078854

RESUMEN

This cross-sectional clinical study was designed to explore the relationships between family functioning, coping styles, and neck pain and neck disability. It was hypothesized that better family functioning and more effective coping styles would be associated with less pain and pain-related disability. It also was hypothesized that these relationships would be stronger in older people because they have fewer resources, more limited coping styles, and may depend more on their family for support. In this study, 88 women with chronic non-traumatic neck pain completed the Family Assessment Measure (FAM), Coping Inventory for Stressful Situations (CISS), Neck Disability Index (NDI), and a Visual-Analogue Scale (VAS) measuring the subjective intensity of neck pain. Zero-order and partial correlations and hierarchical stepwise regression were performed. CISS was not correlated with the NDI orVAS. Good family functioning was correlated with lower NDI and VAS scores. Age was found to moderate the relationship between the FAM and both NDI and VAS. This relationship was significant and positive in older patients, but non-significant in younger patients. It was concluded that better family functioning is associated with lower neck disability and pain intensity, especially in the case of older women suffering from non-traumatic neck pain.


Asunto(s)
Adaptación Psicológica , Personas con Discapacidad/psicología , Relaciones Familiares/psicología , Dolor de Cuello/psicología , Estrés Psicológico/psicología , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Estudios Transversales , Evaluación de la Discapacidad , Femenino , Humanos , Persona de Mediana Edad , Dolor de Cuello/fisiopatología , Dimensión del Dolor , Análisis de Regresión , Estrés Psicológico/fisiopatología , Encuestas y Cuestionarios , Adulto Joven
19.
J Manipulative Physiol Ther ; 38(9): 637-643, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26548737

RESUMEN

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.


Asunto(s)
Acupresión , Manipulación Quiropráctica , Cefalea Postraumática/terapia , Cefalea de Tipo Tensional/terapia , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Método Simple Ciego , Adulto Joven
20.
J Can Chiropr Assoc ; 59(3): 288-93, 2015 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-26500363

RESUMEN

OBJECTIVES: Modify the Tampa Scale for Kinesiophobia (TSK) for 'fear of passive motion' beliefs. METHODS: With permission, a 14-item modification, the TSK-PM (passive movement), was created. Test-retest reliability was tested first. Construct validity was tested in chronic whiplash patients by comparing the TSK-PM with the TSK, the Neck Disability Index (NDI) and cervical ranges of motion. RESULTS: The TSK-PM showed high test-retest reliability (r = 0.83) and high correlation with the original TSK (r = 0.84). Low, non-significant correlations were found with other variables. NDI scores were strongly correlated with ranges of motion. CONCLUSIONS: While having high test-retest reliability and a single factor structure, the TSK-PM failed to demonstrate distinctive construct validity vs the original TSK. The original TSK is likely to be sufficient to assess fear of being moved in neck pain patients in a clinical setting. Modifications to the current version of the TSK-PM might improve its construct validity in future studies.


OBJECTIFS: Modifier l'échelle de Tampa (TSK) pour l'évaluation de l'indice de kinésiophobie pour définir la « crainte du mouvement passif ¼. MÉTHODOLOGIE: Un questionnaire TSK-MP (mouvements passifs) a été créé en modifiant 14 points de la TSK avec permission. Tout d'abord, on a évalué la fiabilité de test-retest. La validité conceptuelle a été testée chez des patients souffrant d'entorse cervicale chronique en comparant le TSK-MP avec la TSK, l'indice d'incapacité cervicale (NDI) et les amplitudes de mouvement cervical. RÉSULTATS: Le TSK-MP a montré une grande fiabilité test-retest (r = 0,83) et une forte corrélation avec la TSK originale (r = 0,84). On a observé de faibles corrélations non significatives avec d'autres variables. Les résultats de l'indice d'incapacité cervicale étaient fortement corrélés avec les amplitudes de mouvement. CONCLUSIONS: Tout en ayant une haute fiabilité test-retest et une structure à un seul facteur, le TSK-MP n'a pas démontré une validité conceptuelle distincte par rapport à la TSK originale. La TSK originale est probablement suffisante pour évaluer la crainte d'être déplacé chez les patients atteints de douleurs cervicales dans un cadre clinique. Les modifications apportées à la version actuelle du TSK-MP pourraient améliorer sa validité conceptuelle dans des études futures.

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