Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 2—The Patient Assessment for Low Back Pain–Impacts (PAL-I)

Bushnell, Donald M.; Blum, Steven I.; Liedgens, Hiltrud; Martin, Mona L.; Freynhagen, Rainer; Wallace, Mark; Argoff, Charles E.; Eerdekens, Mariёlle; Kok, Maurits; Patrick, Donald L.

doi:10.1097/j.pain.0000000000001309

Cited by 7 publications

(4 citation statements)

References 18 publications

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“…In addition, the reported health transition (HT) is included. (4) Overall improvement as measured by the short-form McGill pain questionnaire (SF-MPQ) or symptom scale based on the Clinical Study Guideline for New Developed Chinese Medicine ( 29 – 31 ). The questionnaire can be used to assess the pain performance of patients with lower back pain, including the Pain Rating Index (PRI) calculated from the SF-MPQ scale where the PRI is the sum of sensory item scores and emotional item scores; the Visual Analog Scale (VAS) ( 27 , 32 ); and the Present pain intensity (PPI).…”

Section: Methodsmentioning

confidence: 99%

Efficacy of electro-acupuncture in postpartum with diastasis recti abdominis: A randomized controlled clinical trial

Liu

Zhu

Jiang

et al. 2022

Front. Public Health

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BackgroundElectro-acupuncture (EA) has promising effects on diastasis rectus abdominis (DRA), defined as a separation of the two muscle bellies of rectus abdominis. To study, there is scant knowledge or scarce high-quality evidence.ObjectiveWe aimed to evaluate the long-term efficacy and safety of EA in treating DRA during postpartum. It was assumed that the improvement of DRA was more obvious in the EA group than in the control group.DesignRandomized, controlled, blinded trial (Clinical Trial Registration: ChiCTR2100041891).SettingHangzhou Hospital of Traditional Chinese Medicine in China.ParticipantsFemales aged 20–45 years without a past medical history of pathological rectus abdominal dissection were recruited from DRA inclusion criteria from 42 days to 1 year postpartum.Intervention110 participants were randomly assigned in a 1:1 ratio to a control group with no EA intervention (n = 55), and EA group (n = 55). The EA group received ten sessions of EA combined with physical exercise or only physical exercise over 2 weeks with a 26-week follow-up after treatment.MeasurementsOutcomes were assessed at baseline, week 2, and week 26. The primary outcome was the change of the inter recti distance (IRD) and electromyographic evaluation of the pelvic floor. Secondary outcomes included elasticity of linea alba (LA), paraumbilical subcutaneous adipose tissue (SAT) measurement, body mass index (BMI), percentage body fat (F%), dyspepsia symptoms, menstrual symptoms, quality of life (QoL), pain performance of patients with lower back pain, postnatal depression symptoms (PDS), postpartum self-image, and DRA-related symptom assessment including urine leakage, frequency, and urgency, constipation, sexual dysfunction, and chronic pelvic pain.ResultsA total of 110 maternal (55 in each group) were recruited. The mean difference in IRD from baseline to week 2 and week 26 in all states of the two groups were reduced compared with those before treatment, with statistical significance (P < 0.05). The mean of IRD at the horizontal line of the umbilicus in the end-expiratory state was smaller in the EA group than in the control group, but the difference was not statistically significant (P > 0.05) at week 2. The mean of IRD at the horizontal line of the umbilicus in head-up and flexed knee state was smaller in the EA group than in the control group, and the difference was statistically significant (P < 0.05) at week 26. Five (9.1%) and thirteen (23.64%) adverse events were reported in EA and control groups, respectively. No serious adverse events were reported.LimitationThe frequency intensity of EA parameters was selected between 4 and 6 because of individual tolerance differences.ConclusionEA is an effective approach to improve IRD, electromyographic evaluation of the pelvic floor, BMI, the elasticity of LA, paraumbilical SAT, and symptoms of DRA, with durable effects at 26 weeks after treatment.Primary funding sourceThe Construction Fund of Medical Key Disciplines of Hangzhou (Project Number: OO20200097), Hangzhou Medical and Health Science and Technology Project No. A20200483, and Zhejiang Traditional Chinese Medicine Science and Technology Plan Project (Project Number: 2021ZQ065).Clinical trial registrationhttp://www.chictr.org.cn/index.aspx, identifier: ChiCTR2100041891.

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Section: Methodsmentioning

confidence: 99%

Efficacy of electro-acupuncture in postpartum with diastasis recti abdominis: A randomized controlled clinical trial

Liu

Zhu

Jiang

et al. 2022

Front. Public Health

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“…The mean score for all assessed items (excluding withdrawal items) is a single overall assessment of the effect of pain on quality of life. PAL-I has demonstrated validity and potential utility for evaluating the efficacy of treating chronic BP in clinical trials [70]. In a multicenter observational study by Bushnell et al (2020) he also showed very robust estimates with substantial evidence of validity [71].…”

Section: Patient Assessment For Low Back Pain-impacts (Pal-i)mentioning

confidence: 99%

“…Its versatility, along with high specificity, gives PAL-I an advantage in research in a variety of chronic BP populations. In addition, PAL-I is currently the only tool for the subjective assessment of the effectiveness of drug therapy by a patient that fully complies with the recommendations of the US Food and Drug Administration (FDA) [70].…”

Section: Patient Assessment For Low Back Pain-impacts (Pal-i)mentioning

confidence: 99%

Application of Patient-Reported Outcomes in Back Pain in Adults: Part 1

Trefilova¹,

Shnayder

Novitsky³

et al. 2022

jour

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The aim of the research is generalization of information about the most common foreign and domestic scales and questionnaires used in acute and chronic back pain (BP). The analysis of Russian-language and foreign literature was carried out with a search depth of 5 years (2016–2021) in the following databases: e-Library, PubMed, Oxford Press, Clinical Keys, Springer, Elsevier, Google Scholar. For the diagnosis of acute and chronic BP and the assessment of the characteristics of its course in dynamics, both a standardized study may be use: collection of complaints, anamnesis, objective examination, assessment of neurological status, as well as valid scales and questionnaires. For the timely diagnosis and monitoring of the development of BP in patients, a wide range of scales and questionnaires were proposed, which were conventionally ranked into 4 groups: scales for assessing the quality of life of patients with BP; scales for assessing the characteristics of pain in BP; scales for assessing the outcomes of the disease in BP; scales for assessing disability in BP. The first part of the thematic review presents an analysis of the advantages and disadvantages of scales for assessing the quality of life of patients with BP. These perspective scales for assessing the quality of life of patients with BP are popular in the world neurological practice. It is necessary to adapt to the use in domestic clinical practice the Stratford Functional Back Pain Scale, the Index of Disability Associated with Pain, The Patient Assessment for Low Back Pain–Impacts.

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“…It also causes a huge economic loss ranging from 12.2 billion to 90.6 billion ( 6 ). In addition to pain and impaired function, CLBP limits leisure activities, social activities, and public engagements as well ( 10 ). Pain could negatively impact social relationships, such as poor relationships between children and peers ( 11 ) and reduced marital satisfaction between partners ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

Association of Chronic Low Back Pain With Personal Space Regulation

et al. 2021

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Background: While most previous studies regarding patients with chronic low back pain (CLBP) mainly focused on pain, disability, psychological damage, and intervention measures, the effect of CLBP on personal space remains unclear. The study aimed to assess the personal space of patients with CLBP and healthy controls, explored the differences between the two groups, and examined whether pain, dysfunction, anxiety, and depression affected the personal space regulation.Methods: The cross-sectional study recruited 24 patients with CLBP and 24 healthy controls at Shanghai Shangti Orthopedic Hospital and Shanghai University of Sport, Shanghai, China, from December 2018 to January 2019. A stop-distance paradigm was applied to measure the comfortable and uncomfortable distance under four conditions. A self-rating anxiety scale (SAS) and a self-rating depression scale (SDS) were used to examine the anxiety and depression levels of all participants. The pain intensity and dysfunction in the CLBP group were evaluated by the numeric rating scale and Roland-Morris questionnaire (RMDQ), respectively.Results: When approaching another individual or when being approached, the interpersonal distance under all the conditions in the CLBP group significantly differed from that in the healthy control group with larger space distances (p < 0.01). Gender had a significant main effect on the regulation of personal space in patients with CLBP (p < 0.05). The average pain intensity, scores on RMDQ, SAS, and SDS had a significant positive correlation with the interpersonal distance under the Same or Opposite Gender condition (p < 0.05).Conclusion: People with CLBP show an atypical personal space behavior and indeed have a greater interpersonal distance to strangers. The higher the pain intensity, dysfunction, anxiety, and depression, the greater the interpersonal distance in patients with CLBP. In the future, the effect and underlying neural mechanisms of pain and negative emotions on social withdrawal in patients should be examined.

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Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 2—The Patient Assessment for Low Back Pain–Impacts (PAL-I)

Abstract: The Patient Assessment for Low Back Pain–Impacts is a newly developed patient-reported outcome instrument to assess specific impacts of chronic low back pain for use in clinical trials and practice.

Cited by 7 publications

References 18 publications

Efficacy of electro-acupuncture in postpartum with diastasis recti abdominis: A randomized controlled clinical trial

Efficacy of electro-acupuncture in postpartum with diastasis recti abdominis: A randomized controlled clinical trial

Application of Patient-Reported Outcomes in Back Pain in Adults: Part 1

Association of Chronic Low Back Pain With Personal Space Regulation

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