Benefits and harms of treatments for chronic nonspecific low back pain without radiculopathy: systematic review and meta-analysis.

BACKGROUND CONTEXT: Currently, there are no published studies that compare nonpharmacological, pharmacological and invasive treatments for chronic low back pain in adults and provide summary statistics for benefits and harms. PURPOSE: The aim of this review was to compare the benefits and harms of treatments for the management of chronic low back pain without radiculopathy and to report the findings in a format that facilitates direct comparison (Benefit-Harm Scale: level 1 to 7). DESIGN: Systematic review and meta-analysis of randomized controlled trials, including trial registries, from electronic databases up to 23rd May 2022. PATIENT SAMPLE: Adults with chronic nonspecific low back pain, excluding radicular pain, in any clinical setting. OUTCOME MEASURES: Comparison of pain at immediate-term (≤2 weeks) and short-term (>2 weeks to ≤12 weeks) and serious adverse events using the Benefit-Harm Scale (level 1 to 7). METHODS: This was a registered systematic review and meta-analysis of randomized controlled trials. Interventions included nonpharmacological (acupuncture, spinal manipulation), pharmacological and invasive treatments compared to placebo. Best evidence criteria was used. Two independent reviewers conducted eligibility assessment, data extraction and quality appraisal. RESULTS: The search retrieved 17,362 records. Three studies provided data on the benefits of interventions, and 30 provided data on harms. Studies included interventions of acupuncture (n=8); manipulation (n=2); pharmacological therapies (n=9), including NSAIDs and opioid analgesics; surgery (n=8); and epidural corticosteroid injections (n=3). Acupuncture (standardized mean difference (SMD) -0.51, 95%CI -0.88 to -0.14, n=1 trial, moderate quality of evidence, benefit rating of 3) and manipulation (SMD -0.39, 95%CI -0.56 to -0.21, n=2 trials, moderate quality of evidence, benefit rating of 5) were effective in reducing pain intensity compared to sham. The benefit of the other interventions was scored as uncertain due to not being effective, statistical heterogeneity preventing pooling of effect sizes, or the absence of relevant trials. The harms level warnings were at the lowest (eg, indicating rarer risk of events) for acupuncture, spinal manipulation, NSAIDs, combination ingredient opioids, and steroid injections, while they were higher for single ingredient opioid analgesics (level 4) and surgery (level 6). CONCLUSIONS: There is uncertainty about the benefits and harms of all the interventions reviewed due to the lack of trials conducted in patients with chronic nonspecific low back pain without radiculopathy. From the limited trials conducted, nonpharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive interventions. However, more research is needed. There were high harms ratings for opioids and surgery.

The Spanish Version of the Functional Rating Index in Patients With Low Back Pain: Preliminary Results of the Validation Study.

OBJECTIVE: To assess the reliability, validity, and the psychometric properties of the Spanish version of the Functional Rating Index (Sp-FRI) in a preliminary cohort of patients with low back pain (LBP). DESIGN: Prospective observational multicenter study. SETTING: Outpatient physical therapy clinics and units from public and private settings. PARTICIPANTS: Patients with LBP (N=22; 52.5±12.5y) entered the study. INTERVENTIONS: The translation and cross-cultural adaptation were performed following international guidelines through a 5-step procedure. MAIN OUTCOME MEASURES: The Sp-FRI was administered along with the Spanish version of Roland-Morris Disability Questionnaire (Sp-RMDQ) and numeric pain rating scale (NPRS) index. Preliminary testing included readability, comprehensibility, ceiling and floor effects, reliability, and validity. Statistical analysis was based on the Fernandez-Huerta index, and the calculation of Cronbach alpha, intraclass correlation coefficient (ICC), and Spearmans correlation coefficient, respectively. All patients completed the Sp-FRI again after 1-2 days to assess its test-retest reliability. RESULTS: None of the participants requested clarification of any of the items at the time of completion. The test-retest reliability of the FRI score was substantial (ICC 0.77). Cronbach alpha was 0.859. Spearman correlation coefficient between Sp-FRI and Sp-RMDQ was 0.66; P<.0001, and between Sp-FRI and NPRS was 0.66; P<.0001. No ceiling or floor effects were detected. CONCLUSIONS: In light of these preliminary data, the Sp-FRI appears to be linguistically accurate and has been adapted to the Spanish-speaking population. It demonstrated reliability and validity and is suitable for clinical and research use among Spanish patients with LBP, with an acceptable degree of internal consistency and concurrent validity.

Validation of the functional rating index for the assessment of athletes with neck pain.

AIM: To validate the culturally-adapted Persian Functional Rating Index (PFRI) for assessing neck pain (NP) in athletes. METHODS: In this cross-sectional study, 100 athletes with NP and 50 healthy athletes participated and responded to the PFRI. Fifty athletes with NP completed the PFRI for at least 7 d later to establish test-retest reliability. RESULTS: The athletes with NP responded to all items, indicating excellent clinical utility. No floor and ceiling effects were found, indicating content validity and responsiveness. The PFRI revealed capability to discriminate between the athletes with NP and healthy athletes. The PFRI demonstrated strong correlation with the Numerical Rating Scale (Spearman's rho = 0.94), and the Persian Neck Disability Index (Pearson r = 0.995), supporting criterion and construct validity. Internal consistency reliability was high (Cronbach's α coefficient: 0.97). The test-retest reliability was excellent (ICCagreement = 0.96). The absolute reliability values of standard error of measurement and smallest detectable change were 3.2 and 8.84, respectively. An exploratory factor analysis yielded one factor explaining 78.03% of the total variance. CONCLUSION: The PFRI is a valid and reliable measure of functional status in athletes with NP.

The functional rating index: reliability and validity of the Persian language version in patients with neck pain.

STUDY DESIGN: Psychometric testing of the Persian Functional Rating Index (PFRI). OBJECTIVE: To determine the reliability and validity of the PFRI in Persian-speaking subjects with neck pain (NP). SUMMARY OF BACKGROUND DATA: The Functional Rating Index is a self-report questionnaire that can be used for patients with back pain or NP. The PFRI has been recently validated in patients with low back pain, whereas it is not validated in patients with NP. METHODS: One hundred patients with NP, mean age of 42 years, participated in the study; 50 patients agreed to be tested on 2 occasions during a 7-day interval for the reliability phase of the study. A visual analogue scale, the Neck Disability Index, and the Neck Pain and Disability Scale were also completed to assess validity. Fifty healthy subjects completed the PFRI for discriminative validity. RESULTS: Floor and ceiling effects were not observed. Independent t test showed a statistically significant difference in PFRI total scores between patients and healthy subjects supporting the discriminative validity of the PFRI (P < 0.001). PFRI and visual analogue scale demonstrated concurrent criterion validity, with Pearson correlation coefficients of 0.75 for test and 0.70 for retest. Construct validity was supported by a significant Pearson correlation between the PFRI and the Neck Disability Index (r = 0.72, P < 0.0001) and between the PFRI and the Neck Pain and Disability Scale (r = 0.63, P < 0.0001). Factor analysis revealed a 2-factor solution, which jointly accounted for 64.75% of the total variance. Additional factor analysis suggested 8-item PFRI as a unidimensional functional instrument for patients with NP. Internal consistency for the PFRI was high. (Cronbach α coefficients were 0.88 for test, 0.89 for retest, and 0.89 for 8-item PFRI.) Reproducibility assessed by test-retest reliability was excellent (intraclass correlation coefficient [ICC](agreement) of 0.96, P < 0.0001). CONCLUSION: The PFRI is valid and reliable for use in a Persian-speaking population with NP.

The functional rating index: reliability and validity of the Persian language version in patients with low back pain.

STUDY DESIGN: Crosscultural adaptation and psychometric measurements of the Functional Rating Index (FRI). OBJECTIVE: To develop and investigate the reliability and validity of the Persian version of the FRI when applied to patients with low back pain (LBP). SUMMARY OF BACKGROUND DATA: The FRI is a self-report questionnaire designed to assess patient's perception of function and pain. Despite the use of this outcome measure in clinical trials in Iran, it was not translated and culturally adapted. METHODS: The FRI was translated into Persian language and crossculturally adapted. The Persian FRI was administered to 100 patients with LBP (male patients/female patients = 22/78). A numerical rating scale, the Roland-Morris Disability Questionnaire, the Oswestry Disability Questionnaire, and the Quebec Back Pain Disability Scale were also recorded. The test-retest reliability (time interval = 7 days) was assessed in 50 patients. RESULTS: There were no missing responses and floor or ceiling effects. The examination of discriminative validity showed that the questionnaire discriminated clearly between patients and healthy participants (P < 0.001). The concurrent criterion validity was confirmed by the Spearman rank correlation between the Persian FRI and the numerical rating scale (0.73, P < 0.0001 for test; and 0.77 for retest, P < 0.0001). Evidence for construct validity was found with a significant Pearson correlation between the FRI and the Roland-Morris Disability Questionnaire (r = 0.61; P < 0.0001), the Oswestry Disability Questionnaire (r = 0.75; P < 0.0001), or Quebec Back Pain Disability Scale (r = 0.76; P < 0.0001). Internal consistency reliability estimates (Cronbach α) for the Persian FRI were high, with 0.89 for test and 0.92 for retest. The test-retest reliability for the total score was excellent with an intraclass correlation coefficient (agreement) (ICCagreement) of 0.81 (P < 0.0001). CONCLUSION: The Persian version of the FRI seems to have an excellent reliability and validity when applied to patients with LBP.

Functional Rating Index: literature review.

UNLABELLED: In 1999, a new self-report outcome measure, the Functional Rating Index (FRI), was developed and tested. This measure demonstrated reasonable reliability, validity and responsiveness. Since the publication of the original testing, numerous independent research teams have examined the psychometric qualities of the FRI and published their findings. The aim of this study is to review the psychometric properties of the FRI as reported by published studies. Researchers independently searched the literature for relevant studies using MEDLINE and Index to Chiropractic Literature from January 2001 to August 2009. Descriptive and outcome data was extracted using standardized forms. The psychometric properties of the FRI were analyzed with established criteria and compared head-to-head with other outcome measures. The search yielded ten studies that provided psychometric data. Reliability: Test-retest: Intraclass correlation coefficient and Cronbach's alpha were good, and FRI is equivalent to the other measures. VALIDITY: the FRI has good convergent validity with pain and function self-report scales and a weaker correlation with items that measure different constructs. Responsiveness: FRI was similar to the comparative measures for standardized response mean, effect size and receiver operating curve statistics. Patient acceptability: time required by the patient and staff averaged 78 seconds per administration, and there were few missing responses. The FRI demonstrates favorable measurement properties of reliability, validity and responsiveness. It provides an alternative to other self-report measures, because it is quicker for a patient to complete and can be used for patients with neck and back pain.

Chiropractic manipulation in adolescent idiopathic scoliosis: a pilot study.

BACKGROUND: Adolescent idiopathic scoliosis (AIS) remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. METHODS: Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment), two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. RESULTS: Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. CONCLUSION: Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. TRIAL REGISTRATION: This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. http://www.controlled-trials.com/isrctn/. The number is ISRCTN41221647.

Effectiveness of an evidence-based chiropractic continuing education workshop on participant knowledge of evidence-based health care.

BACKGROUND: Chiropractors must continue to learn, develop themselves professionally throughout their careers, and become self-directed and lifelong learners. Using an evidence-based approach increases the probability of optimal patient outcomes. But most chiropractors lack knowledge and interest in evidence-based approaches. The purpose of this study was to develop and measure the effectiveness of evidence-based training for chiropractic practitioners in a continuing education setting. METHODS: We developed and evaluated a continuing education workshop on evidence-based principles and methods for chiropractic practitioners. Forty-seven chiropractors participated in the training and testing. The course consisted of 12.5 hours of training in which practitioners learned to develop focused questions, search electronic data bases, critically review articles and apply information from the literature to specific clinical questions. Following the workshop, we assessed the program performance through the use of knowledge testing and anonymous presentation quality surveys. RESULTS: Eighty-five percent of the participants completed all of the test, survey and data collection items. Pretest knowledge scores (15-item test) were low (47%). Post intervention scores (15-item test) improved with an effect size of 2.0. A 59-item knowledge posttest yielded very good results (mean score 88%). The quality of presentation was rated very good, and most participants (90%) would "definitely recommend" or "recommend" the workshop to a colleague. CONCLUSION: The results of the study suggest that the continuing education course was effective in enhancing knowledge in the evidence-based approach and that the presentation was well accepted.

Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis.

STUDY DESIGN: A prospective cross-sectional design was used to evaluate the Scoliosis Quality of Life Index (SQLI). SQLI is a 22-item self-reporting health-related quality-of-life questionnaire for idiopathic scoliosis patients. OBJECTIVE: The goal of this study was to evaluate the psychometric qualities of SQLI. SUMMARY OF BACKGROUND DATA: SQLI, a modification of the Scoliosis Research Society-22 (SRS-22) questionnaire, is intended to be more applicable to patients with adolescent idiopathic scoliosis (AIS) between 10 and 18 years of age. METHODS: Eighty-four subjects with a mean age of 14.9 years participated. We determined reliability, validity, distribution of scores, and clinical utility of SQLI in a hospital setting. Seventy patients were AIS patients (16 postsurgical, 30 braced, 24 unbraced) with a mean Cobb angle of 30.7 degrees, and 14 patients were sibling controls. RESULTS: Reliability: Intraclass correlation coefficient for test-retest reliability of the global index was very good (ICC 2,1 = 0.80); Spearman's rho correlations between items and domains was 0.39 to 0.89 and between domains and global index was 0.55 to 0.78; Cronbach's alpha scores were more than 0.80 (0.82-0.89). VALIDITY: construct validity was established by correlations between SQLI's global index and Quality of Life Profile for Spine Deformities (QLPSD) global index (Spearman's rho, 0.79) and between SQLI domains and QLPSD domains (0.46-0.81); discriminate validity was established by SQLI's global index successfully partitioned controls and AIS subjects (Kruskal-Wallis test, P = 0.0013). Time required by the patient averaged 2.5 minutes per administration. CONCLUSIONS: SQLI is reliable and valid and demonstrates satisfactory distribution of scores. SQLI is a promising instrument in the assessment of AIS patients.

Do multiple outcome measures require p-value adjustment?

BACKGROUND: Readers may question the interpretation of findings in clinical trials when multiple outcome measures are used without adjustment of the p-value. This question arises because of the increased risk of Type I errors (findings of false "significance") when multiple simultaneous hypotheses are tested at set p-values. The primary aim of this study was to estimate the need to make appropriate p-value adjustments in clinical trials to compensate for a possible increased risk in committing Type I errors when multiple outcome measures are used. DISCUSSION: The classicists believe that the chance of finding at least one test statistically significant due to chance and incorrectly declaring a difference increases as the number of comparisons increases. The rationalists have the following objections to that theory: 1) P-value adjustments are calculated based on how many tests are to be considered, and that number has been defined arbitrarily and variably; 2) P-value adjustments reduce the chance of making type I errors, but they increase the chance of making type II errors or needing to increase the sample size. SUMMARY: Readers should balance a study's statistical significance with the magnitude of effect, the quality of the study and with findings from other studies. Researchers facing multiple outcome measures might want to either select a primary outcome measure or use a global assessment measure, rather than adjusting the p-value.